Dr. Stuart Grant, founder of Archetype Medtech, shares his journey designing and delivering breakthrough orthopedic and surgical innovations across the UK, US, and China. Stuart recounts how an early internship led him into medtech, what kept him there, and how building the ASPAC Innovation Center in China helped accelerate a total knee instrument system that dramatically reduced time to market. He explains the leap from corporate leader to entrepreneur: planning for years, earning a PhD in Medtech Product Innovation, and building a consultancy that helps startups and scale-ups turn early clinical unmet needs into market-ready, regulator-approved devices through a network of experts and an “expertise for equity” model. 

Guest links: https://archetype-medtech.com/ 

Charity supported: Sleep in Heavenly Peace

Interested in being a guest on the show or have feedback to share? Email us at [email protected]. 

EPISODE TRANSCRIPT

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello, and welcome back to another episode of the Leading Difference podcast. I'm your host Lindsey, and today I'm delighted to welcome Dr. Stuart Grant. Dr. Grant is a chartered engineer and the founder of Archetype Medtech, a consultancy and innovation studio helping medical device startups and scale ups transform early clinical, unmet needs into market ready products.

With nearly 25 years of experience, Stuart has led global teams across the UK, US, China, and emerging markets delivering breakthrough innovations in hip, knee, shoulder, and trauma surgery. A highlight of his career was establishing the ASPAC Innovation Center in China, where he built R&D capability from the ground up and launched a pioneering total knee instrument system that dramatically reduced time to market. Passionate about advancing medical technology and mentoring future engineers, he bridges creativity, engineering, and regulation to accelerate safer, smarter medtech innovation worldwide.

All right. Welcome to the show. It's so great to have you here today. Thanks for joining me.

[00:01:57] Stuart Grant: It's lovely to be here, Lindsey.

[00:01:58] Lindsey Dinneen: Yeah. Excellent. Well, I was wondering if you could start by sharing a little bit about yourself, your background, and what led you to medtech.

[00:02:08] Stuart Grant: Yeah. So, I was actually, I'm obviously, as you can tell from my accent, I'm British, but I was born in Germany because my, my dad was in the military in the 1970s when I was born. So I was born actually in Berlin, which is quite interesting to be a place to be, grew up in. So I traveled around a lot here in the UK, in Germany with my dad getting posted everywhere. My mom's a nurse. So I was in medtech, not really knowing I was in medtech as a kid, but I, my family was, so yeah. And then obviously went to school, all the places I was at university. I went to university to do product design, and my goal was to be a product designer, a cool product designer, designing fancy products like Johnny Ive.

And when I was looking for a job as a co-op, or an intern as you call them in the US, I was just really unsuccessful finding a job. I was doing a lot of interviews, getting turned down, sending my CV out a lot, and j happened just to advertise on the Board of University, and it said Johnson Orthopedics and no one really knew what that was in. And none of my fellow students at applied because they thought it would be designing baby bottles for putting talcum powder in and shampoo in and stuff like that.

So they're like, "I'm not doing that job." So I desperately applied for it and luckily found out about all this medtech, and I've been here doing medtech for 25 years. So they gave me a job. I had to work hard to keep the job and get reemployed over and over again. But yeah, joining originally Johnson Orthopedics a long time ago is how I found out about medtech. I never knew when I was 18 that really it was a thing that existed.

[00:03:47] Lindsey Dinneen: Yeah. So, okay. So you thought product design, and then when you got into medtech, what were some of the things that attracted you and that actually compelled you to stay and make a career out of it?

[00:04:00] Stuart Grant: Ha. So I was a young guy with the student debts. What compelled me, I was getting paid to stay, but not to be too flippant about it, but, you know, when I was doing this engineering and design work in my early days in the CAD system, it was just so interesting. I was designing these products that were going into people or the instrumentation to make help the surgeon and going to these ORs and watching the surgeon do their job and trying to figure out how how I can make it better from their input was really interesting. I could apply it straight away, basically.

In the early two thousands, there wasn't all these regulations and standards that slowed you down. So you could go and design an instrument, get it machined in the machine shop, get it clean, take it to the surgeon, he can use it, you know, probably be frowned upon 25 years later. But that's what we used to do and really adapt. And probably more interesting than going into product design and fast moving consumer goods where you're designing a, a kettle or a toaster or something, a plastic casing. It was actually much more interesting to do that.

And I stayed because I spent four years here in Leeds, in the UK, was getting a bit bored and wanted to find something else to do, and then an opportunity came up in the US. So I moved over to Warsaw, Indiana, the orthopedics capital of the world, as you might know it. Worked there for, stayed there for seven years. Really enjoyed it.. People sort of bemoan Warsaw for being in the sticks in just a bunch of cornfields around it. But I enjoyed it. It's got, we had a good bunch of young friends there. I was in late twenties, early thirties at the time. There was Noah and Spikes. You'd go for a drink and some nice food. It was all right.

I enjoyed my time and after that I was, after seven years, I was like, "Okay, what do I do next?" And I was looking around for jobs in medtech. Then another opportunity came up in and we were looking for people to go over and help set it up, train the staff on what MedTech product development was. And so I jumped to the chance and spent five years living in China, in Shanghai. After five years is your limit, so I had to come home. I couldn't stay. I wanted to stay, but they wouldn't allow me to. So, so I came back to the UK.

And then started MDR for five years as leading the Joints MDR program, which was lots of fun, as you could probably tell, wasn't really R&D, was a lot of leadership and project management and dealing with a lot of people and a lot of problems on a day-to-day basis. And so, yeah, after that I I left J&J about three years ago and started my own product development agency. And we can talk about a little bit about that later. So that's where I am and where I got to.

[00:06:50] Lindsey Dinneen: Excellent. Yeah, I definitely wanna talk about that as well. But going back a little bit-- and perhaps this is actually something that's occurred since you started your own company as well-- but are there any moments that really stand out to you along your journey of affirming that, "Hey, yeah, I actually am in the right place, in the right industry?"

[00:07:12] Stuart Grant: That's a really hard one is sort of the, is the grass always greener somewhere else, type of question. Right? I guess compare, you shouldn't compare, but comparing to my friends at my university, my product design and what they've done and what I've done they've moved into the car industry a lot. Went to the car development and car industries always had its ups and downs and its problems. And you know, they've had some really cracking jobs working for McLaren and Ferrari and you know, but I think just the interesting things that medtech do that nobody really knows about is really what keeps me moving along and having conversations with people when they, you tell them like, "I used to design hips and knees and shoulders and things like that," and they're like, "Oh, my mother's got a hip and knee" and blah, blah, and you really talk about it. Actually, my mother does have a hip now and she's going in a couple months time to get the other hip done. I do know what brand she's got, so.

[00:08:10] Lindsey Dinneen: See, that's really cool. Yeah. Okay. So, so, on your LinkedIn I noticed that you describe yourself as a fixer, a challenger, and a change maker, which I love. But I'd love to hear from you exactly what you mean by all those things as you have developed in your career, and now as you're doing, of course, your own consulting.

[00:08:34] Stuart Grant: Yeah, so in Johnson and my colleagues are probably, I agree with this, I had a bit of a reputation of getting the more difficult projects. The, that's probably why I got MDR in the end 'cause I would always get the projects that had problems and I enjoyed that. I liked digging deep and solving the problem and wrangling everyone together and pushing everybody along to help. And that was actually one of the reasons why I moved to the US 'cause the original project I moved to was the project leader left and it was in a bit of a shambles. So I went over to sort of, sort of try and get it together and just ended up staying and working on multiple projects. So I like that.

Really challenging, not just the engineering side. The engineering side is obviously really interesting, but the challenging project management and people management and process management in a big corporation, all of those things, people, product, process, all come together just to cause a big headache sometimes, you know, herding cats as say and going, trying to solve those problems as an engineer, always trying to solve these problems, right? So it's you're always trying to figure out how you can move forward.

[00:09:52] Lindsey Dinneen: Yeah. Yeah, absolutely. So, okay, so that kind of brings us to the company. So what was it like going from employee to entrepreneur? Were you, did you feel ready and prepared for that leap? Or what has that transition and pathway been for you?

[00:10:10] Stuart Grant: So I've, I was a long-term planner. I was planning for this for five years whilst I was working for Johnson. So I went and got, when I came back to the UK I started my PhD and I knew getting a PhD was a real way of building credibility immediately, right? Before you step in a room and have a conversation with you, if you've got a PhD in the subject you're about to talk about, people pay attention, hopefully. Right? So I did my, so I did my PhD in Medtech Product Innovation, what the process is. So I spent seven years part-time working for Johnson, getting my PhD, knowing that eventually in my mid forties, there'll be an inflection point, which usually isn't people in big corporations, right, that either stay to the end for until you're six, mid sixties. If you hit 50, usually stay for the next decade, right? Or you leave and do something else.

And I was like, "Okay, 45, I'm gonna pull the bandaid, go in, get my PhD, set up my own company plan, get the plan to do it, get the savings," and so I was working on MDR and a new MDR was coming to an end, and then they'd have to find me a new project, which probably didn't exist. So I also knew that J&J would be like, "Ah, Stuart, you've been here for 23 years. There's not really anything of your level here." I'd be like, "Great, let's go." So this was all a, you always it's a big step, right? I have a family. I can't just sort of walk in, not come in the office anymore. So it was a big plan that my wife and I had for quite a number of years to execute. So it's still a struggle. I've been doing it for three years. It's still hard work, still building the company, finding clients, understanding what their pain points are and improving your picture and all those other things, still is still a challenge, but it's a new challenge.

[00:12:06] Lindsey Dinneen: Yeah.

[00:12:07] Stuart Grant: And as I say, as I said, when people worry about the risk, it's like I can easily just go and get a corporate job again as a move back and have all this new relevant experience. So it's a risk, but you have to balance that by the benefits.

[00:12:21] Lindsey Dinneen: Yeah, calculated risk that you've planned for, so good for you. So, okay, so tell us a little bit about your company now and who you help and kind of where in the development or even ideation process that you can come in and really make a difference.

[00:12:40] Stuart Grant: So, yeah, so Archetype MedTech is a product development, product innovation agency. And what we do, we usually work with startups or scale ups. Startup side, they'll have a proof of concept. They've already defined the unmet clinical need. They've sort of wrangled the technology and validated the actual technology does what it they're trying to make it do, but they just dunno how to make this a medical device product, right? They've they've got the technology, but they dunno how the product make a product that's sellable is releasable and it gets approved by FDA or here in the, i'll say here in the EU, I know I said in the UK, but MDR and I help them work out that product innovation strategy.

So take them all through either they need to do the frontend innovation and understand their needs and the insights and the business case, and then the engineering requirements and specifications. The design and engineering part I help them with, and this is not just me. I have a network of experts, a sort of consortium of experts that come together and bring all these different specialties and then we help them with the testing, what testing they need to do, their risk management, usability, all that fun stuff. And then contact and help them work with the manufacturers. So contract manufacturers, then their regulatory approval.

So really what we try to do is, 'cause we're bringing all this expertise as a group of people together, the entrepreneur, usually a salesman or surgeon at this point, who may be a university spin out, can spend a lot of time and money trying to find these experts, trying to find these resources, trying to understand the product development, the MedTech product development process, which is all written down in various books, but when you get down to the details, it gets really complicated. So what we do is help them go through that as fast and as efficiently as a possible, so they're not wasting capital fishing around for those experts. We already have that network of experts that we can bring in and take them through the process as quickly as possible.

So that's what Archetype Medtech do for our clients. And has been successful. We have quite a number of clients, mostly in orthopedics and surgical 'cause that's my specialty in medtech. And what we also do, we just don't want to be a management consultancy firm. Well, we do if it's right, we share what we call expertise for equity. So we'll take some equity from the company, but we'll cut our day rates or maybe do it for free, do and help them go through the process as quickly as possible. That means we've got skin in the game, right? We're not just taking their money and going, "Great. This is great. Good luck on the commercialization. Not our problem."

[00:15:29] Lindsey Dinneen: Right.

[00:15:30] Stuart Grant: It is our problem. 'cause we want a return on our risk and our investment as well. So, yeah, that's what we try to do. And along with that we do a load of pro bono work with surgeons in the NHS who have had ideas. We help them just get their idea a bit further along so they can start looking for funding and investment, and I can share that with you later 'cause it's a really important program that the NHS run it. If there's any mentors out there that want to get involved I can point them in the right direction.

[00:16:00] Lindsey Dinneen: Actually that's fantastic and I would love to hear a little bit more about the organization and yeah, how people can get involved and help and what do they all do.

[00:16:10] Stuart Grant: Yeah. So the NHS have set up this called NHS Clinical Entrepreneurs Program. This is not my company. This is a completely separate organization. And what it is, clinicians, anybody who works in the NHS-- you know NHS is a 1.6 million people who are employed in the NHS. It's a massive company organization. They come up with clinical needs 'cause they're in the problem and they start working out how they solve it, even through medical device or health tech or an app or anything, right? And they can go into this, it is basically the equivalent of an accelerator program over about nine months. And we have mentors like myself who work with those clinicians to help them develop their idea.

So I've got a couple of clinicians that I work with. One is developing a neurosurgical device for helping him cut out tumors in the brain. At the moment, they use two tools. They use a scalpel and a cordy, a bipolar cordy, and they're very basic tools. And what he has to do, he's under a microscope, and he has to swap these one by one, does this scalpel to cut the vascularization of the tumor. Then he has to seal it. And he has to pass the nurse has to pass in these tools and he can't see a, see the nurse passing him. So he is like, "Can I develop a tool that's in one a scalpel and a bipolar" so he doesn't have to keep changing the tool in his hand? And you can know by the cognitive load and changing that tool in the field that these surgeries take eight to 12 hours to cut out a tumor from the brain. So he's saying every, he swaps his tool about 200 times and it takes three seconds. So you can start doing the maths.

[00:17:59] Lindsey Dinneen: Yeah.

[00:18:01] Stuart Grant: Yeah. And then the other, so the other is a doctor, actually, the doc is a neonatal doctor and he's trying to develop a langoscope for neonatal babies. The langoscopes at the moment haven't really improved in the last 60 years. The Muller blades, they're called, and they're the stainless steel things that basically adult ones have been shrunk down to baby size and changed a little bit. They're not very good. And when you've got a newborn baby who's struggling to breathe, the mother's there obviously upset, so the father's probably there and you're trying to get langoscope down their throat, it's not a great, it is a very stressful situation, so he's kind of developed a, trying to develop a better one, right?

Even the simple things. These things are made of stainless steel and you put a piece of metal on a baby's tongue. A newborn baby's obviously never experienced cold before, so they obviously start freaking out and squirming and you're trying to get this thing down her throat. It's crazy. So I'm helping him to see if he can come up with a better solution. He's got a, got an idea at the moment. He's developed some prototypes and we're gonna help him get it, see if we can get it a bit further along, and hopefully get to the market and solve this real small unmet clinical need, but really important one.

[00:19:16] Lindsey Dinneen: Yeah. That's incredible to hear about both of those stories. That is really exciting. I love I-- this is partly why I love this industry so much is the innovation coming out of it is always amazing. People care so deeply about making a difference and improving patient outcomes, and then to hear about those kinds of innovations, ugh, that's awesome.

[00:19:38] Stuart Grant: Yeah. Yeah. So if there's any experts out there listening who wanna get involved in the N-H-S-C-E-P program, I know Australia does one too. So yeah, get involved and share your knowledge freely to some clinicians who wanna, who have found an unmet clinical need and wanna solve it, but don't know how to.

[00:19:56] Lindsey Dinneen: Yeah. Love it. That's fantastic. So it, it seems like, you know, from your career trajectory and your continuing education all this time that you are not someone who sits still very well. And I think you mentioned this a little bit in your LinkedIn profile, you like to keep moving. So one of the things that I noticed that you do, and I'd love if you share about it, is you do lectures on the history of innovation. Could you share a little bit about that?

[00:20:24] Stuart Grant: Yeah. So. I I really, so I sort of got into reading about innovate. I love reading innovation books, right, nonfiction, innovation books, which I got in about 10 years ago. I read probably one of the first one was "The Idea Factory," which is about Bell Labs. And that was how Bell Labs has invented the telephone system and invented the transistor, won a load of Nobel Prizes. Shockley and Bardine were there. They just had this crazy Medici effect going on in Bell Labs. The Medici effect when you collect everybody together in a small area and they just start bouncing ideas and coming up with some hugely creative solutions. And that comes from Florence when DaVinci and Michelangelo and Raphael were all kicking about Florence and they were all paid for by the Medici family, so this why it's called the Medici. There's a book about it actually called "The Medici Effect."

So I started reading all this and started just going backwards in history and getting to the industrial revolution and how the industrial revolution happened. And going further back to these group of men called the Lunar Men who were in Birmingham here in the UK who basically, it was James Watt, who invented the steam engine, Wedgewood, who was the pottery guy. It is Rasmus Darwin, who was Charles Darwin's great-grandfather. Yeah. All these people, they were called the Lunar Man 'cause they met every month in the full moon and discussed ideas and I think probably got drunk.

[00:22:00] Lindsey Dinneen: I mean...

[00:22:03] Stuart Grant: So yeah, I just love reading it and you know, I love, I'm now a little bit of a brag. As of last month, I'm a fellow of the Institute of Mechanical Engineers, and that is quite prestigious that was created by George Stevenson, and George Stevenson was the guy who created the steam train.

[00:22:23] Lindsey Dinneen: Okay.

[00:22:23] Stuart Grant: So we took Watts' idea of the steam engine, put it on wheels, figured out how to work. And I love, I just love steam trains and that's very dorky of me, I know. But I love, as a mechanical engineer, just seeing all the bits move and actually seeing them chug around all the noise and the steam. And here where I live in Yorkshire, in the UK, up the road in York is the National Railway Museum, which all the steam trains are at. Darlington is west. George Stevenson had his the original railway, the Darton Stock Railway. So George Stevenson created the Institute of Mechanical Engineers 'cause he was a mechanical engineer and his son created the rocket the first really fast once, Robert Stevenson.

So learning all this and then figuring out how, then I went back-- I'm, so this is a long answer to your question-- then I went back went back and like understood why the industrial revolution happened and it was all about the banking system here, how people could get capital. And then the legal system grew up to protect that capital. And then agriculture improved in the UK so people weren't just stuck on farms, subsistence farming. There was enough food being produced to support the population so the population could go and work in factories and obviously James Watt creating the steam power created more power. So people in horses and everybody didn't have to work so hard.

And then there was politics involved with the Hugonos, which were the Protestant, the French Protestants came over and they had all, they had the ability to make all these machine parts, 'cause that's our skill. Some of them came to the UK and the others went to Switzerland. And that's where the watch industry in Switzerland created. And then, you know, and then the scientific approach and the enlightenment came in the UK and it all just sort of bubbled up into the industrial revolution and then cascaded through the 19th century and the 20th century in. Here we are in the 21st century. So I just love knowing that whole pathway of somebody said "We need more legal," and then somebody said, "We need more banking" and as startups, right, investment is the king. So it all started 300 years ago with the UK banking system.

[00:24:35] Lindsey Dinneen: Fascinating. Oh my goodness. That is so interesting. Yeah. Okay. One other interesting thing I caught from your LinkedIn profile is that you are a painter, but you are an exhibited painter, yes?

[00:24:51] Stuart Grant: Yeah, I, well, I try.

[00:24:54] Lindsey Dinneen: Okay.

[00:24:54] Stuart Grant: So yeah. Obviously I did product design right? And I did product design because at school, I was good at art and I was good at maths and physics. So I was looking around going, "What discipline do those three things fit together?" And it looked like it was product design. I was like, "Okay, I'm half an engineer, half an artist, not good at either." So about 10 years ago I decided to pick up art again. It was, started to go to classes and doing landscapes and actually sadly the industrial decline of Britain's, so the old buildings of the industrial revolution and stuff like that. So I paint that stuff.

[00:25:36] Lindsey Dinneen: Oh, that's so cool.

[00:25:37] Stuart Grant: Put it into exhibitions and sometimes get rejected, sometimes get accepted, and try and sell a couple so I can at least call myself an artist.

[00:25:45] Lindsey Dinneen: There you go. I love it. Yeah. Well, and that creativity and that artistry does, you know, impact your work in general, because I think sometimes having that outlet actually spurs some just creative solutions outside of the box that, you know, might have not come to you immediately if you were just like, you know, head down, really working hard on this project. And then if you could take a step back do you feel that it helps you in that way at all?

[00:26:15] Stuart Grant: Yeah. Yeah, it definitely does. Not thinking about work is and just having it percolate in the background and not actually, 'cause it's a very slow deliberate process painting, right? So it does, you just lose hours and hours painting something, which is really nice. Obviously I've got a, I've got a 5-year-old at the moment running around, so I don't do that much painting. I usually just reserve it for when I go to my art class on Wednesday nights 'cause trying to focus is not a thing for a 5-year-old.

[00:26:46] Lindsey Dinneen: Yeah, That's fair. Okay. Well, all right, so pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It could be within your industry. It also could be your history of innovation, but what would you choose to teach?

[00:27:08] Stuart Grant: So I thought about this when you gave that question because I was like, "Well, I've already talked about the history of innovation and that can pretty boring." So my other boring side, when you do a PhD, you always wish you did another subject. That's the thing is like, I wish I studied that instead. So my, as you go through the PhD, you learn other things and you're like, "Oh, that's really interesting." And you go down rabbit holes and you're like, "Oh, well stop. That's not my job. That's not what I'm trying to do here."

One of the ones was how technology and society are interlinked. So technology drives society, and we've got lots of examples of that. Steam engines, trains, telephones, electricity, light bulb, broadband, and now AI. And so technology affects society. Then society drives technology. They're a virtuous circle. Some people say it not virtuous at all, but they, that's what happens. And understanding how those two things, society and culture and technology all interact is really interesting to me.

And obviously not all technologies are adopted. Some are abandoned. Sometimes the better technology is abandoned for an inferior technology for lots and lots of reasons. There's examples. In the eighties, it was VHS and beta max, Blu-ray and HD DVDs. And what else? The keyboard, QWERTY keyboard is meant to be terrible. And that was designed 'cause of typewriters at the time. So the keys didn't smash together, but obviously that's not needed anymore.

So those things interest me and I like to study that more, but I like to study it. Thinking about medtech and how our technology in medtech has affected society and using that lens 'cause we also always talk about clinical needs, right? What's your unmet clinical need? What are you trying to solve here? But there's also a social and cultural need that you are maybe not addressing directly, but you are addressing it. And how that drives medtech, and you know, it's we talk about like medtech equality and democratizing medtech and making it more accessible, but there's always the flip size of medtech inequalities.

The big one probably at the moment is robotic surgery. Hugely expensive. Only available to very few. So how will that filter through society? How does that affect society? Will it just be for the rich developed countries to use robotic surgery? How will that affect it going forward the next 10, 20 years? Because it uses a capital equipment, right? They can't be diffused through society very easily. So that, that's one thing I would like to study and sort of talk about a little bit more, 'cause I think it's really interesting, especially now AI is being talked about and how digitizing healthcare is gonna happen over the next decade. Interesting if we're overclaiming that at the moment and a lot of startups are overclaiming, what they can really do and is it gonna, is there gonna be a backlash? Who knows? Let's see. In our, maybe in a decade, I'll present a course on it.

[00:30:23] Lindsey Dinneen: There you go. Okay. And time will tell. Alright. I like it. Very cool. Okay. And how do you wish to be remembered after you leave this world?

[00:30:34] Stuart Grant: Yeah. My PhD was like, I would probably like, I'd like to remember my PhD findings, but I'm like, no, who cares?

[00:30:44] Lindsey Dinneen: Oh.

[00:30:45] Stuart Grant: I, I've got, of course, my family, making an impact on my, what I've done here with my family, but, and I was really thinking about this question earlier. I was like, "Well, I hope this isn't the end. I hope I haven't peaked."

[00:31:02] Lindsey Dinneen: Yes, that's fair, okay.

[00:31:06] Stuart Grant: So maybe the next 20, 30 years, hopefully I'll be remembered for something, I hope.

[00:31:12] Lindsey Dinneen: Okay. To be determined. I like that. I like that a lot all right.

[00:31:18] Stuart Grant: It's a positive.

[00:31:20] Lindsey Dinneen: Yeah. It's, and it's a forward way of thinking that, you know, you don't have to limit yourself to what you've already done or accomplished or seen. Who knows? The world is exciting. Yeah. I like it. Okay.

[00:31:33] Stuart Grant: Well, yes, I'm yeah, definitely.

[00:31:35] Lindsey Dinneen: Yeah, all.

[00:31:36] Stuart Grant: One of the things we're doing-- I was looking at the Australian MedTech market and really just trying to figure out what's going on to see if there's anything I can do there. And talking to my wife, we decided, 'cause my daughter's not at school yet, we decided, "Let's go to Australia for an extended holiday." And it was gonna be like a month and we'll start working it all out, like we're just gonna go for three months, March, April and May this year, to sort of experience Australia, experience the MedTech market, go meet a lot of people, understand and just sort of grow and try to understand another way of people.

I know Australia, they've got a similar culture to the UK and the US. But they do, they are far away. So they have a different take on things. And I wanna see what a difference is and see if I can get involved. So we're off to Australia on the MedTech market, so if anybody's listening, reach out to me on LinkedIn. It'll be we'll hopefully when I'm over there, we are in Brisbane. We can meet up.

[00:32:32] Lindsey Dinneen: Excellent. Yeah, no, that's really exciting. And I actually have a few people I can connect you with as well, so, yeah. Okay. And then final question. What is one thing that makes you smile every time you see or think about it?

[00:32:48] Stuart Grant: Oh. I think it's, it is back to my old answers, it's back to the steam trains. I just love watching the mechanism going around. My, me and my daughter who's exhibiting engineering characteristics, shall we say. Love, we love going to the railway museum and running around 'cause you can go and touch the trains, you can get on them, you can get your hands greasy if you want to, if you touch the wrong bit of it. She loves seeing them. And they're just, so when these engineers designed all these big bits of metal, they didn't have FEA or CAD or anything. They just sort of took a guess at the curves and how it should look. And some of these parts they designed are so beautiful when you start looking at them, it just makes me smile, like there was a person, a man, we'll have to say a man, right, 'cause it was 200 years ago...

[00:33:44] Lindsey Dinneen: Right.

[00:33:44] Stuart Grant: A engineer who decided he was gonna make it like that out of wood. And they were cast into iron and they just they were just sitting in their shop and just did what they thought was right. And most of the time it didn't break.

[00:34:00] Lindsey Dinneen: Most of the time. There you go. Yeah. That's great. I love that. Well this has really been a fantastic conversation. I'm so grateful for you joining me today and sharing just some of your history and you know, what you're looking forward to next. I think it's, I think it's really incredible when you get to combine all the different things, like you said. You've got sort of that design and problem solving and you've got the engineering and you've got all these cool things that just make you an incredible help to the MedTech industry. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. Thanks for joining and thanks for everything you're doing to change lives for a better world.

[00:34:52] Stuart Grant: Yeah, thanks, Lindsey. It's been a real pleasure talking to you.

[00:34:55] Lindsey Dinneen: Yeah, absolutely. Thank you again.

[00:35:00] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Rachel Knutton, founder and CEO of Alluvia Studio, shares how a 30-year healthcare journey—from hospital marketing and public relations (PR) at HCA Healthcare to medical device commercialization, product launches, and sales—shaped her belief that everything in MedTech ultimately comes down to storytelling. Rachel explains how her “been there” experience in hospitals, cases, and value analysis environments helps her create messaging that’s compelling, compliant, and built to endure. She also opens up about becoming an “accidental entrepreneur,” discovering unexpected fulfillment in leading people, and building an agency culture grounded in authenticity, humor, and joy. 

Guest links: www.alluviastudio.com | www.linkedin.com/rachelknutton | www.linkedin.com/alluviastudio 

Charity supported: Sleep in Heavenly Peace

Interested in being a guest on the show or have feedback to share? Email us at [email protected]. 

EPISODE TRANSCRIPT

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome Rachel Knutton. Rachel is founder and CEO of Alluvia Studio, a strategic medtech marketing agency based in Tennessee that supports some of the largest medtech brands in the world. Her experience in healthcare spans 30 years, including hospital marketing and PR for HCA Healthcare, as well as various roles in medical device commercialization, sales and marketing.

Right. Well, welcome to the show, Rachel. It's so nice to you for having me.

Of course. I would love if you would start off by just, uh, telling us a little bit about yourself, your background and what led you to medtech.

[00:01:36] Rachel Knutton: Yeah, so I actually have a pretty interesting background and I bet I'll cover a little bit more of it as we go through the discussion, but currently I have an MedTech marketing agency. We have 16 employees. been in business technically since 2011, so 14 years. And just really focused on this industry.

My path to getting into MedTech actually came through HCA Healthcare. I started working in hospital world back in 1996. And actually it was accidental. I, you know, I was pretty new outta school, a couple years outta school and I'd answered an ad and I dove right into a really exciting world. It's, you know, of course headquartered here in Nashville. Learned all about hospitals. I supported I think eight different hospitals at that time that were in region, the Nashville region, doing marketing and public relations, walked into my first open heart surgery case, helped feed employees at midnight, handled all kinds of interesting PR events because we're hearing Nashville, a lot of country music stars might get hospitalized.

And I did that for about 10 years. And then I ended up moving into devices a recruiter, and it's when Kimberly Clark Healthcare had gone into the medical devices arena through the purchase of Ballard. so honestly I really didn't know much about it. But I had, you know, I did have my MBA, I had been working in healthcare, which sort of met the qualifications at that time. And I got a early start in marcom. Learned so much, got back into the hospital through that role from the other side of the coin and I had the chance to do product management, launch a product, and then I moved into sales and sold the product a whole bag and then got back into the hospital, you know, working through the whole value EIS ecosystem and working with physicians and being in cases. So it's been a very interesting path for sure.

[00:03:37] Lindsey Dinneen: Yeah. Yeah. Thank you for sharing that. And so I'm curious about a lot of things, but I'll start with this. So what do you find are some of the differences and similarities between marketing and PR for the hospital side of things versus the device side of things?

[00:03:55] Rachel Knutton: I mean, certainly I think PR piece is a much bigger aspect, the community aspect. Um. Every hospital is such an important part of the community. So there's a heavy weight there on that. And then of course, the regional aspect of it. So whereas in the device world, you know, all targeting like very large geographies, maybe either the US or outside of the US. And so in the hospital world, that tends to be more regionalized. I would say. That's like one of the big differences for sure. And then honestly, hospital world, it's more business to consumer. is a lot of physician related marketing as you're trying to drive preference to, you know, using your hospital for surgeries or trying to recruit physicians, but it's a lot more B2C in the, medtech world. world.

[00:04:44] Lindsey Dinneen: Yeah. Yeah. So, okay, so you mentioned know, you responded to an an ad and that led you to was sort of like, well, a say, um, synergy, whatever you wanna say. that was was marketing and communications something that you always had a passion for or what led you to kind of pursue that?

[00:05:05] Rachel Knutton: Yeah. Well actually I was a little bit more of a writer. would say telling stories is origin story. So I wanted to work in magazines. This is back when we still did print and newspapers and things like that. And always wanted to work in the magazine um, industry and I, and it started out writing for a business magazine. Started working for an agency for Ford, doing writing for a sales focused magazine. And so it just sort of morphed into that.

I would say in the marketing and PR world, we were telling stories about patient stories, pitching those to newspapers. We were telling stories about physicians doing new types of procedures employees, you know, trying to promote them within the hospital world. That's also important to that ecosystem. And so I think that's kind of where that transition happened. And I would say that's still what I do today. So it's taken a lot of different forms and product management and working in Excel files and figuring out demand forecast isn't really about telling stories what it is, right? Everything is about telling a story in the end.

[00:06:06] Lindsey Dinneen: Yeah. Yeah. So it sounds like you have the strategist side, the analytical side, and the creative side, which doesn't always, you know, align. And so tell us a little bit about your approach maybe to, say, there's a client of yours that is interested in bringing a product to market, and story tell to help them achieve their goals, and within compliance, because obviously that's a component.

[00:06:35] Rachel Knutton: yeah, I mean, that's certainly in our industry, you know, figuring out are the guardrails. course in marketing, I always think, you know, we, know the rules. But we're also going to make sure that we're not self-limiting within those rules. So I let the regulatory people and the legal people push back. But I know what not to risk, right?

So I think one of the things that's very helpful is having sold devices, having launched devices myself, having worked in the hospital system, I spent a lot of time on the floors watching how devices are used. I spent time in ICU collecting data. I think really having been part of that environment helps feed the story building process. It's almost like a natural part of what goes into building that story. So because of that experience, because I've walked those halls, I've been in those shoes, I kind of know what some of those limitations are and that just automatically configures into the storytelling process.

I know what the product managers are up against when they're trying to launch a product. And theoretically, I should know the right questions to ask and how they got to the product that they have today and how they've, you know, customer feedback has fed into that. And then how do we take that and make sure that the messaging meets the same requirements?

Like you have a, you know, you have design requirements, well, your messaging should have the same requirements and achieve a goal. So I think that's the analytical side is making sure, does the message achieve the goal? Are we being very committed to what's the business objective? How is the marketing objective supporting that? And then is the, how is the messaging fitting into that? I think that's a very important part of the discipline.

We also are very familiar with, you know, claims matrices and the importance of having, you know, data and research to support claims. And so kind of knowing that framework, I think is helpful when you're building messaging because helps you think through like, okay, here's how the client is going to need to organize the messaging. Here's how they're gonna have to reuse the messaging. You know, how can we be very consistent in how we roll that out so they're not having to go back through and through their approval process every time. It's really important part of the discipline in the medtech world that we have to deal with that industries as well, of course, but it's certainly very important in ours.

[00:09:01] Lindsey Dinneen: Yeah. Yeah. I, I really appreciate that insight and I think, you know, it's so interesting to see-- you're totally speaking my language about the consistency of, it's something I've, I've preached so much is you have to be consistent with your messaging and your branding. And it's not like everyone has to have the same cookie cutter language, but when you're aligned, that really translates.

[00:09:25] Rachel Knutton: And it works. this is, you know, I, think this is a little bit of a, it's not a pet peeve, it's a passion project rather of mine is to get people to be consistent because I think what happens is internally, people get tired very quickly of their messaging or their creative. And I do think you need creative variability. We know with AI you need some of that, like that's gonna be important. But probably your customer, your target audience isn't tired of it and they might not have even seen it yet. And it's that very old, like nine times someone has to hear a message.

And so my favorite clients are the ones that work very hard to get the messaging right in the first place. They go through the discipline process of doing it, knowing why we're doing it, getting full buy-in from an extended team, and then just keep with it, with some obviously refinement and tweaking when you get customer feedback. But you know, sadly, I'm sure we've all had this instance where it's like, "Oh, Dr. like this ad. We need a new ad campaign." And it's like, "Well, that's okay. I'm really glad he noticed it." You know? That's all right. That, might be okay.

So, it, I think that the best companies are consistent and, you know, one of our clients is um, intuitive Surgical, and one of the things that we see is like, of course there's fresh creative. Of course there's brand evolution, but the overall message is very consistent and that's, it's fun to see how fruitful that consistency has been for them.

[00:11:06] Lindsey Dinneen: Yeah, absolutely. Love that. So you worked for other companies and then you took a leap and became an entrepreneur and a leader of your business. What was that like? Were you prepared, so to speak? I'm not sure anyone's actually prepared to be an entrepreneur, but you know, how did that go for you?

[00:11:24] Rachel Knutton: Yeah. was certainly an accidental entrepreneur. Some lifestyle choices, particularly marrying someone in the military at the time when we didn't do Zoom calls forced me to look at my career path and go, you know what? I'm not gonna climb the corporate career ladder moving. At that time, it wasn't a thing. And I thought, you know, I'm gonna need to do consulting in order to, you know, support family and then keep my business going.

So I had lifestyle reasons that I became an entrepreneur and wasn't really sure how it was gonna work out, to be perfectly honest with you. And, you know, felt like a lot of people say, "Well, I'm consulting," which just means they don't have a job right now. And I, I know, you know, nothing bad about saying that, that can be very true, but for me, I was like, this is actually something I'm gonna need to do.

And I did it as a as a solo consultant for several years, and then when I, we finally settled down and stopped moving said, "Well, it's time for me to get some help." The thing that was really interesting to me is I never really wanted to manage people even when I was in the corporate world, I just wanted to do great work. I wanted to, you know, I, felt like people slowed me down. You know, I just, I'm like, "Just let me go. I'm a star player." And it was really nothing that I was interested in at all.

And now I have, you know, all these employees and I spend a very large portion of my time managing people. And the thing that has been so surprising is how gratifying that is, how fulfilling it is. One, to, you know, go beyond your comfort zone and find, I've learned so much. I've made a lot of mistakes. I've thought about other leaders that I've been lucky to work with in the past and follow what they do. And maybe some people who had some tendencies that I try not to do or I'll check myself and go, "Oh, am I, you know, am I doing that?"

But I think managing team, developing people is the most exciting piece of it. always loved helping clients, so as I started out in this venture, I had a couple of offers to go work full time for those clients, but at that point I had been helping a few people and I was like, "Well, I can't say no to to the guy at this company, I can't say no to her because she needs my help. And if I have a full-time job, I'm not gonna be able to do that." So I really just wanted to help as many people as possible and I felt like owning my own business will allow me to do that. Now that I have a team, we are able to help so many more people and that is really gratifying.

The other thing is. Where I am, my community is outside of Nashville and we're a micropolitan, which means we're kind of just far away for our commute to Nashville to be impractical. We have a local university here, and so one of the things I wanna do early on was work with the local university talent for people who wanna stay in this upper Cumberland area and have a great profession. And it's somewhat limited still. It is growing, but there's not a lot of big corporate jobs.

So what I love to do is I bring that corporate experience into my small business in terms of professional development, evaluations, how we coach people. And then I try to get rid of all this stuff that I didn't really care about working in the corporate land, you know, and increased flexibility. Let's not have politics and things like that, and so that people can just grow and flourish. And so it is, I'm very passionate about it. I love helping clients and I love helping my team, and so it's really like the best of both worlds for me.

[00:14:58] Lindsey Dinneen: Yeah. Excellent. So you have an interesting name for your company and I would love if you would share a little bit what led to that?

[00:15:07] Rachel Knutton: Yeah. Thank you for asking about that, actually. So when I was the first name for my company was called Good Day Marketing, and when I realized I was really going to stay in medtech, at that time when I launched it, I was like, well, maybe I won't do medtech. Maybe I'll just do other marketing. I was like, "Well, medtech is where people want me. This is what I know. I have expertise. This is where I need to be." It made a lot of sense. I was like, okay, I need to rebrand, and I had gone through a period of testing.

And so I'm a Christian and I'm familiar with scripture. You know, where you're like, you get refined in the fire, you're refined like silver and like gold. And I was like, "Okay, I need to have something about gold." And I discovered there's a type of gold called alluvial gold. And it's the kind of gold that you find in riverbeds. And soil in uh, riverbed is very, very rich because you have so much, you know, marine life and you know, plant life flowing over it, but then there's gold deposited there, and I was like, "That's we do, right?"

Like when we're working with medtech companies, there's so much rich content, there's so much intelligence and innovation baked into what they're doing. Our job though, is to find the pieces of gold that will really help them tell that story and distill that, right? And like purify it. And it goes through a refining process to make sure the message is really clear. leave the extra behind. And then once we get it into a good spot, we shine it and we just like make the best part of that messaging, pull that forward. So it just made a lot of sense for the agency to be called Alluvia Studio.

[00:16:42] Lindsey Dinneen: That's, that's perfect. That's such a great story too. I love the intentionality behind it and the thought process of it. Um. So yeah, so you have some core values with the company, and I'm assuming this also derives from yourself, and three me were the values of authenticity, joy, and humor. Can you speak to those and how you came up with that?

[00:17:06] Rachel Knutton: Sure. Well, authenticity is, I, I just can't not be authentic. So one of the things you and I had talked about before is, I have a hard time talking about myself. just am naturally a little bit humble and I have to ask other people to tell me what I'm good at, right? And they're like, "Well, such a thought leader. You know what this industry so well, you're so great at telling this story." And I think just being able to say, "Hey, I don't know how to frame myself is something that's just innate to me."

[00:17:40] Lindsey Dinneen: Hmm.

[00:17:42] Rachel Knutton: I think I wanna work that way with people. It means that if you need to have a tough conversation with a client, you can have it. something doesn't feel right, I wanna pick up the phone and say, "Hey, this didn't feel right to me. I don't like how this conversation went. I don't like how this project's going 'cause I don't, I sense that you're dissatisfied, I wanna talk about it, I wanna understand it." from the client side, that's how authenticity works.

And then with my team as well. So, for me, their personal lives are very important. I know we all bring our personal life into our work. If we say that we don't, we're lying. And so I ask that, you know, if someone's having a rough day or going through something as much as they're comfortable, at least just let us know so that other people aren't impacted by maybe, you know, a down day or, or take it personally because you know how we all do that, right? We read into it, go, "Oh, did I do something to upset them?" "No, I'm just, I'm not here today." And so I just think it's really important one, and I want people to feel comfortable with them, to feel themselves. And I think it helps with like diverse perspectives well.

And then fun. So like humor, fun to me are lumped together and I just think when you have fun at work, you do your best work. And reminded of a couple of stories with our clients. So a lot of times we think in medtech, like everything's so serious. Everything, you know, and it is, it's a serious business. We're doing important things. There's nothing flip about what we do. However, we're all human beings. And we all need to have fun while we're working together. So we like our clients to have fun working with us, and I like sharing things that are fun about me.

I had someone just this week who is from a very high level financial position in a big company comment that he loved that I had a roller skater in my LinkedIn profile. Now, I never would've thought that, right? I never thought that person would have really appreciated that, but that just goes to show that we all need to have fun. And even if we're working hard, we just like work hard, play hard, like let's just, and when we're stressed, let's just laugh it off and keep going.

[00:19:58] Lindsey Dinneen: Yeah, and the joy aspect, just curious because that is, uh, the huge core value of mine, and so I would just love to hear your take on it.

[00:20:06] Rachel Knutton: It is my purpose life. I have identified that. I got go through a leadership development class about 20 years ago with Kimberly Clark, and we identified our purpose, and bringing joy into other people's lives was mine and what that means for me-- it is funny, early on in my career I, didn't think I was gonna work in medtech. I thought it was more in like hospitality, tourism, something, you know, that's fun, you know, obvious fun.

But what I really realized is that joy, um, joy comes from completing a project, feeling very good about what you do. We are often a very important part when people are presenting about themselves. So they do a lot of presentations. They're presenting to their boss or to a board. We wanna make them look good. We wanna make them feel very confident and relieving that stress is a joyful experience for them.

So for me it's very personal. know, as much as we can, we want to help them feel that and experience that, and that comes down to how we communicate with them. You know, let's laugh a little bit. Our job is to look good. We, this business is not about Alluvia. This business is about you, and we are here to be a partner with you in that process.

[00:21:29] Lindsey Dinneen: Yeah. Oh my goodness. Yes. That resonates very much. Um, yeah, so, you know, you've you've had an amazing career and you've worked, like you said, on the hospital side, you have had the device side and now your own business. Are there any moments along your journey that really stand out as affirming to you that "Yes, I'm in the right place at the right time?"

[00:21:52] Rachel Knutton: Definitely. When I started my consulting business, I wasn't sure that I was going to be in medtech. So I had been in the hospital world for about 10 years and I had been in medtech for about 10 years, and I thought, "Well, am I supposed to be doing something different?" You know, that's that's a nice time to like, and my relationships and my reputation drew me back in. So it was almost one of those like. I'm meant to be here because I do have the experience that people value and I do have a way of thinking that's very helpful for people and it's a unique perspective that help. And so through my consulting business, I ended up launching two more products through very large publicly traded companies. And I thought, "Well, okay, obviously I'm supposed to be doing this."

[00:22:48] Lindsey Dinneen: Yeah. Yeah. Excellent. Yes, and I think makes sense too because it's, it's also rather niche, you know? So, so having the skill sets really play a good part into-- it's, it's-- basically what I'm trying to get at is it's not an necessarily an easy path. So it's helpful to have had that background to, you know, you've got the communications and the marketing, but also the nitty gritty of, you know, I remember when I first joined, you know, somebody would say a sentence and it was like, half of it was acronyms and it was, it's just such a steep learning curve,

[00:23:21] Rachel Knutton: Yeah. Mm-hmm.

[00:23:21] Lindsey Dinneen: Yeah.

[00:23:22] Rachel Knutton: It's, it really, and it still is. I mean, there's no way to know about every specialty in the world or all of the, you know, technical or clinical issues that our clients customers need to deal with. But being able to figure out which parts you need to understand and which you don't, I think is good. Like, what do you need to filter? do you really need to go in order to help them communicate their message is. Is helpful. And I think having that experience does provide that filter.

And you know, it's funny because I was thinking about your podcast and I love what you're doing with it. Like I love that you're trying to shine a light on our community and it is about so many people trying to help people and save lives. And yes, I mean, I work so heavily with the investor community and startup community that sometimes it starts to feel a lot like it's about money. think money follows great ideas, right? Because there's an economic value to an innovation that's gonna save our healthcare system money, save lives and outcomes and, things like that. So I think it's all important.

One of the things that I've thought about though is. Our unique position is we help people that help people save lives. So, you know, we are not on the frontline innovating new devices. We are not really on the frontline working with the patients. But if they don't tell their story, if there's not awareness of their solution, if it's not implemented correctly-- we think, I think a lot about that at the at the sales level, having been in, in those shoes-- if those things aren't done correctly, then the patient's not gonna be helped and making sure that we make that as easy as possible. people don't really wanna think about marketing, right? Like they wanna think about the clinical aspect. They wanna think about the innovation and the know, technical issues that they need to solve. And new product development, but the marketing piece is really important.

All

[00:25:28] Lindsey Dinneen: Yeah. Yeah, and it's just a fun, well, it's really a special role to play, I think. And I've always felt really grateful for that because, right, if somebody doesn't know that it exists, then they can't buy it. And so even though my role is small in comparison to maybe the scientists and the engineers and everything like that, I still get to play a part, and I think that's just delightful. Yeah.

[00:25:55] Rachel Knutton: Yeah. Yeah, it really is. And it's really helpful too. So, you know, running an agency, I have a lot of creative people. Well, in our industry, we don't get to be quite as creative as other industries, right? Because as you mentioned, you know, we have regulatory reasons and it's a slightly more conservative industry for sure and should be. We're always looking to figure out how do we inject that joy? How do we inject that fun and authenticity into something that still feels as professional, as innovative, and as buttoned up the product is, as the quality process has been, as the clinical study has been, but still, how do we have a unique voice within that?

And so that's really helpful with my creative team too, to say, right, like our guy boundaries are a little bit different, but what we're doing is so much more important than selling a consumer product. Maybe like a luxury item or jewelry or marketing a, I don't know, something sexier, you know, like a vacation. I don't know. To me that'd be like the ultimate, send me around the world and have me market a travel. That'd be very good.

[00:27:05] Lindsey Dinneen: You go.

[00:27:06] Rachel Knutton: But at the end of the day, like it, it's making a really big impact and I think that's really helpful to help people in that. We're always looking for ways to try to get that experience. Like I'm always looking for ways to get experience from my team to be able to do that. I think that's probably my next big goal is like, how do I get them into the hospital? How do I expose them to what the day-to-day life is of a sales rep? You know? think that's really important in our industry to have some sort of exposure to feed on the streets in the hospital setting, how it works, what the sales rep has to go through to get the product implemented, how long it takes for it to actually succeed, right? Because it's not just one sale, it is a long process, a long journey, and an ongoing journey to make sure that that it sticks and that people understand how to use it. And I think having that like empathy or at least point of view can be really helpful to anyone marketing in our industry.

[00:28:10] Lindsey Dinneen: Yeah. Yeah. I I really like that. That's, that would be a really helpful thing for anyone, especially if they're newer to the industry, to have that sort of boots on the ground, this is what it's actually like, kind of experience.

[00:28:24] Rachel Knutton: Yeah.

[00:28:25] Lindsey Dinneen: So, okay, so pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within your industry, doesn't have to be, what would you choose to teach?

[00:28:39] Rachel Knutton: I think it would really be about this, like how to find joy. Like how to find joy in everything. You know, how do you cultivate a joyful outlook on life so that even when you're sitting in traffic or doing something you don't really love to do, how can you integrate that? You know, I think that one thing that's really important to me is my faith. So my values, I'm, Christian, and I really believe the only true joy that we have is when we have a relationship with Jesus Christ. And so that's not part of my business, that's part of my life mantra, but like if I could help people get to the real joy, that would be like the ultimate goal, right? If I can't get them there, if I can get them to, you know, experience joy in the day to day or experience joy in their trials, think that would be something worth, I'd do it for free. I don't even need a million dollars. a million dollars would be great.

[00:29:34] Lindsey Dinneen: Yeah. Right. Excellent. Excellent. Yes. Okay. And then how do you wish to be remembered after you leave this world?

[00:29:43] Rachel Knutton: I think it's that point I just made there, right, is that, maybe, I mean, it's so cliche, but I left things better than I found them. I left people better than I found them. And, you know, and ultimately, you know, if I lead them to Jesus, that is like the ultimate goal for me as a Christian. So for me, that would be a metric that if it was, you know, one person, if it was 1 million people, it doesn't matter. That's the goal.

[00:30:13] Lindsey Dinneen: Yeah. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it?

[00:30:22] Rachel Knutton: It is my business. It really is. I mean, okay, obviously my family and my pets and things like that, but I really love coming to the office. This, we have our own building. Every time I come here, my spirits are lifted. I love seeing my team members and I love working with the clients and just hearing from them and building those relationships. Everything about this is so deeply personal to me that the money piece of it is like the very last thing that I think about. It's the last way that I run my business. It's the last way that I measure success. It's the last way I hire. It is really just follows that, that positive feeling of making an impact and having fun. I, it's just, I know it sounds crazy. We keep saying that, but I think it's really fun to do what I do. I'm

[00:31:18] Lindsey Dinneen: Yeah. I love that answer. That's that's wonderful. And it, I think that's one of those affirmations that yeah, you are in the right place at the right time because you're having fun and you're joyful. I love that.

[00:31:30] Rachel Knutton: Sometimes it's temping to work from home, and then I work from home, and then I come to the office. I'm like, "Why did I wanna work from home? It's so much lighter here. We have a disco ball here and I don't have a disco ball at home."

[00:31:40] Lindsey Dinneen: Oh. Brilliant. I love it. Oh my goodness. Well, this has been such a fantastic conversation, Rachel. I so appreciate you and your time today, and I love the way that you bring joy and fun into medtech and into the lives of the people that you touch. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. Again, thank you so much for everything you're doing to change lives for a better world.

[00:32:18] Rachel Knutton: Thank you. This is a great interview, so I appreciate it. You made it easy.

[00:32:23] Lindsey Dinneen: So glad to hear that. Alright, well thank you so much again, and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time.

[00:32:40] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Shaun Bagai is the CEO and Director of RenovoRx, and a seasoned MedTech leader whose path began with a Silicon Valley startup internship that ultimately pulled him away from medical school and into building life-changing technologies. Shaun shares how early experiences in clinical research, physician training, and commercialization—from Medtronic to multiple high-growth startups—shaped his leadership philosophy around mentorship, hiring for “fit,” and balancing empowerment with accountability. Shaun reflects on legacy, values-driven leadership, and why networking rooted in genuine curiosity can become one of the most powerful tools in a MedTech career.

Guest links: https://renovorx.com/contact-us/ | https://www.linkedin.com/in/shaun-r-bagai/  

Charity supported: ASPCA

Interested in being a guest on the show or have feedback to share? Email us at [email protected]. 

EPISODE TRANSCRIPT

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am delighted to introduce you to my guest, Sean Bagai. Sean has served as Chief Executive Officer and Director since 2014 of RenovoRx. Prior to joining, he led global market development for HeartFlow, Inc from 2011 to 2014, which included directing Japanese market research, regulatory payer collaboration, and key opinion leader development to create value, resulting in a company investment to form HeartFlow Japan. During his tenure at HeartFlow, he successfully orchestrated their largest clinical trial to date and contracted HeartFlow's first global customers. In addition, Sean has launched innovative technologies into regional and global marketplaces in both large corporations and growth phase novel technology companies. Sean is a graduate from the University of California Santa Barbara with a Bachelor of Science in Biology / Pre-med.

All right. Well, thank you so much for being here, Sean. I'm so delighted to speak with you today.

[00:01:54] Shaun Bagai: Thanks for the opportunity. I really appreciate it.

[00:01:55] Lindsey Dinneen: Of course. Well, I'd love, if you wouldn't mind starting off by just telling us a little bit about who you are, what your background has been like, and what led you to MedTech?

[00:02:07] Shaun Bagai: I really appreciate the question 'cause it's really my background and kinda the early part of my journey that landed me where I am today. I actually did an internship at a medical device startup company in Silicon Valley between what would've been college and med school. And while I was applying to med school, my goal was to get some experience in the industry, in a medical technology space, and then go out to med school. And the founder of my company and CEO really advised me not to go to med school once I got in to become, someday an entrepreneur like his own self. And I ended up following his footsteps with the goal of, just like he, did build companies that really make a major impact on medicine.

[00:02:44] Lindsey Dinneen: Wow.

[00:02:45] Shaun Bagai: So from, yeah, so from that early kind of intro to medical technology and learning what an entrepreneur could do in building new therapies and technologies, I ended up running clinical research at that company once I declined med school. We exited to Medtronic where I learned the sales side of things. So, this physician founder CEO along with my mentor, said, look, if you want to build and run companies, you have to really understand what the market's like and how you get a product into the hands of physicians to treat patients and what it takes to really sell the product.

So I spent a couple years flying around the country training physicians on the technology that I learned as a proctor-- which I've done in every company that I've worked with and for-- then went on to sales for about five years and launched Medtronic's first drug coated coronary stent as a sales representative. And then transitioned out of Medtronic after several years, cutting my teeth on the big company dynamics and the sales revenue aspect of it to a startup company called Ardian, which developed a new way to treat high blood pressure using a device.

There I led physician training, transitioned them from clinical research into commercial in Europe. We exited to Medtronic for about a billion dollars and went on to another startup company to help develop their market. And really that was a disruptive technology in how to assess coronary artery disease in leading international market development. They hired me about 15 years prematurely to commercialize them, so I helped them with physician training, market development in Japan, clinical research and left to join RenovoRx where I took over 11 and a half years ago. That company actually went public for about 2.5 billion this last year. So, and all three of these technologies have really already made a major impact on patients, and I feel that RenovoRx, this has probably my biggest one yet in terms of major impact.

[00:04:26] Lindsey Dinneen: Yeah. Okay. So I can't wait to dive into that, but there's a lot before that too to talk about. So, when you were growing up, was medicine and science always a huge interest to you or did that develop later on?

[00:04:41] Shaun Bagai: You know, it's funny you asked 'cause I've done a lot of interviews and that question has never come up. So I've gotta, I've gotta pause for a second. It's interesting. My, my background was really business oriented growing up. I loved business. I loved the idea of how you get something marketable. As a very young child, I had very embarrassing stories of trying to sell things as a kid that I used to bring back from India, for example, like bouncy balls or crocheted place mats or whatnot.

But then sustaining a football injury in high school, I found that physicians couldn't treat me. And I learned that there's gotta be a different way to treat patients. And I arrogantly thought, "Well, I could be a better doctor than you guys and someday treat young athletes like myself." So, my passion went immediately and complete a hundred percent into become a physician to help patients. So that kind of transitioned me to being med school bound from the age of about 15, and didn't look back until I got into med school and got pushed back to business. And now I get the best of both worlds.

[00:05:37] Lindsey Dinneen: Yeah, no, absolutely. So you have so many diverse experiences with a bunch of different companies and you know, everything from it sounds like a quite the small team to obviously these huge enterprise type companies. What are some of the key lessons you learned along the way that help you in your current role?

[00:05:58] Shaun Bagai: I think the biggest aspect I've learned along the way, and what I'd definitely tell the younger entrepreneurs, is to be very open and receptive to different ideas. Also look for mentorship and leadership examples. And I've been lucky throughout my career, I've been able to identify leaders who are not perfect because no one is, but I found skill sets and activities and thought processes that I wanted to emulate, and I feel like I've been successful because I've been able to take the best of those and also look for mistakes and weaknesses and to see how I could either surround myself with people to fulfill my lack of strengths in areas and or improve on myself to help be a better leader by emulating them.

[00:06:37] Lindsey Dinneen: Yeah. And speaking of leadership, as you kind of grew into all of these, you know, more and more responsibility laden roles, were there any moments along the way where you kind of just had these learning curves of, you know, either witnessing something that you were like, "Oof, I don't wanna do that." Or the opposite of it sounds like you had maybe some really great mentors in your life that showed you perhaps a better way of doing things. But in terms of your overall leadership strategy, how did the various good, bad, and ugly shape how you show up as a leader?

[00:07:16] Shaun Bagai: You know, that's a four hour discussion probably, but, but to, to tackle some of the high notes that I learned, it's --and I continue to always learn-- the biggest challenge we face as leaders is trying to find out what makes people work in the right fit for your organization. And as, as you mentioned aptly, I've worked for very large and small teams, big companies, small companies, and not everyone's fit for those positions. You have very talented, enthusiastic, passionate people that could really flourish in a big company structured environment and would die in a startup company.

And vice versa. You have very structured people that cannot understand the idea of progress ahead of process in small companies as well, and finding that balance of trying to get the best out of what someone likes to do and what their fit is. And further really identifying if you can align their passions and their career goals, what the company's goal is, you find the dynamite employee.

So I try to find that balance has been difficult and challenging. My biggest challenge I think, in learning curve for me was trying to have both the non micromanaging skillset and then also the oversight and ability to let people run and to be successful and grow and learn and make mistakes. And then teach them from the mistakes, they'll become stronger leaders under you as well.

[00:08:32] Lindsey Dinneen: Yeah. Yeah, absolutely. All right, well, bringing us to the present day, what does your company do? What are the innovative solutions that you're providing? Because I know you are on the cutting edge of a lot of really amazing technology.

[00:08:48] Shaun Bagai: Yeah, it's been very exciting. We are finding a different way to treat cancer patients, and if you think about therapeutics in general, we as a medical industry and society have really looked at, "Okay, how do we kill a tumor? How do we prolong life?" And a lot of times we forget that there's a patient that's harboring that tumor and maybe the life isn't really worth it when you beat them up with chemotherapy every day and they're on a couch, not eating, not spending time with family. And what we've developed invented and really built out now commercial with a clinical research program as well, is how to localize therapies such that you don't have the systemic toxicities, but you do have the effect for patients live longer. And tumors that really don't behave well when it comes to cancer therapy, like pancreatic cancer is where we spent the bulk of our time so far.

[00:09:31] Lindsey Dinneen: Okay. And then can you talk a little bit more about what makes your approach so innovative?

[00:09:39] Shaun Bagai: It's really by accident like most great medical are. It's a physician who had an idea based off a single patient where he saw a challenge. And Dr. Ramtin Agah, the founder of the company, had a pancreatic cancer patient, and as a cardiologist his cardiac patient had pancreatic cancer and had a bleeder. And he scrubbed in with a radiologist to treat the bleeder and found that there's no good device to isolate segments around the pancreas because of the way the anatomy is. So what differentiates us is it was after an unmet need first, and then came the device technology and then clinical data, and now adoption where tumors like pancreatic cancer tumors don't have high blood flows posing them not susceptible to chemotherapy and not a good target for local delivery. So he developed and invented this therapy and technology to really get high doses of chemotherapy in these types of tumors in a manner and mechanism that's very different than we've ever seen before. And that's looks like it's being successful.

[00:10:34] Lindsey Dinneen: Wow, that's amazing. So you have had some clinical validations, clinical trials as well? Yeah?

[00:10:41] Shaun Bagai: Yeah, we did. Yeah, for sure. We did a phase one two trial initially in pancreatic cancer, non-metastatic. We found that patients that are expected to live between 12 and 20 months, let's say, or even narrower these days, about 14, 15, 16 months-- our patients were living over two and a half years and we were starting to push survival where many patients were 3, 4, 5 years since diagnosis. Since then, we've launched a phase three trial based on that, and that's wrapping up enrollment soon. And based on the success of the therapy and technology in terms of toxicities, a lot of physicians have said, look, we want to treat patients today with this. And given that the device is FDA cleared, we've now begun to commercialize the device component for physicians to use at their discretion, where we're starting to see benefit for patients across the spectrum.

[00:11:25] Lindsey Dinneen: Wow, so, so this is a very highly targeted-- it's able to get right to the source, right, so that there, it kind of helps to-- like you mentioned, there are some cancers that are much harder to treat by just sort of your, well, more standard practices with chemotherapy. So can you explain a little bit more about how it works in terms of the delivery?

[00:11:50] Shaun Bagai: Yeah, think about tumors like pancreatic cancer tumors as cities with freeways next to them with no off-ramps. And that's one of the biggest issues is that when we think about tumors in general, we think of a ball of blood vessels with a lot of tumor cells. So blood supply gets there, they feed the tumors, but it also creates a, you know, off ramps or a highway to the tumors where chemotherapy reaches.

Other tumors like pancreatic tumors, glioblastoma or brain tumors, non-small cell lung cancer bile duct cancer, uterine tumors, many others, they don't have this large blood supply. So it's like there's a freeway going next to a tumor and the chemotherapy doesn't see that tumor. So the way we've developed our technology, it's a double balloon catheter based system, so it's minimally invasive. It goes in through the patient's leg artery. And the patients are-- it's not a full surgery. It's more of a minimally invasive, same day outpatient procedure where the device isolates blood flow next the tumor, and uses pressure to force the chemotherapy to leave the vascular system to then bathe and saturate the tumor with chemo.

So again, if you think about that freeway without an off ramp, we basically are forcing and creating and finding these micro channels like an off ramp to actually access the tumor. And this is where all our patents lie as well. So we developed this whole new method and mechanism of delivery of drugs and chemotherapy.

[00:13:07] Lindsey Dinneen: That is amazing. So I'm sure that there are probably many stories as you've done this and just throughout your whole career. But are there any moments that really stand out to you as kind of affirming for you that, "Wow, I am in the right industry at the right time."

[00:13:26] Shaun Bagai: I, I've luckily been validated with that thought process my whole career. As as a son of Indian parents, many say, "How did you not go to med school once you got in? Were you a disappointment to your family? Do you regret not gonna medical school and becoming a physician?" And I've been very lucky that I spent my whole career successfully helping technologies treat patients.

The first moment was my first job going from declining med school through running clinical research and being the lead physician proctor, I used to fly around the country and teach doctors how to open up leg arteries that otherwise would be amputated. And by with this new technology, it was great to see how great patients were doing because of our technology. And every company I've worked on since has had that same effect on patients. So luckily, it's been always along the way, and very luckily, it was very early in my career to validate this this was the right pathway.

[00:14:13] Lindsey Dinneen: Yeah. You know what you've mentioned too at the beginning that it sounds like a huge passion of yours, and maybe it has always been the case, but is making a difference in people's lives, being a part of companies that are, you know, actively improving and helping save lives. And so, I'm curious too, where did that passion come from? Was that part of that sort of, "I'm gonna be a physician, I'm gonna, you know, I'm gonna do this whole thing, I'm gonna save the athletes," but then, you know, kind of evolved from there? Or is that more deep seated?

[00:14:46] Shaun Bagai: You know, it's interesting, I think it evolved along the way. I've always tried to be a helpful person in general, just as a human being. The, again, the, I think the initial idea was I wanna help patients because they couldn't help me as an athlete. So orthopedic surgery or cardiology were kind of the two i ideas or areas I wanted to specialize in when I thought the med school route. And then it was a matter of, I love the science, I love the technology, I love the medical science as well, and I love the business aspect of it. So I learned that there's this whole industry called medical technology that allows you to do all of that. And after seeing the benefit to our patients as a young clinical researcher, I really got the the addiction to trying to find ways to treat patients better.

[00:15:29] Lindsey Dinneen: Yeah. Well, and I think I'd be curious to know too, 'cause I think, you know, that passion also comes from probably some core values that you hold that have sort of guided you. And I would wonder too is with, as having had such a diverse amount of really cool industry experience, what are some things that have been the guiding lights as you've gone around, you know, just things that you come back to as core values for how you wanna show up in the world?

[00:15:59] Shaun Bagai: It's a very interesting question. I think one of the most interesting books that I have opportunity to be exposed to is "True North" and it's basically CEO's paths on aligning values with the company values and goals and making sure that that what you're doing is the right way to do things and the right thing to do. Often people can misstep as leaders in taking shortcuts and how you treat people. And there are no shortcuts. It's the hard work, it's the lead by example. It's putting in the late hours and demonstrating this is how you get things done. So I think that's probably a biggest part of making sure you align well with the company goals and having those values in place.

And also how you treat people. We have a lot of leaders who are not the nicest people to their employees. I'm not gonna name any current companies, but, we all hear stories, they all exist. And I find that back to the, one of the original ideas is that when you align yourself and when you actually care about the people you work with and like the people you work with, they work harder and you work better as a team.

And at the end of the day, all of us who work hard spend more time working than with our families and loved ones. And you want to actually make that fun and challenging and interesting and successful and it's almost like a second family, the people you work with. And it's important to keep that in mind 'cause people lose that a little bit.

[00:17:12] Lindsey Dinneen: Yeah. Well, and I wanna go back to something you said too because this is actually a timely, interesting topic because of something that recently happened that I heard, and, you know, basically it was this idea of, if the personal goals aren't aligned with the company goals, they're not really worthwhile. And I was really struck by that comment and I was surprised by it because I don't feel that is true. Basically, to your point, part of it is you are spending, you're a hard worker, right? And so you're motivated to come in, you know you're doing things that matter. So it makes sense that you're going to have sort of, what would we call it, sort of innate personal goals that would hopefully align with the company's goals? But I'm curious, as a leader yourself, when you're helping your team maybe even develop or nurture those kinds of personal goals, how do you help them succeed both, you know, personally and professionally themselves, but then for the company so that as a whole, we are successful?

[00:18:13] Shaun Bagai: I, I believe honestly, that's easier to do in a smaller startup type company than the large organizations. And the reason is because people who choose these types of companies have really strived to learn and grow, be exposed to, they're passionate about what they're doing 'cause it is so hard to be successful and there's always risk. And so I feel like building, running, working with and for companies that are kind of in a growth smaller phase, it almost weeds out the wrong types of people in terms of their ability to be passionate and work hard enough for that common goal.

Because pretty quickly, and I've heard this before, and we've gone through this with our own companies, "This is too much work." And I've got someone else who was working 90 hours a week because they were so passionate about what we're doing with patients and they were touched by cancer. We've had cancer patients in the company, we've had family members with the cancer, so I feel like by nature you almost weed out the people that aren't the right fits.

And there's also personal goals, and you know, people always have selfish motives at the core in certain areas, but being in a small company, you can identify where someone like to grow. And being in a small company, everyone does everything. In large siloed companies, you kind of miss that. And some people like that. They like the control, they like the punch and punch out, which is great. But when you're trying to build a small organization that's growing and pivoting and shifting, people like that fast-paced environment, and that's how I got lucky in how I grew. I got to do everything as a young, you know, post undergrad where I did clinical research and clinic, preclinical research and marketing and a little bit of sales and physician training, and that really allowed me to spread my wings and everyone I've mentored and guided and worked with feels the same way.

[00:19:48] Lindsey Dinneen: Yeah. Yeah. I love that perspective. I think you touched on something that's really key is the alignment of goals in the sense of, we all know we're striving towards the same things, like we all want our patients to be healthier and live longer, better lives, you know, or what, whatever the mission statement is, per se, but being aligned and having that shared passion makes such a difference. So, okay, pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach?

[00:20:28] Shaun Bagai: You know, it's I used to think about that question when I was younger and thought "I have no talents."

[00:20:31] Lindsey Dinneen: Oh, no.

[00:20:33] Shaun Bagai: Yeah. But I've learned over the years that the things that make me successful are the ones that you don't think about. At least I didn't think about forefront. I think networking is probably the biggest piece, is really thinking about people who can have a positive impact and influence, and keeping in touch and not judging people, not dismissing people, not holding grudges. And you find along the years that you end up collecting a lot of interesting people that could be helpful for you down the road or you could help connect them. So I like connecting other people who can help people.

And it's amazing. Throughout my career, I come back and I remember a fellow in Germany, I worked with my first company and he was in town for a conference. Fast forward 15 years, I'm like, "Hey, Dr. Naber, I'm in town. Why don't we meet? What are you up to these days?" "Oh, I'm working with this company called HeartFlow, and we have a new medical technology on looking at coronary artery disease. What are you up to?" "Oh, I'm the head of the hospital system in Frankfurt."

It's like, wow, a lot's changed in 15 years and all of a sudden he became one of our biggest investigators and it's, and it wasn't because I thought I'd get something out of him. It's just I like keeping in touch with people and who knows where your path cross, and I've been able to connect other people to other people in the same regard. So, I remember I gave a talk about nine years ago on, on how I got to become a CEO of this company and I had this kind of Brady Bunch PowerPoint presentation. "Well, this person got me a job as an intern at this company. I met this doctor here. I met this company there," and there was like this spider web of how I got here. And it's amazing how all these people had an impact on my life at some point or another. And a lot of my team members are the same thing. It's amazing how many people you end up knowing if you're friendly, nice nonjudgmental, don't hold grudges, and people learn, grow, mature, change careers, and it's good to really treat everyone well and it comes back.

[00:22:12] Lindsey Dinneen: Yeah. Could not agree more, and oh my goodness, I was just thinking about, yeah the, also the fact that, you know, as, as large as the industry is, it actually is also very small, so people know each other and so you also need to be cognizant of that as you're interacting. But I'm curious, just real follow real quick follow up to your point, what would be your advice for somebody who feels a little bit, maybe awkward or they're introverted, so it's a little bit harder to start those conversations. What would be a piece of advice for somebody who might either be new to networking or just not be comfortable with it very much?

[00:22:52] Shaun Bagai: It is interesting 'cause I've been an extrovert mostly, but I'm also shy, which is oxymoronic. And I've got team members who have no problem walking up to, let's say a famous CEO or person and saying, "Hey, I'm i've got a question for you." And I think it's a matter of trying to break outta your comfort zone and ask questions because I find that most leaders do like to give back and do like to mentor. And a lot of them are very intelligent and a lot of 'em think a lot of themselves. And people like to talk and to teach. So, and that's more often the case than not.

So for someone a little bit shy or trying to break into that idea is finding the right mentors and asking questions. People like to talk usually. And using that and being confident there, and also understanding that you may get blown off. You may get a no, you may get, you know, and not being disgruntled and going after it again and again, even though it's, it's difficult sometimes, but just to push yourself forward and be out there.

[00:23:47] Lindsey Dinneen: Curiosity and persistence. I like it. There you go. There we go. All right. And how do you wish to be remembered after you leave this world?

[00:23:59] Shaun Bagai: You know, I think about one of my first mentors, Dr. Josh McElroy. He has made an impact on medicine-- yeah, get emotional when I think about it-- that's mentored so many young people and built so many technologies that helps patients, and leaving this world having an impact on medicine where I help build therapies and technologies that made an impact for generation lives to come is really important.

[00:24:23] Lindsey Dinneen: Yeah. And that's a beautiful legacy. Yeah. All right. And then final question. What is one thing that makes you smile every time you see or think about it?

[00:24:33] Shaun Bagai: You know, I think it's the comradery with my team at work. And it's interesting 'cause the best days I work, it doesn't matter what's happening. If we're aligned and we have the same mission and we are pushing for the same direction. When you have 10 people wrong go about in the same direction, it feels amazing. And that's something that I really enjoy. And of course, it's not gonna be like that every day, every minute. And the challenges are always big and there's always, especially with an intelligent senior staff, there's always disagreements and arguments. But being open-minded and aligning and they, we always come around and align, those are the things that really make me smile.

[00:25:08] Lindsey Dinneen: Yeah. That's great. That's awesome. Well, this has been a fantastic conversation. I really appreciate your time and your insights. I really appreciate, especially you going a little bit deeper into, yeah, kind of, kind of the lessons learned and what makes you tick and your passion for this industry and your current role.

And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to support and we just wish you continued success as you work to change lives for a better world.

Shaun Bagai: Thanks for the opportunity, Lindsey.

Lindsey Dinneen: Thank you also to our listeners for tuning in, and if your feeling is inspired as I am right now, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time.

[00:26:01] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Hyedi Nelson, the Director of Health Strategy at Bellmont Partners and an award-winning strategic health communications leader, shares her journey from studying mass communication to becoming an expert in medtech communications. She discusses the importance of storytelling, building trust, and collaborating with various stakeholders, including engineers and regulatory bodies. Hyedi also touches on the evolution of social media in the medtech space and offers insights on fostering creativity while staying compliant. 

Guest links: https://www.linkedin.com/in/hyedinelson/ | https://bellmontpartners.com/health-and-medical-public-relations/ 

Charity supported: Equal Justice Initiative 

Interested in being a guest on the show or have feedback to share? Email us at [email protected]. 

EPISODE TRANSCRIPT

Lindsey Dinneen: [00:00:00] Hi, I'm Lindsey, and I'm talking with medtech industry leaders on how they change lives for a better world.

Diane Bouis: The inventions and technologies are fascinating, and so are the people who work with them.

Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

Diane Bouis: I got into the business to save lives, and it is incredibly motivating to work with people who are in that same business, saving or improving lives,

Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is the Leading Difference.

Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to introduce you to my guest, Hyedi Nelson. Hyedi is an [00:01:00] award-winning strategic health communications leader with deep experience partnering with MedTech companies of all sizes and stages, with a special affinity for working with entrepreneurial startup companies. She has dedicated her career to leveraging her strategic communication skills and expertise to help improve health outcomes. Hyedi is the Director of Health Strategy at Bellmont Partners, a full service PR and communications agency where she helps medtech organizations navigate and communicate around complex crisis situations and mergers and acquisitions, launch breakthrough technologies, raise capital, drive clinical study patient enrollment, and ultimately position themselves effectively with key partners and interested parties, including investors, healthcare providers, current and prospective employees, media, and patients and caregivers.

All right, Hyedi, welcome to the show. Thank you so much for being here today.

Hyedi Nelson: Thank you for having me.

Lindsey Dinneen: Of course. I would love, if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and what led you to medtech.[00:02:00]

Hyedi Nelson: Sure. Absolutely. So my name is Hyedi Nelson. I'm currently the Director of Health Strategy at Bellmont Partners. We're a full service communications and PR agency located in the Twin Cities of Minnesota, which I'm sure you're well aware, that's considered Medical Alley. My whole background, my whole career has been spent in health and medtech communications. So, I kind of gotten to that area and just really fell in love with it. I guess the backstory on that, I was graduating undergrad from the University of Minnesota in mass communication and still kind of didn't really know what I wanted to do and timing-- I'll date myself here-- but that was around 2008 and so if you recall, it's kind of a tough time, you know, in the economy and a lot of my friends who were graduating were having a hard time finding a job.

And around the same time I ended up just kind of looking for a class to take to fill some re remaining requirements for graduation. And I took a health [00:03:00] theory class and I just like became obsessed with health and I started to think, well, maybe there's something there. And the professor of that class actually shared with me that they had a two year master's MA program that was like a joint program between the School of Journalism and the School of Public Health. And so you've got this really nice combination of you know, communication theory and how to create, you know, more communication strategies and influence public health, but you also got a really good overview of the healthcare field as well as some basic knowledge in like epidemiology and biostats to like really give you the tools you need to do a good job as a healthcare communicator.

So I ended up applying for that and finishing out that program and kind of positioning myself in a better place a couple years later to graduate and look for employment. So during that time, I was asked to participate on a Social Media for Healthcare panel. [00:04:00] So at the time it was like social media was super new to healthcare. They were really far behind, you know exactly what I'm talking about. And I met someone who was PR professional and I was not super familiar with the world of prPR but we started talking and she shared that they were really looking to expand their health and MedTech practice within the, within their agency. And kind of one thing led to another and I applied and started working there, and the rest is history there. That's kind of what I've been doing ever since.

Lindsey Dinneen: Wow. That's amazing. Yeah. So first of all, thank you for sharing a little bit about that. There's so much I kind of wanna dive into. But I'm curious, was journalism and marketing and those kinds of interests were, did you have those, you know, growing up? Or was this something that developed in college, or how did that all come about?

Hyedi Nelson: I think for me, just the love of writing, first and foremost, was what really did it for me. I read a lot, so I was always just [00:05:00] like really amazed that people could, like, use words to, you know, make you transport yourself into this other place, or get you to take some sort of action. It seemed like kind of a magical thing. And then you know, just going through school and everything, I realized that like my skillset definitely wasn't like math or that side of things and was really drawn more to the the writing piece of it all. So, I thought about, "Do I wanna be an English major?" Do I, I actually went into college wanting to go into the music industry and did an internship for a record label-- I suppose that's another story for another day-- but ended up deciding an English major, wasn't sure I what I wanted to do with that. And so, trial and error kind of decided that communications more broadly, you know, whether it's journalism or strategic communications felt like it would be a really good fit for kind of where my interests lied.

Lindsey Dinneen: Nice. Yeah. And so-- okay, well what's funny is I actually did wanna dive a little bit. So we're gonna, if we can take a [00:06:00] very quick detour into the music aspect, because I did notice on your LinkedIn that's something you still do, is you actually help musicians-- is that correct-- with some of their PR and marketing?

Hyedi Nelson: Yeah. I, a couple years ago started my own consulting side hustle thing where I really use, you know, my skills that I do like in my full-time job and a communication strategy and promotion and publicity and project management to help independent artists, just because I have a lot of friends and my partners a musician. And I see kind of the struggles that they go through with how the industry is, is really like how it exists and how the payment structures aren't there and it's really hard for them to make a living as well as the fact that they're expected to like not only be a super creative person who's putting like this music out into the world, but also like a business person and a marketer and, you know, all those things. [00:07:00] So, kind of doing that to like merge all of my passions together and do something kind of fun and different than what I do, you know, during the day.

Lindsey Dinneen: Yeah. No, I love that. I love that. Especially because I don't know if we've talked about this before-- it's, I know we've had a few different conversations before this-- but yeah, i'm also a professional ballerina and so I understand. Stand having the two sides of, you know, the art, the artist and the medtech enthusiast and sort of the both worlds. So I just I love that you do both too.

Hyedi Nelson: There's gotta be some sort of like where that helps us in our job somehow, like having that too. I don't know, but I think so, yeah.

Lindsey Dinneen: Yeah. I think part of it is, you know, creative problem solving and, you know, sort of the skill sets that are learned. Are you a music musician yourself?

Hyedi Nelson: I mean, I am not very good at it, Okay. I do play, yes.

Lindsey Dinneen: Yeah. And so I think a lot of the, of it comes from the [00:08:00] discipline of having, you know, grown up learning some kind of an artistic endeavor because it's, there's so much discipline that goes into it. There's so much you have all of these skill sets that you're learning. And anyway, I don't wanna get too far off on the tangent, but that is one thing that I do think it helps honestly. But yeah. So, okay. So back to your career. So now you are working with Bellmont Partners, and can you just share a little bit about what your day-to-day kind of looks like helping these medtech, health, tech life science companies succeed?

Hyedi Nelson: Sure. Yeah. I mean, every day can be wildly different than the last. But in my role, I really, I've been with the agency now for about 12 years and we've really grown tremendously our business in this space because I think one, there just continues to be like more of a need for our services in this area, but also I think, we've just uncovered so many more like [00:09:00] areas and places where our team that works on our health and medtech accounts specifically are like super passionate about and we just like wanna do more and more.

But I would say day to day I work with a number of companies that are in, you know, early stage or more in the startup phase. So a lot of my work is helping them, you know, develop and execute communication strategies that you know, look really different than companies that are at a later stage. So we're focused more on things that are really educating the market or priming the market for you know, once they have FDA clearance or helping with patient enrollment and clinical studies sharing their story in a way that will resonate to really position them for the next step, either raising another round of financing or, you know, maybe positioning themselves for a specific type of exit, or even doing work that helps them start to recruit, you know, potential employees that they're looking to hire.

So. That's a lot of [00:10:00] what I do. And that can, the actual tactics that kind of align with that can be, you know, connecting with members of the media and then trying to tell those stories through those outlets and those vehicles, supporting trade show, you know, if some of my clients have a booth at a trade show are gonna be at the podium finding the way to really leverage that big investment of their time and resources. You know, a lot of storytelling, a lot of interviewing, key opinion leaders and experts, which is one of my favorite things to do. And then taking that content and using it, you know, in a lot of different ways to help them reach their goals.

Lindsey Dinneen: Yeah. Excellent. And so, you know, medtech and health tech, all of that is just such a heavily regulated industry for very good reason. Now, when you are on the PR side and the marketing side, it's a very different animal, say, then, you know, other types of PR for other industries basically. And so I'm wondering how do you navigate being [00:11:00] cognizant of all of the regulations and being compliant with all of that, with your storytelling and perhaps, you know, wanting to share more, I suppose.

Hyedi Nelson: Yeah, I have so many thoughts around this topic. It's actually funny, I'm working on an event that Bellmont Partners is putting on in the spring that's gonna like tackle that exactly. It's about like infusing creativity into medtech marketing while being compliant, basically. So exactly what you're asking about. Part of, I think my answer to this question starts with the fact that I worked for a couple years for an integrated nonprofits' healthcare provider and payer and I worked on their individual Medicare plans. And so everything I was doing needed to be reviewed and approved by CMS. And I think working in that space and within those types of constraints really [00:12:00] primed me for being able to like be as creative as possible without like sacrificing anything that would make them fall out of regulation or compliance.

I will say that a lot of it has come from experience seeing different things and just learning what the guidelines are and what's okay and what's not. I love to get really close and have a great working relationship with my clients' regulatory folks. And I think sometimes there's a little bit of like tension between marketing and those folks. And I've seen that. But you know, if you really keep in mind like that, what they're trying to do and they're doing their jobs and and knowing when it, you know, it might be appropriate to push back or trying to work together collaboratively, you can still come out with a really great product.

And then I think we as an agency, just at the end of the day, like, we don't wanna get a warning letter. We don't want our clients to get a warning letter. And so, we just always have that in mind and [00:13:00] and know that like at different stages that the company is in, we're able to say different things. So early on, we might need to be a little bit softer in our language and only talk about certain things, but knowing that down the road we'll be able to say more, is also helpful.

Lindsey Dinneen: Yeah. Yeah, I think that's great advice, and I think it's, it's helpful to know that there are ways to do that. I love the fact that you collaborate so well with the regulatory people. I think that makes so much sense. I, and actually that brings up a really good point I wanted to ask you about too, is just in general with-- especially with this industry-- I feel like when you're doing marketing and PR, that collaboration within the company itself is so critical. So you're not just necessarily speaking-- and please correct me if you have a different experience-- but you're not just necessarily speaking to the marketing people, but hopefully if you have the opportunity, you're also speaking to the engineers and many different facets of the company. [00:14:00] And one thing that I've always really enjoyed the challenge of, and I'm curious about your take on it, is how do you translate sort of that engineering speak, the scientific speak-- which is really important to include as well-- but how do you translate that into, again, storytelling and messaging that might resonate with a broader audience than a highly, you know, technical background might have?

Hyedi Nelson: That's a really great question, and what I spent a ton of my time doing is figuring out just that. We love and I love-- especially when we're first starting out with a new client, but we do this kind of on an ongoing basis-- is getting a bunch of people around a table that might not necessarily sit around a table. And that can either be an actual table or like, you know, how we're talking right now. And, we try and have a good representation of all of those different voices, like you're talking about. Members, you know, they're out in the field and they're, you know, more of like on the sales side of things as well as those engineers, as well [00:15:00] as, you know, maybe that, you know, an end user, maybe a patient, if that's possible, in addition to leadership, marketing and the other folks that you'd expect us to be talking to. And we play that third party role of asking questions, hearing the different ways that people that all work for the same company answer the questions differently because, you know, they have different perspectives and you know, different priorities.

And I think one thing that I feel like I've developed a skill around is being able to like hear all of that and take all of that into consideration 'cause it's all very valid, but then pull out the pieces that ultimately you know, get at what we've heard or the company's objectives. And so I think then taking that and then applying it, whether it's distilling down technical information into digestible language, or if it's just, even just tweaking it to pull out like things and prioritize [00:16:00] it differently because certain audiences obviously care about certain things more than others. I think part of it is just putting yourself in those audience's shoes and thinking about what they care about.

And it seems like kind of obvious, but it's not like everyone is working on so many different things and there's so many different competing priorities that feel like that's kind of where myself and my team, like we really provide value because we're able to like come in and take that perspective and do that. And then of course, you know, making that a collaborative process as well. So making sure I didn't dilute the messaging too much and really working with those subject matter experts to make sure, like explaining, "Yeah, we can't say it that way because they won't understand it, but does this, is this what I'm saying, still accurate?" And having those kinds of conversations, and sometimes it takes a little while.

You know, I found out that engineers, scientists, you know, these really brilliant, you know, medical professionals, like, they're so smart and they've gone [00:17:00] to a ton of school and they do this every day, like they are the experts. And so when I'm coming here being like, "No, we don't wanna say it that way," like, I think, like, I understand why there's like a little bit of hesitation on their part to just be like, "Okay." So really trying to like communicate why, you know, the why behind things. And make sure that they know that, you know, we're all working towards the same goal and just trying to figure out the best way to get there.

Lindsey Dinneen: Oh, I love that. Yeah, I think building that trust that, you know, also on some level, their baby, so to speak, is in good hands. You know, you care just as much-- maybe not just as much, but you do, you, I'm sure that you take on a kind of ownership in, you know, with your clients and their success, and you want them to be able to talk about these amazing innovations they're producing. So being able to build that trust in that room with all those people is such a critical part, but I think it makes a [00:18:00] profound difference.

Hyedi Nelson: Absolutely. Yeah, totally agree.

Lindsey Dinneen: Yeah. So, you know, you mentioned kind of at the beginning a little bit about social media, and I'm curious how you've seen the evolution of it in terms of specifically for your clients and for, you know, the health tech, biotech, medtech industries in general. How have you found that companies can actually leverage it in a way that makes sense since it's so niche and they're not necessarily going to need to be on every platform?

Hyedi Nelson: Yes, and it changes like every day, I feel like, the rules and the best practices and how you measure things. I think that what we've found for our clients and for this space that works the best is starting off by using social media as a listening tool. And trying to, we call it an audit, but like really just trying to get a, like a lay of the land before [00:19:00] diving into anything or adjusting anything. So oftentimes, what I think is the most helpful to inform a good social media strategy for a specific company is by taking a look at, you know, what others in their space are doing, what maybe their competitors are doing, where their key audiences are spending their time. And being able to pull some insights from that kind of research can be really valuable in deciding what platforms they actually need to be on, what type of content is gonna resonate, how much they actually do need to post. And those kinds of things because it's so different from company to company.

You know, for example, our clients that are in the urology space, like there's a ton of urologists on, you know, formally Twitter now X, it's just remarkable. But a lot of, you know, when we work maybe in more in the neurology space, it's not so much so, you know, so [00:20:00] it's you can't just go in assuming anything basically. And then I think the other thing is like not taking a set and forget it approach. So like once you start, you say, "Okay. This company, we think LinkedIn makes the most sense for you because you're really focusing on you know, speaking with investors or potential employees. And here are the things that you should be talking about right now." But then knowing that like that's not always gonna be the goals and that's not always gonna be the things that are resonating. And you might start looking at metrics and realize that like maybe what you thought wasn't quite right. So having some humility and being able to like, keep an eye on that and make informed, you know, recommendations to change course if you need to, I think is really important. And that's kind of the approach that we take for, you know, most of our clients when we're talking about social media.

Lindsey Dinneen: Yeah. Yeah, I love that. And what an interesting example about urologists and X, like I, I didn't know that either. So that's such a cool example that, you know, like you [00:21:00] said, research is so critical and trying things and being willing to, to change if it doesn't work. You know, being willing to take those risks, so to speak, although that's kind of a over little bit too strong of a word. But to take those opportunities and see what resonates and what doesn't. Yeah, so, I'm curious, so when you are engaging with a potential client, what are some things that you want to make sure is a good fit for both parties? And then I guess alongside that, when should a startup company or a medtech company engage with you?

Hyedi Nelson: That's a really fantastic question. A few thoughts come to mind. I think in terms of fit, this would probably be different if you were talking to, you know, other consultants or agencies. But for us specifically, we really like to be very [00:22:00] collaborative and be seen as a partner to our clients. And I think both parties get the most value out of it when that approach is taken. So, we always say it's kind of cheesy, but like Bellmont Partners, like "partners is more than just a part of our name," but it's true. And I think that actually works really well in most cases because a lot of our clients, especially the startups, are very lean teams and maybe we are their marketing team or maybe they have one person and they aren't able to hire anyone else yet. And so, you know, by default we really do become that extension of the team.

But it's, you know, of course always great when they invite us to be at the table for certain conversations or you know, kind of understand the bigger picture, strategy and business objectives, because it really does help us do our jobs better and be able to connect more dots and bring up things and ask questions that maybe others, just because they're so in it from day to day, might not see. You know, and for them, I think, you [00:23:00] know, obviously they need to be okay with that and comfortable with that. And I think that thing you talked about earlier, that really important piece about trust is you know, something that might-- obviously trust needs to be built and it's something that can take some time-- but once we get to that point, it's like that's when everything just works a lot better and fits really well.

So, and then, throughout the years, I think we've started working with companies earlier and earlier than we have in the past. And I think that's for a number of reasons. One, I think companies are starting to understand the importance of that. And I think just the way that, you know, the changing in the way investing is being done and other things that need to kind of happen early on or setting that exit strategy and figuring out how communications plays a role in that early on is just becoming more and more important.

I think, from the very beginning is great. I mean there, you know, there needs to be some funding [00:24:00] available, but, you know, we've worked with companies with, you know, just some seed funding, and I think because we're so passionate and because we like wanna be able to build that relationship early on, like oftentimes we will like work in maybe a different way than we would work with other clients, where it's just to "call us when you need us" kind of thing. And you know, maybe we just consult with you and answer some questions and then you can execute. We, you know, we just at the end of the day want them to be so successful that like, that's okay. So, really there's not a time that's too early at least even just have a conversation. So that's what I would say about that.

Lindsey Dinneen: That's great. Yeah, I mean, I think also starting off on the right foot, to be frank, is a huge thing. So if there's the ability for a company to engage with you as early as possible, it's just gonna set them up for success because there's so much value that you all bring to the table. So I'm [00:25:00] also wondering, are there any moments that stand out to you that, you know, along your career path helping these clients just really reinforce the idea that, "Wow, I am in the right industry at the right time."

Hyedi Nelson: Oh, I feel like I'm still like, I have those moments, like every day still, it's, which is why I am still doing this. I guess, I suppose one moment in particular stands out to me. It was like very early on in my career when I was still like even trying to figure out probably honestly like what PR was. But I had the opportunity to sit in on an interview between this amazing entrepreneur, inventor, and a health reporter with a, you know, major daily newspaper. And he was explaining how he came up with the idea for the technology that he created and was in the process of, you know, trying to develop into something that was [00:26:00] gonna go to market. And, you know, he's telling this incredibly personal story about his family and how it affected them directly and how he kind of made it his life's mission to focus on finding a cure and a better solution that was than what was currently available.

And it was like this moment where everything clicked, it was like so powerful. I was like, overcome with a million different emotions. And then I was also like, "I am helping tell this story" and that felt really great too. And so I think that was really powerful. And then, yeah, like moments like that happen all the time where, you know, when my clients get FDA approval and you know, something that they've been working on for so long and, you know, I played a very tiny role in that. But like, it's, that is very cool, and that is a very real confirmation that I'm doing what I'm supposed to be.

Lindsey Dinneen: Yeah. Yes. I could not agree more. I totally relate to the-- you know, I'm not the engineer [00:27:00] who's creating this incredible product. I'm not the scientist who's vetting it. I'm not, you know-- but I, I do get to, to help tell the story and that feels really cool to get to play a part. So, yeah.

Hyedi Nelson: We're so lucky, aren't we?

Lindsey Dinneen: I know. I know. Yeah. Okay, so pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach?

Hyedi Nelson: I feel like there's a couple areas I'd probably focus in on. I think one is more around like more specific to like what I do in my job every day, or even just like how I approach my job and the world, I guess is like-- always looking for connections or dots that can connect. I think even when it does not seem like it is possible, like it probably is. And so [00:28:00] teaching people how you might be able to connect those dots and then, like, why that's important. Whether it's making a connection to someone who, you know, might be looking for something you have to offer or maybe it's oh, there's this weird connection to this investor of this product that like all of a sudden like this new collaboration could be formed that you had never thought of before. It works in so many different ways and I feel like, that is something that like, I feel like I've gotten really good at over the years and would be really like, really fun to share that with other people because it makes me really excited.

And then I think the other thing is more about, so I like to really, I like to speak to college students. I will oftentimes like do guest lecturing at some of the local universities and typically what I'm talking about is like my career path or you know, what the field is like in general or what it's like to work at an agency or that kind of [00:29:00] thing. And I think that being able to teach some sort of masterclass on how to develop confidence-- or even if it's not totally real and you're kind of faking until you make it-- but of being comfortable being in a room that you might not feel like you deserve to be. And I think that can be applied in so many different places.

So like for me over the years, especially working with startups, I find myself in rooms with, you know, physicians with a bunch of letters after their name and they, you know, like performed all of these major surgeries, or I'm with, you know, CEOs of companies who've also founded, you know, dozens of other companies and sold them. And people that on paper and sometimes in person are very intimidating. But like at the end of the day, I'm being hired to do my job for a certain reason. And it took me a long time to be able to get [00:30:00] there to that point and realize that and be able to be like, "Yes, I should be in this room." And now I can do my job better now that I feel that way.

Lindsey Dinneen: Yeah, I love that so much. And I think, and I very much relate to that. I very much understand where you're coming from. I think a lot of people probably struggle with that at some point during their career. You know, imposter syndrome is super real. And I also think that one of the things that I've found for me is really helpful is to be curious and if you're curious, that makes such a difference 'cause you're asking good questions and "Yeah, I'm not the expert, like you're the expert at X, Y, and Z, but I am the expert in the room with this really niche thing." But still being able to say, "I don't know anything about this, can you please educate me?" is-- it can be really helpful too in, in navigating those otherwise uncomfortable rooms to be in. [00:31:00] Did you find that as well?

Hyedi Nelson: Oh, absolutely. But like, you just put it way more eloquently. Yeah, that's really great advice. And I think it just, it sets the tone and like the environment in like a very safe way that I really love. And yeah, like we're all communicators and journalists and, you know, marketing strategists, like most of us come from a place of curiosity anyway, so really leading into that makes a ton of sense.

Lindsey Dinneen: Yeah. Love it. And how do you wish to be remembered after you leave this world?

Hyedi Nelson: I mean, gosh, like hopefully people thought I was nice. I, you know, it would be amazing to have people think about me in that I really cared about others and really cared about making a difference. And whether that's through my profession, but you know, also in how I'm [00:32:00] raising my child or how I'm spending my, you know, free time and volunteer work and that kind of thing. I hope that's what really shines through. And you know, maybe some of the things that, you know, you aren't as proud of people just kind of forget that conveniently.

Lindsey Dinneen: Yeah, I, yes, I understand. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it?

Hyedi Nelson: I have two answers I think for this. So, professionally, I would say I worked with a hearing aid manufacturer for a while, and part of what we did is tell some of the stories that they would do on the philanthropic side. And I-- there are things that you just don't think about until all of a sudden it's right there in front of you. And one of the things like [00:33:00] I didn't, I guess I just didn't realize, was like how powerful and impactful someone not being able to hear, to being able to hear like what that looks like and how that can be.

So, what we would often do is pitch local media in certain areas about someone being gifted hearing aids, and then there would be, like a news story would be the deliverable there, and and it would be like this moment of someone being able to hear again. And there were a couple instances where it was like a child hearing their mom's voice for the first time. And like, obviously like I was also crying, but like smiling and I can, if I need to smile, like I can just like cue that up in my memory and it makes me smile.

And then my other answer is like, anytime I see any sort of living creature of any kind, basically like if I'm on a walk and there's like a caterpillar, like I smile and I get very excited. So that's probably the other [00:34:00] one.

Lindsey Dinneen: I love both of those answers so much. Yeah, those videos of especially the child hearing their mom for the first time or something like that. Oh my goodness. I'm just like, "Did I need to cry today? I guess I did!" But also it makes me smile and also every little living creature, so yeah. I, I love that so much. Well, this has been an amazing conversation and I really appreciate your time today and I am so excited about, you know, where you are heading professionally. In fact, I feel like I saw on your LinkedIn profile, you just won an award, didn't you? 2025 Women in Business something?

Hyedi Nelson: That was, that was a very cool, unexpected thing. Yes, the Minneapolis St. Paul Business Journal, our local business journal, has a Women in Business list, and one of my colleagues was kind enough to nominate me and I was selected and got to do the whole you know, award ceremony and, you know, remarks and [00:35:00] it's been great. It's been, I've met so many really amazing people through that experience, so.

Lindsey Dinneen: Love it. Well, congratulations on that, and I am delighted to continue to stay in touch and, you know, follow everything that you're doing. But thank you so much for your time today, and thank you so much for everything you're doing to just change lives for a better world.

Hyedi Nelson: Well, and likewise, thank you for this podcast existing. It's so wonderful and you're such a great host and and keep up your amazing work as well.

Lindsey Dinneen: Thank you. All right. Thank you so much and thank you to our listeners, and if you're feeling as inspired as I am right now, please share this episode with a colleague or two and we'll catch you next time.

Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving MedTech clients worldwide to securely design, manufacture, and test class two and class three medical [00:36:00] devices. Velentium Medical's four units include research and development pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval, contract manufacturing, building medical products at the prototype, clinical and commercial levels in the US as well as in low cost regions, in 1345 certified and FDA registered Class VII Clean Rooms, cybersecurity generating the 12 cybersecurity design artifacts required for FDA submission, and automated test systems assuring that every device produced is exactly the same as the device that was approved. Visit velentiummedical.com to explore how we can work together to change lives for a better world.

Katie Bochnowski is the Senior Vice President of Customer Success & Services at NowSecure. Katie shares her journey from studying cyber forensics at Purdue University to becoming an expert in mobile app security and forensics. She discusses the impactful work her team does in securing mobile apps, especially in the medtech industry. Katie also offers valuable advice on building relationships within organizations, the importance of security best practices, and staying curious as a professional. 

Guest links: https://www.linkedin.com/in/katiestrzempka/ | https://www.nowsecure.com/

Charity supported: Save the Children

Interested in being a guest on the show or have feedback to share? Email us at [email protected]. 

EPISODE TRANSCRIPT

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am absolutely delighted to introduce you to my guest, Katie Bochnowski. Katie is Senior Vice President of Customer Success and Services at NowSecure co-author of the book, "iPhone and iOS Forensics," and a recognized expert in mobile forensics and app security testing.

Katie holds a master's in Cyber Forensics and Bachelor's of Science and Computer Technology from Purdue University. In her current role, Katie oversees customer support, onboarding and success departments, as well as the mobile AppSec Professional Services Organization that is responsible for pen testing, training, and consulting.

All right. Well, welcome. Thank you so much for being here. I'm so delighted to speak with you today.

[00:01:37] Katie Bochnowski: Awesome. I'm really happy to be here.

[00:01:39] Lindsey Dinneen: Excellent. Well, I would love, if you wouldn't mind just starting off by telling us a little bit about yourself, your background, and what led you to medtech.

[00:01:48] Katie Bochnowski: Awesome. Sure. So, I'm Katie Bochnowski. I work for a company called NowSecure. My background, dating back many years to school is in computer technology and more specifically cyber forensics. Where I am now is mobile app security. How I got into that industry is, is really from that forensic background. Our company used to do data recovery and forensic investigations on mobile devices, and we kind of quickly realized that mobile apps are storing a lot of data. So we shifted into proactively working with organizations to secure those apps that reside on devices. And in terms of medtech, obviously you can probably make that connection, but we began working closely with first, companies that really care about the data that's being stored, and transmitted on those apps, which absolutely includes medtech industry.

[00:02:43] Lindsey Dinneen: Awesome. Okay, so going back a little bit. So when you were first deciding on college paths and career paths and all those lovely things, what drew you to where you ended up?

[00:02:55] Katie Bochnowski: You know, I don't have a great, like "aha" moment for this question. It was just one of those things. I grew up, I had a computer in my house. I did Typing Tutor when I was really young on MS Dos, and I just always en enjoyed that. I had a friend in high school and we both got interested in making our own website with HTML. So, it was just enjoying being around computers and also tinkering to figure out what was wrong with something from a technology perspective. Purdue is where I attended. Purdue had a more generic computer technology degree that I didn't have to know exactly what I wanted to do. You could try different paths, so that's kind of what got me into it. It's not like I knew I wanted to do that my whole life, but I never really went back or questioned it. I always just kind of enjoyed it along the way.

[00:03:45] Lindsey Dinneen: Yeah. Excellent. Okay, so the phrase cyber forensics is just exciting. So, can you dive a little bit more into exactly what that means and entails and what it looks like?

[00:03:57] Katie Bochnowski: Yeah, absolutely. So, it is exciting- -so much so, in fact, that my senior year of college, the very first time they offered this class, it was called Cyber Forensics, it was an elective and it sounded amazing. And, it was amazing. It was really cool. We went through from start to finish, how you collect evidence from a computer and technology perspective, how you keep it pristine, how you collect the data off of it.

We even got to work with local law enforcement as part of an internship to do all that, so I was very lucky in that my very last semester of my four years, they offered this and I just really, really liked it. It always was there in the back of my mind. So yeah, cyber forensics is really the collective of all things digital, which is everything, now. I don't do, necessarily, that work anymore, but I can't even imagine all of the data collection off of Alexas and, and all of those devices. But yeah, that's, that's kind of how I got into that.

[00:04:56] Lindsey Dinneen: Wow, that's really cool. Yeah. So, okay, so talking about this data collection and all of these things, I'm curious, what are maybe one or two things that just really surprised you when you started getting into the industry and doing the work?

[00:05:11] Katie Bochnowski: I know people always said this, and it shouldn't have been a surprise, but when I first started working for NowSecure-- which was actually called Via Forensics back in the day when I first started-- we worked on a lot of individual cases, so people saying, " Can you recover my deleted text messages, and pictures..." and things like that, and the amount of data that really does reside on those devices still after you delete them, going back months, years. So, I don't know if that's still the case now. I don't know if they do a better job of that, but that was surprising to us.

What was also surprising was how much apps are storing and transmitting data on those devices when you don't think about it. So a lot of these cases that we would work on, they would focus so much on voicemails, emails, photos, and text messages, but nobody ever said, "Hey, can you go check the Facebook app or the Messenger app you're using?" That was something we realized pretty quickly, and were shocked to see-- this was 15 years ago-- how many apps were storing incredibly sensitive information on those devices.

[00:06:20] Lindsey Dinneen: Yeah. And so now that there's more awareness of this and people are maybe, hopefully taking a little bit more ownership of even their own awareness and education with all of it, what do you see are the changes and shifts towards better protection?

[00:06:38] Katie Bochnowski: Yeah. Great question. So there's a couple things: One, people are more aware, so they are leveraging the best practices really for these things. So there's places you should and shouldn't store data on devices, and you should use encryption for sensitive information and encryption that can't easily be broken into. The platforms themselves, too--Android, iOS-- have also made improvements in protecting those sandboxes. But, it's not everything, so you absolutely still have to be mindful of that. A lot of organizations like medtech companies and financial organizations do add a lot of those extra protections. But a lot of people don't, still. They're not either, don't think about it as much or aren't aware of it.

And then the other thing that we see is everyone could have, you know, a hundred percent perfect intentions in storing and protecting that data, but you make a mistake, or you accidentally leave a debug flag on or something like that, where this information still can be accessed even though developers and security organizations are following the best practices there.

[00:07:51] Lindsey Dinneen: Hmm. Yeah. So as you look toward the future of device security in general and cybersecurity, what are you looking forward to in terms of improvements, and hope for the future? Because I know there's a lot of things to worry about, just in life. But, what are some of the things that you're hopeful about?

[00:08:11] Katie Bochnowski: Yeah. I'm hopeful for the--I'm going to call it the camaraderie--we're seeing between security and development groups. Not that there was argument or debate between them before-- there probably was a little bit-- but we are seeing a lot more organizations have what they refer to as a Security Champions Program, which brings those groups together.

Security used to be seen, and probably in a lot of cases still, is seen as that blocker. Developers are being rushed and pushed to release features quickly. They have deadlines, timelines, and then if security finds an issue, it has to go back to the drawing board to remediate. But, with these programs, we're seeing either a development group that has a security champion there, or just teams kind of melding together a little bit more to build that testing earlier on. That's a trend we're seeing increase more and more. And, I believe that's going to only continue because it's just the right thing to do for everyone all around.

[00:09:12] Lindsey Dinneen: Yeah, and that collaboration piece is so critical to eventual success, or hopefully even shorter-term success, like said, so that there's not as many iterations. It's like, "No, let's just integrate and do this from the start well together." Yeah.

[00:09:27] Katie Bochnowski: Yep.

[00:09:27] Lindsey Dinneen: Cool. Okay, so, you started with NowSecure, and then eventually you got your first medtech client. Could you talk about that experience?

[00:09:36] Katie Bochnowski: Yeah, absolutely. Actually, before I even started with NowSecure, I worked for a Fortune 100 company in their security department doing firewall rule management. And, it was all good and everything, but I remember thinking throughout my career, I'm the type of person that likes to do things meaningful, making an impact on people.

So, for many years, I was like, "Okay, what am I doing? I'm just executing firewall rules, I'm recovering data..." That's why the forensic work was so appealing to me because you were actually helping assist with investigations that mattered. Then, getting into the mobile app security industry was certainly important, but it took it to a whole new level for me when we got our first medtech client.

I remember going on site and seeing some of the things that the apps can do in conjunction with medical devices, implants, et cetera, and thinking, "If you get this wrong, this can impact a human life." That helped bring all of this to a whole new level, and it's something I talk about internally within our organization as well to help people understand how meaningful it is --what we do, what the medtech industry does, and how important it is to get security right. It's just helped me with a new perspective. I love working with our medtech industry clients. It's contagious to be around them and see how much they care about what they do, and, how important it is to their lives --makes an impact on the way I work as well, then.

[00:11:06] Lindsey Dinneen: Yeah, I love that. I think that's so true. I get so inspired by even just talking with these incredible founders, their devices and their heart behind why they're doing what they're doing. It's not an easy road so choosing to do so, and then hearing that passion is what drives them sometimes in those crazy late nights, early mornings, hassle in between, you know?

So you started getting medtech clients, and now you've developed a niche offering for that group. I'm wondering, what are some of the common themes that you see companies maybe aren't aware to consider when they're starting their development of their devices and apps? And, perhaps just some general advice: What should people be on the lookout for?

[00:11:50] Katie Bochnowski: Yeah, so I guess you-- I shouldn't say unique, but specific to organizations like medtech industry or, financial or healthcare and the apps they build-- is that highly sensitive information. And so I guess my advice and the thing I would point out that I see in those types of applications is not only, of course, best security practices and understanding what's unique in mobile is super important because web apps have been developed for many, many years. Mobile apps now have been many years, but people don't necessarily know that it is unique in the way that they are developed and the different attack surface, right? You have the local device attack surface. You have the attack surface of other apps that could be malicious that are installed on that device.

So, understanding what those mobile unique security best practices are is my number one piece of advice for developers. Number two would then be multiple layers of security protection. So, developing a secure app is one part of it, and a very important part of it. What we see is a lot of organizations sometimes are dependent on either the protections of the device OS itself--the Android OS protections or iOS protections. And, there are tools out there that offer protections like tamper detection: If you detect the app is being tampered with, don't launch it. If you detect the app is installed on an exploited, rooted, jailbroken device, don't launch it. Or, don't allow login.

Those are important, but those can be bypassed and so I say multiple layers of protection. I'm not against those protections. I think they're very important. I think you should do them, but you should also assume in some cases they can be bypassed, and you need to have that foundational security in the way you develop your applications.

[00:13:48] Lindsey Dinneen: Yeah. So, you've had a really interesting career so far, and I'm sure you've seen a lot of things over the years. What are some moments that really stand out to you, especially with your medtech clients, as, as hitting home that, "Wow, I am in the right place at the right time, making an impact."

[00:14:09] Katie Bochnowski: I think it's hard because it's not like there's one single moment. Because what you want to avoid in this industry is a breach, is something like this "oh my gosh," this big negative moment. And so honestly, it's seeing the organizations we work with, not having that happen. When you do see a breach that might be mobile-specific, I immediately jump in and see, "Okay, what happened? How did they exploit this? What was the actual vulnerability that led to this?" We check for that, and we help our customers test for that and knowing, "Okay, whew. They're covered." And we see that kind of stuff all the time. So I don't have, necessarily, a big moment, but I do have those moments along the way where it's like, you see something in the news, and you are not surprised by the way that was exploited. It's something that is foundational to mobile app security, and you know your customers are protected.

[00:15:09] Lindsey Dinneen: Yeah. Well, that's a really good reminder in general because sometimes you get those big, crazy, sort of in-your-face moments that are going, "Yes, okay, I know why I'm here." But then, those don't happen all that much, usually. So having those little encouragements along the way of, "No, you're on the right path, you're doing the right things is incredibly...

[00:15:30] Katie Bochnowski: It's funny; it actually reminds me of sometimes we'll work with customers and they'll use our products or services--and, they'll be upset because we haven't found anything in a certain amount of time. Seriously. And they're like, "You must not be testing enough" or " You haven't found anything high risk in six months." Sometimes, we have to remind them that's good. "Green is good," is what we always say. "Green is good." And, of course you want to check and make sure you're doing everything, in depth as possible. But, if you do a full two-week pen test and nothing big is found, that's good. You're doing a great job. So, take the win. Green is good.

[00:16:07] Lindsey Dinneen: Green is good. I love it. Words to live by. You have had a really interesting trajectory even through NowSecure, but throughout your career and you've stepped into different kinds of leadership roles. I'm wondering how has that evolution been for you as a leader? What are some of your key takeaways that you've discovered work really well, and maybe some lessons learned?

[00:16:29] Katie Bochnowski: Yeah, so I was not the person coming out of college that said, "I want to get my MBA, I want to be a CEO, I want to be, you know, high up in an organization." I just knew I liked computer technology, I liked tinkering--that kind of stuff. So I wanted to do things that were interesting. Via forensics, and now, NowSecure really was amazing for me because I got to do all of that. I got to grow with the company. I was really the first employee with the co-founder here, and as the company grew, I naturally started developing the managerial and the leadership roles as we hired more people and got more clients.

So for me, I learned on the job, along the way, and when I think about it, I see people that are very ambitious to be a manager and, that's okay too. The best leaders that I've seen have been leaders that have naturally and organically developed a mutual respect, trust, and collaboration with their teams, seeing them as partners and peers and not someone to delegate things to in an authoritative way. And that's not just necessarily from a managerial perspective, because I see individual contributors, on my team for example, that exhibit amazing leadership skills, developing those relationships with other departments. And when you do that, you get-- I don't mean this in the way it's gonna sound, but you get people to do things for you because they want to, because they want to support you.

And so that's what I always like to focus on is, just building those relationships, having empathy for other people. And, of course there's delegation that comes with that, but when you do that, then they want to do that for you or for the organization because you've, you've built that foundation.

[00:18:20] Lindsey Dinneen: Yes. That's great advice. I really appreciate that. There were several things in there that, stood out to me. One of them was your comment about even individual contributors can be leaders, so even if you are not technically in a managerial role, or you don't have anyone working underneath you at the moment, doesn't mean you can't develop those skill sets and lead yourself and lead your own direction. So I think that's a really important note. And, something to give a little bit of perhaps inspiration, too. So if you want to be in that leadership role at some point, but you're not there yet, doesn't mean you can't build the skills along the way.

[00:18:54] Katie Bochnowski: Yeah, absolutely. And I think about, I, I have heard people in the past say, "Oh, I can't go ask them to do something. I don't have the authority to do that." I hear that a lot. " I'm not their manager. I can't tell them to do that." And then there's people that don't even think that way, and just build that relationship and get others to collaborate and work with them. Those are the natural leaders that managers are going to see and want to promote to be the next manager. Right? So, if I'm gonna give another piece of advice, it would say, never say, "I don't have the authority, or I don't have the power to do that." Or "It's above my pay grade" is something that I'm like, "Oh, don't say that," because nothing is. You just need to learn to work with others to figure out how to do that.

[00:19:41] Lindsey Dinneen: Yeah, and I think you're absolutely right about relationship building and collaboration being such a key to success in general. I mean, I think about all of the opportunities that are created and these sort of magical, what feel like magical, synergistic moments that happen, but they're not magical. They're because of intentionally cultivating these relationships. So yeah, I love that. And then helping people come up alongside you. So that's actually a concept I'd love to hear about your experience, either as a mentor or mentee, or anything like that that you've experienced that has really been inspirational to you.

[00:20:18] Katie Bochnowski: Yeah. Well, I guess I have maybe two examples. I had someone that was working on my team many years ago and, again, we worked very closely as, I saw him as a partner and he got to a place basically at the organization where I would always tell him, "We could switch jobs, and you could do this and I could report to you and it doesn't matter," because I saw him grow that quickly. And he is now in another position that's probably double my pay and I don't know. But that's... you want to see that. And, some people might be threatened by that, but you shouldn't be, if you are doing the right thing because you want to see people grow into those roles.

I don't know if this directly answers your question, but there is a leader who's a CEO of another organization who I have always looked up to, and I just see this is exactly how she leads. You know, everybody respects her. Everybody wants to support her and her mission at her company. Even when you're not working at her company like me, you just see the way she leads and the way she has built relationships throughout all of the employees in her organization. It's just something that I aspire to.

[00:21:27] Lindsey Dinneen: Yeah, absolutely. And sometimes it's really helpful 'cause you'll get your share of... well I think most people at least have had the experience of getting their share of people in leadership roles that they would maybe not wish to emulate. So getting to be inspired by the people who are doing it correctly is is lovely. Yeah. Yeah. I love that. What is your number one, if you could boil it down, piece of advice for ordinary folks who are looking to up their own security game and just be more aware.

[00:22:04] Katie Bochnowski: Be curious; don't wait for someone to show you or teach you how to do something. Part of what I oversee is managing a group of mobile app pen testers, and the best pen testers that I've seen are not the ones that have tons of experience or skill. It's actually, we've had two interns come straight out of school, come in and just dive into things without being asked, and just go figure it out and learn. And so be curious. Go try online exams and labs, even if you have no clue what you're doing, just try it, research and figure it out, and be curious. And I guess that's my biggest thing.

[00:22:45] Lindsey Dinneen: I love it. Yeah. Curiosity gets you far in life. Yeah. I love that. Okay, so pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It doesn't have to be in your industry, but it could be. What would you choose to teach?

[00:23:07] Katie Bochnowski: Okay, this might take a nerdy turn.

[00:23:11] Lindsey Dinneen: Excellent.

[00:23:12] Katie Bochnowski: And I would need a lot of education or somebody else who's an expert in this to actually teach the class. But, I've personally gotten really interested the last couple years into brain health, neuroplasticity, managing stress, and the importance of it. And, this is from a personal situation that I went through and not really understanding how just everyday, little stressors--I never saw myself as a highly stressed person. I was actually quite the opposite--but, when you internalize a lot of, just like I said, everyday stressors, doesn't have to be anything big-- arguing with my daughter every morning to get dressed before school has an impact on your body and your brain health. And it started having physical symptoms in me that got scary, right?

I don't need to dive into that, but from that, it helped me in meeting with a bunch of health experts and learning that what an impact your brain health really has on you. So if I could go back and teach some of the exercises that I was given--super simple things like these little games on your app that just help work different areas of your brain that you don't normally work. When you get into a routine at work, and every morning you wake up, send your kid to school, sit down at your desk, do the same meetings, emails, you have the same routine every day--you don't have, just a change in your routine, or try new hobbies, things like that, then your brain doesn't grow and, and that affects your health, and your mood, and all of that.

I've just learned so much about that, and I remember getting to a point where I was like, "Why isn't this a class, a required class, in high school, college, and beyond. It should be part of onboarding at every job. So I guess that's my answer. I don't think I'm quite qualified to teach it, but I'd love to attend it.

[00:25:14] Lindsey Dinneen: There you go. You can facilitate it. How about that?

[00:25:16] Katie Bochnowski: Yeah.

[00:25:17] Lindsey Dinneen: Excellent. Excellent. Yeah, and how do you wish to be remembered after you leave this world?

[00:25:24] Katie Bochnowski: Oh, this is the hard one for me. I think it's probably a cliche answer, but just, you know, caring for others, doing things for others, being kind-- just being a good person...

[00:25:38] Lindsey Dinneen: Yeah.

[00:25:38] Katie Bochnowski: ...is really all I want.

[00:25:40] Lindsey Dinneen: Yeah. Very nice. And then final question. What is one thing that makes you smile every time you see or think about it?

[00:25:50] Katie Bochnowski: Oh, this is also gonna be probably a common answer--my daughter, my daughter, who is six, going on 16, very much a teenager, but I remember a friend of mine telling me 'cause I remember asking her, when your child grows up, isn't it so sad that, oh, they're no longer a baby, they're no longer one, like to see them grow up. And she said, "Well, maybe a little bit. Each stage is something so new that you're so proud of, of what they've developed and grown that you don't even really think about that." Oh, and it's so true. It's just seeing her read and seeing her-- she's going to be a future leader. I guarantee it.

[00:26:27] Lindsey Dinneen: Yay!

[00:26:28] Katie Bochnowski: Just the way I've seen her, and so just seeing that, that pride overcomes any kind of, oh, I miss that one. But, of course, I still miss her when she was a baby. But, yeah, so that makes me smile. That and yoga!

[00:26:42] Lindsey Dinneen: Yes. Yoga is so wonderful. I mean. Yeah. And speaking of ways to help de-stress, calm down a bit. Yeah.

[00:26:51] Katie Bochnowski: It has helped me dramatically, for sure. So...

[00:26:53] Lindsey Dinneen: Excellent. Excellent. Well, it has been a true pleasure and honor to have you here today, Katie. So thank you so much for spending a little bit of time, and we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. We're grateful, and I wish you the most amazing continued success.

[00:27:33] Katie Bochnowski: Thank you for having me. This was awesome. I appreciate it.

[00:27:37] Lindsey Dinneen: Awesome. And yeah. Thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you shared an episode with a colleague or two, and we'll catch you next time.

[00:27:52] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Charu Roy, Chief Product Officer at Enlil, shares her extensive journey in the software industry, which began in the late 1980s and evolved into her leadership role in medtech. Charu discusses her role at Enlil, where she oversees the development of an AI-powered platform to enhance medical device lifecycle management. She emphasizes the importance of understanding customer needs, fostering team potential, and ensuring cybersecurity in medtech software solutions. With profound insights on her career growth, leadership style, and the technological advancements propelling the industry forward, Charu's story is an inspiring tale of innovation and dedication to improving lives. 

Guest links: https://enlil.com/ |  https://www.linkedin.com/company/enlil-inc/

Charity supported: ASPCA

Interested in being a guest on the show or have feedback to share? Email us at [email protected]. 

EPISODE TRANSCRIPT

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and today I'm absolutely delighted to introduce you to Charu Roy. Charu is the Chief Product Officer at Enlil, where she leads product strategy, vision, and execution for the company's AI powered medtech development platform. With over two decades of experience building and scaling enterprise software products, Charu brings deep industry expertise in product management, user-centered design, and go to market leadership. Before Enlil, she held senior product roles at industry leaders, including Epicor, Oracle, I-2 Technologies slash Aspect Development, HP and Agile Software, where she drove software innovation across enterprise cloud SaaS and data driven solutions. Known for her ability to align customer needs with business strategy, she is passionate about delivering products that transform complex industries and enable measurable impact.

Well, welcome, Charu, to the conversation today. I'm so excited to be speaking with you.

[00:01:54] Charu Roy: Thank you so much for having me. I'm very really excited about being here on this podcast.

[00:02:00] Lindsey Dinneen: Oh, awesome. Yeah. Well, I would love, if you wouldn't mind starting off by sharing a little bit about yourself, your background, and what led you to medtech.

[00:02:10] Charu Roy: Sure. As every other sort of person who gets into the software world, I came in a while back in 1987 to 89, where I did Master's in Computer Science at University of Louisiana. That was my first introduction to America, really. And computer science brought me to the Bay Area where I worked at HP, Hewlett Packard. In those days, it was called Scientific Instruments Division in Palo Alto. And there I programmed robotic hands to, to sort of move that, the vial from samples, drug samples from athletes so that they could get tested for drugs. So, I didn't know the importance of all this. It was my first job. I enjoyed myself seven years, you know, software programming, really, and understood how a large company works.

And then slowly I started getting a little bored. So I went on to my next startup and was involved in the same kind of principles that drive things today. So I just sort of built my way up. In terms of the software, I joined different groups, ran consulting services, ran engineering, and sort of worked myself up through the ranks and into sort of more decision making capabilities, and you know, continued to join companies and learn new things and leave them for some better opportunities.

So I moved from Hewlett Packard to a startup that was called Aspect Development, which got sold to I-2 Technologies for $9.3 billion in those days. So, you know, I went through that acquisition, trying to understand the market, what kind of software triggers buying, you know-- so sort of just the software aspects of how to sell software, how to develop software, how to deploy it. So in general, I was learning all of the ropes until I came to Agile PLM, which is a company which, very popular company which made it very sort of easy to deploy software, especially software called Product Lifecycle Management.

So I was -- here, I was in and out of companies, learning and understanding the world of software until I fell into med device companies being my customers. So med device being our customers meant, you know, a lot more strictness, a lot more process, with the software itself. So here I was trying to now go through those kind of features, trying to understand what med device needed when they were building products.

So, from Agile, I went to Conformia. Again, it was the same, it was regulatory product for wine, spirits and pharma --very adjacent to med device. But again, it was the same thing about how to be provide, how to provide a traceable platform where our customers can trace there, the make of the wine or make of the spirit, or make of a pharma drug or make off of med device. All the principles underlying it are the same because it's a regulated product at the end of the day, but so that's how I kind of fell into it, and I enjoyed every bit of that until I got acquired by Oracle.

And so I continued at Oracle doing the same thing over and over again; rebuilt the same products again at Oracle in the clouds, and I was managing the old Agile products. So it's an interesting journey where I was, you know, started off as a software programmer. And I didn't know anything about, you know, the use cases until the time I sort of joined Oracle and understood my customers better. And that's how I came in there. And of course I was at Epicor and finally I made my way to Enlil, which is a very small company, and I'm doing the same thing again. It's just with a different set of customers, very small to medium sized companies. So that's how my career sort of spanned 30 years.

[00:06:11] Lindsey Dinneen: Wow. Oh my goodness. Well, there is so much to dive into all of that. Thank you for sharing. It's so cool to hear about all of the winding paths that lead us to maybe, you know, where we're meant to be in, in any given season. And yeah, I just love learning about it. So, okay. So I'm curious, you know, way back when did you like growing up, did you always have an interest in computers and computer science? Is this something you knew you wanted to get into?

[00:06:40] Charu Roy: Not at all, actually it was a suggestion, and in those days, parents kind of suggested that you be a engineer or a doctor or a chartered accountant. The choices were very limited. And so my father said, "you will do computer science." And I said, "okay." And there I was and there was no, no sort of emotional attachment to any of those professions. And, I liked it well enough to continue, and I found it was easy enough to understand the principles and work at it. So yeah, there was no-- you know, in these days I think kids are training themselves like by seven or eight to program. And I'm seeing, you know, machine language I mean AI, ML, LLMs being taught to seven year olds and sort of trying to shape them, but in those days it was just some very simple choices, I guess. So, yeah, not a very romantic story. I was never programming younger in my younger days, but I think you know, compared to all the choices youngsters have these days, but just fell into it.

[00:07:44] Lindsey Dinneen: Sure. Oh, how fun. You know, even though, yes, it was somewhat prescribed for you, at least originally, and I'm so glad that you fell in love and it ended up being a happy place for you because...

[00:07:57] Charu Roy: Yeah, and I think I fell in love with the customer, how customers reacted to the software. I didn't fall in love with the software delivery process or anything else, but it was just the way customers said, "oh, I like that. It's gonna make it easier for me to do something. I'm having a tough time tracking it on paper. I just hate it what I'm doing right now, and your software will help." So I think that's a part that makes me feel really pleased that okay it's going into some good hands and it's going to be used.

[00:08:30] Lindsey Dinneen: Yes, by people who really appreciate and value what you can contribute, what maybe comes --at this point, I guess-- naturally to you. And so it's, you're able to translate somebody's ideas or dreams into a really tangible solution.

[00:08:48] Charu Roy: Yeah. And in fact, somebody's pain points, like they're really sort of, trying their best to use little resources they might have, wasting a lot of time on either tracking something on paper or in emails. And I think those are the kind of pain points that I really like to understand and say, "Hey, will the software help really help your day to day life? Will it make it easier to find things?" I think that's where I find my sort of biggest thrill of when a customer says, "Yes, you shaved off three hours of my time by giving me this efficient system."

[00:09:26] Lindsey Dinneen: Nice. Yeah. Oh my goodness. Yes , and the products that you're making are indeed life impacting and make a difference. And that is rewarding because you know that the work you --do all work is important, but it's really fun when you get to know personally the impact that you get to have.

[00:09:45] Charu Roy: Right, right.

[00:09:46] Lindsey Dinneen: Yeah. Yeah. So, okay, so I'm, I'd love to dive in a little bit more to your current company and role and learn about that, and how you're helping, you're still helping people you know, win through this.

[00:10:00] Charu Roy: So, yes, absolutely. Enlil is part of Shifamed, the portfolio. Shifamed invests in med device devices typically, so ophthalmology devices or cardio devices. Enlil came about as an enterprise software company within the portfolio because they realized that they needed some software to throw all their data into, right? So they had early designs, prototype data. They might have had some user requirements, what kind of standards they might have to follow. So all those were floating about, again, in emails and paper.

Enlil came in saying that we can store this data more successfully, more cleanly in a structured fashion so that our users can find that data. And this becomes really important as the med device company moves on and tries to apply for regulatory approval at that time, they need all that history and the data behind the device. And they wanna be able to find it easily and present it to auditors.

So, Enlil's a structured way of describing all the data that the customer has and being able to find it easily and then run their audits using the data. So it's a very crucial part of their lifecycle, their product lifecycle. And so it's really important for us to be secure, reliable, available, 24/7. All of that applies to us and basically defines how they go about driving their product lifecycle.

[00:11:34] Lindsey Dinneen: Yeah. Well, and you know, one thing that stood out to me when you were talking about that was of course the security aspect. And as we all know, we're, we're probably much more so than in the past, hyper aware of the critical need for cybersecurity and the role it plays specifically in medical device technology. And I'm curious if you could speak a little bit more to that particular element.

[00:11:55] Charu Roy: Yeah, we have a lot of layers of security, you know, right from the folks who are accessing the software. The software is hosted in a well-known, reputable cloud service environment. So apart from them providing us cybersecurity and access control and everything else, we have another set of layers on top of that. So our users are vetted and they all have a password. People can be invited and not just sort of show up. So, there's a lot of control of what they can see and can do. Every button sort of, you know, has a role behind it or a layer of control. So not everyone can do everything and press any and all buttons. So, security is at many levels. And we also have a lot of audit trails, e-signatures, and so on. So everything is done to protect the data, and audits are run regularly by them and by us to make sure that nobody who's supposed to be, you know, people who are not supposed to see the data, don't see the data.

[00:13:01] Lindsey Dinneen: Yeah. Excellent. Yeah, I know that's just something that is, should be at least, on the forefront, especially of startups' minds as they're thinking about this and working towards having a really secure device. So it sounds like you've built in all of that safeguarding really well and really intentionally. So, so, okay, so I know that -- well, there's a few things that really stood out to me on your LinkedIn profile, and I'm just curious if we could dive into a couple things. One was, I love how you said that you're "passionate about teams and people delivering to their full potential," and I was wondering if you could speak a little bit more to that.

[00:13:42] Charu Roy: Yeah, so, you know, along the years I've noticed that people in my team, the team members, they're there, they're working hard, but I do like to understand what's making them tick, what might they be wanting to do, which they haven't got gotten to do yet. Can we unlock some potential, some skill, some talent? And I think that comes about by sort of just talking about it , trying to give them openings about, "Hey, look, I've got this cool project or this cool feature. Any thoughts on that?" Just to understand, are they happy doing what they're doing, or is there something more they could do?

And so I think that human touch, you know, is -- it was given to me, or at least it was taught to me by some mentors along the way. And I think that's a part that I really like to explore and see how can teams do better, not just in a numbers, not just turnaround features and releases on time, but are they happy doing it? Did they contribute something meaningful along the way? Did they feel they grew in the process? Did they feel they were recognized for some new responsibilities that they may not have stepped up for in some other companies? So that's a feeling I'm trying to always give them and sort of hoping that we contribute to their growth, not just the company and the bottom line.

[00:15:02] Lindsey Dinneen: Yeah, that's critical and key,, and really speaks to who you are as a leader. And I'm actually very curious, you know, you mentioned earlier having kind of worked your way up at HP and then, you know, that may be opening some doors for you for of course, your future opportunities, and I'm curious, what has your own leadership journey looked like? Has, does leadership come naturally to you? Have you spent a lot of, you know, time and resources, whatever, developing those skill sets or how did that work for you?

[00:15:29] Charu Roy: I think I was thrown into the deep end of the pool several times, you know, like, so I kicked into the pool, so to learn to swim. So similarly I was made to take on responsibility pretty much the very beginning. So I kind of knew that there were certain things expected that I should be doing, can be doing and then this introspection saying that, did I give the right amount of energy to that particular responsibility and did I do well?

So just a lot of introspection and being able to understand, did I do well as a leader? But I've been honing it, honing skills. I mean, nothing out of an MBA school, nothing out of, you know, college that helped me. I think it was just about pure interest in psychology, pure interest in humans, you know, just being able to connect and how did I make them feel? How did they make me feel in those interactions? And is that, was that good? Was there something we could do to incorporate more people to get that feeling of ownership or anything?

So it wasn't a, you know, by rote or something that I learned in a school. It was more of just sort of. Being thrown into situations where I had to come out of it somewhat gracefully and some somewhat feeling like I had also learned along the way.

[00:16:46] Lindsey Dinneen: Yeah. Yeah, that, that's wonderful and incredible. And I think, you know, you mentioned learning along the way, and one thing also that stood out to me was, the recommendations on your profiles are so lovely for you. And two things stood out: they, one thing was somebody mentioned you're always learning, which is a gift in and of itself. And then the other thing was you're always letting others succeed. And that's such a beautiful gift and I'm wondering if you could talk more about both of those as well.

[00:17:16] Charu Roy: Yeah, I think it's not about just me being sort of the boss and being able to tell people what to do, though I think success comes from enabling or encouraging the teams to again contribute without any barriers, any levels, or politics. I love the fact that we are in a small company, and I can say safely that, you know, politics --in larger companies there are politics. People are always trying to sort of be showing that they are very valuable. But in a small startup, it's very quickly apparent that there are certain valuable players there and startups, everybody is valuable, right?

So I think being able to encourage the team members to do what they think is best for the problem to solve it. And of course, there are reasons why you can't sometimes accept the solution, but the fact that they're thinking about it and the fact they're able to openly express their opinions and say, "No, you're wrong, Charu." I think this is the way to do it. I love that. I think, somebody disagrees with me in a meeting, I just think that's the best thing that could have happened as a style of management.

Because I'm not, you know, insecure in that sense. I don't sulk afterwards. I have had bosses and so on who don't like that kind of, you know, disagreements in public. And I think that's a part where I beg to differ, and I want to have people say what they think, what are they feeling, what are the problems, really the truth, and fix it, really. So I think it's less waste of a time when people are honest, and get to the point, and we are able to solve it together rather than hide behind, you know, facades, I guess.

[00:19:01] Lindsey Dinneen: Yeah, that's beautiful. And yeah, I've often said for me personally, that, you know, more heads are better than one. I mean, I could have a, an opinion on whatever it is that we're talking about, but really, until we collaborate and start sharing those ideas and those thoughts and opinions , all of a sudden those kinds of sparks happen where, you know, you start with one thing and then it, and then somebody else catches that and they take it even to the next level and it just keeps going. And it's so cool to see the creativity and problem solving and innovation that comes from allowing those conversations.

[00:19:36] Charu Roy: Yes, exactly. Creativity and innovation. You've said it so well. That comes with smart people being in the same room, arguing, not agreeing, and then something comes out of that, right? I mean, either your thoughts get clearer because you've seen every side of the coin and you're able to say, "Okay, I know the pros and cons and we can go this way, knowing the full effect of what we are going to do." So I think surrounding myself with smart people who have varied opinions, I think that's a beauty and a blessing really.

[00:20:12] Lindsey Dinneen: Yes it is, and you've nailed it with varying opinions. You know, it's easy to get yourself into a situation-- and not necessarily intentionally-- but just it's easy to give into a situation where you've surrounded yourself with people who all kind of have the same opinions on things. And so inviting those conversations to take place that might be difficult, might be challenging, might be frustrating at times, but allowing for that and being open to other points of view and experience. I mean, that's the beauty of a really good collaborative environment is all of those varying opinions that don't necessarily match yours.

[00:20:50] Charu Roy: Yes, exactly. Exactly.

[00:20:52] Lindsey Dinneen: Yeah. Yeah. So, okay, so looking back, could 10-year-old you have ever imagined where you'd end up today?

[00:21:00] Charu Roy: No, absolutely not. I thought I wanted to be a doctor or something vague. 10-year-old me was climbing trees and eating guavas off the trees in Delhi. So it was really crazy childhood. And you know, it wasn't filled with studies and rules and stuff. So I think coming to this, a country when I was young, being able to absorb everything, the culture, the of course the education itself and being able to sort of grow within the companies that I joined, i, I think that was the journey that I was sort of a pointing more towards rather than the childhood me. The childhood me was horrible, I think.

[00:21:46] Lindsey Dinneen: Oh man. Honest reflection right there. That's awesome. Yeah, okay. Are there any moments that really stand out to you, perhaps with your current position or, you know, something in your past where you really thought, "Wow, what I'm doing makes a difference. I am in the right industry, at the right time, in the right place."

[00:22:07] Charu Roy: I think it's the technology now that, you know, speaking from a technical viewpoint of shipping software, meaning full software, more easily, the time is now. I feel that the culmination of everything I've learned about pain points and users and customers, all of that's culminating in in the product that I'm managing right now, using new technologies, having the right technologies to choose from and being able to propel that software forward to our users. I feel that, "Wow, what a time to be a product officer really, when we have so many choices and being able to be able to apply that to real world problems and real pain points."

I had the same pain points 20 years ago, even 30 years ago, but we couldn't do much. We had to, you know, write painful programs. We had to write database queries and, you know, things like that. It was quite painful, I would say. And then now to see all the tools where we can create things overnight and be able to ship it to customers, just hitting the nail on the head. We had to experiment a lot in the old days but I think the time now is is really special. We are on an sort of an industrial revolution or a computer science revolution here with the AI, MML, the LLMs, being able to do so much with probably less resources than before. So.

[00:23:39] Lindsey Dinneen: Yeah. So seeing the impact of the work and getting to not have it be so painful.

[00:23:45] Charu Roy: Yes. It used be very painful and now I'm thinking, I think we're at the right time, right place now with this product. And it's not just about the products. It's the kind of help we are getting as software professionals to help deliver software and support our users. I think that's really special and I, we are still learning, we're still trying to understand all the technologies that are available to us and how can we make our lives easier and our customers feel that we've solved some problems for them.

[00:24:14] Lindsey Dinneen: Yeah, absolutely. And I think that there's just, it is really wonderful again-- just to, to circle back to this kind of been a running theme of getting to be able to experience for the end user or with the end user, that moment of, "Oh wow, I needed this is so helpful and it's gonna make a difference."

[00:24:36] Charu Roy: Yeah. I remember in my past, same sort of software tracking wine being made. And that software was pretty cool. It, it used to track where the wine sat and which barrel for how long. And so the pleasure of talking to wine makers, and being able to show them how the software track the progress of the wine and being able to print out a label at the very end for them, saying that "this wine sat in these bottles or these barrels for a while," and that technology application for a simple, naive user, I thought that was it. That was the, you know, the culmination of all the learnings that I had over the years to be able to explain the software so easily to a end user who might be a distiller or a winemaker or somebody, a farmer. I thought that was pretty cool. And that since then, of course, technology has changed, but I think we're beginning to see the effect on a naive user, which we couldn't do, you know, 30 years ago.

[00:25:37] Lindsey Dinneen: Yeah, absolutely. Oh my goodness. That is, it is so cool. And I love the work you're doing and just learning all about your history so far and just exciting to see where it's gonna end up too, and as you continue along your career path, but pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want, could be within your area of expertise, it doesn't have to be. What would you choose to teach?

[00:26:06] Charu Roy: I would probably think about teaching psychology of the individual. I don't have a PhD or a even basic courses in psychology, but I just love the fact that, you know, you can apply psychology, figure out how a user might or somebody might react to something that you say, do, think so I, if it was a master class and I'd be teaching you know, teaching more about life interactions, you know, ordinary interactions. How can they be made more meaningful, more fruitful, using psychological tricks or phrases?

I don't know all of those things, but I would really think that I could teach that based on, you know, facial expressions, body mannerisms, or body-- what do they call it, sort of, you know, criminal stories. They read your mind based on certain mannerisms of flutter viol. So yes, psychology is a masterclass I would teach, but more applied to daily interactions, maybe work situations and being able to use psychology better to improve your own work relationships with people and even just general interactions. Yeah, so that would be my attempt at being a psychologist and eventually be a criminal psychologist.

[00:27:28] Lindsey Dinneen: Yes. Oh my goodness. That would be so interesting. Yeah, I love that idea. And the masterclass sounds fabulous, so I'm signing up whenever you do it.

[00:27:37] Charu Roy: Okay, I'll go get my degrees for it then.

[00:27:40] Lindsey Dinneen: Right, right, right. Yeah. Ah, details. Awesome. How do you wish to be remembered after you leave this world?

[00:27:50] Charu Roy: This is something that I've always felt deeply about. It's not what you say or what you do, it's how you make people feel, that Maya Angelo said that this much nicer than what I'm saying, but and I've had a few people say this to me, saying that, "We worked together 30 years ago, but that day you made me feel good." And I don't even remember what I said, what I did, but the fact that they remember me for what I made them feel. The fact that somebody also told me that they "don't avoid me when I'm walking up to them because, because I make them feel like things are okay, things are good, however bad the problem is." So they say that with other people they would duck and, you know, go away in the opposite direction. But with me they're waiting for me to come up to them. I'd like to continue that, that feeling that somebody feels like, "Hey, you are coming up to them and you just make them feel good in some fashion." Nothing else. I think that feeling, if I could evoke in people, they say, "Oh yeah, she made me feel good that day. I don't know what she said, but she made me feel good." That's enough.

[00:29:01] Lindsey Dinneen: Yeah, that, yes, that is more than enough. What a beautiful legacy. Yeah, and then final question, what is one thing that makes you smile every time you see or think about it?

[00:29:15] Charu Roy: I think my dogs smile. I would say he's got missing teeth and so when he looks at me when I first come, you know, come back home and he is smiling almost, and he is sniffling and, you know, trying to sneeze and smile at the same time. Oh my God, what kind of a character dog this is? So that makes me smile and laugh the whole time, especially the missing teeth. Poor thing. He doesn't understand that his teeth are missing because of me, and yet he's smiling at me, so.

[00:29:50] Lindsey Dinneen: That is so sweet and cute. Oh my goodness. I love, I know somebody at one point said, "You know, dogs don't actually smile." I don't believe them. They smile.

[00:30:00] Charu Roy: They smile and they choke while they smile because my dog has a small nose, I guess. So he chokes when he smiles, and so he is choking, and he is smiling, and this missing teeth there. I was like, "Oh my God."

[00:30:16] Lindsey Dinneen: Oh my goodness. Yes. I mean, that would just I, yes, I can just sort of picture this. I love, love dogs and so I'm just picturing this and I, that would bring me joy every single day, definitely. Excellent. Well, this has been such a wonderful time spent with you today. Thank you for sharing your stories and your journey and your advice, and I really appreciate some of those in particular, your leadership advice, and the impact that you can have as a leader, inviting the collaboration, having conversations that encourage people to have varying opinions and maybe outright disagree with you. I love what you're wanting to, you know, wanting your legacy to be, and so that's how you're intentionally showing up in the world. And so I just wanna thank you so, so very much for being here. We're really grateful to have you.

[00:31:10] Charu Roy: Thank you, and thank you so much for your intelligent questions and insightful questions that go above and beyond just you know, a company and it's gold. It's there, there's something so human about your questions-- and I love when I'm like, "Oh my goodness, this is so, so interesting to see in this day and age, somebody taking the time to ask such questions" and I really appreciate you for that.

[00:31:36] Lindsey Dinneen: Oh, thank you. Well, I really appreciate that feedback too, because it's, you know, you come up with an idea-- speaking of sometimes echo chambers, you come up with an idea and you think, "Oh, this is how I'd like to go about this, but does it resonate with somebody else?" So that's delightful to hear.

[00:31:51] Charu Roy: Fantastic, thank you, thank you for having me.

[00:31:54] Lindsey Dinneen: And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to support Thank you so much, and gosh, I just wish you the most continued success as you work to change lives for a better world. And to all of our listeners for tuning in, I wanna thank you for being here as well. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time.

[00:32:31] Charu Roy: Thank you.

[00:32:32] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Garrett Schumacher is Business Unit Director of Product Security at Velentium Medical and the co-founder and CTO of GeneInfoSec. Garrett discusses his journey from medical student to cybersecurity expert and educator, dedicating his career to securing medical devices. He shares insights on the intersection of cybersecurity and healthcare, highlighting the challenges of protecting genetic data. Garrett gives honest advice about navigating cybersecurity and data privacy concerns, how to be a good leader, and what medtech startups should consider as they design and develop their devices. 

Guest links: https://velentiummedical.com/ | https://www.geneinfosec.com/ 

Charity supported: Save the Children

Interested in being a guest on the show or have feedback to share? Email us at [email protected]. 

EPISODE TRANSCRIPT

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello and welcome back to another episode of the Leading Difference Podcast. I'm your host, Lindsey, and today I am excited to introduce you to my guest, Garrett Schumacher. Garrett is the Business Unit Director of Product Security at Velentium Medical, where he has led the cybersecurity efforts on 200 plus medical device products and systems.

He is the co-founder and CTO of GeneInfoSec, a startup focused on securing the world's most valuable and private data, our genetic information. In his work, Garrett has trained engineers, developers, manufacturers, healthcare delivery organizations, and laboratories across the globe in cybersecurity, and is an active member of several related industry working groups.

He also teaches secure product development and medical device cybersecurity at the graduate level for the University of Colorado Boulder's Department of Computer Science as an adjunct professor in the little bit of time left in his days, Garrett is either rock climbing or spending time with family.

Thank you so much for being here, Garrett. I'm so excited to speak with you today.

[00:01:48] Garrett Schumacher: Yeah. Thank you for having me.

[00:01:49] Lindsey Dinneen: Of course. Well, I'd love, if you wouldn't mind, by starting out and sharing a little bit about yourself and your background and what led you to medtech.

[00:01:59] Garrett Schumacher: Yeah. So I guess my background, I mean, it started as I always thought I was gonna be a doctor. I did my undergrad in physiology, thought I was gonna do med school, the whole nine yards. And towards the end of my, let's say junior year, just started being like, "I don't think this is what I want to do."

I always had a fascination with tech. I was really involved with a lot of the tech groups on campus at the University of Colorado Boulder, early days of Hack CU, one of the largest collegiate hackathons. And I really regretted not doing a computer science degree, but I was three quarters of the way done. So sometimes you just gotta finish it up, right? Get the degree, find out what's next.

After that I went and did a master's in genetics. I wasn't sure exactly what I wanted to do either yet, but hey, a master's degree is not a bad thing to do if you're unsure. And actually I was in a PhD program and dropped out early with a master's. Different story. But yeah. And then I started I helped the University of Colorado Boulder start their cybersecurity programs. So it was getting into the cyber world. I did a, I guess it was a bootcamp, at the University of Denver in cybersecurity. And so that all culminated in me always focusing on healthcare and cybersecurity together.

And then COVID happened and that made the world change for a lot of people. And basically I was looking for a new job and I found Velentium, and I think that's where it really spoke to me, where I could do my love of medical and human health with cybersecurity and technology development. And so yeah, I think that's really how I got into it. I had been doing projects related to that before, but Velentium's where it really culminated and I found a place that let me do all the things I love, not just one or the other.

[00:03:39] Lindsey Dinneen: That's awesome and such a wonderful gift. So can you share a little bit about what you do now and sort of your growth trajectory even throughout Velentium 'cause I know you've had quite an interesting and exciting career through the company as well.

[00:03:56] Garrett Schumacher: Yeah. Yeah. So I started out as a cybersecurity engineer, and just started helping internal projects, external projects with groups that were seeking FDA approval on a medical device and trying to navigate these kind of new cybersecurity requirements. That's where it started. And even since then I've been, so I teach a class at the University of Colorado Boulder on Medical Device Cybersecurity. We're going into our sixth year of that, seventh semester, starting here in the fall. And I also co-founded a startup in the genetic information security space.

So, and we can talk about that later. And so I, yeah, talk about what I do. It's all of those things and, it's not, doesn't happen in 40 hours, I promise you that. But after working as a cyber engineer for about a year, I think I got promoted to like Senior Staff Cybersecurity Engineer. Then probably three years ago, I took over more of an operational leadership role within the unit, the team, where I was doing project management and overseeing the other engineers and still doing engineering work. Definitely decided project management is not for the faint of heart and apparently my heart's very faint. It's not for me.

So anyways, and then fast forward to just here in like January, February, Velentium made some really awesome changes. They rebranded as Velentium Medical to make sure everyone knew we do medical. And then they created four business units so that they could really say, "Look, we have different core areas of our business. Each of them have their own different operational needs and what have you." So, I was promoted into Business Unit Director of Product Security.

And so now we're a business unit. We're a business within a business trying to better serve our clients and implement the processes we need for our small scope of work compared to a large contract development and manufacturing organization. So just that's been my growth goal so far is, come in as an engineer, work my way up to the leadership roles while also still loving to be an educator and and still having my own startup space in the biotech side of the house.

[00:05:58] Lindsey Dinneen: Yeah. Excellent. Well, first of all, congratulations on all of that. That is very exciting and it's really fun to see that growth and that development. And I'm also so curious now, can we talk a little bit about your startup? So first of all, let's talk about that and then I wanna talk about the crossover between the two, if that's okay. So.

[00:06:16] Garrett Schumacher: Absolutely. Yeah. So, well the name is GeneInfoSec, so it's just short for genetic information security. We're not trying to hide anything there. We focus on protecting the world's most sensitive data. At least that's our opinion is genetic information affects you. And the data you have today is not gonna be any different, for the most part, from the data that you have in, 10, 20, 40 years.

But then even beyond that it's partially your children's data, your grandchildren, great-grandchildren, and then even on the, in the inverse, all the way up to your great-great-grandparents, right? You share some, to an extent, some genetic makeup with them. And so it's this really interesting space where networked privacy is-- it's a very different form of networked privacy. It's not just that I upload a photo to LinkedIn and now I could be implicating someone else that's in the photo. It's, I share my info, and I'm also sharing info that belongs to my cousins in, in, in a sense.

And so if you think of the Golden State Killer case in California, that was a really interesting one where the federal authorities had genetic information or samples from a cold case in the eighties. And they sequenced that. They uploaded it to a third party, an open public genetic database, and said, "Hey, here's my data. Who am I related to?" And through that they were able to triangulate like, "Okay here it is. This is the guy that did it" many years later. So, there's a case where it's, there could be positives. We want to use it to find that kind of information and protect people.

But at the same time, that brings up a lot of privacy implications. And then you can go all the way to the extreme, the sci-fi of designer bio weapons, maybe tailored to certain persons or ethnicities or groups of people. So during grad school, a couple guys and I, we founded this startup, and that's what we focus on through a technology that really our founder, Dr. Sterling Sawaya, he invented, called molecular encryption. It's a way of encrypting molecules before we generate data from them so that the generated genetic data is already, quote unquote encrypted, or at least protected in some manner. So, so that's what we do. And yeah, I guess why we do it a bit.

[00:08:27] Lindsey Dinneen: Yeah. Wow. So, okay, so that brings up a really interesting question. I can guess the answer to this, but is there any safe way to-- this is a funny way to put it-- but recreationally to test your genetic data in the sense of the way that a lot of us would think about it in terms of, "Oh, I'd really love to learn more about my ancestors and things like that." But there are so many security concerns, like you've pointed out. So is there any quote unquote, safe way to do so at this time?

[00:08:58] Garrett Schumacher: You know that-- it's a great question. There's been a lot of things going on in the news recently, like with, I'm sure people have heard of 23 & Me, and how they went bankrupt and now a company called Regeneron is buying them and all their assets for a lot of money, but not that much compared to what 23 & Me was worth a few years ago. So that brings up a lot of issues, right? 23 & Me still owns a lot of samples, like maybe around 10 million samples. And the sequencing they've been doing is very small.

So if your genome's a whole book, they've been kind of flipping through the pages and picking specific letters, and that's the data they have. So that's not the most sensitive, it's not the full story. But if you have the samples, you can always generate the full book someday. And as that cost of full human genome sequencing decreases rapidly, someone's probably gonna want to do that someday.

So, okay, so back to your question though, is there a safe way? What I would say is that I, I don't tell people not to do it. I would say if you have health reasons, concerns, and your doctor suggests a genetic test, a lot of those tests are also that similar, picking a few letters, a few known letters and trying to just read that for a very specific purpose. If your doctor and you come to the agreement that you should do that, you should just do that.

However, I do not promote, and even to my family members, I highly don't recommend, using these services. I used to really love who's that group out of Utah? Ancestry.com. They used to be a great group. They were trying to sequence the world's DNA for understanding basically the family tree of everyone. Because anyways, they have interest in understanding who's related to who and how that relates to their religion. So they used to do it for internal purposes, keep it on pretty tight, secure. Well then, they sold to a venture capital group.

So, it's really tough to say that there's these groups that there's a good place out there to do it. There are some companies that have security or privacy focused DNA sequencing services. But it's really odd, like you have to set up a cryptocurrency account, pay with cryptocurrency, set up a PO box so that you're not like actually shipping to and from your home. And then ultimately the price of it and how they're getting it to be cost effective is China's doing the sequencing. So you do all those privacy measures and your sample gets sent off to another country. And the FBI has disclosed that they know that when certain countries like that are doing the sequencing, whether you want them to do a little tiny test, like a COVID test or whatever it is, they're sequencing the whole thing. They're keeping the data. This is known, disclosed, not conjecture.

So, yeah, so sorry-- long-winded answer of saying, I'm interested too, I wanna learn about this. I've got family members that have done it. But right now I recommend just thinking very carefully and critically about whether the immediate fun of it is worth the potential long-term impacts, and maybe if you're someone that's security or privacy conscious, maybe wait a few years because there are some things on the horizon that will make this a lot better.

[00:12:02] Lindsey Dinneen: All right! Thank you for the honest answer. I really appreciate it. So, okay, I wanna go back to your work with Velentium specifically and talk about-- you've gotten to work with so many different clients over the years and you've seen so many different variations on a theme. And I'm curious, what are some of the common mistakes or pitfalls you might see a younger startup make when they are perhaps first designing their device, and cybersecurity is maybe not quite top of mind. So what are some of the things that you see that are challenges we can overcome?

[00:12:41] Garrett Schumacher: Yeah I think one of the biggest challenges is that a lot of people aren't maybe aware yet of the scrutiny and the requirements that the FDA-- and not just FDA, but the European union's medical device regulations and the bodies over there that review submissions. And any, if you look across the board, pretty much almost every regulatory market has, very much in the last couple years, placed a lot of scrutiny on cybersecurity. So a lot of companies, especially smaller ones starting out in the space, may not be aware of this. And so then oftentimes they'll find out too late, they'll submit. They'll get feedback back, "Oh no, we have 90 days to respond and we didn't do cyber. We gotta do cyber now."

And they don't know how to spell it yet, which is a joke. But there's that. And then there's also, or they'll get in just late at the game, "Hey, we're submitting in a month or three" and "Oh, we gotta do this thing retroactively." And so then therefore, we haven't been able to support someone through the full process, at the proper time, doing the right design things to inform the design during the design, not after. So I think that's probably the biggest mistake is not seeking that external support early and often. And if you're getting that, it shouldn't just be someone that can help you navigate the regulatory space. It shouldn't be someone that can just do the pen testing for you at the end. Really I think in that context, you need a partner that can do everything end to end.

So that's what we've really tried to make our processes and our services geared towards is being that partner. And whether you have the bandwidth and you will do a lot of the documentation and work, but you just need someone to guide you, consult you, give you the materials to do so, or if you are truly looking for, no, we need to augment our own team and have you do a lot more of the work for us. That's great. We can do that. So, so that's, I think, the biggest challenge. And I think that the answer is just getting the right partner early and working with them often throughout that entire development, not at the end.

[00:14:37] Lindsey Dinneen: Yeah, absolutely. And I really appreciate that perspective. I think that there's a lot more awareness, it seems like even in the industry that, "Oh, cybersecurity is a thing now." But as you said, getting to partner with somebody who does know the ins and outs from the start and can really help guide you through is really critical. Now you do quite a bit of speaking and presenting. You're obviously still teaching a college class and all of those wonderful things. I'm curious how that has played into your career as well, and is that something that you will always want to do? You've got this educator side of you as well.

[00:15:13] Garrett Schumacher: Yeah, I mean, I love it. I actually taught at a high school for one year between my master's program and my undergraduate, decided that that's not for me, but that teaching at those higher levels where people are really wanting to be in the room. So now I teach at the graduate level, half of the students will be older than me. And now everybody wants to be there and we can have very mature conversations and they even can challenge me with some really great questions that I'm not ready for, right? And I think the best way to learn is to teach. Absolutely. That's, yeah. I think a lot of people have said that. I completely agree. So I plan to always do that.

I mean, I love, even with our internal engineers and external clients, like the idea of helping people understand something and humanizing it for 'em. That's really my big flag I'm waving right now is humanizing it. We don't have to use alphabet soups and crazy language. We can make it easy to understand and we can humanize it for the masses. So that's really what I'm trying to do, one of my big pushes. And so I don't foresee myself ever going away from that, I even do a lot of international training on the cyber biosecurity space where I go to all these countries and these biosafety laboratories and help biologists understand cybersecurity as a fundamental practice and how they can improve their personal security, their professional security. And to me that's the most rewarding thing.

[00:16:36] Lindsey Dinneen: Yeah. Oh my goodness. That's so cool. Thank you for sharing about that. So, as you are looking towards the future in the industry itself, but also I suppose your own career, what are some things that you're excited about? What are some trends that you see as being positive? I know that, recently, it's been a little bit challenging-- as a nice word-- for a lot of medical device companies and they're a little worried about funding and those kinds of things, and so, that's maybe a trend that's a little not as fun, but what are the things that are empowering and exciting to you as we move forward?

[00:17:13] Garrett Schumacher: So not to make it about artificial intelligence or machine learning, 'cause everybody does. It's definitely, its hype curve. But that is actually one of the things that I think I'm most excited about, but also most scared about. We've seen a lot of companies with layoffs because they believe this artificial intelligence enables them to be more efficient and therefore they can do more with fewer people. And that saves money. And I understand that. I think that one of my big pushes right now is trying to help people understand that AI, at least right now, it's not taking over human jobs-- that it can instead augment, improve how we do those jobs. But people have to be ready for it.

So even in, in my own space, like, making sure that our team and our people are ready for that. Because if you aren't getting into that space, if you aren't with the curve, then you're gonna fall behind. And yes, you could be replaced in that sense that someone has done it and so now they're doing it better than you. And so if you're not using these tools, these resources to, to improve your efficiency and to just maximize your capability-- like for example, my team, maybe I don't need to hire a person. Maybe we can build out things that enable us to, with the same amount of people, to better serve more clientele.

So that's what I'm really trying to navigate. But it is scary thinking about that future and am I even gonna be ready and technically savvy enough to navigate that new future in the next year, in the next five, 10 years. And especially as someone who I've always had this, this goal of maybe someday, and I'm getting talked out of it very quickly, but maybe like being a Chief Information Security Officer at a large company or a Chief Product Security Officer, something like that. And yeah, quickly, I'm-- "Eh, we'll see." But it's those kind of things that, if we can navigate them correctly, may maybe that is something in my future. So that's, I think, one of my big fears and also passion projects right now.

And then also, same on that funding vein-- with my startup, we're experiencing that as well. And we actually, we had a lot of funding potential pre COVID. And then even though our technology-- like in some ways COVID brought the need for our technology to the forefront of people's minds-- it also killed a lot of funding opportunity. And so yeah, I mean, navigating that space of how do you get funding and then does it come from venture capital backed or equity, private equity, and I've seen those worlds. I even advise startups. So I mean, that is also probably one of the biggest challenges I'm facing currently as well.

[00:19:41] Lindsey Dinneen: Yeah. Yeah. It's gonna be really interesting to see how things evolve, and it's been fascinating to read the news and see even the headlines where it's like, the FDA is using AI to review submissions and all sorts of things, and you really do wonder how we'll move forward and time will tell, I suppose.

[00:20:01] Garrett Schumacher: Yeah.

[00:20:02] Lindsey Dinneen: So you have stepped into quite a number of leadership roles fairly young in your career, if you don't mind me just saying so, and so I'm curious how you have navigated that growth for yourself. First of all, do you feel like you were a natural leader or were those skills things you developed along the way? And secondly, what advice might you have for younger leaders?

[00:20:27] Garrett Schumacher: Great questions. Yeah, definitely nothing is natural about it. I think for anyone, I mean, it's nothing that you just do and you're just like, "Yep, I'm a leader. That's easy." So it definitely something, just like all aspects of work and maturity, is you have to work on it. But I think how I got there was-- and someone told me a couple tips early in my career, I suppose-- and it was a couple are: find a mentor, and as the mentee you have to put in the effort. If you set up meetings and they're not there, whatever, like they're busy, and you are asking them to give their time for you. So, find mentors and then be a good mentee, meet up with them.

I had several people that were critical in my early career. One was Bunky Davis and she was amazing. She was no longer with us, but her and I grabbed coffee every single month. She had navigated biotech startups for like 50 years, was also just a phenomenal cyclist, Olympian, like just amazing. And we'd meet up every month for coffee without missing. And we did that for several years. And, and I had another mentor from the University of Colorado Boulder, Lloyd Thrall, who came from the Department of Defense, and just a spectacular, stellar guy, and we would go meet up all the time.

And so learning from these people I think I saw-- well, there's that. And then everybody has their bosses and their horror stories from work, whether that's a high school job or professional later on. And so you see the ways that people can be, you don't want to be. And so that, that makes it easy. But without having those mentors, yeah, I don't know if I would've exposed myself to the good ways, right, and the better ways, and be challenged. So that was really critical was finding a good mentor and then being a good mentee.

And then I think the other thing is interacting with people and just listening, active listening. So going to the professional shows and meeting people, listening to them, reading a lot of great books out there on how to be a leader, and you don't take all that exactly word for word, but there are golden little nuggets that you can just pick up out of all those things. So, no, definitely something that I have actively worked on and still am trying to work on. And then I'm constantly trying to listen and being that, have that open door policy for my people too. Because if I hire really smart people, I want them to do the thinking and therefore I need to listen.

[00:22:44] Lindsey Dinneen: There you go. I love it. All right, so. You've had a really interesting and exciting career so far, and you're obviously very passionate about medtech and cybersecurity and biotech and all those things, and I'm wondering if along the way there are any moments that really stand out to you as affirming, "Wow, I am in the right place at the right time."

[00:23:09] Garrett Schumacher: Yeah. Yeah. One was we had a really special project where and I won't give any names away, but basically my stepmother has an implant inside of her and it's it's not life sustaining, but it's one that you want working just so that your body's working normally, and so that you're not, not embarrassed. You can go into public spaces and be a normal person, right? And whether it's pain management, incontinence, those kind of things. So she had this implant and it was, she had one that came from the leading provider of that at the time. And it, the battery life, right, is supposed to last like 10 or 15 years, and it seemed like pretty much seven or eight was all she was getting out of it. And after decades of having far more surgeries than she needed, all the way up to the very last device she got in her-- it failed within the first year, I think-- so it was like, okay, time to pivot.

And we found this new company and they've become a huge leader in the space, recently acquired by another one of the big leaders in medtech in general. And we were hired to do the security work for that project. And the only reason that I actually found out-- because my stepmother was literally like in the process of getting this new device inside of her-- I was at that client's facility doing a pen testing and security testing engagement and some consulting and just visiting them. And I FaceTimed my family in the break room and there was a sign behind me and they're like, "Oh my gosh. We're literally, we just got that implanted in your stepmother like, a couple weeks ago. It's working great. She's so happy with it. It's smaller, it works better, all these things."

And it's like, "Wow." So I got to lead the security effort and what they're actually doing is adding remote programming capabilities so a doctor can, over the phone, be improving that therapy for you. But that leads to a lot of cybersecurity implications, right? That kind of connectivity. And so I gotta lead the security work on that for something that is in a near and dear, your family member. And it's those kind of things where it's not, you're not just helping patients. It's, I'm helping someone that I care very deeply about. And it hits home differently when it's not just, "Oh, I want this device to be secure. I want them to get FDA clearance. I want whatever." It's, "No, I need now, I need for my own family member for it to be the best." And it's not that project got special scrutiny from us-- we bring that to every project-- but it helps to have the actual experience of one of those projects.

[00:25:33] Lindsey Dinneen: Yeah. And to have that real-- well, you were mentioning it-- not just patients that I kept thinking, "Yeah. Not just patients, people," and the idea of it's sometimes probably necessary honestly, to have a little bit of separation from a clinical point of, "I'm helping all of these patients, and that's a really good thing." But then if you could take a step back and go, "And these patients are human beings that rely on what I'm doing for safety and for security and for this lifesaving, life enhancing device." That's-- what a gift to get to experience something like that.

[00:26:04] Garrett Schumacher: It is, it's especially like, if you work in the diabetes-- we've had several projects with insulin pumps-- and insulin's a drug that is, highly toxic if given in the wrong dosage. 99% of the world population would die if it's in the wrong dosage if it's too high. And the only reason the other 1% exist is 'cause they're insulin intolerant. They just, they don't respond to insulin and that's why they have their own type of diabetic issues. And I've got several cousins, a brother-in-law, that also use that stuff every day, rely on those kind of technologies. So, yeah, just it's a little bit more special when it's when you get to do that. But we try to do that for everyone. We try to think of everyone's that person that we're trying to help.

[00:26:42] Lindsey Dinneen: Yeah, absolutely. All right. Well, this has been so great, but pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. What would you choose to teach and why?

[00:26:59] Garrett Schumacher: Ooh. Well, yeah, first of all, a million dollars for-- I feel like I, I'd have to go with something like that I know deeply, very deeply on. But okay, if I wanna have some fun here, I would say rock climbing, because rock climbing is my other big passion. It's the one thing that takes me away from a computer screen typically. And so if you're paying me a million dollars to teach rock climbing, A, these people really wanna learn how to be good rock climbers, so they're gonna be very engaged. And B, that's going to mean that I can go now actually make money on something that has only ever been a passion for me. So, that would be fun. That would be awesome.

[00:27:33] Lindsey Dinneen: Awesome.

[00:27:33] Garrett Schumacher: If you're offering, Lindsey, I'll accept.

[00:27:35] Lindsey Dinneen: Okay, deal, right? Yeah. I'm gonna have to earn my first million first, and then I'll let you know.

[00:27:40] Garrett Schumacher: I'll wait.

[00:27:41] Lindsey Dinneen: Okay, fair? Fair enough. What got you into rock climbing?

[00:27:45] Garrett Schumacher: Oh man. Well, so my mother was, I grew up in like a small farming town in the northeast corner of Colorado. There's not a mountain for, until you get to Denver area, right? In the summers, she worked at the local college, and in the summers she ran the ropes course and they had a giant rock wall. So, I mean, as a 10-year-old, I'm just hanging out there. I didn't know that there was routes or certain ways or techniques. I just, who can get up the fastest, right? But that was always fun. That was my summers. I always, and I was, shoot, I was always told I was a monkey. I was always on stuff climbing something. I've had my share of injuries from it, trust me.

And then in college, it just was natural. I went to CU Boulder, as I've probably already said, and a lot of outdoor climbing opportunities. A lot of, they, they built a new gym there inside the school. And so that then it became this thing where, oh, I can actually-- as you move away from high school sports, basketball and American football and those things, you miss that. You can miss some competitiveness and some team-based things. So now I had another active thing that I could-- and I, again, I wasn't so formal in technique or things like that-- so now I could work with people, socialize and work on that technique in something that I was able to do at that level, instead of, I'm not gonna go beat myself up playing football again.

So, yeah, I think that's where it came from. And then it's just been my big hobby ever since. And I mean, now I have a bunch of friends down in Austin, Texas, and we go on a big climbing trip once a year, and I see them once a year. It's fun. So it's like expanded my friend group and it keeps me sane.

[00:29:14] Lindsey Dinneen: Huh. Excellent. Yes. That's wonderful. All right. How do you wish to be remembered after you leave this world?

[00:29:22] Garrett Schumacher: Oh, that's a good one. How do you humbly answer that? When part of the answer I would wanna say is humble, but that's something I always try to work on, is I just wanna be a good guy. I want people to remember that, he was kind, considerate-- would do something at the drop of a hat for you without expecting anything in return-- just kind, generous. And I think a family guy would be a big one. My, my friends and family first and foremost. And maybe second to that, hardworking. Yeah.

[00:29:46] Lindsey Dinneen: Yeah. I love that. All right. And final question. What is one thing that makes you smile every time you see or think about it?

[00:29:55] Garrett Schumacher: Oh, my wife. I wake up to her every day and that's she's the best part about everything. So yeah, she's my favorite person, and I'm lucky enough to, when I'm not traveling, wake up next to her and see her at night, and that's the best part.

[00:30:08] Lindsey Dinneen: Yeah, absolutely. What a wonderful thing. Well, this has been a fantastic conversation, Garrett. I'm so thankful for your time today. Thank you for sharing some of your stories, some of your advice. And I just honestly wish you the most continued success as you work to change lives for a better world.

[00:30:26] Garrett Schumacher: Thank you. Thank you, Lindsey, for having me. This was my first podcast ever. So it went great. Yeah, it was fine.

[00:30:32] Lindsey Dinneen: Awesome. You rocked it. Good job. That's wonderful. All right, well, celebrating that and celebrating all your future successes to come. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and thank you so much for being here and thank you for doing what you do.

[00:31:05] Garrett Schumacher: Thank you.

[00:31:07] Lindsey Dinneen: Excellent, and thank you also to our listeners for tuning in, and if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time.

[00:31:19] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Sarah Ptach, President and CEO of Canyon Labs, discusses her journey from professional sports and advertising to leading Canyon Labs, a company specializing in medical device and pharmaceutical testing. Inspired by her father's Parkinson's diagnosis, Sarah transitioned to healthcare to make a meaningful impact. She delves into her leadership philosophy, emphasizing the importance of trust, transparency, and collaboration in building a strong company culture. Sarah also highlights Canyon Labs' dedication to elevating industry standards and ensuring patient safety. 

Guest links: https://canyonlabs.com/ | https://www.linkedin.com/in/sarahptach/ 

Charity supported: The Michael J. Fox Foundation for Parkinson's Research

Interested in being a guest on the show or have feedback to share? Email us at [email protected]. 

EPISODE TRANSCRIPT

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello, and welcome to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am super excited to introduce you to my guest, Sarah Ptach. Sarah is the President and CEO of Canyon Labs, a leading provider of medical device and pharmaceutical testing, consulting, and sterilization services. She joined the company during a critical ownership transition with a clear goal in mind: to raise the standard of service in the industry and build a true end-to-end solutions partner. Drawing on her background in packaging engineering and testing, Sarah focused on expanding beyond packaging alone to create a more integrated, accessible, and expert driven experience for clients.

Sarah began her career in professional sports and advertising, but a desire to create more meaningful impact led her to the healthcare space after her father was diagnosed with Parkinson's disease. She went on to help grow and successfully exit a packaging firm before bringing her vision and leadership to Canyon Labs. In addition to her role at Canyon, she co-leads Kilmer Innovations and serves on the board of the Medical Device Packaging Technical Committee of the Institute of Packaging Professionals. She remains deeply committed to advancing healthcare through innovation, expertise, and strong partnerships.

All right. Well, thank you so much for being here, Sarah. I'm so excited to welcome you to the show.

[00:02:05] Sarah Ptach: Likewise. Thank you, Lindsey. I appreciate you having me.

[00:02:08] Lindsey Dinneen: Of course. Well, I'd love if you would start off by telling us just a little bit about yourself, your background, and what led you to MedTech.

[00:02:16] Sarah Ptach: Yeah. Thank you. So I'm Sarah Ptach. I'm the president of Canyon Labs. I have kind of an interesting story of getting into to medtech. I originally started my career actually in professional baseball. I was a contract negotiation person mainly for closing pitchers. And I ran track in college. I thought like, "oh, I wanna be in sports." And I like to say that's the most fun I never wanna have again. It was, it was a great start of a career. It teaches you a lot about negotiation, teaches you a lot about high stakes opportunities. But, you know, in the end it, it felt very kind of un unfulfilling in that perspective.

And so I had kind of then taken that into to marketing for a pretty big ad agency in Chicago and hit the same thing. I felt like I was-- you know, now I was just selling people stuff that they didn't need instead of promoting people that, you know, that make a ton of money in the sports industry. And at the time my dad was diagnosed with Parkinson's disease and I wanted to feel like I was making a difference.

So I, I went back and got my MBA and my whole goal of that was really to, to use my skills to, to do something that makes a difference in people's lives. So, I had reached out to a really small medical device company and it's " I'm willing to make no money as long as we, we have a difference in a change we can make in the world." And at the time that company couldn't hire me but I ended up getting introduced to another company through that that was in medical device packaging validation. And that was the first dip of medical device that I had.

And that company's Packaging Compliance Labs. I was one of the first employees there and we grew that company until it sold a couple years ago. And through that, learned a ton about the medical device space. I kind of made it my personal mission beyond just my job to, to go try to participate in the industry as much as possible, push the status quo of things as much as possible, and really kind of learn where the testing realm or validation realm can make a difference in, in medical devices.

And so after that, I was given the opportunity to step in and run and grow Canyon Labs. And Canyon is a whole platform. So for me, it was taking the packaging knowledge that, that I love so much and making that a full service offering. You know, I had always dabbled in sterilization or heard about Biocom, but never really gotten my hands on it. And to be able to be that full service solution with Canyon has not only been a awesome offering to, to give to our clients to really be able to go A to Z, everything from your regulatory to your microbiology, chemistry, packaging, bio comp, and toxicology. But also a good learning challenge for me.

I thought that I was, you know, a pretty good packaging engineer and now learning chemistry and microbiology and toxicology, I'm like, "oh, wow. I'm definitely not as smart as I maybe thought I was originally," and I luckily have some amazingly intelligent individuals that, that work on our team, but it's, it's an awesome opportunity to, to not only get to help bring some life-changing medical solutions to market but also have a really good technical brain challenge every single day.

[00:05:26] Lindsey Dinneen: Wow. Oh my goodness. I love that. And yes, I mean, sometimes I feel like actually, you know, not being the smartest person in the room is such a gift because then you get to talk to all these really cool people with really amazing experiences and learn. And I'm just one of those people who's constantly-- well, I'm curious all the time, so if I don't understand something, I'm like, "can you tell me more?"

[00:05:48] Sarah Ptach: Yeah. No I love that. I completely agree. I think that the better that you can be at facilitating conversations, the, you know, the more successful your organization will be. And it, I really think as the leader of a company it's less about being the, you know, smartest person in the room and more about being the facilitator of that collaboration.

[00:06:10] Lindsey Dinneen: Yeah. Yeah, absolutely. I love that. So, okay, so going back in time a little bit-- so, so I know you started off with professional sports, which is really cool. Like what a, what an interesting, unique opportunity and experience and you know, you'll maybe never want that particular brand of fun again, but. I still love that you got to do it. And so I'm curious though, was that always the sort of planning goal for you? Or when you were trying to think about career paths and all of that, younger, what were you envisioning?

[00:06:39] Sarah Ptach: Yeah. I think I, I always envisioned myself as a leader. The packaging side of things became my kind of technical passion. But I mean, from a young age, I've always been the captain of the track team or the, you know, the head of any school organization I was a part of. So I always knew I, I wanted to be a leader. I think now, you know, being in that role, you, you learn so much about what different styles and brands of leadership is. I think, you know, to go back to your question about being the smartest in the room, I actually think that, you know, the CEO's job isn't to have all the answers. It's to create the culture where the answers emerge. And, you know, I've always wanted to be a leader. I've been passionate on that side, but I really think that the more, you know, more so than just having leadership pieces to you. It's about having that power to bring people together in that way.

[00:07:31] Lindsey Dinneen: Yeah. That's a beautiful way to put it. And I actually would love to dive into this more because I know creating a really positive, good company culture is really important to you, and it's frankly, easy to get wrong, unintentionally-- sometimes maybe it just is what it is, but like sometimes it's not a desire to create it, but it happens. So I'm curious, how have you really intentionally cultivated your current company culture, and where did those lessons come from?

[00:08:00] Sarah Ptach: Yeah. Deep question. You could answer that in a bunch of different ways and I could talk your ear off about lessons learned on that side. But I, I think the, you know, the most overlooked competitive advantage, both internally and externally is trust. Like the trust in your team to make decisions, the trust in your clients and even the FDA and your labs work. There's trust across it all. I think internally, from culture standpoint, it's have that trust in people and build, you know, people in a way that, that helps them feel most confident to, to make the decisions that they need to succeed.

You know, when we first started talking you, you asked if I have any kind of lesson learned stories and some, I dunno, harsh realities per se. I think one of the more difficult kind of lessons that, that I learned in the course of just being a leader, is knowing when you have a passion for someone and what passions they might have. And I stayed that in the standpoint that I'm a huge believer in people. I want them to be like the greatest version of themselves, and I want them to dream big and go big and, you know, sometimes that's not always what people want for themselves too. And it's, it's a tough reality somewhat to to come to at times.

But, you know, really finding what is the growth that people truly want. What is the environment that they want to live in, and how do you help foster something that, that meets the plethora of those ideals that you'll have across an organization is really important. But I think the, the culture I've worked really hard to foster at Canyon and frankly, my, my team fosters alongside me every day. This is by no means just a Sarah show on that piece. But it's a culture of trust, like I said, and it's a culture of transparency.

I always like to tell my team, "you know, when I ask questions or probe I'm not trying to get an answer or I'm not trying to, you know, question your way of thinking. I'm trying to understand so that I can be at the same table that you're at and we're not, you know, talking oranges and apples and not realizing it." And so I really try to make sure we foster an environment where there's collaboration, there's trust to have that collaboration. There's trust to have challenges made of each other without it being an inflection of, you know, disliking someone. And then creating that opportunity to ask questions and always stay inquisitive in a way that's meant to greater raise everyone up together.

[00:10:28] Lindsey Dinneen: Yeah, that's a wonderful culture that you're cultivating and I love that. But I think you hit on something really key amongst all of the really great points you made, but one of them that really stood out to me was, you talked about how it's not just the Sarah show in this way. It's a whole group effort. And I think that is a critical component that sometimes is forgotten. Like we sometimes think, you know, it's the leader's sort of job or role or just is. It is their leadership. That sort of filters down into the rest of the company and we think it's like a top down way of doing culture, but culture is about absolutely everybody involved in the company. So I'm curious, how do you empower your team members or, and, or when a new team member comes in, how do you communicate, "Hey, this is who we are, these are our values," and make sure that it is a good cultural fit too.

[00:11:23] Sarah Ptach: Yeah. You know, we really at Canyon do a lot of things that are just small to, to reinforce and drive culture. We have these bracelets that you can earn, and what they mean is they're all of our company values and you can honor a fellow coworker for, for going above and beyond, or embodying teamwork or really showing integrity. And they get that read out in front of their whole department, and then they get a bracelet to wear proudly. So we do little things to to enhance our culture.

And then there's the more macro level pieces, and I think having a baseline understanding of why we all show up to work every single day. You know, it really is to empower life changing medical innovation, and it's to ensure that all the products on the market are not gonna hurt somebody and they are going to, you know, do what they're meant to do in a positive way. You know, if we can all show up with the basis of "everything I do every day is for patient safety," then I think the getting on board with the culture is a lot easier if we all have that base, like regardless of how your day goes, regardless of your email inbox going crazy, we all agree that, you know, patient safety is what we're here to do. And you know, how we can have fun along the way, support each other, do teamwork is just gravy on top of that. So I'd say it's starting with culture that gets that base level item. And once you get that, everything else is just working better together.

[00:12:48] Lindsey Dinneen: Yeah. Yes. And honestly, that's a great segue to my next question, but I was really-- I think you, again, honed in on something really critical and having everybody around a shared mission is so cool because that passion and that excitement and that " we're all in this together" and when disagreements or issues come up, which --we're human, they do-- then you can always go back to that shared mission and values of the work we're doing matters. We are all on the same side to provide value to our clients to ensure safety for our patients. So, I think that's a really key thing that you touched on there. Yeah.

[00:13:33] Sarah Ptach: Don't get me wrong. I mean, it's a difficult thing to, you know, to keep going on teams. We, Canyon, we did two acquisitions this year. And with that comes a lot of combining cultures, changing culture together, all getting on the same page. And it's not easy, bumps along the road, you know, I think showing that we're all on the same page and working and rowing in the same direction is a conversation I have every single week. And so it's something you can keep reinforcing. And I think it's stacking bricks. You don't just have a house, you gotta continually stack bricks on it. And everyone needs to be involved in saying, "yeah, I wanna be a part of this team and I wanna be a part of this shared mission." And it doesn't build itself overnight.

[00:14:19] Lindsey Dinneen: Yeah, absolutely. So speaking and then mentioning back to that segue, 'cause I just didn't ask the question, but can you share more about Canyon Labs and the incredible work that your company is doing for this industry?

[00:14:34] Sarah Ptach: Yeah. Yeah. So like I said we're a full service contract testing and consulting firm within the medical device and pharmaceutical space. You know, a lot of the work we're doing is to help a lot of medical devices and drugs in their validation stage. So, you know, we're working through anything from, you know, designing your package to helping your sterilization strategy. You know, sterilization has been something I talked to, I've spoken on a lot this year. You know, it's a hot topic item in the industry. It's something that a lot of people are dealing with 'cause it has EPA implications as well as now tariffs affecting it as well as supply chain issues within it. So I'd say that's a division I talk to a lot and we help a lot of people navigate those.

But the underlying whole piece of Canyon is being that trusted lab partner and we're really trying to raise the standard of service in this industry. You know, I came into Canyon being on the other side of the table and sending samples off to get biocom tested or to go through their sterilization validation. And, you know, for me it was this baby I was sending off to be tested and I don't think I was always met with the best customer service or the best accessible expertise when I needed it. And so we, when we built Canyon, we really built it to, to change that. You know, I want our clients to feel like we're one phone call away for any question that they have. You know, we're not just gonna send them their samples back, say, "sorry, it failed. Let us know when you're ready to give us another PO." That, that transactional relationship is, it's a currency that I don't wanna participate in. And so we really saw it after changing that in the industry.

[00:16:16] Lindsey Dinneen: Yeah. Excellent. Well, yeah and I love the fact that you were on that flip side and it could bring such a valuable perspective to the company and go, "okay, here's some lessons learned." You know, and you're always gonna get a mix of it, right? You're gonna get like, "Ooh, I don't know if this is how it should be or needs to be," and you're gonna go, "oh, but here's something that they did excellently." So to bring that very valuable perspective is really cool.

[00:16:40] Sarah Ptach: Yeah it's been fun. It's you know, in Canyon's infancy a couple years ago, we had the opportunity to come together with a lot of people from different experiences on our leadership team, and so it's-- as long as we all have the baseline humility to say "the way I did it in the past is not necessarily correct," you know, we could all come together and say, "here's what I did, here's what I did, here's what I did. Okay, let's pick the best of all worlds." So it it was a cool opportunity to have a lot of people with a lot of past experience come to a table that was completely, even in that standpoint.

[00:17:18] Lindsey Dinneen: Yeah. Excellent. So I know that you are-- well, okay, so I took a look at your LinkedIn profile and had a wonderful time learning a little bit more about you, but I know you are involved so much. Like you are just, I don't know if you sleep because...

[00:17:35] Sarah Ptach: Sometimes.

[00:17:36] Lindsey Dinneen: Yeah. But the, I especially noticed, you know, you're a founding board member for thePACKout and you've done you're involved in a lot of different boards and groups and you're, it seems like you're just, you know, volunteering as kind of your heart and soul and serving in that way. And so I was wondering if you could speak a little bit about those opportunities that you're with too.

[00:17:55] Sarah Ptach: Yeah. I think, first and foremost, before any job or role or position I've ever held, I am baseline, a huge proponent of this industry. And, you know, going back to my original reason to be here, it was my dad having Parkinson's and Parkinson's doesn't have a lot of treatment at this point. And it was like, I hate that. So how do I participate in solving that? And I think being involved in the industry, the super cool part, especially about packaging, is there's so much room for improvement at this point. You know, a lot of the standards that we function off of, they are being improved on a yearly basis, but they weren't made that long ago.

So the, you know, the baseline ground zero is not that long ago. And I mean, there's people in the industry that are still in the industry that were there when they made ISO 11607. So it's, you know, it's, it's got a lot of room for improvement. I love how much the industry is trying to go back to patients now, and, you know, we're not just trying to design packages or devices that work well for, you know, me, the manufacturer, or me, the physician, but instead it, you know, really does consider patient comfort, patient safety.

So the, a lot of what you'll see of my involvement in the industry is related to patient facing parts of of standards. I'm part of the Kilmer Renovations and Packaging Group and specifically I lead the aseptic presentation group, which is meant to evaluate the way that healthcare technicians interact with packaging in a way to help reduce hospital acquired infections. You know, we used to only design packages as an engineer because it's the perfectly engineered package. And, you know, we didn't think about the nurse that's trying to open it and your perfectly engineered package is just way too hard for a nurse to open and the device goes flying across the room.

So it you know, we, we weren't considering those things. So our group is trying to correlate opening methods with types of packages and designs of packages. And we're trying to prove that with the different opening techniques that they teach in school for your surgical techs, your nurses, what is the best way for these different packages so that we can make that training and that design fit in the best way possible for positive patient outcomes.

So, it's, a lot of my industry involvement is passion based, but I'd also say that a lot of the industry problems they, they can't be solved by just one company and they can't be solved in a silo. So, you know, the only opportunity you get to get all these stakeholders at the same table are these industry groups. And it's unique, I think, to the medical device industry in general that a lot of us care beyond our day jobs. You know, it's like, "cool, this is my day job, but I genuinely, passionately care about the development of my industry. And so I'm willing to, you know, volunteer my personal time."

And I see that across the board every day. And it's really cool. I mean, you have people who have huge jobs at, you know, Johnson and Bausch & Lomb and Medtronic, and they're, you know, they're still willing to put their personal time on the table to advance the industry. So, yeah, all my industry involvement's pretty passion based, but it's the medical device industry and medtech industry is one that's super unique. A lot of people feel that personal passion.

[00:21:20] Lindsey Dinneen: Yeah, I couldn't agree more. And thank you for sharing a little bit more about your involvement and your passion for the industry. And I feel so similarly, I, you know, when I joined the industry now a few years ago, I remember having this just moment of getting to meet all these super cool, intelligent innovators that are just literally changing the world and thinking "how lucky am I to be here and play a small part in this big changing thing," and then getting to see exactly to your point, how passionate the people are in the industry and how it's not just a job, it's like a calling.

[00:21:59] Sarah Ptach: Well, I think the difference is, you know, in, in medtech, the origin or margin for error is not just financial, it's human. So where you have, you know, maybe your traditional job, you know, the margin of error is a financial impact. You know, the margin of error for people in our industry is human impacts, and that can be positive and negative. So it's hopefully the passion to make those more positively. So.

[00:22:24] Lindsey Dinneen: Yes, indeed. Yeah, so, you know, I love the impact your company is making and the industry itself, like you said, is just such a cool place to be, and I think it really does invite those kinds of passionate people who are willing to just kind of be evangelists in a way for the rest of the industry in some fashion and really moving things forward. But because of the impact that's made, I'm wondering are there any moments that really stand out to you as affirming that, "hey, I am in the right place at the right time, in the right industry."

[00:22:57] Sarah Ptach: Yeah. I mean, I definitely have some stories where you've-- without disclosing the details of a client-- but you know, you've been part of a launch that you watched that device go change the industry. I was a part of a company that was launching a, it's basically a, an organ transplant way of improving on how organs make it from, you know, the donor to the recipient. And it has improved patient outcomes tenfold to what they used to be. It's made it so that you could take, say, subpar lungs that used to not be able to be donated. And because of this technology, now it can, 'cause it, it has a way of it staying more intact while being transported.

And you know, you get involved in those projects and, you know, you might just be helping at a small portion of it, like the sterilization or the packaging or just the biocom testing. But, you know, you watch the outcomes of that and it's like, "wow. Like I, I did that." You know, I've talked to people that work in consumer product goods and, you know, their Super Bowl is seeing their package on the grocery store aisle. And, you know, my, my Super Bowl is seeing the product that you played a part in, reach the market and change the world. Like that's, it's so cool.

And to your point before you, you get to be in the room with such cool, innovative, smart people that came up with that product. I am, I'm honored to be the lab testing that is that silent backbone of medical innovation. But to be, you know, that trusted partner to, to get them to the finish line is a, it's a unique feeling, but it's really cool when you get to see a product that you played part of either touch a family member.

I've been in an operating room before where I was the one being operated on 'cause I tore my ACL or did something and all I'm doing is looking at all the packaging, like, "Ooh, I did that. I tested that." Such a cool experience. It's sometimes it can be concerning 'cause you're sitting there while your doctor's trying to tell you to just get ready for surgery and you're staring at all the packaging. But it's, it's an awesome round to be in.

[00:25:02] Lindsey Dinneen: Oh my goodness. I love that story so much. Yes. I mean, I could see that I, and I've talked to other folks who have similar experiences where they're, you know, they're kind of going along, something happens, they end up needing medical attention, or a family member does, and they go into the, to the hospital and they're like, "oh. I worked on that device" or "Oh, I did the cybersecurity for this one" or whatever, and just like how cool of a just full circle moment is that, and getting to watch in real time and in real life the impact that your work does. That is a huge honor and gift.

[00:25:34] Sarah Ptach: Yeah, I I really did tear my ACL and my, and I also broke my back at one point in time, but my back surgeon and I have a really cool relationship and I think it's half because I was probably the biggest pain in the butt patient, 'cause leading up to that surgery it was like, "what device is it? What's the sterilization modality? Tell me what testing they did on it." And I got very lucky. My, my surgeon, his name's Dr. Michael Glisi, he has played actually a big role in getting some better improved medical devices to market both with Globus and with Arthrex. And now he plays a role in training other surgeons on how to best use those medical devices and technology.

But it was such a unique relationship to get with him 'cause he's uniquely involved in the industry. So I think he, he maybe tolerates my 9 billion questions better than the average surgeon that just wants to operate on you and see you off. But it was a cool experience to get to, to have that relationship with him now after surgery and watch the impact that, that he's making on the industry as a surgeon too. So I think all stakeholders in this industry hold different areas of importance too.

[00:26:49] Lindsey Dinneen: Yeah, absolutely. Oh my goodness. Yes. And, yeah, I could talk about all of this for days and I'm loving this conversation, but I am gonna pivot it, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want, could be within your industry, but it doesn't have to be at all. What would you choose to teach?

[00:27:13] Sarah Ptach: Ooh, that's a good question. I do think I would teach it on people leadership. You know, I, i've been in a lot of different roles and scenarios of people, leadership, especially through acquisitions, seeing, you know, the good, bad and ugly of what other folks do. And I've been really fortunate to have a lot of different mentors in my career that took very different leadership strategies. And I'm by no means saying that I'm the perfect people leader, but I think-- I can tell you a lot of different options and why they do and don't work.

So if I was to teach a masterclass it'd probably be in that and I'd be heavy on the transparent leadership side. I'd be heavy on fostering a culture of people that are comfortable talking about issues. And it's not a easy thing to balance, I think with also driving, you know, the work product of the business and the financial success of the business. But being able to marry that, to marry, you know, having a great people culture and having, you know, people that, that love being a part of your company.

It, to me, it is the most important part of actually driving your financial success of your company too. And I don't think a lot of people correlate that. You know, they think "I'm the ultimate financial driven CEO. I am the gross margin king." And, you know, " I'm driving my shareholder value." But I really think that, while all that is important, it starts with the people and the more you can get people to care about what they're doing beyond just their job, the more that the natural effect is improved gross margin and better financials. So the masterclass I'd probably teach is how to combine positive people, environment, and culture with good company financial success.

[00:29:07] Lindsey Dinneen: Ooh, okay. That's a very powerful masterclass I wanna go take so, so sign me up for that, for sure. That's incredible. Yeah. And you have so much advice and insight and I could just tell, like, again, we could probably talk about this for hours and be very happy, so, yeah, I love that. Okay, and then how do you wish to be remembered after you leave this world?

[00:29:30] Sarah Ptach: Yeah. Someone that, that cared deeply about the industry and was willing to to give it my all. You know, you, you jokingly said, "when do you sleep?" I'd argue not a lot, but it's because I love it. Like it's 'cause I love what I'm doing and if that means I'm gonna sacrifice some sleep to make sure the thePACKout is an awesome conference or the, you know, KIPP aseptic presentation team has what we need to change a standard or Canyon, you know, do something better and greater, I'll do it all day long. So yeah, I'd like to be remembered as, at the end of the day, she just really cared. And she was in it 110% at all times.

[00:30:12] Lindsey Dinneen: I love that. That's a beautiful legacy. Yes, absolutely. Okay, and then final question, what is one thing that makes you smile every time you see or think about it?

[00:30:23] Sarah Ptach: Oh, I love that one. I think someone realizing that the solution to the problem that they came up with was truly right and the solution. And it's like you worked through it yourself. You made it through maybe the hard parts of that decision making, but then you executed and hot dang, it worked. Like that is such a cool experience, especially when it's someone's first time ever having like the leadership role of solving a problem or, you know, the project manager role of solving that problem. It's super cool 'cause you get to watch someone's thought process play out. You get to watch where they see the pros and cons of their decision or the faults that could occur. And then you get to watch 'em navigate that, and then it succeeds and it's like, "hot dang, you did it." It's great. I love that. So that's probably something that makes me smile the most is when someone sees, their true potential being achieved, and they get to see it in the form of something as tangible as solving a problem.

[00:31:22] Lindsey Dinneen: That is awesome. I love that so much. Oh my goodness. Well, this has been such an amazing conversation. I'm so thankful for you and for you being willing to share some of your time with me and with our listeners. So thank you so much for all the work you do, and thank you for being in the industry, being passionate about this industry and for being a change maker too, in the way that, you know, companies can operate and be successful. And we don't have to think about it just in terms of financial success, but we talk about it in terms of cultural success too. And so, I just really appreciate your perspective, so thank you for all the hard work you're doing to change lives for a better world.

[00:32:02] Sarah Ptach: Thank you. Yeah, thank you, Lindsey. And likewise what you do. It's awesome to see you highlighting some of the stories in the industry and bringing together really good conversations like this. So thank you.

[00:32:11] Lindsey Dinneen: Awesome. And we are so honored to be making a donation as a thank you for your time today to the Michael J. Fox Foundation, which is dedicated to finding a cure for Parkinson's disease through an aggressively funded research agenda and to ensuring the development of improved therapies for those living with Parkinson's today. So thank you for choosing that organization to support. Again, thank you so much and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two and we'll catch you next time.

[00:32:49] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Tyler O'Malley is the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen, Inc. Tyler shares his journey in the MedTech industry and discusses Exagen's innovative approaches to autoimmune testing solutions, including cutting-edge diagnostics for lupus and other diseases. With over a decade of experience, Tyler provides insights into the challenges and breakthroughs in the field, highlighting the significance of early diagnosis and personalized treatment, while also discussing the challenges and opportunities in effective leadership during different stages of company growth.

Guest links: https://exagen.com/

Charity supported: Save the Children

Interested in being a guest on the show or have feedback to share? Email us at [email protected]. 

EPISODE TRANSCRIPT

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Tyler O'Malley. Tyler serves as Associate VP of Clinical Affairs and Market Access at Exagen, Inc., a leader in autoimmune testing solutions. In his role, he oversees clinical trials, bioinformatics, and medical policy development for Exagen's current diagnostic portfolio and pipeline of proprietary solutions. With more than a decade of experience, O'Malley has contributed to more than a dozen clinical trials focusing on clinical validity and utility evidence for autoimmune diagnostics.

His expertise is widely recognized with numerous publications in esteemed peer reviewed journals, and notably, he's the first author of one of the largest clinical utility studies in lupus diagnostics. O'Malley graduated from Georgia Gwinnett College with a Bachelor of Science in biology, concentrating in biochemistry. His 11 year career in research and development and medical affairs encompass medical science, education, assay development, and clinical research coordination.

Well, welcome to the show, Tyler. I'm so excited to have you here today.

[00:02:01] Tyler O'Malley: Thanks, glad to be here.

[00:02:02] Lindsey Dinneen: Yeah, absolutely. Well, I would love just starting off by telling us a little bit about yourself, your background, and what led you to MedTech.

[00:02:11] Tyler O'Malley: Sure. So, I'm the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen. We're a specialty diagnostics company focused on autoimmune rheumatic diseases. So we develop proprietary testing technology for conditions like lupus, rheumatoid arthritis, Sjogren's disease, as well as many others. And yeah, our focus is trying to find solutions for patients who are dealing with what are many times challenging chronic diseases that can present themselves in very mysterious ways oftentimes. And so, these are challenges that patients have that have, for the most part, gone unsolved for many decades, and so there's a lot of opportunity out there.

In terms of, myself, my background, I've been with Exagen for the past 11 and a half years. So I've been doing this for a while now, and I've worked in a couple of different areas within the organization, doing work within the lab assay development, as well as outside the lab doing clinical research, statistical analysis, which led to the bioinformatics role. And then as well as doing some work trying to align our clinical evidence with medical policy for our tests which is the market access role. So, a little bit of everything, but there are some through lines that I assure you do make some sense if you really think about it.

[00:03:33] Lindsey Dinneen: Excellent. Excellent. Well, thank you for sharing a little bit about that. There's so much to dive into, but going back a little bit in your story, when you were thinking about careers-- you're a eager high school student ready to embrace college, and you're ready for the next step --is this something that you could have imagined yourself doing or has this always been a passion of yours? Or is this something you kind of found yourself in?

[00:03:57] Tyler O'Malley: Not at all. So, no I, so I will say I've always been interested in autoimmunity. So that's always been something that has always piqued my interest, whether I was in high school or college. And so I guess in that sense, it's not a surprise. But the laboratory diagnostics component of it was not something that was on my radar when I was in high school or college.

And I guess the journey to Exagen was, after graduating from high school, went and got a bachelor's degree in biology with a biochemistry focus. So, that's sort of my background there. And while I was getting the degree and focusing on biochemistry, I had the opportunity through a resource scholarship at Georgia Tech to work in a graduate lab, which was a really interesting experience where, you know, for a little over a year I had the opportunity to work alongside PhD candidates, postdocs, on a research project that was partially funded and get the experience and understand what it's like to work towards a PhD and what it would look like to kind of go down that path of graduate level research.

And I think it had the opposite effect that it was intended to have in that it kind of showed me I didn't want to do that. So, I think in a lot of ways I was happy I had that experience 'cause it showed me before I went down that path that it was something I didn't wanna do. Nothing against it, I guess I wanted to do something that maybe had more of a translational impact, a little bit closer to the patient.

And so, finished my degree, and at the time I was living in Georgia, so I finished my degree in Georgia, left and moved out to California, and ended up at Exagen by pure chance through a recruiter. And that was back in 2014, and basically just joined Exagen at the time when it was a smaller company, and grew with the company, and was fortunate enough to have the ability to learn a lot of different functions within the company as it grew, and there were a lot of different things that needed to be done a as the company was growing. And so it, it's been kind of a, an interesting ride since then.

[00:06:08] Lindsey Dinneen: Yeah, absolutely. And of course all of those different experiences, I'm sure, have woven their way in, like you said. Sometimes you have to kind of look for that line, but there is one that's, apparent when you look back. So, can you talk a little bit more about the company, what it does, especially in regards to its testing technology, and I'd love to hear about some of the innovation that's just coming out of this incredible organization you're a part of.

[00:06:35] Tyler O'Malley: Sure. So our our testing, again, primarily focuses on addressing unmet needs in patients who have autoimmune connective tissue diseases. And specifically we have some proprietary technology around biomarkers that help diagnose systemic lupus. And lupus is kind of the prototypical autoimmune disease in that it can manifest in just about any different way. It can show up in your skin, your heart, your lungs, your kidneys, just about any way you can imagine, and sometimes in multiple different ways. And so in that way, it can be challenging to diagnose 'cause it can look like so many different things. And much of the testing that is used for lupus or has been used traditionally is very antiquated. Antibody tests that were developed many decades ago that have been refined to some extent over the years, but for the most part are not overly sophisticated.

So, what Exagen has done over the past 15 or so years is brought forward some technology, that was originally licensed from University of Pittsburgh, looking at measuring a form of the complement system, which is a part of our immune system. It's a very ancient form of our immune system. It's a collection of proteins that come together to help fight off pathogens and help clear debris to keep our our immune system healthy. And what we're able to do is measure essentially the buildup of a complement fragment that builds up on your red blood cells and on your B lymphocytes. And what this does is it gives us a unique ability to detect lupus that's much more sensitive than the conventional means. And what that means, when I say sensitivity, is that it's able to pick up more lupus patients than the conventional testing.

So, one way of thinking about this is like, if you have a hundred patients in a room that all have lupus, right? Because they've been assessed by a doctor, they've been clinically diagnosed, and you were to test them, and say your conventional test is 50% sensitive, meaning half of the room would test positive on this test and the other half would test negative. This test that we're talking about here, it would pick up two thirds of the room, right, as opposed to conventional testing, which would pick up fewer patients.

So, that's the kind of technology that we're trying to develop here, which is trying to be more inclusive, pick up more patients sooner, give better insights to physicians to combine with their clinical assessments such that patients can get earlier treatments and hopefully stave off some of the more kind of disastrous outcomes of the disease that come with not getting treated soon enough and not getting treated appropriately for their symptoms.

[00:09:31] Lindsey Dinneen: Yeah, of course. That's incredibly important and I'm so glad that the company is working to create those solutions, like you said, because previous methods while maybe somewhat useful, are more antiquated at this point. And so it's really important to have these new strides in innovation. So as you're dealing with all of this, I'm sure that there are stories that have come up about real people having impacted lives because of the technology that your company is bringing. Do you have any examples that you could share with us about that?

[00:10:05] Tyler O'Malley: Sure. Yeah, there's been a number of individuals that we've had the fortune of meeting over the years. And they come and share the story with our team. We like to bring folks in with, for example, when we bring on new sales team members, we try to bring on a patient just to be able to share their story. So, recently we had an individual, who is connected to someone who works in our organization-- again, just pure chance-- who happened to have a very unique story.

So first of all, lupus, for those who don't know, is a condition that primarily affects women. Lupus is a disease that affects women at a ratio of nine to one, nine to one female to male or so, in other words, around 90% of lupus patients are women. But that's not to say that it isn't an issue for that subset of of men that do develop lupus. And in fact, the disease tends to be more severe in that 10% of lupus patients that are men.

So this individual who we've had the chance to meet and hear his story, really interesting because he's-- you would never know if you met this guy-- because he's a CrossFit guy. He is probably the healthiest guy you can imagine looking at him. But he went a harrowing journey to get to his diagnosis. And it all started with, relatively -- well, I don't wanna downplay it-- but let's call it "less severe symptoms" like alopecia and rashes, things like this that sort of make you think, "Well, gee, that's strange," or "I wonder what that is all about." And then leading up to much, much more severe symptoms like severe edema and pericarditis that was ultimately life threatening.

And ultimately, he was able to get the right testing and get to the right doctors, but it was not a short journey from the time that these symptoms initially presented themselves to the time where he was able to get to the test and to get to the right diagnosis and onto the right treatment. The good news is, he's in a much better place now after finding out what's causing his symptoms and getting to a treatment management plan that works for him and he's even back to getting to an exercise routine that works for him.

It's maybe not exactly the same as what it was before, but I mean, that's the thing. Now, you can lead a relatively normal life with lupus. It wasn't that long ago, call it several decades ago, where the mortality rate for lupus was as high as 50% in the first year after diagnosis. Treatment advances have greatly improved that and have changed the lives of people who live with Lupus now, but it used to be a very severe diagnosis. It still is, but it's very manageable now.

[00:12:54] Lindsey Dinneen: Wow. Yeah. And so catching it and having that answer to, like you said, really difficult health journey where you're just not sure what's going on. And I really appreciate you talking a little bit about how Lupus looks different and manifests itself differently in different circumstances so it can be difficult to initially diagnose. So I love the fact that the company is focusing on things like that, when caught early can maybe make a huge difference in somebody's life like the gentleman you mentioned. Thank you for sharing about that.

So now your own career has been really interesting in that you have gotten to do a lot of different things within the company and learn so much. Now as you've continued to grow with the company, you've, I'm sure, developed a lot of different leadership skills along the way, and I'm curious what it's been like in that sense of your journey to embrace leadership and how do you go about it? What have you found works really well, and maybe what advice would you have for somebody who's a little bit earlier in their career?

[00:13:58] Tyler O'Malley: Yeah. Really interesting question. And I, I guess, my experience was, I came into an organization that was, I think at the time, maybe in the entire company was maybe 60, 70 people. So, as you can imagine, it was a very flat organization. I reported directly to the Chief Scientific Officer when I first joined the organization as a relatively low level R&D employee. So that afforded me, I think, a unique opportunity because I was often involved with project planning and discussions that I don't know that you get that opportunity in different types of corporate settings.

And I think what has proven very useful in terms of my development, and as I look back and reflect on kind of what's led me here is, I can just recall, so, so many times, especially early on in, in a startup-- which can sometimes be chaotic and there's a lot of moving parts and things are moving fast-- there would be times where I would be in meetings where I wasn't necessarily expected to do very much, I think, or contribute much. And I would just sort of observe, right? And I think there's so much you can learn through not just listening to the conversation, but the body language of the people around the table. The way that people present, the way that people take criticism, the way that they respond. It was almost like a, it was a lesson every day just watching that.

And I think where I thrived and maybe added value at times was realizing when people were talking past one another and just, at times, trying to find a way to come into that and say, "Well, right, but did you consider maybe what this person was trying to communicate here?" And, you can't always resolve those sorts of situations, but sometimes you can. And that's really valuable when you can help two individuals get past an impasse like that. So, and I think it helps you build credibility doing that too, being a bridge builder in that sense.

And, and I think, that was something I don't know-- whether intuitively or purely by accident, I don't know-- I figured out over time was that, maybe as a young person in your career, sometimes it can be easy to get caught up on sort of the X's and O's of your job, whatever it is that you're doing-- if you're a computer programmer, you're doing bioinformatics or whatever the case may be-- you can get really caught up in the technical skills that you're trying to hone and develop. But there's so many soft skills that you have to build as well at the same time. And there's the relationships that you build, as well, that you don't know when you're gonna need them or when they'll pay off. But things change at organizations and you're glad when you have those relationships when it comes time to need them.

[00:16:51] Lindsey Dinneen: Yeah. Absolutely. Yeah. I love your discussion on the idea of being a bridge builder, because I've been thinking a lot about that recently where there's so much unintentional missed communication, just literally just passing by where, one person is saying something, the other person's saying something, and as an outsider, you're able to have a little bit of a distance to go, "Oh, you're kind of saying the same thing, but I'm not sure that you guys realize that, and here's how." Yeah, that translating is a really important skillset and a fun one when you can nail it down. So as you look towards the future of your own career and the company's trajectory, what are some things that you're looking forward to?

[00:17:35] Tyler O'Malley: Well, we obviously have a number of exciting pipeline initiatives that bring a lot of energy to me as I think about what we're trying to do going forward. I'm excited about where the company is headed in terms of its trajectory. I've described my time at the company as, even though I've been at the same company for 11 and a half years or so, I really feel like I've worked for three different companies in that time, in that, there was a period of time that was a startup up until the point the company went public.

And then there was this time from when the company was public, where we raised a lot of money, there were a lot of expectations and didn't exactly kind of work out exactly as we had hoped. And then there was a leadership change. And now we're sort of in this third phase now where the arrow's pointing up and we have realigned our strategy here and we found a way to be sustainable and to be able to continue to build on something where hopefully we can continue to find interesting technology that's out there.

We have an ongoing partnership with, as an example, Johns Hopkins University to try to develop a test to help address lupus nephritis. So this is a particular form of organ manifestation of lupus. It's one of the more common manifestations of lupus, and one of the more devastating forms of lupus, in that almost 50% of lupus patients will have kidney involvement at some point in their disease. And as much as 10 to 20% of patients who do have lupus nephritis will go on to unfortunately develop end stage kidney disease and require dialysis or kidney transplant. So it's obviously life altering and can be, very impactful to individuals. So, to be able to work on something like that and be able to potentially alter the trajectory of someone's life in that way is pretty cool to think about.

And, not everyone gets to do that. I mean, it's not that other jobs aren't meaningful, it's just not everyone gets the opportunity to do that kind of thing. And if you can also find joy in what you're doing in your job. I think that's also great too. I mean, it's really cliche, the things people say, and so I won't do it. The whole, like, " If you like what you do, you never work." Believe me, it's work. I do feel like I'm working sometimes, for sure, but I can't complain. I do, for the most part, have fun with what I'm doing. I'm fortunate enough, I have a great team of people, well-- three teams of people-- that I really enjoy working with, and being able to work with people and see them grow and develop and be a part of that is also super rewarding as well too. So, yeah, I'm just, I'm having a lot of fun.

[00:20:26] Lindsey Dinneen: Yeah. Excellent. Wonderful. Well, gosh, I'm gonna pivot the conversation just for fun a little bit. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. Now, this could be within your industry, but it doesn't have to be. What would you choose to teach?

[00:20:45] Tyler O'Malley: I think that-- maybe this is kind of fun, probably not-- but I think that ,I don't know why, and it's funny because it's-- I don't even know if this qualifies because I don't even know how I would teach it-- but I think I'm fairly good at guesstimating numbers and it's really useful in that it helps in a lot of different situations to be able to shortcut math. And to be clear, it's not that I'm doing long division in my head or anything like that, but it's, if you can kind of shortcut and get the approximate number, it can be really useful. And it's a nice kind of party trick too kind of thing. Again, I don't know how I would teach it 'cause it's sort of like it's up here, and I don't know how I would externalize that, but yeah, that's something I feel like would be kind of cool to figure out how I could teach that.

[00:21:35] Lindsey Dinneen: Absolutely. Yeah. It's a superpower. So it would be very cool to try to then-- you've got this innate ability-- so then to try to break it down into how does somebody else develop the skill sets that you just sort of possess, and go from there. That would be really entertaining. I love it. Great answer. Okay. And then the next question is, how do you wish to be remembered after you leave this world?

[00:21:59] Tyler O'Malley: Yeah. Well, that's a deep question. I think that the most meaningful impact that you can have is the impression you leave on the people that you interacted with, right? And I think, for me, I would just hope that the people that I've had the chance to spend time with-- obviously family, friends, people I worked with, people who worked on my teams-- I would just hope that as they would reflect on the time that we had together, that it would be a memory that was time well spent and that hopefully there are some good shared experiences that we had and that hopefully I left something that was meaningful. But as it relates to the work that we're doing, I hope that the impact that we're having-- some of it has a longer reach than even what we can see today, 'cause I think, truly being selfless is trying to build things that you'll never realize the benefit of: planting trees that you'll never sit under yourself. It's for someone else down the line in the future.

[00:23:14] Lindsey Dinneen: Yeah. Yeah. I love thinking about it in those terms too: being willing to do your bits of good and let them go out into the world and not necessarily know the ripple effects and still use that as a worthwhile use of your time. I love that. And then final question, what is one thing that makes you smile every time you see or think about it?

[00:23:39] Tyler O'Malley: Yeah, I think the easy answer is probably my kids. So I have two kids, and that's kind of the reprieve from the work life and kind of focusing on all this important stuff that we're trying to do here at work, but being able to kind of break away from that and focus on building them up and watching them grow and develop and become their own person is really cool. It's obviously a unique experience and it's a nice thing to be able to think about when you need something to kind of bring you back up.

[00:24:12] Lindsey Dinneen: Yeah, absolutely. Just a different way of looking at the world from such a fun perspective. I love that.

[00:24:19] Tyler O'Malley: Yeah.

[00:24:20] Lindsey Dinneen: Yeah. Well, Tyler, this has been such a great conversation. I so appreciate your time today telling us a little bit about your story, the company, and all the incredible work that you guys are doing to change lives for a better world. And we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and thank you so much for being here and thank you for doing what you do.

[00:24:59] Tyler O'Malley: Thank you. It's it's been a pleasure.

[00:25:01] Lindsey Dinneen: Excellent, and thank you also to our listeners for tuning in, and if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time.

[00:25:14] Dan Purvis:  The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world. 

Sarah Aswegan, a seasoned biopharma leader and strategic advisor for global rare disease solutions, shares her journey from sales in pharma to her consulting work today. She discusses her experience in transitioning biopharma companies from clinical to commercial success, the evolution of medtech in diagnosing and managing rare diseases, and the collaborative efforts required to bring innovative treatments to market. She also shares insights on current trends in gene therapy, the dynamics of funding, and the importance of data in advancing care for rare disease patients.

Guest links: www.saraaswegan.com 

Charity supported: 

Interested in being a guest on the show or have feedback to share? Email us at [email protected]. 

EPISODE TRANSCRIPT

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and today I'm delighted to welcome to the show, Sarah Aswegan. Sarah is a seasoned biopharma leader helping organizations transition and grow from clinical to commercial success. She prides herself on the success of leading multiple global cross-functional teams and contributing to the success of the franchise areas she oversaw and served. Until recently, she's applied these experiences while serving in a consultancy capacity for many small to midsize biotechs entering or expanding in rare disease. She has also successfully helped organizations to start and scale adjacent spaces to biopharma, and most recently has been serving as a Global Head of Commercial Assets, Brands, and Care Solutions, and has led transformational change at UCP, having been part of the design and scale of the business unit for rare disease. She maintains a strong network among clinicians, access, bioethicists, and patient advocacy globally.

Well, thank you so much for joining us today. I'm so excited to speak with you.

[00:01:52] Sara Aswegan: Thanks, Lindsey. It's nice to be here.

[00:01:54] Lindsey Dinneen: Wonderful. Well, I'd love, if you wouldn't mind, sharing a little bit about yourself and your background and what led you to medtech.

[00:02:02] Sara Aswegan: Yeah, thanks Lindsey. You know, I, I started my career ages ago in the pharma side of things, and as my career has grown, so has the exposure across pharmaceuticals, into biotech and including aspects of medtech. As we look at some of the areas I've spent the last 18 years in rare disease, the medtech component is coming in largely around if we think about the diagnosis component and then the management of the different conditions over the lifespan of a child or adult affected by a rare condition. You can see things really evolving.

I started my career on the sales side of things. My education is in business and communication, so anyone can learn the science if you have good mentors and people to help you along the way. And I was really, really fortunate to work amongst a team of amazing individuals, both in the US and then now having lived away for about 15 years outside of the US that have helped open my eyes to what can be possible and the differences by markets.

And as I mentioned, I spent the last 18 years in the rare disease space really helping companies of all sizes build out and scale their teams, bringing in new assets and bringing solutions to the field of rare disease. And it's something I'm very passionate about.

[00:03:06] Lindsey Dinneen: Yeah. Well, thank you for sharing a little bit about that. So I'm curious, that's a very specific niche and I would love to understand how you arrived at that and how you realized, "Oh, this is what I'm meant to be doing."

[00:03:19] Sara Aswegan: Yeah. So I made a move geographically and company-wise to a small firm at the time. We were just a very small team. We called it the bootstrapping team at Shire Human Genetic Therapies, and I moved from the Chicago area to Boston, and that was my first really exposure to rare diseases. And, it's a completely different field and it continues to evolve even to this day. But the closeness and proximity you have to patients and their families and those with unmet need. And I have, you know, a couple of close friends as well as a family member that's been affected by a rare disease. So as you're seeking care and support for them, it's not always about the medications. It's about that total person and thinking really holistically about the individual and their care teams that are impacted by those conditions.

So the external community we were serving really drove me and introduced me to something that I've stayed with, and it brings great passion to try to find ways to support individuals in our western society, but also looking at low middle income countries and helping facilitate diagnosis to treatment to, again, that whole supportive care and largely from the internal teams within the organizations I've worked with has just is been tremendously rewarding and also equally challenging.

It's beautiful to see progress. I mentioned diagnosis and. One of the areas I worked in initially was in the lysosomal storage disease area. And it's the age-old question on diagnosis. Do you facilitate newborn screening, for example, so when your child is born, you have a heel prick done and you can do a series of tests depending on the state you live in, and in some countries in Europe it's also provided. But if there's not a therapy, is it okay to do that type of diagnosis support. And so that challenge, you know, in seeing the policy evolve on a state by state basis.

When I began in the rare disease space and MPS Type Two Hunter Syndrome, it's a condition that affects mostly boys and a very small part of our population. We knew we could do newborn screening and there was a therapy available, but it wasn't only realized until a few years ago to introduce newborn screening to help those families at the point of birth to know if their child was affected, and therefore start a different trajectory on how they planned for care for them and plan for if there was a medication or other supportive tools and resources available for them.

So it's been extremely dynamic to see how things have evolved. And then now as you see medical and pharma medical technology advance as well into gene therapies. You're seeing news about gene therapy and it's a one time treatment and then the individual hopefully will not have be re redos in their lifetime. Along with that come challenges on that diagnosis piece to make sure they're eligible for the gene therapy. So again, through the device and technology sector, it plays a key role. In addition to the supportive care that goes on for some of these really severe conditions, people have some pretty dynamic needs and it's great to see how things are progressing, but it's still as equally as frustrating, whether you're on the manufacturer side or the family side, to see things be kind of slow sometimes.

[00:06:15] Lindsey Dinneen: Yeah, of course. And you're dealing with a specific situation where many times-- please correct me if I'm wrong-- but it seems like many times there's these kinds of studies and conditions are not funded very well in terms of finding solutions to the problem. So how is that something that you, well, first of all, of course we're in a very interesting season of life right now. So how are you seeing funding evolve over the years for these different diseases that are a little bit more rare, and what can we all do in terms of even just awareness and understanding?

[00:06:51] Sara Aswegan: Yeah, so that's a huge question. We could probably have about five conversations on this just to scratch the surface, Lindsey. I think if I reflect on the question on what we've seen around funding, I mean there are some wonderful, supportive grants available for the brilliant scientists we have around the world that have a curiosity. So making sure we can facilitate that ongoing academic environment to explore and test the hypothesis. And one of the things that you see coming along, and it's not really around-- I won't think about funding as just pure financial-- but it's the funding of the smarts that go around the table. You see a lot more collaboration amongst academia, industry governments coming together to help build and scale so that there's an awareness and understanding of a condition.

I mean, a pediatrician could go through their entire career and never see a boy with Hunter Syndrome. It's just that rare. At the same time, and on the converse of that, if you're working in an industry where you do have access to more funds, the introduction of AI and looking at how we look at drug targeting, drug target selection, genetics and precision medicine have come along quite leaps and bounds in the last several years, but we're still not quite there. But you're seeing advancements with the different cell and gene therapies, having that precision medicine as an option. It's coming forward.

The challenge is the size of studies are normally very small because the population is small. So thinking about patient recruitment, how can we help facilitate better identification of individuals that may be out there and not have received diagnosis because of the rarity of the condition? So looking at technology and advancement of integrated electronic health records up to and including, how do we look at the trial designs? And how do manufacturers, academics, industry, and agencies work together to think a little differently around even designing clinical endpoints for the studies that really are meaningful, that will make a difference. And how do you balance that, right? Correct risk benefit conversation, in the spirit of doing no harm. But if there's one chance and there's something available, how do you do that?

And coming all the way downstream. If you think about where the organizations have advanced their thinking, their approach, and put funds behind, it's also that ongoing care of the individuals. If you look at the upstream, the types of tests that are available. It could be cancer, it could be the area I am so passionate about in genetic disorders, but it can also be thinking about the workflows that come into play in helping facilitate consistency of care across state borders, across country borders. It's a key piece that are really advancing in real time, but we're still trying to overcome the hurdles that are real.

And that's things around data privacy. How do we navigate that in a really meaningful way with the right ethics and integrity. If we think about the regulators, this isn't a huge anti-infective or cardiac study that's ongoing, that there are gonna be tens of thousands of people. So how can we think a little bit differently on advancing the care. In the area I'm working in, Lindsey, especially with some of these individuals that are kids, if they don't get access to care by a certain age point, their window of treatment has closed.

And so what could we do to help facilitate earlier diagnosis and then that advanced care. And so I think we can see a lot of really good intentions, and I think the most beautiful thing is even the collective gathering of different patient organizations that have a shared interest of a disease coming together and also helping raise research funds to help support the scientists that have a hypothesis on something that may really make a difference and may matter.

[00:10:21] Lindsey Dinneen: Yeah. Yeah. Okay, so, there has been so much innovation in the last few years-- of course, even before that, but it seems to be extremely exciting in the last few years-- especially things like CRISPR and all sorts of new technologies emerging. What are some of the exciting trends that you're seeing in this space specifically that give you hope as you continue to look forward and look for solutions?

[00:10:45] Sara Aswegan: I think for me, I mentioned, I touched on it lightly. I think it's that collective, that collaboration and the openness now. The FDA has advanced the way that they think and engage with agencies as well as industry partners. And so what I mean by that, Lindsey, is they're not just engaging with the scientists or with the manufacturers, the drug developers. They're also bringing patients in. And so that collaborative environment, they're even beginning conversations when there's discussion on clinical trial design to understand what really matters. Is it a six minute walk test or is it something around real behavioral or other abilities that can be learned and retained over time that help benefit the quality of life? If you're not gonna be able to cure something, what's really important at that patient front to help facilitate something meaningful.

So I think that type of conversation also with the agencies looking at, there was an amazing session held in Europe recently in the mucopolysaccharidosis or the lysosomal storage disease area, looking at advancements of science and saying, can we look at biomarkers alone and create that relationship and understanding there is a clinically meaningful impact if we can address this biomarker. And so, companies like Ultragenyx have really pushed to have that conversation and dialogue and have a drug filed now that's under review based on biomarker endpoints alone, where five years ago, you would never have imagined that being possible.

[00:12:12] Lindsey Dinneen: Yeah. Yeah. You touched on something that I would really love to explore a little bit deeper, and that is, when there's a situation that right now we don't have a cure for this disease-- and, you know, obviously we're still working towards it-- but if we don't have a cure, but we are trying to improve the quality of life, how do you balance that in your specific field in terms of: obviously you want the patients to live the best quality of life that they can while balancing so many other, and I don't mean this in a callous way at all, just from a practical perspective, balancing all of these other considerations and things that are also desiring funding and all those competing priorities. So how do you balance that? How, how does that come into play?

[00:12:57] Sara Aswegan: So that's a big one. It's a tough one. And I'll oversimplify it and just say data. And what I mean by that, Lindsey is really looking at, with the technology at our fingertips, regardless of the geography you're living in, there's a lot of meaningful information that can be captured. And it's not, again, around one aspect of a disease, but it's the totality of health. So really looking at what could be possible in capturing, is it around energy levels, activity levels. And you'll see that oftentimes in play with the gene therapy, for example, when it's administered, you may have up to 15 years of follow up that you're capturing specific data points.

But even in advance of a drug approval, and an area I am also equally passionate about, is access to unlicensed medicines for individuals that can't travel to a clinical trial site and could benefit from an investigational therapy, how do we do that with the right balance in place? And part of that is data and having the willingness of a participant or family member to be so consented in and participating in the study for their child to share that data and share that real world data or real world evidence so that you can measure back and show what impact that drug or treatment or intervention has been having on the individual.

So I think it's around that and figuring out how we can overcome some of the complexities and challenges that are real. Not everyone has electronic health records. There's still lots of paper-based offices out there. But in the meantime, there's a lot of advancements in technology. So how do you appropriately use that, that it's also not overburdensome for the individual, for the family as well, that you're doing what really matters and measuring back and having the right conversations with the individuals affected, the investigators, the clinicians, but then the regulators, and going back and sharing why this can be something to help substantiate. It's not your standard phase 1, 2, 3 clinical trial design. That's, yes, there's rigor, but it's a different way of looking at using data to help us advance our understanding of a disease and what's needed by the individual affected.

[00:14:53] Lindsey Dinneen: Yeah. So, so when you're speaking with these families and or-- well, first of all, let me actually back up. Do you have direct communication with some of these families and patients that you're working with?

[00:15:04] Sara Aswegan: Yes.

[00:15:05] Lindsey Dinneen: Yeah. And so when that happens, how. How is it for you? I mean, this is such a challenging area that you have devoted your life to and to, and I'm so impressed with that. And, you're doing the work that's helping save lives and make a difference. But that must be really challenging from a personal level to have these difficult conversations. So how do you balance that as a practitioner and somebody who's desiring to help, but you also have this real life compassion and human being that you're trying to help?

[00:15:38] Sara Aswegan: It's tough and it's tremendously rewarding. At the same time, I have so many patient stories I can share with you of meeting them and meeting 'em where they are. I made a trip to Sao Paulo, Brazil once, Lindsey, and met a family that were living in the favelas there, and their aim was to help raise awareness for Hunter's Syndrome because their son had been undiagnosed. They knew something was wrong. He was nonverbal. He had some physical presentation that you could understand. There was something going on, but the technology wasn't there for them. The access to the care center wasn't there for them to get a diagnosis. They were taking buses for hours to different clinics to figure out what's wrong with our son.

And he finally received a diagnosis of Hunter Syndrome and they wanted to share the photos because kids with Hunter Syndrome do have some different dysmorphism. So there's something that's strange. They have a bossy forehead, or their bridge of their nose is a little different. Their bellies might be a little bit bigger. So if you start looking at all of these different clues and putting it together, you might suspect and go-- there's other things going on, for sure. So I'm oversimplifying this. However, getting a diagnosis for him by just raising awareness to other families of the physical presentation and what their experience was extremely meaningful for them.

And on balance, a family in Florida that I met and their son was diagnosed at age 18 months because their grandmother had seen a program on Mystery Diagnosis and said, "That sounds like my grandson." And so creating the conversation and meeting people where they are is really important because you may have some individuals that are very aware of how drugs are developed and all of the rigor that goes through that to then others that just they don't understand that some drugs are intended for a specific indication, specific population, and helping explain why their child may not be eligible for a particular study. It's tough, and that's not my responsibility, but the clinical teams and the clinicians that are having those conversations. So it's listening and really coming with a open heart and mind and having empathy to help figure out how can you educate.

It's even moving into gene therapy. What does gene therapy actually mean? What are the risks? I'm afraid this sounds like it's something so futuristic. What will this mean for my son or daughter in 10 years from now? And, we may not have all of the answers, but you know, science has advanced and it's that risk benefit that you have to exercise. But really it's that coming with compassion and a listening ear and understanding and being honest. And if I can't help, maybe there's someone else that can help or there's a, did you know, there's a clinic here or a center there and helping that network stay connected and thrive is really important.

And also being their voice, Lindsey, I mean, we can, we have an opportunity on our pharma, biomedtech side of the world that we can share what we've observed and try to apply that as we come to work every day and think about that family we met in Brazil or in Boston or in Florida or in, you know, Frankfurt, and whatever they may be experiencing. So it's being their advocate in other areas as well.

[00:18:34] Lindsey Dinneen: Yeah, exactly. So with what you deal with, I am wondering what kinds of misconceptions or myths do you often encounter that are interesting and yet you would prefer to correct so that those of us in the general population are more informed?

[00:18:52] Sara Aswegan: That's a good one. So I think having worked in the rare disease space, one of the biggest scrutinies there, there's on two sides of the coin. One is around diagnosis and why we can't do more around diagnosis. And sometimes the science is just not there yet. So again, to some of these experiences, like the story of the family in Brazil, it may not be about a blood test. It may be about a physical appearance and helping people piece things together.

I think on the other end is at the point of delivery of the diagnosis and then if there is a treatment or intervention that can be taken, and not everyone has the same principle in their heart. There are companies that are motivated for different reasons, but certainly the big topic is are around drug prices, whether it's a gene therapy or a chronic lifetime medication, of how do we navigate that and how do we navigate that in a better way? And I think we have to start looking as an industry, as a community of people, of how do we address that?

The cost of doing a clinical trial is tremendous. It's hugely expensive. Does it warrant though huge price tags on drugs forever in perpetuity? What's that right balance? And I think having a level of social responsibility and looking at alternatives. And so imagine if we could reduce the time for clinical studies for requirements because we're able to look at other data. Things like the biomarker approach and the follow on real world data that could be captured, could that help us in the total overall offering and the cost to the overall health system? Maybe.

I think that as an industry, every company operates with different principles and wanting to do best for the patient community. Some are more profit driven than others, and so that's a reality, and it's one that I get so often at dinners with friends or in personal conversations, professional conversations, and it's a tough one. At the same time, a study of 60 individuals could be double digit millions of dollars. Just the cost of facilitating the study, the production costs of some of these highly technical compounds of different therapies also becomes a factor. So you have to put all these pieces together and really explore what's driving that.

[00:20:57] Lindsey Dinneen: Yeah, of course. And yes, I'm sure that's a really difficult conversation to have too, when you're especially working directly with patients and trying to explain all of that and that's a lot. That's a challenge.

[00:21:10] Sara Aswegan: Yeah. Yeah.

[00:21:11] Lindsey Dinneen: But on the flip side, you know, of course the work that you do makes a huge impact, and I'm wondering if there are any stories that come to mind that just really reinforced to you, "You know what? I am in the right place at the right time, in the right industry."

[00:21:25] Sara Aswegan: Absolutely. And I think it goes to, I touched on it very briefly, and there are people that aren't living in near major cities, near major medical centers, and that should not make them obsolete from receiving the best care. And there are two things that have happened and partly because of the pandemic, but also partly because of the willingness to educate and have that connected community amongst clinicians, is around that access to unlicensed medicine and finding pathways that it's not just because a doctor says your son or daughter needs this medication. I'm going to reach out to the manufacturer to see if I can get access because they're not near a clinical trial site or they don't wanna participate, or they're unable to participate in a study. But finding means to do that.

And there have been some really creative ways that clinicians have been able to do that, of setting up qualified treatment centers where the individual can go to receive the treatment and then that continuity of care is provided then over the life of their disease. It's something that's become real and meaningful, and you would be shocked at the number of individuals around the world that are receiving access to medicines that normally might have only 10 years ago been available if you were living in the Western Europe or the United States because studies weren't conducted in their country and so there's no pathway for access that is all changing.

Those dynamics are changing. It takes a team of people, though. It takes regulators, it takes lawmakers, it takes industry. It takes our logistics teams to be sure if something's stored at cold chain, that that product is delivered in the right context at the right time, just in time for that patient to receive it. So it's a complex challenge, but it's one that we've seen serve individuals in a really meaningful way. And without that, they wouldn't have, they wouldn't have another option.

[00:23:11] Lindsey Dinneen: Yeah. So having that impact and just being able to reinforce in those moments of maybe when it's especially difficult or you're especially frustrated like, "Oh my gosh, I wish I could help X, Y, and Z," at least you can look back and go, "Yes, but look at all this that we are doing."

[00:23:26] Sara Aswegan: You know, Lindsey, also it's that education piece and being curious and asking questions. The scientific community and one of the lead leaders in the NPS community is in North Carolina, Joe Munzer. Dr. Joe Munzer, he's brilliant. And one of the initiatives that we started was something called a masterclass. And so with Dr. Munzer and seven or eight other clinicians from around the world, we literally went on an educational program around the world. And some of the individuals that had just come out of their postgraduate work, pediatric geneticists or neurologists meeting the number one or two people that know this space so well, being mentored by them.

And now those individuals are facilitating their class, the same type of class in their local language to their local communities and creating that level of education and awareness. I mean, it's just to see that real impact over time. I actually get goosebumps just thinking back on the impact that has had. And you've got a community of clinicians that they're, I mean, there's a lot of needs still to study medical genetics. And so hopefully we have individuals that are scientifically interested and will continue that that journey so that they can be the next teachers across borders. That makes the difference.

[00:24:37] Lindsey Dinneen: Yeah. Absolutely. Wow. Yeah. Thank you for sharing that. I was also getting goosebumps just listening to it because that's incredible ripple effect that you had and continue to have. That's amazing.

[00:24:47] Sara Aswegan: Yeah. Yeah.

[00:24:47] Lindsey Dinneen: Yeah. Oh man. Okay. Well, I could talk about this for a long time, but pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach masterclass on anything you want. It can be within your industry, but doesn't have to be. What would you choose to teach?

[00:25:05] Sara Aswegan: Wow. That is a great question, Lindsey. A masterclass-- a million dollars-- a masterclass on anything I would want. I would be drawn to some of the advancements we're seeing in gene therapies, but I think that would be, I wanna try to serve a broader population. Do you know? I think it's, I think if I could look, I would do something around looking back on some of these, if you will use cases and best practices, to share those learnings, just because we know the impact that it will have and has had and continues to have.

And not just on the scientific community, but it ripples down into the patient communities of asking that question of "what can be possible, how can we together." Instead of " no," it's actually, "yes and" or "no and" we hear something else, another construct. And really breaking it down to really enforce what I've talked about on several moments during our conversation today is it can't just be the manufacturer, the, or the developer. It can't just be academia. It can't just be health authorities or regulators.

It's a collective community and it has to include that patient within that conversation to help for that learning and advancement and understanding. And so I think it's something around that, the best practices, use cases, and really things that made a difference. Meeting people where they are of a good understanding of the science, not good understanding of the science, that crosses all levels. Drug development overall. The total continuity of care for my individual affected. It's not just about a drug, but it's about assistive devices or other tools that they can have a better life. And so being really thoughtful about that I think would be something that would be really amazing. That it's actually captured and taught back.

[00:26:47] Lindsey Dinneen: Yeah, absolutely. That would be a fantastic masterclass. All right, and then how do you wish to be remembered after you leave this world?

[00:26:56] Sara Aswegan: Well, at some point I know my husband will admit I have the best sense of humor.

[00:27:01] Lindsey Dinneen: Yes.

[00:27:02] Sara Aswegan: I think for me, Lindsey, I really would hope that people would say an open heart, a generous heart, and just a connector of people, personally, professionally. It takes two seconds to be kind and open and nobody has all the answers. So help people connect with others and be willing to say, "How can I help?"

[00:27:20] Lindsey Dinneen: Yeah, absolutely. Yeah. And then final question, is one thing that makes you smile every time you see or think about it?

[00:27:31] Sara Aswegan: I just came in from my garden and I have to say, seeing my advancement of fostering my garden and I've got things blooming now. There is hope.

[00:27:40] Lindsey Dinneen: I love that. I feel that way every time I somehow succeed in keeping a plant alive.

[00:27:45] Sara Aswegan: There is hope. It's really around the simple things, right? That's it.

[00:27:49] Lindsey Dinneen: Yeah, absolutely. Now, for any of our listeners who are excited to get to know about you and your work a little bit more, can you just share briefly what is it that you do right now to help companies succeed and how can people get in touch with you?

[00:28:02] Sara Aswegan: Thanks, Lindsey. So I am currently doing some advisory board work for a couple of consultancies as well as helping some small and mid-sized biotechs figure out their pathway and how they go to market. How do they facilitate access to unlicensed medicines? I'm passionate about the rare space, so I'm serving also on a couple of special projects on getting drugs and diagnostics into low middle income countries. And it's something I'm very passionate about and I've got a great network of people. So if I can't help, I'm always happy to say, "Not me, however, I know someone you should talk to."

And to get in touch, it's not easy to spell, but it's www.saraaswegan.com. And again, if I can't help, I might know someone who can. And I think it's just, it's really good to share our knowledge and experience and really make a difference however we can.

[00:28:47] Lindsey Dinneen: Yeah. Absolutely. Well, thank you, Sara. This has been absolutely incredible to learn from you, to hear about your story. So thank you for sharing and being open. I really appreciate that. And my goodness, I just wish you the most continued success as you work change lives for a better world.

[00:29:03] Sara Aswegan: Thanks Lindsey, and thanks for everything you're doing. Really, hats off. Thanks a million.

[00:29:07] Lindsey Dinneen: Of course, and have the best rest of your day. And thanks also to our listeners for tuning in. If you're feeling as inspired as I am right now, I'd love it if you shared this episode with a colleague or two and we'll catch you next time.

[00:29:22] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.