Development of 18 Quality Control Gates for Additive Manufacturing of Error Free Patient-Specific Implants

Abstract

Unlike subtractive manufacturing technologies, additive manufacturing (AM) can fabricate complex shapes from the macro to the micro scale, thereby allowing the design of patient-specific implants following a biomimetic approach for the reconstruction of complex bone configurations. Nevertheless, factors such as high design variability and changeable customer needs are re-shaping current medical standards and quality control strategies in this sector. Such factors necessitate the urgent formulation of comprehensive AM quality control procedures. To address this need, this study explored and reported on a variety of aspects related to the production and the quality control of additively manufactured patient-specific implants in three different AM companies. The research goal was to develop an integrated quality control procedure based on the synthesis and the adaptation of the best quality control practices with the three examined companies and/or reported in literature. The study resulted in the development of an integrated quality control procedure consisting of 18 distinct gates based on the best identified industry practices and reported literature such as the Food and Drug Administration (FDA) guideline for AM medical devices and American Society for Testing and Materials (ASTM) standards, to name a few. This integrated quality control procedure for patient-specific implants seeks to prepare the AM industry for the inevitable future tightening in related medical regulations. Moreover, this study revealed some critical success factors for companies developing additively manufactured patient-specific implants, including ongoing research and development (R&D) investment, investment in advanced technologies for controlling quality, and fostering a quality improvement organizational culture.