Medical Device Design: Innovation from Concept to Market

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 RegulationIncludes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and morePresents additional content around software and biocompatibility concerns

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