11. FDA mass firing and Medical Devices with Etienne Nichols

The FDA is undergoing massive job cuts. Whether we like it or not, this will undoubtedly change the approval landscape of medical devices. And it already has.My guest Etienne Nichols and I talk about the implications of these changes for Manufacturers and what they can do to remain competitive in this evolving landscape.Etienne Nichols is an all around talent in Medical Devices. He started as a mechanical engineer and is now leading the community of Greenlight Guru with his podcast: the Gobal Medical Device Podcast. On it he welcomes guiests of all fields to share their knowledge on making better devices.More ways to reach us:https://www.linkedin.com/in/mathieupeteau/https://www.linkedin.com/in/etiennenichols/I have a newsletter with weekly tips on improving emdical device cybersecurity. You can find it here: http:// cyberdoctornotes.comEpisode timestamps:00:00 FDA dismissals01:51 About Etienne Nichols04:09 Dismissal implications07:28 Making better submissions13:31 Improving Q&R 18:18 Predictions on submissions21:12 MEDUFA26:01 Secrecy in Medical Devices28:48 AI for submissions31:51 Best MDMs do thisAny questions or feedback I'm very happy to hear your thoughts: [email protected] yours,Cyber Doctor