Facilitating industry translation of custom 3d printed bone prostheses and scaffolds through Quality by Design
File version
Version of Record (VoR)
Author(s)
Martinez-Marquez, Daniel
Mirnajafizadeh, Ali
Carty, Christopher P
Stewart, Rodney A
Year published
2019
Metadata
Show full item recordAbstract
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 ...
View more >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.
View less >
View more >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.
View less >
Conference Title
Procedia Manufacturing
Volume
30
Copyright Statement
© 2019 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/) Selection and peer-review under responsibility of the scientific committee of the 14th Global Congress on Manufacturing and Management (GCMM-2018).
Subject
Biomedical engineering
Manufacturing engineering
Nanotechnology
Science & Technology
Technology
Green & Sustainable Science & Technology
Engineering, Manufacturing
Science & Technology - Other Topics