Facilitating industry translation of custom 3d printed bone prostheses and scaffolds through Quality by Design

The new generation of patient-specific 3D printed bone implants require the integration of diverse emergent technologies that control material and product characteristics to imitate patients’ bone geometrical features. Despite the significant market opportunities, the emerging nature of the 3D printing manufacturing industry as well as the complexity and variability in product characteristics is posing a serious challenge to regulatory bodies tasked with managing and assuring product quality and safety. Therefore, this study explores quality control technologies and activities throw a case of study of a European firm to disseminate industry best practices. The outcomes of this study are: a comprehensive quality control workflow process map; lessons learned in industry to guide medical regulatory bodies to standardize these products, and researchers and industry for the development of new medical technologies for industry translation in this domain.