The Med-Tech Talent Lab

by Mitch Robbins

Welcome to the Med-Tech Talent Lab the #1 catalyst for advancing careers and building high performing teams. Sponsored by The Anthony Michael Group…helping companies secure in demand talent in Regulatory Affairs, Quality, Clinical, Engineering, R&D and Commercial areas for Medical Device, Digital Health, Diagnostics and other organizations across the US Life Sciences sector.

Podcast episodes

  • Season 3

  • Being a Regulatory & Quality Executive w/ Anthony Watson, VP of RA/QA at Windgap Medical

    Being a Regulatory & Quality Executive w/ Anthony Watson, VP of RA/QA at Windgap Medical

    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/

  • Being a Market Access Executive w/ Philip Macdonald

    Being a Market Access Executive w/ Philip Macdonald

    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/

  • Becoming a Regulatory & Quality Executive w/ Melanie Leibowitz-VP RA/QA-Proscia

    Becoming a Regulatory & Quality Executive w/ Melanie Leibowitz-VP RA/QA-Proscia

    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!

  • Being a Med-Tech VP of Reg Affairs/Quality w/ Kevin Bentley-Zoll Respircardia

    Being a Med-Tech VP of Reg Affairs/Quality w/ Kevin Bentley-Zoll Respircardia

    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!

  • Med-Tech Startups-When to hire your first Reg Affairs & Quality FTE

    Med-Tech Startups-When to hire your first Reg Affairs & Quality FTE

    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/