Medical Device Design,
Edition 1 Innovation from Concept to Market
By Peter J. Ogrodnik

Publication Date: 26 Nov 2012

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.

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
About the author
By Peter J. Ogrodnik, Managing Director of Intelligent Orthopaedics Ltd; Professor at Staffordshire University, UK
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 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


Book details
ISBN: 9780123919427
Page Count: 376
Illustrations : 50 illustrations
Retail Price : £92.50
  • Enderle et al, Introduction to Biomedical Engineering, 2/e. $102.00, 2005. 9780122386626. 9500 units LOT / Bookscan 981
  • Biomaterials Science 2e, Ratner, $120, 2004, 9780125824637, 17,150 units / Bookscan 2556
  • Clinical Engineering Handbook, Dyro, $165, 2004, 9780122265709, 1505 units / 235

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