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English
Academic Press Inc
01 April 2026
Medical Device Design: Innovation from Concept to Market
By:  
Imprint:   Academic Press Inc
Country of Publication:   United States
Edition:   3rd edition
Dimensions:   Height: 235mm,  Width: 191mm, 
ISBN:   9780443403187
ISBN 10:   044340318X
Pages:   625
Publication Date:  
Audience:   College/higher education ,  Primary
Format:   Paperback
Publisher's Status:   Forthcoming
1. Introduction 2. Classifying Medical Devices 3.. The Design Process 4. Implementing Design Procedures 5. Developing Your Product Design Specification 6. Generating Ideas and Concepts 7. Quality in Design 8. Design Realization/Detailed Design 9. Evaluation Chapter 10. Manufacturing Supply Chain 11. Labelling and Instructions for Use 12. Postmarket Surveillance Chapter 13 Sustainability and Resilient systems 14. Protecting Your IP 15. Exploiting IP 16. Obtaining Regulatory Approval to Market 16. Active medical devices 17. Software in Medical Devices 18 AI in Medical Devices Appendix A. Useful Websites FDA Medical Devices B. Tables C. ISO 14971 Annex C Pre–Risk Analysis Questionnaire Appendix D. Generic Codes for Class I Medical Devices (MHRA)FDA Class I and II Exempt Devices E. Basic Materials Properties for Materials Selection E.1 Density E.2 Stress and Strain

Professor Ogrodnik is a Chartered Mechanical Engineer, a Member of the Institution of Engineering Designers and a Fellow (regional) of the Royal Society of Medicine, an Honorary Consultant at the Royal Stoke University Hospital. For over 20 years he has conducted research into optimising the treatment of tibial fractures. Using this research base he has enhanced the application of engineering design principles to the solution of medical devices, his book Medical Devices Design is a core text in core R&D departments. He has founded two medical devices companies (one manufactures and sells medical devices to the NHS and beyond) and is named inventor on numerous patents. He was a founding director of the University spinout Intelligent Orthopaedics Ltd, and is a founding partner of Metaphysis LLP. Through this corporate involvement Professor Ogrodnik has an understanding of the realities of applied research for industry; for example he was a member of the AWM Healthcare Technologies cluster opportunity group.

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