Medical Device Design, 1st Edition

Innovation from concept to market

Medical Device Design, 1st Edition,Peter Ogrodnik,ISBN9780123919427


Academic Press




235 X 191

Design, develop and bring medical devices to market successfully by following this integrated approach to designing recognized US and EU procedures.

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Key Features

      • The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how.
      • Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand.
      • Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products.



      This book 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. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly.


      Medical and Biomedical Engineers, plus medical and clinical professionals, involved with medical device design, from concept through to commercialization and FDA/regulatory approval.

      Peter Ogrodnik

      Affiliations and Expertise

      Professor of Engineering Design at Staffordshire University (UK) and co-founder of Intelligent Orthopaedics Ltd.

      Medical Device Design, 1st Edition




      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 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 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


      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 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

      8.6 Computer-Aided Design

      8.7 D4X

      8.8 Design for Usability (DFU)

      8.9 Summary


      Chapter 9. Evaluation (Validation and Verification)

      9.1 Introduction

      9.2 Risk Analysis

      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 Summary

      Further Reading

      Chapter 11. Labeling and Instructions for Use

      11.1 Introduction

      11.2 Standard Symbols and Texts

      11.3 Labeling

      11.4 Marking

      11.5 IFUs and Surgical Techniques

      11.6 Surgical Technique

      11.7 Declarations

      11.8 Translation

      11.9 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 Getting to Market

      14.7 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


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