Design of Biomedical Devices and Systems: 3rd Edition (Hardback) book cover

Design of Biomedical Devices and Systems

3rd Edition

By Paul H. King, Richard C. Fries, Arthur T. Johnson

CRC Press

515 pages | 87 B/W Illus.

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Hardback: 9781466569133
pub: 2014-07-29
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pub: 2014-07-29
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Apply a Wide Variety of Design Processes to a Wide Category of Design Problems

Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order.

What’s New in the Third Edition:

This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods.

  • Familiarizes the reader with medical devices, and their design, regulation, and use
  • Considers safety aspects of the devices
  • Contains an enhanced pedagogy
  • Provides an overview of basic design issues

Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.


"This book is a comprehensive overview of all the pieces that need to come together to bring a medical device from an idea to an approved device. It is an impressive compilation of information that is not easily found elsewhere, and included extensive references for every chapter. The writing is clear, yet succinct. The book is well organized with labeled subsections that let the reader find exactly what content he/she may want to explore. Each chapter has exercises that can be used as a self-assessment or to supplement a class."

—Anna Iwaniec Hickerson, Keck Graduate Institute of Applied Life Sciences, Claremont, California, USA

"The risk management process section of this text will be very valuable to a capstone design class where teams will likely need to implement strategies to mitigate risks in the development and execution of their design projects. While risk estimation may not be feasible to attempt in an academic design course due to the limited scope and duration, this section offers the reader excellent exposure to analyses such as FMEA that are commonly used in industry."

—Shelly Gulati, University of the Pacific, Stockton, California, USA

Table of Contents

Introduction to Biomedical Engineering Design

What is Design?

What is the Thrust of this Text?

What Might Be Designed?

The Essentials of Design—Overview

Biomedical Engineering Design in Industrial Context

An Overview of the Industrial Design Process

How this text is Structured

The Real Purpose of this Text

Case Study


Fundamental Design Tools

Brainstorming and Idea Generation Techniques

Conventional Solution Searches

Function Analysis

Elementary Decision-Making Techniques

Objectives Trees

Introduction to Quality Function Deployment Diagrams

Introduction to Triz

Extended Triz Design Techniques

Case Study: Cancer Clinic Charting

Suggested Reading

Design Team Management, Reporting, and Documentation

Design Team Construction and Management (Industry Based)

Student Design Team Construction and Management

Reporting Techniques: Presentations, Posters, Reports, Websites

Introduction to Databases

Suggested Reading

Product Definition

What is a Medical Device?

The Product Definition Process

The QFD Process

Summary of QFD

Requirements, Design, Verification, and Validation

The Product Specification

Suggested Reading

Product Documentation



A Comparison of the Medical Device Records

Suggested Reading

Product Development

Product Requirements

Design and Development Planning

System Requirements Specification

Design Input

Design Output

Formal Design Review

Design Verification

Design Validation

Design Transfer

Suggested Reading

Hardware Development Methods and Tools

Design for Six Sigma



Design for Six Sigma Tools

Component Derating

Safety Margin

Load Protection

Environmental Protection

Product Misuse

Reliability Prediction

Design for Variation

Design of Experiments

Design Changes

Design for Manufacturability

Design for Assembly

Design Reviews

Suggested Reading

Software Development Methods and Tools

Software Design Levels

Design Alternatives and Trade-Offs

Software Architecture

Choosing a Methodology

Structured Analysis

Object-Oriented Design

Choosing a Language

Software Risk Analysis

The Requirements Traceability Matrix

Software Review

Design Techniques

Performance Predictability and Design Simulation

Module Specifications


Design Support Tools

Design as the Basis for Verification and Validation Activity


Suggested Reading

Human Factors

What is Human Factors?

The Human Element in Human Factors Engineering

The Hardware Element in Human Factors

The Software Element in Human Factors

The Human Factors Process



Conduct User Studies

Set Usability Goals

Design User Interface Concepts

Model the User Interface

Test the User Interface

Specify the User Interface

Additional Human Factors Design Considerations

Fitts’s Law

Suggested Reading

Industrial Design

Set Usability Goals

Design User Interface Concepts

Model the User Interface

Test the User Interface

Specify the User Interface

Additional Industrial Design Considerations


Suggested Reading

Biomaterials and Material Testing

The FDA and Biocompatibility

International Regulatory Efforts

Device Category and Choice of Test Program

Preparation of Extracts

Biological Control Tests

Tests for Biological Evaluation

Alternative Test Methods

Other Considerations for Design

Materials Design Example



Suggested Reading

Risk Analysis—Devices and Processes



Deciding on Acceptable Risk

Factors Important to Medical Device Risk Assessment

Risk Management

The Risk Management Process

Tools For Risk Estimation

Risk Analysis and Systems

Other Process Issues


Suggested Reading


Testing Defined

Parsing Test Requirements

Test Protocol

Test Methodology

Purpose of the Test

Failure Definition

Determining Sample Size and Test Length

Types of Testing

Highly Accelerated Stress Testing

Highly Accelerated Life Testing

Other Accelerated Testing


Suggested Reading

Analysis of Test Data

The Definition of Reliability

Types of Reliability

Failure Rate

Mean Time Between Failures


Confidence Level

Confidence Limits

Minimum Life

Graphical Analysis

Suggested Reading

Product Liability and Accident Investigations

Product Liability Laws

Accident Reconstruction and Forensics



Suggested Reading

The FDA and Devices

History of Device Regulation

Device Classification

Registration and Listing

The (k) Process

Declaration of Conformance to a Recognized Standard

The PMA Application


Good Laboratory Practices


Human Factors

Design Control

The FDA and Software

Software Classification

The FDA Inspection

Advice on Dealing with the FDA

Suggested Reading

Food and Drug Administration History and Relevant Nondevice Regulations

A Brief History of the FDA Relevant to Food and Drugs

Drug Development

Drug Testing

FDA Postproduction Oversight and Enforcement

The Future of Drug Therapy?

The FDA and Combination Products

Veterinary Medicine

The FDA and Cosmetics

Summary and Conclusions

Suggested Reading

Biological Engineering Designs

What is a Biological System?

Special Issues When Dealing with Nonhuman Subjects

Unintended Consequences

Environmental Interactions

Biological Principles

Characteristics of Biomaterials

Design Objectives

Resistance Development

Information Sources

Useful Techniques

Regulations and Standards


Biological Engineering Design Examples

Suggested Reading

International Regulations and Standards

Definition of a Medical Device

The Medical Device Directives

Software Standards and Regulations

Rest-of-World Standards

Suggested Reading

Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing




Trade Secrets



Suggested Reading

Manufacturing and Quality Control

A History of GMPS

The GMP Regulation

Design for Manufacturability

Design for Assembly

Highly Accelerated Stress Screening

Highly Accelerated Stress Audit

The Manufacturing Process

Suggested Reading

Miscellaneous Issues


Learning From Failure (and Lies)

Design for X

Universal Design

Prevention Through Design


Product Life Issues

Product Testing Issues


Suggested Reading

Professional Issues

BME-Related Professional Societies

Standards-Setting Groups

Professional Engineering Licensure

Registration as a Professional Engineer

Rules of Professional Conduct

Codes of Ethics

Forensics and Consulting

Continuing Education

Concept to Product?


Prepare Yourself Prior to any Further Developments

Find Funding Sources

Next Steps

Case Study: Pathfinder Technologies

NCIIA Examples

Development of Max Mobility Corp, Mark Richter, PHD, PE, Owner


Suggested Reading


About the Authors

Paul King, PhD, PE, attended Case Institute of Technology for his BS and MS and then obtained his PhD at Vanderbilt University in 1968 (mechanical engineering.) That same year, he became one of the founding members of the Department of Biomedical Engineering at Vanderbilt University. He developed and taught most of the early required coursework in the Department of Biomedical Engineering. In approximately 2001 he and coauthor Richard Fries published the first edition of the textbook Design of Biomedical Devices and Systems. This textbook is being used in multiple universities in the United States and abroad.

Richard Fries, PE, CSQE, CRE, is a licensed professional engineer in the state of Wisconsin and certified by the American Society for Quality as a reliability engineer and a software quality engineer. He has degrees from Loyola University in Chicago and Marquette University in Milwaukee. He is co-inventor of patent 5,682,876, entitled "absorber switch locking device." He has authored eight books and chapters in several others on reliability and regulatory compliance. He has also written numerous articles in professional journals on hardware and software reliability, human factors, standards and regulations, and engineering education.

Arthur T. Johnson attended Cornell University for his undergraduate and graduate degrees. His PhD was awarded in 1969. He joined the faculty of the University of Maryland in 1975 and was professor from 1986 until 2009, when he became professor emeritus. He has written three books: Biomechanics and Exercise Physiology, Biological Process Engineering, and Biology for Engineers. He has been most recently active in teaching electronic design, transport processes, and engineering in biology courses, and in working to continue development of the airflow perturbation device as a noninvasive measurement of respiratory resistance.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Biotechnology
TECHNOLOGY & ENGINEERING / Industrial Design / General