Additive Manufacturing in Customized Medical Device

The long-established application of rapid prototyping in additive manufacturing (AM) has inspired a revolution in the medical industry into a new era, in which the clinical-driven development of the customized medical device is enabled. This transformation could only be sustainable if clinical concerns could be well addressed. In this work, we propose a workflow that addresses critical clinical concerns such as translation from medical needs to product innovation, anatomical conformation and execution, and validation. This method has demonstrated outstanding advantages over the traditional manufacturing approach in terms of form, function, precision, and clinical flexibility. We further propose a protocol for the validation of biocompatibility, material, and mechanical properties. Finally, we lay out a roadmap for AM-driven customized medical device innovation based on our experiences in Hong Kong, addressing problems of certification, qualification, characterization of three dimensional (3D) printed implants according to medical demands.