3D printing is an emergent manufacturing technology recently being applied in the medical field for the development of custom bone prostheses and scaffolds. However, successful industry transformation to this new design and manufacturing approach requires technology integration, concurrent multi-disciplinary collaboration, and a robust quality management framework. This latter change enabler is the focus of this study. While a number of comprehensive quality frameworks have been developed in recent decades to ensure that the manufacturing of medical devices produces reliable products, they are centred on the traditional context of standardised manufacturing techniques. The advent of 3D printing technologies and the prospects for mass customisation provides significant market opportunities, but also presents a serious challenge to regulatory bodies tasked with managing and assuring product quality and safety. Before 3D printing bone prostheses and scaffolds can gain traction, industry stakeholders, such as regulators, clients, medical practitioners, insurers, lawyers, and manufacturers, would all require a high degree of confidence that customised manufacturing can achieve the same quality outcomes as standardised manufacturing. A Quality by Design (QbD) approach to custom 3D printed prostheses can help to ensure that products are designed and manufactured correctly from the beginning without errors. This paper reports on the adaptation of the QbD approach for the development process of 3D printed custom bone prosthesis and scaffolds. This was achieved through the identification of the Critical Quality Attributes of such products, and an extensive review of different design and fabrication methods for 3D printed bone prostheses. Research outcomes include the development of a comprehensive design and fabrication process flow diagram, and categorised risks associated with the design and fabrication processes of such products. An extensive systematic literature review and post-hoc evaluation survey with experts was completed to evaluate the likely effectiveness of the herein suggested QbD framework.
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.
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. K E Y W O R D Sadditive manufacturing, criticality analysis, failure mode effects, patient-specific implants, quality by designThis is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
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