Global Medical Device Podcast Powered By Greenlight.guru

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data. With insights on using PMAs as a competitive strategy and overcoming internal resistance to high-risk device development, this discussion is essential for MedTech innovators looking to turn regulatory challenges into opportunities.Key Timestamps:00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message03:15 – Introduction to Dr. Mike Drues and his background in PMAs05:45 – Overview of PMAs and when they should be used11:30 – Are PMAs the only pathway for Class 3 device