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Medical Device Design
Innovation from Concept to Market
- 2nd Edition - October 26, 2019
- Author: Peter J. Ogrodnik
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 1 4 9 6 2 - 1
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 1 4 9 6 3 - 8
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… Read more
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Request a sales quoteMedical 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 Regulation
- Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more
- Presents additional content around software and biocompatibility concerns
Medical and Biomedical Engineers plus medical and clinical professionals involved in medical device design, from concept to commercialization and FDA/regulatory approval
Chapter 1. Introduction1.1 What Is Design?1.2 The Design Life Cycle1.3 Medical Devices Definitions1.4 SummaryReferences
Chapter 2. Classifying Medical Devices2.1 Introduction: Why Classify?2.2 Classification Rules2.3 Classification Case Study2.4 Classification Models2.5 Classification and the Design Process2.6 Case studies2.7 SummaryReferences
Chapter 3. The Design Process3.1 Design Process versus Design Control3.2 Design Models3.3 Managing Design3.4 Cross-Reference with Regulatory Requirements3.5 Case studies3.6 SummaryTasksReferencesFurther Reading
Chapter 4. Implementing Design Procedures4.1 Introduction4.2 Review of Guidelines4.3 Overall Procedure4.4 Audit /Review Procedure4.5 The Design Process4.6 Implementing a Procedure4.7 SummaryReferences
Chapter 5. Developing Your Product Design Specification5.1 Introduction5.2 Developing the Statement of Need (or Brief)5.3 The Product Design Specification (PDS)5.4 Finding, Extracting, and Analyzing the Content5.5 Case studiesReferences
Chapter 6. Generating Ideas and Concepts6.1 Introduction6.2 The "Engineer’s Notebook"6.3 Creative Space6.4 Generating Concepts/Ideas6.5 Selecting Concepts and Ideas6.6 SummaryReferences
Chapter 7. Quality in Design7.1 Introduction7.2 Optimization7.3 Design of Experiments/2k Factorial Experiments7.4 House of Quality7.5 Failure Mode and Effect Analysis (FMEA)7.6 D4X7.7 Six Sigma7.8 Application to software development7.9 Case studies7.10 SummaryReferences
Chapter 8. Design Realization/Detailed Design8.1 Introduction8.2 The Process to Design Realization8.3 Assemble Your Detailed Design Team8.4 Design Calculations8.5 Materials Selection8.5.1 Bigger section on biocompatibility 8.5.2 Bigger item on "standard" materials (tables in appendix)8.6 Computer-Aided Design8.7 D4X8.8 Design for Usability (DFU)8.9 Software and embedded systems coding8.10 Additive Manufacturing8.11 Case studies8.12 SummaryReferences
Chapter 9. Evaluation (Validation and Verification)9.1 Introduction9.2 Explanation of Standing Items 9.2 Risk Management (updated for new standard)9.3 Criteria-Based Evaluation9.4 Computer-Based Evaluation9.5 Value to "Healthcare" Analysis9.6 Clinical Studies and Clinical Trials9.7 Literature Review9.8 Format for Formal Clinical Evaluation Report9.9 SummaryReferences
Chapter 10. Manufacturing Supply Chain10.1 Introduction10.2 Identifying Potential Suppliers10.3 Packaging10.4 Procurement10.5 Need for contracts and SLA10.5 SummaryFurther Reading
Chapter 11. Labelling and Instructions for Use11.1 Introduction11.2 Standard Symbols and Texts11.3 GUDID and identifiable markers11.4 Labelling11.5 Marking11.6 IFUs and Surgical Techniques11.7 Surgical Technique11.8 Declarations11.9 Translation11.10 Case studies11.10 SummaryReferences
Chapter 12. Postmarket Surveillance12.1 Introduction12.2 PMS and Its Role in Design12.3 Tools12.4 Using Your Existing Contacts12.5 Vigilance12.6 The Good, the Bad, and the Ugly12.7 SummaryReferencesFurther Reading
Chapter 13. Protecting Your IP13.1 Introduction13.2 Types of IP Protection13.3 Keeping Mum13.4 Talking with Partners13.5 SummaryReferences
Chapter 14. Obtaining Regulatory Approval to Market14.1 Introduction14.2 Class I Devices14.3 Higher Classifications14.4 FDA Process14.5 EC Process14.6 The Design Dossier, Design History File and the Technical File14.7 Getting to Market14.8 SummaryReferences
Appendix A. Useful WebsitesFDA Medical DevicesAppendix B. TablesAppendix C. ISO 14971 Annex C Pre–Risk Analysis QuestionnaireAppendix D. Generic Codes for Class I Medical Devices (MHRA)FDA Class I and II Exempt DevicesAppendix E. Basic Materials Properties for Materials SelectionE.1 DensityE.2 Stress and Strain
- No. of pages: 538
- Language: English
- Edition: 2
- Published: October 26, 2019
- Imprint: Academic Press
- Paperback ISBN: 9780128149621
- eBook ISBN: 9780128149638
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 Engneering Design at Keele University, Honorary Professor Guangxi University of Science and TechnologyRead Medical Device Design on ScienceDirect