Quality by Design for industry translation: Three‐dimensional risk assessment failure mode, effects, and criticality analysis for additively manufactured patient‐specific implants

Abstract

The complexity of patient‐specific implants combined with the current limited expertise in reliability engineering and manufacturability in the additive manufacturing (AM) sector is posing a number of quality performance challenges. Worldwide medical device regulatory bodies are facing increasing pressure to devise adequate standards to ensure long‐term patient safety and product performance. The implementation of the Quality by Design (QbD) system to titanium 3D‐printed bone implants offers a proven system to ensure that products are designed and manufactured correctly from the beginning without errors. This article reports on the development of a failure mode, effects, and criticality analysis (FMECA) coupled with a 3D risk assessment approach. This integrated approach is based on a questionnaire performed with three industry firms and three university research groups with significant experience and expertise in medical device product development and/or research in this field. Research outcomes include a FMECA form containing 137 failure modes with AM materials, AM machine general, fabrication, electron beam melting machine, finishing, and design being as the most sensitive process areas in terms of product quality. We subsequently propose corresponding preventive and corrective strategies for risk mitigation. The approach forms part of the QbD system being developed by the authors specifically for additive manufactured titanium patient‐specific implants.Full Tex