11. FDA mass firing and Medical Devices with Etienne Nichols
Description
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.com
Episode timestamps:
00:00 FDA dismissals
01:51 About Etienne Nichols
04:09 Dismissal implications
07:28 Making better submissions
13:31 Improving Q&R
18:18 Predictions on submissions
21:12 MEDUFA
26:01 Secrecy in Medical Devices
28:48 AI for submissions
31:51 Best MDMs do this
Any questions or feedback I'm very happy to hear your thoughts: mathieu@cyberclinic.io
Securely yours,
Cyber Doctor
United States
