Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.
This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design.
- Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation
- Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more
- Presents additional content around software and biocompatibility concerns
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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. Enhancing Quality in Design 8. Design Realisation/Detailed Design 9. Risk Management, Risk Analysis and ISO 14971 10. Evaluation (Validation and Verification) 11. Manufacturing Supply Chain 12. Labelling and Instructions for Use 13. Post Market Surveillance 14. Protecting Your IP 15. Obtaining Regulatory Approval to Market
Appendix A. Useful Websites Appendix B. Tables Appendix C. ISO 14971 Annex C Pre-Risk Analysis Questionnaire Appendix D. Generic Codes for Class I Medical Devices (MHRA) Appendix E. Basic Materials Properties for Materials Selection Appendix F. Standard Materials in Medicak Devices
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.