# Why Biocompatibility Should be Addressed by Every Medical Device Company

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-11-04
- Length: 48m
- Episode: 166
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-04-why-biocompatibility-should-be-addressed-by-every-medical-device-company
- Listen: https://podcast.greenlight.guru/episode/why-biocompatibility-should-be-addressed-by-every-medical-device-company

## Summary

Mike Drues of Vascular Sciences joins host John Spear to discuss the critical importance of biocompatibility in medical device development, emphasizing that every device, including software, must address it. They analyze recent FDA guidances on skin-contact devices and Nitinol, warning against misinterpreting 'least burdensome' approaches as excuses to skip testing. Drues highlights the dangers of relying on purchasing controls or labeling for risk mitigation, citing the gynecological mesh litigation as a cautionary tale, and stresses the need for objective evidence and early engagement with experts.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-04-why-biocompatibility-should-be-addressed-by-every-medical-device-company#t=0) Introduction and Recent FDA Biocompatibility Guidances
- [4:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-04-why-biocompatibility-should-be-addressed-by-every-medical-device-company#t=291) FDA Draft Guidance on Skin Contact Devices and Risk of Misinterpretation
- [15:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-04-why-biocompatibility-should-be-addressed-by-every-medical-device-company#t=919) Challenges with Material History and Supplier Data
- [21:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-04-why-biocompatibility-should-be-addressed-by-every-medical-device-company#t=1276) Critique of Purchasing Controls and Labeling as Risk Mitigation
- [33:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-04-why-biocompatibility-should-be-addressed-by-every-medical-device-company#t=1981) FDA Final Guidance on Nitinol and Material Specificity
- [38:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-04-why-biocompatibility-should-be-addressed-by-every-medical-device-company#t=2323) Regulatory Submission Takeaways and Justifying Non-Applicability

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- Vascular Sciences (company)
- Greenlight Guru (company)
- ISO 10993 (other)
- Nitinol (material)
- FDA (company)
- 510 K (other)

## Related episodes from other shows

- [232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-01-232-medtech-material-selection-cost-compliance-sustainability-and-biocompatibili) (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)
- [67: Software for Things That Can Kill People](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people) (Embedded.fm)
- [140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-12-140-medical-device-diagnostics-cybersecurity-3rd-party-software-sboms-evaluating) (Let's Combinate)
- [Agile Manifesto Pt. 1](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2022-03-08-agile-manifesto-pt-1) (The Pragmatic Embedded Podcast)

## 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/2020-11-04-why-biocompatibility-should-be-addressed-by-every-medical-device-company. 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.