The Med-Tech Talent Lab

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!

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.