Hardware Podcasts

Why Supplier Quality Management Is So Important For Medical Device Companies

Global Medical Device Podcast · 27 Nov 2019 · 39m · Episode 126

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Greenlight Guru
Also
Ethylene Oxide, FDA, EPA

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