Medical Device Design

Medical Device Design

Innovation from Concept to Market

2nd Edition - October 26, 2019

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  • Author: Peter Ogrodnik
  • Paperback ISBN: 9780128149621
  • eBook ISBN: 9780128149638

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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 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.

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 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

Table of Contents

  • Chapter 1. Introduction
    1.1 What Is Design?
    1.2 The Design Life Cycle
    1.3 Medical Devices Definitions
    1.4 Summary

    Chapter 2. Classifying Medical Devices
    2.1 Introduction: Why Classify?
    2.2 Classification Rules
    2.3 Classification Case Study
    2.4 Classification Models
    2.5 Classification and the Design Process
    2.6 Case studies
    2.7 Summary

    Chapter 3. The Design Process
    3.1 Design Process versus Design Control
    3.2 Design Models
    3.3 Managing Design
    3.4 Cross-Reference with Regulatory Requirements
    3.5 Case studies
    3.6 Summary
    Further Reading

    Chapter 4. Implementing Design Procedures
    4.1 Introduction
    4.2 Review of Guidelines
    4.3 Overall Procedure
    4.4 Audit /Review Procedure
    4.5 The Design Process
    4.6 Implementing a Procedure
    4.7 Summary

    Chapter 5. Developing Your Product Design Specification
    5.1 Introduction
    5.2 Developing the Statement of Need (or Brief)
    5.3 The Product Design Specification (PDS)
    5.4 Finding, Extracting, and Analyzing the Content
    5.5 Case studies

    Chapter 6. Generating Ideas and Concepts
    6.1 Introduction
    6.2 The "Engineer’s Notebook"
    6.3 Creative Space
    6.4 Generating Concepts/Ideas
    6.5 Selecting Concepts and Ideas
    6.6 Summary

    Chapter 7. Quality in Design
    7.1 Introduction
    7.2 Optimization
    7.3 Design of Experiments/2k Factorial Experiments
    7.4 House of Quality
    7.5 Failure Mode and Effect Analysis (FMEA)
    7.6 D4X
    7.7 Six Sigma
    7.8 Application to software development
    7.9 Case studies
    7.10 Summary

    Chapter 8. Design Realization/Detailed Design
    8.1 Introduction
    8.2 The Process to Design Realization
    8.3 Assemble Your Detailed Design Team
    8.4 Design Calculations
    8.5 Materials Selection
    8.5.1 Bigger section on biocompatibility
    8.5.2 Bigger item on "standard" materials (tables in appendix)
    8.6 Computer-Aided Design
    8.7 D4X
    8.8 Design for Usability (DFU)
    8.9 Software and embedded systems coding
    8.10 Additive Manufacturing
    8.11 Case studies
    8.12 Summary

    Chapter 9. Evaluation (Validation and Verification)
    9.1 Introduction
    9.2 Explanation of Standing Items
    9.2 Risk Management (updated for new standard)
    9.3 Criteria-Based Evaluation
    9.4 Computer-Based Evaluation
    9.5 Value to "Healthcare" Analysis
    9.6 Clinical Studies and Clinical Trials
    9.7 Literature Review
    9.8 Format for Formal Clinical Evaluation Report
    9.9 Summary

    Chapter 10. Manufacturing Supply Chain
    10.1 Introduction
    10.2 Identifying Potential Suppliers
    10.3 Packaging
    10.4 Procurement
    10.5 Need for contracts and SLA
    10.5 Summary
    Further Reading

    Chapter 11. Labelling and Instructions for Use
    11.1 Introduction
    11.2 Standard Symbols and Texts
    11.3 GUDID and identifiable markers
    11.4 Labelling
    11.5 Marking
    11.6 IFUs and Surgical Techniques
    11.7 Surgical Technique
    11.8 Declarations
    11.9 Translation
    11.10 Case studies
    11.10 Summary

    Chapter 12. Postmarket Surveillance
    12.1 Introduction
    12.2 PMS and Its Role in Design
    12.3 Tools
    12.4 Using Your Existing Contacts
    12.5 Vigilance
    12.6 The Good, the Bad, and the Ugly
    12.7 Summary
    Further Reading

    Chapter 13. Protecting Your IP
    13.1 Introduction
    13.2 Types of IP Protection
    13.3 Keeping Mum
    13.4 Talking with Partners
    13.5 Summary

    Chapter 14. Obtaining Regulatory Approval to Market
    14.1 Introduction
    14.2 Class I Devices
    14.3 Higher Classifications
    14.4 FDA Process
    14.5 EC Process
    14.6 The Design Dossier, Design History File and the Technical File
    14.7 Getting to Market
    14.8 Summary

    Appendix A. Useful Websites
    FDA Medical Devices
    Appendix B. Tables
    Appendix 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
    Appendix E. Basic Materials Properties for Materials Selection
    E.1 Density
    E.2 Stress and Strain

Product details

  • No. of pages: 538
  • Language: English
  • Copyright: © Academic Press 2019
  • Published: October 26, 2019
  • Imprint: Academic Press
  • Paperback ISBN: 9780128149621
  • eBook ISBN: 9780128149638

About the Author

Peter 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 Technology

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