# How Jon Speer Met His Most Frequent Guest: Mike Drues

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-08-26
- Length: 40m
- Episode: 161
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues
- Listen: https://podcast.greenlight.guru/episode/how-jon-speer-met-his-most-frequent-guest-mike-drues

## Summary

Jon Speer, host of the Global Medical Device Podcast and founder of Greenlight Guru, revisits his 2014 origin story with Mike Drues, president of Vascular Sciences, to discuss their past debates on medical device design controls. They analyze the tension between following the literal letter of FDA regulations versus understanding their intent, arguing that many companies fail because they treat compliance as a checkbox exercise rather than a rigorous engineering process. The conversation highlights the danger of assuming users know their own needs, which stifles revolutionary product development in favor of evolutionary improvements, and emphasizes the critical importance of validating validation methods and addressing off-label use in risk management.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues#t=0) Introduction and Origin Story
- [7:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues#t=474) Letter vs. Intent of Regulations
- [14:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues#t=853) User Needs and Revolutionary Development
- [22:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues#t=1330) Validating Validation and Risk Management
- [26:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues#t=1615) Off-Label Use and Regulatory Strategy
- [34:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues#t=2056) Conclusion: Prudent Engineering vs. Regulation

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- ISO 14971 (other)
- 510 K (other)

## Related episodes from other shows

- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge) (Let's Combinate)
- [S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda) (Being an Engineer)
- [043 - “Half Knowledge Can Hurt” with Shadeed Salam](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam) (Let's Combinate)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (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/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues. 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.