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.



      Medical and Biomedical Engineers, plus medical and clinical professionals, involved with medical device design, from concept through 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 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


      No. of pages:
      © 2013
      Academic Press
      Print ISBN:
      Electronic ISBN:

      About the author

      Peter Ogrodnik

      Affiliations and Expertise

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