Mitigating Biocompatibility Risks from Material and Supplier Changes in Medical Devices

In this Q&A, Audrey Turley, director of lab operations – biosafety at Nelson Laboratories, spoke with Medical Design Briefs about the critical importance of monitoring and managing material changes in medical devices. Even seemingly minor shifts — such as switching suppliers or altering processing steps — can introduce unknown additives or variations that impact biocompatibility and, ultimately, patient safety. Turley discusses how manufacturers can effectively document and justify changes, maintain regulatory compliance, and strengthen supplier relationships to ensure ongoing device safety. She also shares insights into trends shaping post-pandemic supply-chain strategies and the growing emphasis on proactive risk assessment and communication across the product lifecycle.