Poster Presentations
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Embedding Quality by Design for 3D Printed Bone Implants
Daniel Martinez, , Griffith University
While, a number of good 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 around the world for managing and assuring product quality and safety. Before 3D printing bone implants 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 ensure that products are designed and manufactured correctly from the beginning without errors.
This research presents the outcomes of an adaptation of the QbD approach to custom 3D printed bone implants. The herein suggested QbD framework will ensure that 3D printed bone prostheses will be able to produce error free products for consumers, which will lead to heightened confidence in this emerging manufacturing technology.
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