# Best Practices for Implementing Design Controls for the Medical Device Industry

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2019-11-07
- Length: 26m
- Episode: 1
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-best-practices-for-implementing-design-controls-for-the-medical-device-industry
- Listen: https://podcast.greenlight.guru/episode/best-practices-for-implementing-design-controls-for-the-medical-device-industry

## Summary

Host Bill Loth interviews Mike Drues, President of Vascular Sciences, and Jon Speer, Co-founder of greenlight.guru, about implementing design controls in the medical device industry. The guests argue that design controls should begin at project initiation as 'prudent engineering' rather than waiting for regulatory mandates, helping startups maximize their attractiveness to acquirers. They discuss the risks of ignoring documentation for early funding milestones like the 510(k) and how to manage the transition when a device's classification changes from Class I to Class II or III.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-best-practices-for-implementing-design-controls-for-the-medical-device-industry#t=0) Introduction and Guest Bios
- [3:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-best-practices-for-implementing-design-controls-for-the-medical-device-industry#t=189) When Design Controls Should Begin
- [6:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-best-practices-for-implementing-design-controls-for-the-medical-device-industry#t=389) Prudent Engineering vs. Regulatory Burden
- [10:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-best-practices-for-implementing-design-controls-for-the-medical-device-industry#t=610) The Research to Development Transition
- [14:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-best-practices-for-implementing-design-controls-for-the-medical-device-industry#t=848) Acquisition Readiness and Documentation
- [20:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-best-practices-for-implementing-design-controls-for-the-medical-device-industry#t=1231) Managing Up-Classification Situations

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Growth, exits & acquisitions](https://hardwarepodcasts.com/topic/growth-exits-and-acquisitions)
- [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)
- FDA (other)
- 510 K (other)
- ISO (other)

## Related episodes from other shows

- [157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific) (Let's Combinate)
- [027 - "Become a Historian of the Problem" with Duane Mancini](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini) (Let's Combinate)
- [S1E13 A Holistic View on Product Development | Devon Campbell](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-09-s1e13-a-holistic-view-on-product-development-devon-campbell) (Being an Engineer)
- [Dakota Welker | User Needs, Design Inputs, Verification & Validation](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation) (Being an Engineer)
- [176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski](https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-19-176-the-fastest-way-to-ruin-drug-device-development-and-how-to-avoid-it-with-eri) (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-best-practices-for-implementing-design-controls-for-the-medical-device-industry. 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.