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 

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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.