Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry
Mike Drues of Vascular Sciences, joined by hosts Jon Speer and Etienne Nichols, explains the regulatory and quality distinctions between 3D printing and additive manufacturing, noting that over 100 3D-printed medical devices have received FDA clearance. Drues argues that for personalized, point-of-care devices like patient-specific stents or anatomical models, validation must focus on the manufacturing process rather than the individual product, as clinical trials for single-patient devices are infeasible. The discussion highlights the challenges of regulating point-of-care printing in settings ranging from cath labs to home garages, and the need for software certification and process validation to ensure safety without stifling innovation.