Medical Device Design

Innovation from Concept to Market

Peter J. Ogrodnik

• Publisher: Academic Press
• Year: 2026
• Edition: 3
• eBook ISBN:
  9780443403194
• Topic: Biological Sciences
• Subtopic: Biotechnology
• Index: Biological Sciences

Medical Device Design: Innovation from Concept to Market, Third Edition provides the bridge between engineering design and medical device development. The book clearly explains the process of medical device development - from very early stages of conceptualization to commercialization on the global market. 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, enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.This book is suitable for professional engineers, both new and experienced, as well as students taking a course in medical 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 a step-by-step approach that helps to convey the 'flow' of a design project - Combines real-world experience with academic knowledge - Presents realistic and practical methodologies derived from cutting edge design research - Showcases extensive case studies on all aspects of medical device design in practice

Table of contents

• Title of Book
• Chapter 1. Introduction
• Chapter 2. Classifying medical devices
• Chapter 3. The design process
• Chapter 4. Implementing design procedures
• Chapter 5. Developing your (product) design specification - (X)DS
• Chapter 6. Generating ideas and concepts
• Chapter 7. Enhancing quality in design
• Chapter 8. Design realization/detailed design
• Chapter 9. Risk management, risk analysis and ISO 14971
• Chapter 10. Evaluation (validation and verification)
• Chapter 11. Manufacturing supply chain
• Chapter 12. Labeling and instructions for use
• Chapter 13. Postmarket surveillance
• Chapter 14. Active medical devices and IVDs
• Chapter 15. Software, AI, and medical devices
• Chapter 16. Sustainable healthcare
• Chapter 17. Protecting your IP
• Chapter 18. Obtaining regulatory approval to market
• Appendix A. Useful Websites
• Appendix B. Appendix
• Appendix C. Appendix
• Appendix D. Appendix
• Appendix E. Appendix
• Appendix F. Further worked examples of a PDS∗
• Index