Medical Device Design

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.

• 1. Introduction2. Classifying Medical Devices3.. The Design Process4. Implementing Design Procedures5. Developing Your Product Design Specification6. Generating Ideas and Concepts7. Quality in Design8. Design Realization/Detailed Design9. Evaluation Chapter 10. Manufacturing Supply Chain11. Labelling and Instructions for Use12. Postmarket Surveillance Chapter 13 Sustainability and Resilient systems14. Protecting Your IP15. Exploiting IP16. Obtaining Regulatory Approval to Market16. Active medical devices17. Software in Medical Devices18 AI in Medical DevicesAppendixA. Useful Websites FDA Medical DevicesB. TablesC. ISO 14971 Annex C Pre–Risk Analysis Questionnaire AppendixD. Generic Codes for Class I Medical Devices (MHRA)FDA Class I and II Exempt DevicesE. Basic Materials Properties for Materials Selection E.1 Density E.2 Stress and Strain