135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson

On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses: 03:11 The Formation and Impact of the Office of Combination Products 04:16 Challenges and Changes in the Regulatory Landscape for Combination Products 07:53 Understanding FDA Titles and Organizational Structure 11:03 From FDA to Biogen: Transitioning to Industry and Building Medical Device Competency 16:41 Insights into FDA and Industry Dynamics: Conferences, Regulations, and Mindset Shifts 20:05 Combination Product Mindset in Large Organizations vs. Startups 21:54 Navigating Small Company Dynamics and Supply Chain Management 22:29 The Importance of a Combination Product Mindset 25:14 Challenges and Evolution of Combination Products 26:42 Global Perspectives on Combination Products 27:30 Digital Health: The New Frontier 35:02 Quality Culture and Open Communication Anthony started his career as a naval officer on ships before transitioning to the civilian side of government. He served nearly 20 years at FDA as a reviewer, branch chief, and division director. In his time at FDA, he was one of the original regulatory policy-makers for combination products on the CDRH side. He has led the development of sevral guidance documents that are still in use more than 10 years after he left FDA. He has been active in industry advocay groups and standards efforts related to combination products for nearly 20 years. Since leaving FDA in 2013, Anthony has been developing and leading device and combination product teams in biotech, biopharma, and digital health companies from startups to global scale. He is presently the Vice President of Regulatory Affairs and Quality at Windgap Medical, a drug delivery device startup in Watertown, Massachusetts. He is also an adjunct professor at Northeastern University in the Regulatory Affairs Program and advises companies in the digital health field. LinkedIn url: https://www.linkedin.com/in/anthony-w-77abaa3?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=android_app