Managing PFAS Uncertainty: What Medical Device Teams Can Do Today

For medical device manufacturers, PFAS is no longer just a materials consideration—it is a significant business risk. Navigating this challenge requires balancing patient-critical performance with a fragmented and evolving regulatory landscape. While certain fluoropolymers are essential for chemical resistance and biocompatibility, others enter the manufacturing process unintentionally through processing aids or upstream contamination.

A proactive, risk-based approach begins with total visibility into where these substances reside and why they are being used. By distinguishing between functional necessity and incidental exposure, teams can prioritize high-impact changes, such as addressing unintentional PFAS, while carefully evaluating long-term transitions for performance-critical components. Documenting a clear rationale for material choices ensures supply chain resilience and regulatory readiness. To develop a defensible strategy that protects both development timelines and patient access, explore the full framework for managing PFAS uncertainty.