# Navigating the Twists and Turns of Change Management for Medical Devices

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2019-12-28
- Length: 49m
- Episode: 130
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-28-navigating-the-twists-and-turns-of-change-management-for-medical-devices
- Listen: https://podcast.greenlight.guru/episode/navigating-the-twists-and-turns-of-change-management-for-medical-devices

## Summary

Mike Drues of Vascular Sciences joins host Jon Speer to discuss change management in the medical device industry, emphasizing that companies must perform engineering and biological analysis before deciding whether to notify the FDA or document a 'letter to file.' Drues argues that many firms incorrectly prioritize regulatory notification over safety impact, stifling innovation, and illustrates this with examples involving catheter logo placement and material substitutions. The conversation highlights the risks of 'change creep' and proposes a pragmatic solution for updating the FDA on multiple minor changes.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-28-navigating-the-twists-and-turns-of-change-management-for-medical-devices#t=0) Introduction and the Importance of Change Management
- [5:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-28-navigating-the-twists-and-turns-of-change-management-for-medical-devices#t=337) 510(k) vs PMA: Notification Requirements and Letter to File
- [12:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-28-navigating-the-twists-and-turns-of-change-management-for-medical-devices#t=757) The Correct Order of Analysis: Engineering Before Regulatory
- [21:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-28-navigating-the-twists-and-turns-of-change-management-for-medical-devices#t=1282) The Purpose and Strategy of the Letter to File
- [25:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-28-navigating-the-twists-and-turns-of-change-management-for-medical-devices#t=1505) Case Study: Catheter Logo Placement and Material Changes
- [33:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-28-navigating-the-twists-and-turns-of-change-management-for-medical-devices#t=2036) Innovation Stifled by Fear of FDA Notification
- [38:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-28-navigating-the-twists-and-turns-of-change-management-for-medical-devices#t=2314) Combination Products and Pharma vs. Device Regulations
- [41:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-12-28-navigating-the-twists-and-turns-of-change-management-for-medical-devices#t=2501) Solving Change Creep with a 'Ketchup 510(k)' Approach

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- FDA (other)
- 510(k) (other)
- PMA (other)
- Special 510(k) (other)
- ISO 13485 (other)
- EU MDR (other)

## Related episodes from other shows

- [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)
- [093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti) (Let's Combinate)
- [S5E9 Jon Montcrief | Medical Device Engineering Leaders 8](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-03-01-s5e9-jon-montcrief-medical-device-engineering-leaders-8) (Being an Engineer)
- [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)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (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/2019-12-28-navigating-the-twists-and-turns-of-change-management-for-medical-devices. 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.