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

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Author(s)
Martinez-Marquez, Daniel
Mirnajafizadeh, Ali
Carty, Christopher P
Stewart, Rodney A
Griffith University Author(s)
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Yarlagadda, PKDV

Xavior, AM

Gibson, I

Zhu, Y

Date
2019
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Brisbane, Australia

Abstract

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.

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Procedia Manufacturing

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30

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© 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).

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Subject

Biomedical engineering

Manufacturing engineering

Nanotechnology

Science & Technology

Technology

Green & Sustainable Science & Technology

Engineering, Manufacturing

Science & Technology - Other Topics

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Martinez-Marquez, D; Mirnajafizadeh, A; Carty, CP; Stewart, RA, Facilitating industry translation of custom 3d printed bone prostheses and scaffolds through Quality by Design, Procedia Manufacturing, 2019, 30, pp. 284-291