Medical Device Design
Innovation from Concept to Market
- 3rd Edition - December 1, 2025
- Latest edition
- Author: Peter J. Ogrodnik
- Language: English
Medical Device Design: Innovation from Concept to Market, Third Edition provides the bridge between engineering design and medical device development. The book clearly explai… Read more
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.
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
Biomedical and electrical/electronic engineers in industry designing and developing medical devices; undergraduates and graduate students taking a course in medical device design
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
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
- Edition: 3
- Latest edition
- Published: December 1, 2025
- Language: English
PO
Peter J. Ogrodnik
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.
Affiliations and expertise
Partner in Metaphysis LLP, Award Leader MSc Medical Engineering Design, Keele University, and Honorary Professor Guangxi University of Science and Technology