My special guest for this episode was Mr. Peman Montazemi, the Director of Engineering at the Medical Device company called Diality.

Peman is no stranger to formal education! He earned his Mechanical and Aeorspace Engineering degrees from the University of Virginia, his Masters in Biomedical Engineering from USC, and he is currently pursuing his Executive MBA from UC Irvine.

Over the last 15+ years, Peman has been earning his stripes working for various medical device companies like Advanced Bionics, Smith & Nephew, and others.

As I mentioned, today he is the Director of Engineering for Diality where he is responsible for building, traning, and leading a brand new team from the ground up.

Diality is a privately held, series B-stage medical device company with a mission to develop solutions that help improve the care and lives of patients with kidney disease. The company's vision is a future where its technology enables all patients and partners to control kidney disease.

Key highlights of what we discussed:

Rapid growth = the necessity for rapid new skill development, or in other words, rapid professional development

Layer 1 (A culture that is driven by leadership)

-Expectations, vision, goals, miletones, targets, etc.

Layer 2 (What do the individual teams need to accomplish?)

-Tools necessary, internal vs external resources, project criticality, etc.

Layer 3 (Personal skill gap)

-Why parts of Peman's formal education has helped him the most on the business front?

-What is he most excited about in the Internet of Medical Things space?

...and so much more!

I was honored to host Ms. Topaz Kirlew, a Vice President of Regulatory Affairs at Integra LifeSciences, and formerly at Apyx Medical.

Topaz has over 25+ years experience in Quality and Regulatory Affairs across Biologics, Drugs, Medical Devices and Tissue/Cell Based Products. She's had the opportunity to work for a diverse range of businesses from very larger corporations like Danaher, specifically with Beckman Coulter, to small, yet rapidly growing organizations like Apyx Medical.

During this episode, we discussed various situations of Adversity that Topaz remarkably overcame to be the successful female Executive leader she is today.

Today, Topaz serves as a Vice President of Regulatory Affairs at Integra LifeSciences where she is responsible for developing and implementing Integra's regulatory strategy while providing leadership over submissions, compliance, advertising and promotional review as well as product registrations across the product portfolio for all of Integra's products.

We discussed:

-Her early, formative years. Where she grew up, her family life, etc.

-How she got into the LifeSciences, and specifically Regulatory Affairs

-The challenges she faced rising up through the ranks as a woman of color

-Her perspective on the role and responsibilities of both a mentor and a mentee

...and so much more!

I was joined by Jameil or as many in the industry know him as “Jay” Pendleton, who is a Medical Device Sales leader with over 18 years experience in relationship sales and territory management.

After crushing his own personal sales goals year over year as a high-performing intra-operative sales rep, he was promoted into management having built out a team of Regional Managers in the competitive Western US on behalf of Medtronic.

Holding his bachelor’s degree in business with a minor in psychology Today he serves as Medtronic’s Director of Strategy & Talent for the Brain and Spine Therapies divisions. What exactly is a Director of Strategy & Talent you ask? Great question and I’m glad you asked because that’s a significant part of what we dug into with Jay.

We also discussed the new YouTube podcast that Jay hosts called Sultans of Sales where he interviews a variety of Sales leaders and Surgeons all designed to connect people together in MedTech and other industries while improving people's lives through connections and storytelling.

Some other key highlights we discussed:

How he became the Director of Strategy and Talent.

How did he come up with the idea for the role?

With all of the momentum in the last few months that he has gained with the content that he puts out on social media, what's the purpose of it all and why does he think it is getting the attention that it is?

What advice would he have for those Hiring Managers, Talent Acquisition Professionals, and HR folks who see the value in these types of strategies to build brand awareness and attract talent, but are nervous to get started?

...and so much more!

I was joined by Mr. Michael Katz, Director of Quality for Viz.ai

Michael has a Bachelors of Science in Human Biology from Boise State and Masters Degree in Regulatory Science from John Hopkins.

His career is off to an impressive start having joined the Med-Tech industry in 2016 as a Regulatory Affairs Analyst.

In 2018 he had the opportunity to make his way into the exploding Software as a Medical Device sector today and serves as the Director of Quality for a company called Viz.ai

For those unfamiliar, Viz.Ai the company was inspired by a patient who underwent a successful brain surgery but yet died because the surgery came too late. Dr. Chris Mansi, at Stanford Business School, joined forces with machine learning post-doc Dr David Golan and together they founded Viz.Ai with a goal of using artificial intelligence to make healthcare work faster and smarter. Not just to change, but to radically transform it. In essence, the organization uses AI to synchronize stroke care, reducing systemic delays that stand between patients and life-saving treatments.

Some key highlights we discussed:

-How did he get into the RA/QA space to begin with?

-So many want to get into SaMD and are frustrated by the catch 22 of needing experience to gain experience. How did he land his role with Viz.ai?

- It begs the question, are companies overlooking talent that very well could be successful and do a great job for the organization just because they haven't worked in a SaMD environment before?

-What learning curve has he been going through as it relates to SaMD specifically?

-Has he hired folks from outside the SaMD space? Did they face similar learning curves, or other challenges that he hadn't thought of prior to hiring them?

-What has he found different, if anything about building a Quality (and Regulatory) program in a SaMD environment vs. a traditional Medical Device Company?

I was joined by Mr. Ed Nathanson, Vice President of Talent and Talent Branding at EQRx.

Over the last 30 plus years Ed has built a storied career holding multiple different types of roles within recruiting, human resources, talent acquisition and the talent branding space. From 2014 until 2020 he built an organization called Red Pill Talent which as a company had the singular mission to help companies be awesome at hiring. Ed and his team helped clients build world class internal recruiting and employment branding functions to attract and hire the best possible talent.

Ed’s been featured multiple times both as a featured speaker or as the keynote speaker with companies like Linked In, Glass Door and Mass Bio just to name a few. In his current role as the Vice President of Talent and Talent Branding at EQRx, he’s building and leading a team that is responsible for executing cutting edge talent attraction and retention strategies as EQRx continues to scale.

For those of you unfamiliar with the company, EQRx is really at the forefront of a revolution. The company is working to make medicines more affordable for people who need them, working to make drug pricing transparent, and reinstating the trust between the pharmaceutical industry and its patients.

During our conversation, Ed and I discussed how the market of Talent Branding/Recruiting has evolved and how his passion turned into creating a business consulting to others.

Some key highlights we discussed:

- How he ended up creating a business consulting to others, etc.

-How he would define what Talent Branding is.

-How has the market changed over the last 18 months with respect to how companies need to be engaging with talent and how talent is (or isn’t responding)

-How does he see the game of recruiting/branding continuing to evolve

-Do job descriptions have their place? How should they be best utilized

-Tools he's been having his team utilize to engage with talent

-How does he monitor his team’s performance? Is there a metric for putting out content, or engaging with other’s content, etc.?

I was joined by Susan Andrews, Recruiting Manager for a company called Penumbra. Susan is a recruitment enthusiast and candidate experience Manager with over 15 plus years of full life cycle recruiting experience across a variety of disciplines and environments including agency, corporate and professional services firms throughout the United States.

She's got relevant experience as it relates to ATS Integrations whether that’s UAT, remediation, end user training and she has a variety of experience developing and implementing a best sourcing and recruitment practices and a variety of processes and recruitment techniques all while designing and facilitating training classes across different functional areas.

Susan earned her bachelor’s degree from the University of Texas at Austin and she’s currently one of the recruiting managers at a company called Penumbra. If your not familiar with Penumbra, it is a global medical device organization headquartered in Alameda, CA, that designs, develops, manufacturers and markets novel products that address challenging medical conditions in markets with significant unmet need in both the neuro and vascular space.

During our conversation, Susan and I discussed her role as an Internal Recruiter from responsibilities of an internal recruiter, to favorite social media platforms that she uses for recruiting.

Some key highlights we discussed:

-As a Corporate Recruiter, she constantly has a significant work load on her desk. How does she stay organized?

-What is one thing she thinks Hiring Managers misunderstand about an Internal Recruiter’s role & responsibilities?

-What social media platforms is she using these days for recruiting?

-Which seem to be the most effective for engaging prospective candidates?

-Are job postings giving the ROI they are meant to give? At all levels, or just lower level positions?

-What is one of the most common mistakes she sees candidates making?

...and so much more

I was joined by Dave Nazzaro, the Sr Director of Hardware Engineering and Advanced Technologies at Insulet Corporation.

Dave holds his Bachelor’s of Science degree in Mechanical Engineering from the University of Massachusetts at Lowell and for the last 17 years he has progressively risen through the ranks having worked for a variety of organizations including Fluident, Apple and of course Insulet.

Dave was actually on the product design engineering team that was responsible for the development and launch of the first generation Apple watch. For those of you unfamiliar with Insulet Corporation, it is an innovative medical device company based in Acton Massachusetts. The company was founded in 2000 with the mission of improving the lives of people with diabetes. Specifically through the use of the revolutionary OmniPod Insulet Management System which delivers without any tubing in an automated fashion virtually pain free and it has two straight forward parts that communicate wirelessly. Insulet now also leverages the unique design of it’s pod by tailoring it’s Omnipod technology platform for the delivery of non insulin substantious drugs across therapeutic areas.

During our conversation, Dave and I discussed both hiring and promoting practices.

Some key highlights that we discussed:

-When he hires, what are the core foundational attributes he looks for and how does he measure them ?

-Does he value a technical skillset or a soft skillset more?

-He himself, has successfully been promoted time and again…how has he put himself in position for these promotions? How did he go about figuring out what was necessary to accomplish to be put in position for promotion?

...and so much more

I was joined by Mr. David Pudwill, a Regulatory Affairs expert for both medical devices as well as combination products.

David holds a Bachelor's Degree in Biomedical Engineering and his Masters in Mechanical Engineering. David actually spent 9 years of his career working directly for the FDA as a lead medical device reviewer. After that he spent several years with a med-tech organization called Convatec where he was responsible for developing and growing Global Regulatory and Quality teams as large as a hundred people worldwide, while developing new ways of thinking about Regulatory Affairs for both in market support as well as new product development and a digital transformation.

David currently runs a consulting/educational based firm called Mr. Regulatory. The organization really started as an educational platform primarily discussing all things regulatory, guidance documents, things like that on his Youtube channel. He is in the process of growing the content on that channel, but he is also providing consulting services to a variety of start up organizations across the med-tech space when it comes to Regulatory strategy and he is really helping organizations primarily who don’t yet have a regulatory in house force be able to define the right path and gain access to the market.

During our conversation, David and I discussed his experiences with the FDA as well as how he decided to start his own show vs working for another organization.

Some key highlights we discussed:

-What did working for the FDA teach him that was beneficial for working in-industry

-What mistakes did he make as a leader that he learned from and is better off because of

-What do companies get wrong about Regulatory Affairs? (timing, importance of the function, submission documentation, etc)

-What mistakes does he see up and comers, who are striving to be promoted, making along their journey?

...and so much more

I was joined by Ms. Arvita Tripati, the Head of Quality, Regulatory Affairs and Privacy for a company called Luminostics (Clip Health).

Arvita has built a storied career over the last 13 plus years in Regulatory, Quality and Compliance. She’s spent time with recognizable organizations like Coopervision, Accurate, Alivecor and a variety of other companies.

Arvita holds her Bachelor’s of Science focused in European Intellectual History and her Masters in Business Administration with a concentration in Marketing

Luminostics leverages a patented technology platform which allows for rapid, accurate, infectious disease testing and other health monitoring at the point of care and soon at some point by consumers in their own homes. The unique technology uses a consumer smart phone optics paired with an adapter and the combination of signal processing A/I to detect or measure viruses, bacteria, hormones and proteins with high sensitivity and specificity from samples including swabs, blood, urine and saliva.

During our conversation, Arvita and I discussed her leadership philosophies and her views on performance management.

Some key highlights we discussed:

-What she sees as her responsibility as the leader vs her staff’s responsibility for their professional development

-Ideas for performance plans/roadmaps to help staff get where they want to go

-How does she strategically identify projects against the professional goals of her staff? (aligning goals to opportunities affording relevant experience)

...and so much more!

Over the course 14+ years, Mr. Ankur Kaushal has worked in Regulatory Affairs for a variety of the "big players" in the Med-Tech industry like Abbott, Roche, Johnson & Johnson, and Medtronic . He has gained a variety of experience across class II and III medical devices, invitro-diagnostics and digital therapeutics, and he holds his Bachelors Degree in Engineering and Masters Degree in Biomedical Engineering & Regulatory Affairs.

Ankur joined me to discuss the key similarities and differences working with very large organizations vs smaller/mid-sized companies.

We started off by understanding Ankur's childhood and upbringing and transitioned into understanding how he got involved in the Life Sciences and Regulatory Affairs specifically.

Ankur shared so many great insights and make sure to listen to the episode in its entirety, especially if you are one of the "rising stars" trying to climb the leadership ranks in similar fashion to that of Ankur.

Ankur Kaushal's LinkedIn Profile:

https://www.linkedin.com/in/ankurkaushal/

Big Health Website:

www.bighealth.com