Hardware Podcasts

The Best of Jon & Mike Through the Years

Global Medical Device Podcast · 29 Dec 2022 · 50m · Episode 296

What this episode covers

Jon Speer, founder of Greenlight Guru, and Mike Drues of Vascular Sciences reflect on their 107-episode podcast partnership, discussing key regulatory strategies including the 510(k), De Novo, and Emergency Use Authorization (EUA). They emphasize the importance of understanding all market pathways, interpreting regulations rather than just following them blindly, and conducting realistic usability testing. The conversation highlights the critical mindset of asking whether one would use the device on a family member, underscoring the gravity of medical device development.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, 510(k), De Novo, Emergency Use Authorization

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