# Why Supplier Quality Management Is So Important For Medical Device Companies

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2019-11-27
- Length: 39m
- Episode: 126
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-27-why-supplier-quality-management-is-so-important-for-medical-device-companies
- Listen: https://podcast.greenlight.guru/episode/why-supplier-quality-management-is-so-important-for-medical-device-companies

## Summary

Mike Drues of Vascular Sciences joins host John Spear to discuss supplier quality management, emphasizing that medical device companies retain ultimate responsibility for third-party services even when work is delegated. They use Ethylene Oxide (EtO) sterilization as a case study for supplier failure, noting that relying solely on EtO vendors creates a single point of failure when capacity is constrained by environmental regulations. Drues advocates for a risk-based approach to supplier criticality, suggesting multiple levels of assessment rather than a binary critical/non-critical classification, and highlights the business necessity of creating win-win partnerships with backup suppliers to ensure supply chain resilience.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-27-why-supplier-quality-management-is-so-important-for-medical-device-companies#t=0) Introduction: Mike Drues and Vascular Sciences
- [1:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-27-why-supplier-quality-management-is-so-important-for-medical-device-companies#t=107) Defining Supplier Quality Management and Responsibility
- [7:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-27-why-supplier-quality-management-is-so-important-for-medical-device-companies#t=450) Ethylene Oxide (EtO) Sterilization Crisis
- [16:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-27-why-supplier-quality-management-is-so-important-for-medical-device-companies#t=961) Qualifying Backup Suppliers and Validation Costs
- [25:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-27-why-supplier-quality-management-is-so-important-for-medical-device-companies#t=1526) Risk-Based Supplier Criticality and Triage
- [33:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-27-why-supplier-quality-management-is-so-important-for-medical-device-companies#t=2014) Final Thoughts on Supply Chain Resilience

## Topics

- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Greenlight Guru (company)
- Ethylene Oxide (other)
- FDA (other)
- EPA (other)

## Related episodes from other shows

- [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)
- [Supply Chain Challenges in Medical Device Manufacturing](https://hardwarepodcasts.com/podcast/ontrack/2025-06-17-supply-chain-challenges-in-medical-device-manufacturing) (OnTrack)
- [110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin](https://hardwarepodcasts.com/podcast/lets-combinate/2023-11-15-110-cxo-cdmo-in-the-future-supply-chain-reverse-knowledge-transfer-trust-and-fas) (Let's Combinate)
- [243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work](https://hardwarepodcasts.com/podcast/lets-combinate/2026-06-24-243-why-kitting-a-finished-medical-device-with-a-drug-create-so-much-work) (Let's Combinate)
- [179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing) (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/2019-11-27-why-supplier-quality-management-is-so-important-for-medical-device-companies. 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.