# How To Improve Your Medical Device Design Reviews

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2019-11-07
- Length: 24m
- Episode: 3
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews
- Listen: https://podcast.greenlight.guru/episode/how-to-improve-your-medical-device-design-reviews

## Summary

Michael Drues, Jason McKibbin, and Jon Speer of Greenlight Guru discuss strategies for improving medical device design reviews, emphasizing that they are critical checkpoints within design controls rather than mere regulatory checkboxes. The experts argue for more frequent reviews, the necessity of truly independent reviewers to avoid bias, and the importance of fostering a culture of trust and open dialogue. They highlight that design reviews should address both 'designing the device right' and 'designing the right device' to prevent costly errors and ensure patient safety.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=0) Introduction: Michael Drues, Jason McKibbin, and Jon Speer on Design Reviews
- [2:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=132) Jason McKibbin on Design Reviews as Checkpoints and Gates
- [3:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=210) Jon Speer on Frequency and the 'More is Better' Philosophy
- [4:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=286) Michael Drues on the Necessity of Independent Reviewers
- [7:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=454) Jason McKibbin on Achieving True Independence in Small Companies
- [10:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=603) Jon Speer on Timing Reviews Based on Product Risk and Team
- [12:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=737) Michael Drues on Design Reviews as Prudent Engineering
- [14:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=844) Distinguishing Design Reviews from Phase Reviews
- [17:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=1036) Jason McKibbin on Key Areas for Improvement: Frequency, People, and Trust
- [19:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=1156) Michael Drues on Asking the Right Questions and Designing the Right Device
- [21:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-to-improve-your-medical-device-design-reviews#t=1307) Jon Speer on Slowing Down and Being Deliberate

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- Medicis (company)
- FDA (other)
- ISO (other)
- Medical Device Online (other)

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- [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)
- [Code Reviews](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-07-26-code-reviews) (The Pragmatic Embedded Podcast)
- [A Look Inside Medical Device Manufacturing with Philips’ Natalia Mendez](https://hardwarepodcasts.com/podcast/manufacturing-happy-hour/2022-09-27-a-look-inside-medical-device-manufacturing-with-philips-natalia-mendez) (Manufacturing Happy Hour)
- [064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-21-064-pharma-and-medical-device-development-processes-dfss-and-design-reviews-with) (Let's Combinate)

## 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/2019-11-07-how-to-improve-your-medical-device-design-reviews. 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.