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: [email protected]

Securely yours,

Cyber Doctor