REVIEW ARTICLE


A Review of the Design Process for Implantable Orthopedic Medical Devices



G.A Aitchison1, 2, D.W.L Hukins1, J.J Parry2, D.E.T Shepherd*, 1, S.G Trotman2
1 School of Mechanical Engineering, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK
2 Surgicraft Limited, 16 The Oaks, Clews Road, Redditch, Worcestershire, B98 7ST, UK


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Creative Commons License
© Aitchison et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the School of Mechanical Engineering, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK; Tel: 0121 414 4266; Fax: 0121 414 3958; E-mail: d.e.shepherd@bham.ac.uk


Abstract

The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes.

Keywords: Design, implant, medical device, orthopedic..