Medical Device Design - Edition 3 - By Peter J. Ogrodnik, BSc, MSc, Ph.D Elsevier Health Inspection Copies

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Medical Device Design,

Edition 3 Innovation from Concept to Market

By Peter J. Ogrodnik, BSc, MSc, Ph.D

Publication Date: 01 Dec 2025

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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.

Key Features

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

About the author

By Peter J. Ogrodnik, BSc, MSc, Ph.D, Partner in Metaphysis LLP, Award Leader MSc Medical Engineering Design, Keele University, and Honorary Professor Guangxi University of Science and Technology

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

ISBN: 9780443403187

Page Count: 625

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Biomedical and electrical/electronic engineers in industry designing and developing medical devices; undergraduates and graduate students taking a course in medical device design

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