# The Best of Jon & Mike Through the Years

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-12-29
- Length: 50m
- Episode: 296
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years
- Listen: https://podcast.greenlight.guru/episode/the-best-of-jon-mike-through-the-years

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years#t=0) Introduction: Jon Speer and Mike Drues' 107-Episode Partnership
- [3:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years#t=222) Interpreting Regulations and the Spirit vs. Letter of the Law
- [14:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years#t=852) Regulatory Strategy: 510(k), De Novo, and Knowing Your Options
- [27:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years#t=1625) Usability Testing: Realism vs. Contrived Studies
- [37:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years#t=2222) Emergency Use Authorization (EUA) and FDA Communication
- [42:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years#t=2565) The Core Ethic: Would You Use the Device on Family?

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Sensors & measurement in products](https://hardwarepodcasts.com/topic/sensors)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

large enterprises

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- 510(k) (other)
- De Novo (other)
- Emergency Use Authorization (other)

## Related episodes from other shows

- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou) (Let's Combinate)
- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (Let's Combinate)
- [S5E7 Matt Zachek | Medical Device Engineering Leaders 7](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-02-16-s5e7-matt-zachek-medical-device-engineering-leaders-7) (Being an Engineer)
- [S6E19 Stuart Grant | MedTech Innovation](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-05-09-s6e19-stuart-grant-medtech-innovation) (Being an Engineer)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.