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