# Risk Management from a Regulatory & Product Development Point of View

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2019-11-07
- Length: 22m
- Episode: 4
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-risk-management-from-a-regulatory-product-development-point-of-view
- Listen: https://podcast.greenlight.guru/episode/risk-management-from-a-regulatory-product-development-point-of-view

## Summary

Host John Speer and guest Mike Drues, president of Vascular Sciences, discuss the complexities of risk management in medical device development, specifically focusing on the tension between regulatory documentation and product liability. They analyze ISO 14971 and TR 24971 as frameworks, highlighting the dilemma of addressing off-label use in risk assessments to avoid higher liability exposure. The conversation covers strategies for limiting discussion to on-label risks while still considering unintentional misuse, and concludes with advice on navigating FDA interactions regarding intended use.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-risk-management-from-a-regulatory-product-development-point-of-view#t=0) Introduction and ISO 14971 Overview
- [2:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-risk-management-from-a-regulatory-product-development-point-of-view#t=132) Risk Management Tools and Standards
- [5:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-risk-management-from-a-regulatory-product-development-point-of-view#t=331) The Off-Label Use Liability Dilemma
- [10:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-risk-management-from-a-regulatory-product-development-point-of-view#t=635) Intentional vs. Unintentional Misuse
- [14:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-risk-management-from-a-regulatory-product-development-point-of-view#t=872) FDA Regulation and Practice of Medicine
- [18:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-risk-management-from-a-regulatory-product-development-point-of-view#t=1098) Pragmatic Advice and Conclusion

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- ISO 14971 (other)
- TR 24971 (other)
- FMEA (other)
- FDA (other)

## Related episodes from other shows

- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (Let's Combinate)
- [161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products](https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-06-161-iso-14971-and-ich-q9-explained-risk-management-frameworks-in-medical-devices) (Let's Combinate)
- [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)
- [091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-28-091-combination-products-handbook-part-1-foundation-learning-from-the-process-ca) (Let's Combinate)
- [258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q) (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-risk-management-from-a-regulatory-product-development-point-of-view. 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.