In this episode, host Mitch Robbins interviews Mickey Brown, Vice President of Access and Reimbursement at Cerapedics, discussing his 30+ year career journey and insights on healthcare market access.

Key Highlights:

• Mickey shares his transition from 15 years on the payer side (Blue Cross, United Healthcare) to manufacturer roles at Medtronic, Cochlear, and now Cerapedics
• Learn how stepping outside his comfort zone at critical moments propelled his career forward
• Discover the biggest challenges facing market access professionals in 2025
• Understand common reimbursement strategy mistakes companies make and how to avoid them

Practical Takeaways:

• Why waiting too long to develop reimbursement strategy hurts product launches
• The key differences between director and VP-level thinking
• What makes an outstanding market access professional
• How to effectively engage with increasingly inaccessible payers

Whether you're in medical device sales, reimbursement, or aspiring to leadership roles in healthcare, this conversation offers valuable insights from both sides of the healthcare ecosystem.

In this episode of The Med-Tech Talent Lab, host Mitch Robbins sits down with Erica Logan, Director of Talent Acquisition at Sequel Med Tech, to discuss the biggest hiring pitfalls companies face—and how to fix them.

With nearly two decades in staffing and corporate recruiting, Erica has seen it all. From hiring at fast-scaling startups to navigating high-volume recruitment in MedTech, she shares hard-hitting insights on what separates a great hiring process from a broken one.

In this episode, we cover:

✔️ The most common hiring mistakes companies make (and why they keep happening)

✔️ How bad candidate experiences damage employer branding & long-term success

✔️ Why hiring managers need coaching—and how TA leaders should step up

✔️ The truth about AI in hiring and how it’s actually being used behind the scenes

Whether you’re in talent acquisition, HR, or leading a team, this conversation is packed with actionable takeaways that will help you attract, hire, and retain top talent in today’s market.

🎧 Tune in now to level up your hiring strategy!

#Hiring #TalentAcquisition #Recruitment #MedTech #Leadership

In this episode of The MedTech Talent Lab, host Mitch Robbins sits down with Mike Winterling, Chief Operating Officer at Junkosha USA. Mike shares his journey from spending nearly three decades at WL Gore & Associates to making the leap into a leadership role at a much smaller company, Junkosha.

He discusses the challenges of transitioning from a well-established corporate environment to a more agile, fast-growing organization, and offers valuable insights for leaders navigating similar changes. Whether you’re scaling a team or managing cultural differences in a global company, Mike’s experience offers a blueprint for building a high-performing team in a lean environment.

Tune in to hear about the importance of company culture, the impact of hiring right, and the adjustments needed when leading a small, dynamic team in today’s competitive marketplace.

So you just passed over a valued employee and chose to promote someone else.

How do you do immediate damage control to not lose this person?

How do you "comfort" them and give them hope for their future internally?

Adam Saupe and I take this head on and provide you with real-world, actionable strategies you can implement straight away.

Some highlights we covered:

-The power of empathy and validation

-Clearly explain why they didn't get the promotion, but what they need to do next to keep moving forward

-Double-down on engagement with them

-Reinforce your willingness to continue to provide them with mentorship

...and so much more

Many have labeled our guest today as a Talent Acquisition Visionary. Most recently he was recognized by CIO Views Magazine as one of the most influential leaders in the Talent Acquisition industry in 2022.

I'm referring to Mr. Doug Fauth, the Sr Director of Global Talent Acquisition & Development at Microvention.

MicroVention, founded in 1997, has pioneered the development of catheter-based, minimally invasive, neuroendovascular technologies. Doug joined the company in 2016 after working for companies like Ernst & Young, Broadcom Corporation, Activision-Blizzard, Life Technologies, and Southern California Edison (SCE).

At the start of his career, which now spans over 25+ years, Doug worked in a College & University setting where he was involved in career counseling and bringing companies on-campus to interview and hire current students, later transitioning to internal talent acquisition for organizations.

Some highlights of what we covered:

-Rising above the noise to get a company's message in front of talent and have it make them take action

-Doug's philosophy on Talent Branding and why it's so different from most

-Leveraging job postings as valued real-estate and breaking away from worn-out ways of writing them that don't work anymore

-An innovative way of communicating with your employees

-Doug's take on Employee Value Propositions and how to create one so that candidates will take note and want to speak with you!

...and so much more

Joining me on this episode was the VP of Quality Systems & Compliance at Roche Molecular Solutions, Ms. Michaela Hart. Michaela is a leader I personally have a lot of respect for. With her no BS style, she's led teams for the better part of 30 years for a variety of organizations, but primarily at Roche. She likes to go fast in business and in life being an avid race car driver!

She really works her butt off to empower teams while holding them accountable.

To help inspire other leaders, she wrote a book in 2015, "Let them Lead"..How to Command Less & Accomplish More (available on Amazon).

She's also in the process of writing a brand new book which we discuss during the episode as well.

-Hiring givers & firing takers

-Performance management, what exactly does this truly mean?

-Managing across multi-generational workforces and the key differences

-The importance of having a personal 'board of advisors'

-Michaela's upcoming book, "Let them leave"

...and much more!

Joining me for this episode was Mr. Tim Marjenin, VP of Neurology Regulatory Affairs at MCRA, the leading Medical Device, Diagnostics, and Biologics CRO with Integrated Clinical, Regulatory, Reimbursement, Compliance, & Quality services.

Prior joining MCRA, Tim worked for the FDA for 16 years as a Scientific Reviewer and then as a Assistant Director (Branch Chief) over the Neurostimulation Devices branch.

During this epsiode, Tim and I discussed:

-What he would want to ask prospective Consulting partners if he were the one choosing the Consultant

-What Tim thinks start-ups often get wrong when it comes to the timing of engaging a Regulatory Consultant

-How important is fee consideration when companies choose a Consultant

-The #1 factor that should be considered when choosing a Consultant or Consultancy Firm?

...and so much more!

I was so excited to host Duane Mancini, the Founder & CEO of Project Med-Tech, primarily because Duane and his team are adding so much value to the industry at large by way of the fantastic content they put out on a regular basis.

Duane hosts the Project MedTech podcast where he interviews leading experts in the Medical Device industry on a variety of topics related to major successes, pitfalls, and trends.

Recently, Project MedTech has morphed into a full-blown business of resources for Med-Tech startups at any phase the company is working through.

For over 10+ years, Duane has held a variety of roles in the Med-Tech industry (Chemist, Sr Technical Advisor, and multiple Business Development roles with companies like NAMSA and LabCor.

Duane holds his Bachelors and Masters degrees in Medicinal and Biological Chemistry from the University of Toldeo.

Some of the highlights we discussing during this episode:

-How Project Medtech support Startups and the resources they can provide

-How crucial it is to understand Regulatory, Reimbursement, & Commercialization and how each affects business decisions

-The most surprising feedback Duane has received from an Investor's point of view

...and so much more!

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.?

How do you successfully recruit top-tier engineers in a location no one’s heard of?

Summary:

In this episode, Mitch Robbins dives deep with Julia Campbell, Talent Acquisition Manager at Terumo Medical Corporation, to explore the art of recruiting technical talent in the MedTech space. Julia shares her journey from falling into recruitment by chance to becoming an integral part of Terumo’s hiring strategy.

They discuss the unique challenges of hiring for highly specialized roles, managing hiring manager expectations, and Julia's secrets for identifying top candidates.

With over 14 years of experience, Julia offers invaluable insights into building teams that propel innovation and growth.

🎧 Why You Should Listen:

If you're involved with recruiting for technical roles, or you're a candidate in a technical role, this episode is packed with actionable advice.

Julia’s strategic approach to building trust with hiring managers and candidates alike will leave you rethinking your own recruitment processes.

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

Joining me for this episode was Mr. Nick Zweig, the Associate Director of Talent Acquisition at Beta Bionics based on Concord, MA. Nick eats and breathes Talent Acquisition. It's by no means just a job for him. He is so passionate and enthusiastic about recruitment and helping companies build high performing teams.

Nick has been in recruitment, both on the 3rd party search side as well as being the internal champion for several organizations over the last 16+ years. He has worked for major organizations like Fresenius Medical Care as the Manager of Talent Acquisition for the Manufacturing, Quality, and Supply Chain functions.

Currently, he is helping Beta Bionics to scale the organization at rapid pace.

Beta Bionics is a MA public benefit corporation, and the team is developing a Bionic Pancreas called the Eyelet which is a fully-integrated medical device that is designed to reduce the burden and costs of Diabetes care by automatically and autonomously managing blood sugar levels 24/7 in people with Type 1 Diabetes.

During the show, Nick and I discussed the idea of a "Talent Acquisition Experience"

Some highlights covered:

-When should "Acquisition of Talent" begin? Hint: Before you have an open position

-What Place do Job Descriptions Have in 2021?

-Employer Value Proposition vs Performance Profile

-What is Employer DNA?

-Tactical vs Strategic Talent Acquisition (Brand Awareness)

Nick Zweig on LinkedIn:

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

Beta Bionics on the web:

www.betabionics.com

Mr. Lee Lisemby, the Vice President at Revlar Labs, joins me to discuss his own personal and professional journey overcoming may challenges that would have caused many others to simply throw in the towel and give up. Growing up Lee faced three challenges, a speech impediment, ADHD, and Dislexia. Rather than getting down on himself, like so many others unfortunately would, he faced his challenges head on and is thriving as a accomplished leader as a direct result.

Lee spent 8 years as an enlisted member of the United States Navy. He earned a Bachelors degree in International Business and holds his Lean Six Sigma Black Belt Certification.

Over the last 12+ years Lee has held various leadership roles across multiple sectors (including Med-Tech) and even led the Quality efforts for the implementation of a new space suit for NASA used on a Lunar and in a Mars environment. His core competencies are in Supply Chain & Procurement and Operations Strategy utilizing his servant leadership to deliver superior performance and negotiate mutually beneficial vendor relationships.

Listen in on Lee's story and the advice he'd share for others facing adversity and wanting more for themselves for their greater future.

It was a pleasure to host this conversation with Dina Justice, the Vice President of Regulatory Affairs at Terumo Medical. Dina is the epitome of a strong woman in the workforce, but more specifically within the Life Sciences community. During this episode we discuss some of the trials and tribulations Dina endured and overcame both as a single mother and as a female leader who has continued to progress her career to the level of Vice President. She shares some amazing perspective and great insights for women who are trying to find the balance between family and work.

Marcelo Trevnio, the VP of Regulatory & Quality at Agendia has built a storied career for himself. He earned his Bachelors Degree in Industrial & Systems Engineer and a Masters Degree in Business Administration. Marcelo also has his Certification in Regulatory Affairs Management and he is a Master Medical Device Auditor through Exemplar Global and is also known as a Biomedical Auditor through ASQ. Over the years, Marcelo has worked his way up the ladder holding various progressive leadership roles at organizations like Medtronic, Nihon Kohden, Applied Medical, and now Agendia.

Agendia is the only Molecular Diagnostics company focused solely on breast cancer. The organization uses groundbreaking genomic testing to generate reliable and meaningful clinical data about the unique biology of a woman's breast cancer.

During our conversation, Marcelo and I discuss pivotal moments and experiences during his own career journey to-date that helped him achieve his level of success. We also discuss what he looks for when building high performing teams, and several recommendations he has to those aspiring to climb the rungs of leadership themselves.

Marcelo Trevino on LinkedIn:

https://www.linkedin.com/in/marcelo-trevino-0015921/

Agendia:

https://agendia.com/

Dr Leon Eisen joins us on the very first episode of the Med-Tech Talent Lab to discuss the common pitfalls and mistakes Founders and leaders of start-ups often make.

Dr Eisen is the Founder and CEO of Oxitone Medical. Leon has a storied background having successfully launched several Israeli start-ups and is the gentleman who invented the first Wrist Sensor Pulse Oximetry monitor. At his current organization, Dr. Eisen and his team have established a new model of care known as digital continuous care which incorporates modern wearable medical technology and modern AI predictive analytics as a natural evolution of remote patient monitoring.

On this first episode of the Med-Tech Talent Lab, we discuss top 5 mistakes start-ups make when organizing AND scaling.

Dr. Leon Eisen on LinkedIn:

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

Oxitone Medical:

https://www.oxitone.com/

Joining us for episode #109 was Ms. Kathy Jeffery, the Chief People Officer at Element Science. Kathy comes to the show with over 20 years experience as a Senior leader overseeing People Operations, Talent Acquisition, Organizational Development. She’s had the opportunity to scale five start-ups across industries, including Pear Therapeutics in the Digital Health space. She holds her Bachelors in Human Resources from DePaul University in Chicago & her Masters in Managerial Communication from Northwestern University.

For those unfamiliar with Element Science, the company is a Medical Device & Digital Health start-up that leverages data science & machine learning to develop lifesaving wearable solutions designed to deliver an outstanding experience.

Some highlights:

-What exactly is culture & how do you define it?

-In a rapidly scaling organization, how do you balance culture while ensuring you retain core vision & values

-How Kathy & Element Science are attracting sought-after Med-Tech Talent in one of the most competitive hot beds, the San Francisco Bay area

-How to keep the focus on employee development as the organization continues to scale

-How start-ups can support internal Diversity, Equity & Inclusion

....and so much more!

Kathy Jeffery on LinkedIn:

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

Element Science on the web:

www.elementscience.com

Summary

In this episode, Mitch Robbins interviews Mark Rhein, The Head of Talent & Learning at Glaukos Corporation. Mark shares his experience in building a learning and development program at Glaukos focusing on middle-level leadership development. He emphasizes the importance of prioritization and designing programs that provide the biggest value to employees. Mark also discusses the company's unique approach to performance management, which involves regular check-ins and feedback conversations. He shares insights on workforce planning and the need for flexibility in a rapidly growing organization. Overall, Mark highlights the importance of continuous learning and adapting to meet the needs of the business.

Takeaways

• Prioritize learning and development programs that provide the biggest value to employees.
• Design leadership development programs that focus on middle-level leaders, who have a direct impact on the majority of employees.
• Implement regular check-ins and feedback conversations as an alternative to traditional performance management.
• Streamline workforce planning and focus on critical roles and areas of expertise.

Chapters

00:00Introduction and Background

01:12Building a Learning and Development Program at Glauco's Corporation

05:01Focusing on Middle-Level Leadership Development

07:23Designing and Implementing Leadership Development Programs

09:16Expanding Learning Activities and Classes

11:15Balancing Time Constraints with Learning and Development

20:34Providing Feedback and Recognizing Achievements

22:09Streamlining Workforce Planning

32:27Lessons Learned and Advice for Building a Learning and Development Program

35:27Exciting Innovations at Glauco's Corporation

About Mark:

Mark has built a storied career over the last 25+ years building Learning & Development programs across industries. Deloitte, Sprint, Abbott, & now Glaukos are just some of the fine organizations Mark has contributed to. Mark’s expertise, which I know we are going to dig into today, lies in the areas of Organizational Development, Performance Management, Leadership Development across all levels & project Management.

Mark Holds his Bachelors degree in Enviornmental Design from the University of Missouri-Columbia & his Masters Degree in Executive Leadership & Organizational Change from Northwestern University.

https://www.linkedin.com/in/mark-rhein-7b3944/

About Glaukos:

Glaukos Corporation is a ophthalmic medical technology & pharmaceutical company based out of Southern California that is focused on novel therapies for the treatment of glaucoma, corneal disorders & retinal disease.

www.glaukos.com

The average merit increase year over year historically has been hovering around 2-3%. Yet there are those vastly underpaid against the market rate for their particular scope of expertise, but most don't know how to ask for a raise and GET IT.If you'd like to learn from pro, veteran Headhunters as to tactful and tactical ways you can negotiate your next raise, you won't want to miss this live episode of The Med-Tech Talent Lab.Some highlights of what we discussed:-Why tenure is not a bonified reason (alone) to command a raise-When you should negotiate-What research you should complete before negotiation-How to maximize the probability of obtaining your raise...and so much more!Did you know The Med-Tech Talent Lab goes live every Thursday at 11am Pacific/2pm Eastern on LinkedIn? Make sure to connect with, or follow, Mitch Robbins on LinkedIn to be notified each time the show goes live!https://www.linkedin.com/in/mitchrobbins/

Joining Mitch for episode #108 was Ms. Jana Melamut, the Senior Manager of Talent Acquisition at NeoGenomics Laboratories. Jana comes to the show with over 24 years of recruitment & staffing experience. She's worked in both the 3rd party agency world & of course on the corporate side of talent acquisition. Companies like Veeva Systems, Alcon, & The Medical Affairs Company have all been graced by her talents. She received her Bachelors Degree in Business Administration from The University of Florida. NeoGenomics Laboratories is a premier cancer diagnostics, pharma services & information services organization serving oncologists, pathologists, pharmaceutical companies & academic centers in their pursuit of providing better futures for people living with cancer.

Some highlights from what we discussed:

-The importance of, & how to, of building relationships with hiring managers

-How to establish trust with them

-The importance of strong intake meetings & Jana's process for conducting them

-Setting up a search plan & interview expectations

-Iterating on those expectations when results just aren't happening

...and so much more!

Jana Melamut on LinkedIn:

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

NeoGenomics Laboratories on the web:

www.neogenomcs.com

Joining us for episode #107 was Mr. Jason Kroh, the Chief Technology Officer at Strados Labs.

Jason comes to the show with over 25 years of experience in Med-Tech. At the front end of his career he held positions in both Product & Electrical Engineering and began to work his way into Executive leadership roles overseeing R&D, Engineering & eventually becoming a CTO.

He’s worked for companies like Vero Biotech, CardioMEMS, & Cybersonics to name a few.

Jason has simultaneously been a Panel Reviewer for the National Science Foundation reviewing both Phase I and II SBIR & STTR grant applications. Jason holds his Bachelors of Science in Biomedical Engineering & his Masters of Science in Electrical Engineering. Since 2018 Jason has been the CTO at Strados Labs.

For those unfamiliar with the organization, Strados is home to the world’s only FDA-cleared device called the RESP Biosensor which is clinically validated to capture lung sounds including coughing, wheezing, rhonci & other adventitious breathing sounds over time without requiring episodic patient intervention. This leads to a stronger understanding of treatment response & earlier insight into exacerbations to prevent uncessary hospitalizations…especially for people suffering from chronic respiratory diseases such as COPD & Ashtma.

Some highlights of what we discussed:

-How Jason got into Med-Tech

-The roles & responsibilities that were pivotal for propelling his career to the Executive level

-Making the transition from contributor to leader

-How Jason manages the stress of Executive responsibilities & balances with other aspects of life

-The difference between average & top performance, especially in Engineering

-The future of Cybersecurity in the Medical Device industry

...and so much more!

Joining me for episode #106 was Mr. Naveen Agarwal, the Founder at Creative Analytics Solutions.

If you’re in Med-Tech, & you browse LinkedIn, chances are you’ve seen some of Naveen’s content, especially centered around Risk.

Naveen comes to the show with over 25 years industry experience. He’s worked for well known organizations like Kimberly-Clark as a Research Scientist and for J&J in Business Analytics & Quality Management.

Over the last 7 years or so he has led Creative Analytics which is a consulting firm providing Quality Systems expertise to Medical Device organizations through it’s trademarked platform called Exceed Innovative Quality Solutions Platform across 4 broad areas (Customer Experience, Regulatory compliance, Risk Management & Quality Culture)

Some of the highlights we discussed:

-Biggest pitfalls when it comes to device manufacturers risk management programs

-What are some low hanging fruit teams can go after when it comes to improving risk management safeguards?

-Regarding the new QMSR , from a risk perspective, what will be the biggest challenges for companies when it comes to implementation ?

...and so much more!

Naveen Agarwal on LinkedIn:

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

Naveen's Substack:

https://naveenagarwalphd.substack.com/about

Creative Analytics Solutions:

https://www.linkedin.com/company/exeedqm/

Mitch Robbins had the pleasure of hosting Mr. Jason Gorman, the Vice President of Regulatory, Quality & Compliance at Propeller Health for episode #105. Jason comes to us today with over 25 years of experience across the Med-Tech industry. He has a proven track record for developing & implementing Quality Management Systems, Risk Management strategies & Regulatory Compliance processes to meet the highest standards of excellence in customer satisfaction. Prior to working for Propeller Health, Jason spent over a decade working for Accuracy. For those unfamiliar with Propeller Health, now owned by Resmed, it's a precision digital health company on a mission to uplift every person living with chronic disease so they can take control of their health and live a better life. The Propeller Platform includes FDA-cleared & CE Marked medical devices, consumer apps support & coaching and secure access to clinical data for provider monitoring.

Some highlights:

-Jason's journey into Quality & Regulatory

-The evolution of his interest & responsibilities related to privacy & security

-Cybersecurity's disruption to Med-Tech in relation MDR & QMSR changes

-Jason's prediction for the evolution of Reg Affairs & Quality roles with regards to Cybesecurity

-The relationship between Quality Management Systems & Information Security Management Systems

-Cybersecurity vs AI....what is the common thread?

...and so much more!

Jason Gorman on LinkedIn:

https://www.linkedin.com/in/jason-c-gorman/

Propeller Health on the web:

www.propellerhealth.com

For this episode, I had the pleasure of hosting Ms. Jennifer Mascioli-Tudor, Founder & Principal of JMT Compliance Consulting.

In this episode, we discussed:

-Jennifer's transition from corporate to consulting

-The challenges and rewards of consulting

-The importance of community, and the need for vulnerability and connection in the industry

....and so much more!

Takeaways

• Transitioning from corporate to consulting requires a willingness to embrace uncertainty and risk.
• Building a community and fostering connections is essential for success in consulting.
• Being vulnerable and taking risks in reaching out to others can lead to valuable connections and opportunities in the industry.

About Jennifer Mascioli-Tudor:

Jennifer comes to the show today with over 23 years experience in Med-Tech Regulatory & Quality. Having worked in a variety of different capacities for many organizations…. Companies like J&J, Medtronic, Boston Scientific, Outset Medical & GE Healthcare have all been graced by her talents.

She’s currently an instructor at UC San Diego & simultaneously runs her consulting practice. Jennifer holds her bachelors of science degree in Physiology/Chemistry & French from Eastern Michigan University & her MBA from the University of Phoenix

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

About JMT Compliance Consulting:

JMT Compliance Consulting helps organizations navigate the quality and regulatory landscape providing coaching, mentoring & foundational business support. Where appropriate the team also provides COO & CQRO leadership to support growing businesses.

www.jmtcompliance.com

Mitch Robbins had the opportunity to host Mr. Garth Conrad, the VP of Quality for Flex Health Solutions. Garth shares his career journey and insights on leadership and building a strong company culture. He emphasizes the importance of relationships, curiosity, and drive in achieving success. Conrad also highlights the role of mentors and coaches in career development. He discusses the differences between individual contributor and managerial roles, as well as the qualities that separate top performers from the average. Conrad stresses the significance of aligning values, beliefs, and behaviors to create a positive company culture. He encourages professionals to gain experience in different functional areas and to actively solve problems. Near the end of the show Garth humanly shares the vision for the legacy he hopes to leave behind.

Takeaways

• Build strong relationships and value the people you work with
• Cultivate curiosity and a drive to understand the 'why' behind things
• Develop leadership skills by managing yourself, then a small team
• Establish a network of mentors and coaches for guidance and support
• Focus on making your people successful as a leader
• Create a positive company culture by aligning values, beliefs, and behaviors
• Gain experience in different functional areas to broaden your skills
• Be proactive in solving problems and taking initiative
• Build leaders within the organization and help others succeed in their careers

About Garth Conrad:

Mr. Garth Conrad comes to The Med-Tech Talent Lab with almost 25 years of industry experience across Med-Tech. He's worked for a variety of the large strategics like Medtronic, J&J, BD, etc. Garth holds a bachelors of science degree in materials engineering, an MBA, and he is also a Lean Six Sigma Black Belt.

Garth on LinkedIn:

https://www.linkedin.com/in/garth-conrad-38b3835/

About Flex & Flex Health Solutions:

Flex Health Solutions is a division of Flex which is a $30 billion dollar organization with about 170,000 employees worldwide. The company is a global supply chain and manufacturing solutions provider.

https://flex.com/resources/flex-health-solutions

In this episode, we talk with Mr. Mark Rhein, the Head of talent & Learning at Glaukos Corporation. Mark shares his experience in building a learning and development program at Glaukos, focusing on middle-level leadership development. He emphasizes the importance of prioritization and designing programs that provide the biggest value to employees. Mark also discusses the company's unique approach to performance management, which involves regular check-ins and feedback conversations. He shares insights on workforce planning and the need for flexibility in a rapidly growing organization. Overall, Mark highlights the importance of continuous learning and adapting to meet the needs of the business.

Takeaways

• Prioritize learning and development programs that provide the biggest value to employees.
• Design leadership development programs that focus on middle-level leaders, who have a direct impact on the majority of employees.
• Implement regular check-ins and feedback conversations as an alternative to traditional performance management.
• Streamline workforce planning and focus on critical roles and areas of expertise.

Chapters

00:00Introduction and Background

01:12Building a Learning and Development Program at Glaukos Corporation

05:01Focusing on Middle-Level Leadership Development

07:23Designing and Implementing Leadership Development Programs

09:16Expanding Learning Activities and Classes

11:15Balancing Time Constraints with Learning and Development

20:34Providing Feedback and Recognizing Achievements

22:09Streamlining Workforce Planning

32:27Lessons Learned and Advice for Building a Learning and Development Program

35:27Exciting Innovations at Glaukos Corporation

About Mark Rhein:

https://www.linkedin.com/in/mark-rhein-7b3944/

Mark has built a storied career over the last 25+ years building Learning & Development programs across industries. Deloitte, Sprint, Abbott, & now Glaukos are just some of the fine organizations Mark has contributed to. Mark’s expertise, which I know we are going to dig into today, lies in the areas of Organizational Development, Performance Management, Leadership Development across all levels & project Management.

Mark Holds his Bachelors degree in Enviornmental Design from the University of Missouri-Columbia & his Masters Degree in Executive Leadership & Organizational Change from Northwestern University.

About Glaukos:

www.glaukos.com

Glaukos Corporation is a ophthalmic medical technology & pharmaceutical company based out of Southern California that is focused on novel therapies for the treatment of glaucoma, corneal disorders & retinal disease.

In this episode of The MedTech Talent Lab, host Mitch Robbins sits down with April Spillane, VP of Market Access & Reimbursement at Intrinsic Therapeutics. With over 15 years in the industry—10 of those dedicated to spine—April shares her unique career trajectory, from clinical and business development to leading market access strategies at a high level.

She opens up about the challenges of balancing a demanding career with motherhood, the leadership lessons she’s learned along the way, and what it truly takes to thrive in market access and reimbursement. April also discusses the evolving healthcare landscape, the complexities of payer policies, and why persistence is key in the fight for patient access to cutting-edge technologies.

Whether you’re a MedTech leader, aspiring executive, or just curious about the behind-the-scenes battles to bring life-changing medical innovations to market, this episode is packed with valuable insights.

Listen now to hear how April is shaping the future of MedTech access and advocacy!

Summary

In this episode, Mitch Robbins interviews Alan Beckman, the Vice President of Market Access at Blue Wind Medical. They discuss Alan's background, his transition from sales to market access, and the challenges and rewards of working in market access. Alan shares his insights on interviewing and hiring, the qualities of a successful market access professional, and the changes in market dynamics post-pandemic. He also talks about managing stress and maintaining a routine, his desired legacy, and the exciting developments at Blue Wind Medical.

Takeaways

• Market access is a complex and challenging field that requires a focus on patients and a willingness to navigate the intricacies of coding, coverage, and payment.
• Honesty and transparency are crucial in the interview process, both from the employer and the candidate.
• Building a strong network and seeking guidance from experienced professionals in market access can be invaluable for career growth.
• The gratification of helping patients and improving access to therapies is a rewarding aspect of working in market access.
• The post-pandemic healthcare landscape has presented new challenges for market access, including the need to partner with healthcare systems and address delayed procedures.
• Managing stress in market access involves maintaining a routine, focusing on family and patients, and finding ways to stay active and mindful.
• Success in market access requires tenacity, a patient-focused mindset, and the ability to navigate rejection and overcome obstacles.
• Blue Wind Medical is experiencing exciting growth and is poised to make a significant impact in the UUI space.

About Alan:

Alan received his Bachelors in Economics from Rutgers University & MBA from Fairleigh Dickinson University & comes to us today with almost 30 years of experience across Med-Tech & the greater LifeSciences having held positions in sales, progressive roles in sales leadership and for the last 14 years leadership roles overseeing Reimbursement, Market Access & Healthcare economics. Back in the day he worked for companies like Cephalon and Abbott Labs. More recently he was a Senior Director of Healthcare Economics & Reimbursement for LivaNova before joining BlueWind Medical in 2022 as the VP.

https://www.linkedin.com/in/alan-beckman-mba-abb5986/

About BlueWind Medical:

Bluewind Medical, is introducing a transformative new treatment for urgent bladder leaks. The company’s product, Revi, is a miniature device implanted near the ankle that sends signals up through the nerves to the bladder to help manage symptoms. With up to 95% patient satisfaction, Revi is a long-term solution designed to help calm and control your bladder symptoms.

https://bluewindmedical.com/

Joining us for this episode was Mr. Ken Mariash, the CEO at Sinaptica Therapeutics. For over 20 years Ken has been leading & growing new business ventures on both the 'Buy Side' and the 'Build Side.' He started his career in management consulting at Charles River Associates then jumped to industry at CLS, then Baxter BioScience (acquired by Takeda) and then Boston Scientific with leadership roles in marketing, strategy & corporate development. Ken holds degrees in both Biochemistry & Business Economics from Brown University.

Today, Ken is leading the team at Sinaptica to advance their personalized closed-loop neuromodulation therapy for Alzheimers which has generated unprecedented Phase 2 sham-controlled clinical data that was recently published in the Oxford journal, 'Brain.' Sinaptica has FDA Breakthrough status for its novel proprietary approach which combines rTMS, EEG, and Neuronavigation with a sophisticated ML-derived personalization engine based on a novel brain target--the precuneus, the central hub of the Default Mode Network, a brain network involved in episodic memory. The company has completed all clinicals to date with non-dilutive funding and is now in-process of obtaining financing to complete the clinical product (SinaptiStim-AD) ** and prepare to initiate a pivotal study in one year's time.

Some of the major highlights we discussed:

-How Ken's upbringing shaped his early & future career days

-Pivotal roles that were instrumental in Ken's career development to becoming a CEO

-How Ken manages stress, especially during difficult times

-Ken's perspective on the toughest part of being a CEO

-Career advice for others coming up behind him

...and so much more

Key Takeaways:

• Early interests and experiences can provide clues to future career paths.
• Pivotal roles and responsibilities can shape a career and provide valuable skills and experiences.
• Opportunities and the belief of others can play a significant role in career progression.
• Being a MedTech CEO requires managing time and maintaining focus amidst numerous demands. Maintaining focus is crucial for productivity. Techniques like taking short walks, facing the sun, and prioritizing tasks can help regenerate focus.
• Managing stress involves letting go of outcomes, maintaining an optimistic outlook, and imagining a future where goals are achieved.
• Establishing a daily routine that includes meditation, setting intentions, exercise, and prioritizing sleep can contribute to mental and physical well-being.
• Building a high-performance team requires individuals with an all-in mentality, personal responsibility, and a focus on winning together.
• Culture is a system of unspoken values that determine the behaviors that get rewarded. Leaders must actively shape and reinforce the desired culture.
• Leadership involves pushing others to achieve their best, providing honest feedback, and being open to personal growth.
• Career and life advice includes becoming excellent in your area of focus, being curious and hungry to learn about other areas, and seeking new opportunities.
• The future of Synaptic and their work in Alzheimer's therapy is exciting, with promising data showing the potential for significant impact.

Find Ken Mariash on LinkedIn:

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

Sinaptica Therapeutics on the web:

https://sinapticatx.com/

Note: (SinaptiStim is a trade mark of Sinaptica Therapeutics)

In this episode, we were joined by Mr. Anthony Incontro, the Talent Acquisition Manager for Vertos Medical. We discussed the importance of creating a best-in-class candidate experience and how to streamline the application process. We also explored the challenges of collaborating with hiring managers and delivering tough feedback to candidates. Anthony shares insights into the growth and culture at Vertos Medical, a company focused on developing innovative treatments for lumbar spinal stenosis.

Takeaways

• Treating candidates with respect and transparency is key to creating a best-in-class candidate experience.
• Streamlining the application process by eliminating unnecessary steps can improve the candidate experience.
• Engaging candidates throughout the process and providing regular updates can help alleviate their anxiety and maintain their interest.
• Hiring managers should understand that hiring is a two-way street and that candidates have choices. Treating candidates with respect and valuing their time is crucial.
• Delivering tough feedback to candidates requires empathy and clear communication. It is important to provide constructive feedback that can help candidates improve.
• Company growth and culture play a significant role in attracting and retaining top talent.

Chapters

00:00Introduction and Background

01:16Importance of Candidate Experience

05:49Streamlining the Application Process

06:36Engaging Candidates Throughout the Process

09:32Managing the Hiring Manager's Role

12:14Delivering Tough Feedback to Candidates

Anthony Incontro on LinkedIn:

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

Vertos Medical on the web:

vertosmed.com

About Anthony Incontro:

Anthony received his bachelor’s degree from Rutgers University in Labor Relations & Human Resources Management, and since 2005, he has been building his career in Talent Acquisition. Anthony’s had the opportunity to work across the LifeSciences ecosystem in both Pharma & Medical Device having worked for various organizations like Johnson & Johnson, Novo Nordisk, Alcon, Integra LifeSciences & Acadia Pharmaceuticals to name a few. Today, as I mentioned, he leads Talent Acquisition for Vertos Medical.

Joining us for this episode was Mr. Michael Tutera, the Vice President of Market Access at Nalu Medical.

Michael came to the show today with almost 25 years of experience across the Medical Device, Biopharma & Pharma sectors. Michael got his start in the industry by way of Sales and over the years has continued to take on progressive amounts of responsibility in Sales leadership and then of course both Reimbursement & Market Access leadership.

He’s worked for companies like Forest Laboratories which many of you now know it as Allergan, Mallinckrodt Pharmaceuticals, Intersect ENT which is now part of Medtronic, and of course now now, Nalu Medical.

For those unfamiliar with Nalu, it has been repeatedly recognized for its revolutionary technology & innovation including being named as one of the top 100 new products in the world by R&D Magazine. The company was also the gold winner of the 2021 Medical Design Excellence Award and winner of MedTech Visionaries Award for Best MedTech Company & Best Medical Device in the field of neurology. The Nalu Neurostimulation System gives patients more options for managing intractable, chronic pain.

Some of the highlights we covered:

-How Mike's upbringing shaped the early beginnings of his career

-Mike's take on high performance, especially in Market Access

-Why some make it to the top of their pyramid & others don't

-Toughest challenges in 2024 for Med-Device organizations to achieve market access

-How Mike handles stress as a leader with many varying personal & professional responsiblities

...and so much more!

Joining us for this episode was Mr. Anthony Watson, the Vice President of Regulatory & Quality at Windgap Medical. Tony comes to the show today with almost 30 years of experience in the greater LifeSciences industry. Prior to working on the industry side, he spent almost 20 years working for the FDA where prior to resigning, he was the Director for the Division of Anesthesiology, General Hospital, Infection Control & Dental Services.

If you can’t tell already, Tony has a tremendous breadth of experience working for companies like  Sanofi, Biogen, Pear Therapeutics and of course now Windgap Medical. He has been at the forefront of the development of FDA emerging technology global regulatory schemes affecting the evolution of regulated combination products, SaMD products & human factors and he is an expert when it comes to building new Regulatory teams, defining problems & finding optimal solutions. He holds his BS in Engineering from the United States Naval Academy & both his Masters in Management Information Systems & MBA from the University of Maryland.

Some of the highlights we discussed:

-How his formative years shaped his career trajectory

-His transition from FDA to the industry side of the business

-His take on leadership & lessons learned from his Military experience

-What separates top performers from the average in RA and/or QA

-Advice for those aspiring to lead the entire RA and/or QA functions

..and so much more!

Find Tony on LinkedIn:

https://www.linkedin.com/in/anthony-w-77abaa3/

Learn more about Windgap Medical:

https://windgapmedical.com/

Joining us for this episode was Mr. Philip MacDonald, a Market Access Executive who has helped 100s of thousands gained access to proper care. He's worked for strategics like Medtronic, Abbott & Siemens. He's also worked for start-ups like Vertos Medical. He holds a Doctorate in Health Economics & a Masters in Healthcare Administration.

Some of the highlights we discussed:

-What separates top performers from the average in market access

-Primary challenges manufacturers & sponsors face in 2024 to gaining market access for medical devices

-A look back on what he would do differently if he could go back in time

-Advice for those aspiring to lead the Market Access function

..and so much more!

Philip on LinkedIn:

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

SummaryIn this episode, Mitch Robbins interviews Melanie Leibovitz, a regulatory and quality executive with over 25 years of experience in the medical device and digital health sectors. Melanie shares her journey from growing up in New Jersey to falling into the regulatory and quality field. She emphasizes the importance of soft skills for executive roles and offers advice on developing these skills. Melanie also discusses the role of AI in regulatory and quality and encourages professionals in the field to adapt and learn new skills. She concludes by sharing her hope of leaving a legacy in the industry.

Takeaways

• Soft skills, such as communication and problem-solving, are crucial for regulatory and quality professionals to excel in executive roles.
• Building a strong network and finding mentors who can provide guidance and support is essential for career growth.
• AI has the potential to enhance regulatory intelligence and make the work of regulatory professionals more efficient.
• Regulatory and quality professionals should embrace challenges and persevere in order to make a difference in the industry.

Tune in for this and so much more!

Joining us for this episode of The Med-Tech Talent Lab was Mr. Kevin Bentley, the Vice President of Regulatory Affairs & Quality at Zoll Respircardia.

Kevin is a 30 year veteran in the fields of medical device quality and regulatory. Since 2017, Kevin has served as the Vice President of Regulatory Affairs and Quality for a company called Zoll Respircardia, which is a leader in innovative technologies that address the unmet needs of people with central fleet apnea.

Kevin and his team are responsible for driving regulatory strategy. For successful commercialization and maintaining commercialized status across a portfolio of novel class two and class three products. Prior to this, Kevin served in a variety of RAQA leadership roles for companies like Angiotech, Angel medical systems, LSI solutions, and others.

Simultaneously over the years, Kevin has maintained a vibrant consulting practice called Acumen regulatory and quality consultants. Where he and his team assist MedTech startups with creating and executing regulatory strategies for novel devices, which includes meeting with the FDA, Health Canada, and notified bodies to determine the least burdensome path to device approval.

Some of the highlights we discussed:

-His formative years and how they helped shape his interests

-Pivotal career moments that helped him get to his VP spot today

-Tips of what to look for when interviewing candidates

-How does he spot top performance compared to 'average'?

...and so much more!

The Med-Tech Talent Lab kicks off its 3rd season with a guest who is no stranger to the show! Mitch Robbins sat down with Michelle Lott, Founder of Lean RA/QA, a consulting firm helping Med-Tech startups across the US with all things Regulatory & Quality to discuss when exactly is the right time to hire your first full-time RA/QA employee.

During the episode Mitch & Michelle discussed:

-Indicators for when it's time to hire a full time RA/QA professional

-How fractional help makes the most sense early

-The scope of responsiblity this RA/QA 1st FTE usually takes on

-Where Med-Tech start-ups get it wrong in the beginning with their Regulatory strategy

...and so much more!

Check out Michelle Lott & Lean RA/QA here:

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

and Lean RA/QA here:

https://leanraqa.com/

During this final episode of The Med-Tech Talent lab, 2023 Mitch Robbins & Adam Saupe reflect on what's been a topsy turvy year in the employment market for Med-Tech. They share their learnings, insights, and forecasts for what is to come in 2024.

Thanks to all our loyal listeners and newcomers alike! Excited to bring you a brand new season of The Med-Tech Talent Lab podcast in 2024!

"There will be two types of recruiters: those who use AI, and those who don’t have jobs." 🤯

In this episode of The MedTech Talent Lab, I sit down with Noor Manji, Director of Talent Acquisition at Hearing Life, to unpack the realities of recruiting, job searching, and how AI is reshaping the hiring landscape. Noor brings over 20 years of experience across agency and corporate recruiting, and he’s got strong opinions on what works (and what’s broken) in talent acquisition today.

We cover:

✅ The truth about online applications—and why referrals win 80% of the time

✅ How top candidates bypass the black hole of job boards and command attention

✅ The biggest mistakes hiring managers make that cost them top talent

✅ Why AI won’t replace recruiters—but those who don’t adapt will get left behind

✅ What it really takes to move from recruiter to talent acquisition leader

If you're a recruiter, hiring manager, or job seeker looking for real, no-BS insights, this episode is a must-listen.

Noor on LinkedIn:

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

Hearing Life on the web:

www.hearinglife.com

While job descriptions can certainly be helpful they can also backfire and deter would-be qualified candidates from moving forward and applying.

During this episode of The Med-Tech Talent Lab podcast we discuss how to leverage (or disregard) the contents of a job description in an effort to best position yourself for response to your inquiry.

The advice as to what to do regarding your experience vs what the job description says varies depending on a variety of circumstances which we dive into during this discussion.

Some highlights:

1. Job Requirements Dilemma: The episode opens with a debate on the necessity for candidates to meet every criterion listed in job descriptions, considering the varied perspectives of different organizations, especially those with strict compliance requirements.
2. Balancing Requirements with Candidate Potential: The experts share anecdotes and experiences where job descriptions were modified to accommodate outstanding candidates lacking specific formal qualifications. This highlights the dynamic nature of job requirements and the flexibility that some organizations may exercise.
3. Strategy for Applicants: There's a consensus on the frustration candidates face when their applications go unanswered. The advice leans towards applying to roles closely aligned with one’s qualifications and using professional networks for support and advocacy.
4. Insights on Hiring Manager’s Perspective: The discussion sheds light on the responsibilities of internal HR and the need for setting realistic job expectations, emphasizing the crucial role of clarity in job descriptions.
5. Emphasis on Networking: The significance of networking is underscored, advocating for its use as a tool for candidates, especially when their qualifications don’t exactly match job requirements.
6. Final Takeaways: The podcast wraps up with a general agreement that while job requirements are essential, there’s room for maneuver, suggesting a balanced approach for candidates. It encourages understanding the hiring environment's nuances and leveraging personal and professional networks.

...tune in for so much more!

In this episode of "The MedTech Talent Lab" podcast, host Mitch Robbins is joined by Talent Acquisition veteran Nick Zweig. They discuss the benefits of recruiting and job searching during the holiday season. Despite the common preference for a fresh start in January, the hosts argue that starting the recruiting process during the holiday season can actually be more advantageous. They point out that new budgets are approved in January, making it a busy time for recruiters. They encourage companies and candidates to take advantage of the holiday season to begin their job search or open up new searches. An "against the grain" approach to why it's actually advantageous to recruit and job search going right up into the holidays vs waiting until all industry competition gets after it in the New Year.

If you've ever experienced a significant relationship that came to a close, you'd probably agree with the similarities to that of getting laid-off.Usually, depending on circumstances, there's:-A period of grief-A period of reflection-An opportunity to learn, grow and move FORWARDDuring this live episode of The Med-Tech Talent Lab podcast we discuss how to leverage the unfortunate event of getting laid-off to your advantage.