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

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

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-solutionsHide

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

Chapters

00:00 Introduction and Background

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

05:01 Focusing on Middle-Level Leadership Development

07:23 Designing and Implementing Leadership Development Programs

09:16 Expanding Learning Activities and Classes

11:15 Balancing Time Constraints with Learning and Development

20:34 Providing Feedback and Recognizing Achievements

22:09 Streamlining Workforce Planning

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

35:27 Exciting 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, 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

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:

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

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/

In 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

Tune in for this and so much more!