Design of Biomedical Devices and Systems

by King, Paul H.; Fries, Richard C.

• ISBN13: 9780824708894
• ISBN10: 082470889X
• Format: Hardcover
• Copyright: 2002-09-03
• Publisher: CRC

Summary

Specifically designed as an introductory text for students in biomedical design tracks or as a hands-on reference for those entering the field. Introduces new concepts in hardware and software design, including the use of computer-aided tools to predict and document safety-related design issues.

Author Biography

Paul H. King is Associate Professor of Biomedical Engineering and Mechanical Engineering, Vanderbilt University, Nashville, Tennessee Richard C. Fries is Manager of Reliability Engineering at Datex-Ohmeda, Inc., Madison, Wisconsin

Table of Contents

Preface	v
Introduction to Biomedical Engineering Design	1	(10)
What Is Design?	2	(1)
What Is the Thrust of this Text?	3	(1)
What Might Be Designed?	3	(1)
The Essentials of Design	4	(1)
How this Text Is Structured	5	(3)
The Real Purpose of this Text	8	(3)
Homework Exercises	8	(1)
References	9	(2)
Fundamental Design Tools	11	(20)
Brainstorming and Idea Generation Techniques	11	(4)
Conventional Solution Searches	15	(2)
Function Analysis	17	(3)
Elementary Decision-Making Techniques	20	(3)
Objective Trees	23	(1)
Introduction to Quality Function Deployment Diagrams	23	(2)
Introduction to TRIZ	25	(2)
Summary	27	(4)
Homework Exercises	28	(1)
References	29	(2)
Design Management, Documentation, and Reporting	31	(24)
Design Team Construction and Management	32	(7)
Documentation Techniques and Requirements	39	(5)
Introduction to Databases	44	(3)
Reporting Techniques, Presentations, Posters, and Reports	47	(8)
Homework Exercises	51	(1)
References	52	(3)
Product Definition	55	(14)
The Product Definition Process	56	(3)
Overview of Quality Function Deployment	59	(1)
The QFD Process	59	(6)
Summary of QFD	65	(4)
Homework Exercises	65	(1)
References	66	(3)
Product Documentation	69	(30)
Documents	70	(17)
Records	87	(5)
A Comparison of the Medical Device Records	92	(7)
Homework Exercises	95	(1)
References	96	(3)
Product Development	99	(56)
Hardware and Software Techniques	100	(31)
Structured and Unstructured Design Techniques	131	(24)
Homework Exercises	150	(1)
References	151	(4)
Computer-Aided Design	155	(16)
Definitions of CAD, CAM, and CAE	156	(1)
The Computer-Aided Design Process	157	(2)
Components of CAD/CAM/CAE Systems	159	(6)
Windows-Based CAD Systems	165	(1)
Rapid Prototyping	165	(6)
Homework Exercises	168	(1)
References	169	(2)
Human Factors Issues	171	(28)
What Is Human Factors?	171	(8)
Human Factors Process	179	(5)
Safety	184	(1)
Documentation	184	(2)
Anthropometry	186	(4)
Labeling	190	(1)
Software	191	(2)
Feedback	193	(1)
Prompts	194	(1)
Defaults	194	(1)
Error Management/Data Protection	195	(4)
Homework Exercises	195	(1)
References	196	(3)
Industrial Design	199	(20)
Set Usability Goals	201	(1)
Design User Interface Concepts	201	(3)
Model the User Interface	204	(1)
Test the User Interface	205	(1)
Specify the User Interface	205	(2)
Additional Industrial Design Considerations	207	(12)
Homework Exercises	217	(1)
References	218	(1)
Biomaterials and Materials Selection	219	(26)
The FDA and Biocompatibility	221	(6)
International Regulatory Efforts	227	(1)
Device Category and Choice of Test Program	228	(3)
Preparation of Extracts	231	(2)
Biological Control Tests	233	(1)
Tests for Biological Evaluation	234	(6)
Alternative Test Methods	240	(1)
Endnote	241	(4)
Homework Exercises	241	(1)
References	242	(3)
Safety Engineering: Devices and Processes	245	(10)
Medical Case Example	246	(1)
Safety in Design	247	(2)
Medical Case Example - Revisited	249	(2)
Process Improvement	251	(1)
Miscellaneous Issues	251	(1)
Other Process Issues	251	(1)
Summary	252	(3)
Homework Exercises	253	(1)
References	254	(1)
Prototyping and Testing	255	(20)
Prototyping	255	(3)
Testing	258	(5)
Types of Testing	263	(12)
Homework Exercises	270	(2)
References	272	(3)
Quality Control and Improvement, Reliability, and Liability	275	(26)
Reliability versus Unreliability	276	(1)
Quality versus Reliability	276	(1)
The Definition of Reliability	277	(2)
History of Reliability	279	(1)
Types of Reliability	280	(4)
Device Reliability	284	(2)
Optimizing Reliability	286	(1)
Reliability's Effect on Medical Devices	287	(1)
Product Liability	287	(10)
Conclusion	297	(4)
Homework Exercises	298	(1)
References	299	(2)
The Food and Drug Administration	301	(32)
Recent History of Device Regulation	302	(2)
Device Classification	304	(3)
Registration and Listing	307	(1)
The 510(k) Process	308	(6)
PMA Application	314	(3)
Investigational Device Exemptions	317	(3)
Good Laboratory Practices	320	(1)
Good Manufacturing Practices	320	(1)
Human Factors	321	(1)
Design Control	321	(2)
The FDA and Software	323	(1)
Software Classification	324	(1)
The FDA Inspection	325	(1)
Advice on Dealing with the FDA	326	(1)
Manufacturer and User Facility Device Experience Database	327	(6)
Homework Exercises	327	(1)
References	328	(5)
Licensing, Patents, Copyrights, and Trade Secrets	333	(30)
Patents	334	(11)
Copyrights	345	(5)
Trademarks	350	(5)
Trade Secrets	355	(8)
Homework Exercises	359	(1)
References	360	(3)
Premarket Testing and Validation	363	(20)
Standard Tests	364	(3)
Allocation of Software Testing	367	(1)
Verification and Validation Test Method Commonality	368	(2)
Validation and Test Overview	370	(4)
The Essentials of Software Testing	374	(3)
Drug Development	377	(1)
Clinical Trials	378	(5)
Homework Exercises	379	(1)
References	380	(3)
System Testing	383	(10)
Purpose	383	(2)
Failure Definition	385	(1)
Types of Testing	385	(8)
Homework Exercises	390	(1)
References	391	(2)
Regulations Tracking	393	(32)
Regulations	394	(2)
Standards	396	(4)
Coping with Increased Quality Assurance and Regulatory Issues	400	(1)
Medical Device Directives	400	(12)
ISO 9000	412	(1)
Canadian Regulations	413	(6)
Pacific Rim	419	(6)
Homework Exercises	420	(1)
References	421	(4)
Manufacturing and Quality Control	425	(16)
A History of GMPs	426	(2)
The GMP Regulation	428	(3)
Design for Manufacturability	431	(1)
Design for Assembly	432	(3)
The Manufacturing Process	435	(6)
Homework Exercises	439	(1)
References	439	(2)
Product Issues	441	(24)
Product Safety and Legal Issues	441	(15)
Accident Reconstruction and Forensics	456	(9)
Homework Exercises	461	(1)
References	462	(3)
Professional Issues	465	(12)
BME Related Professional Societies	465	(3)
Standards Setting Groups	468	(2)
Professional Engineering Licensure	470	(2)
Code of Ethics	472	(1)
Forensics and Consulting	473	(2)
Continuing Education	475	(2)
Homework Exercises	475	(2)
Miscellaneous Issues	477	(14)
Learning from Failure	477	(1)
Design for Failure	478	(3)
Product Life Issues	481	(5)
Product Testing Issues	486	(5)
Homework Exercises	488	(1)
References	488	(3)
Design Case Studies	491	(26)
Multidetector Brain Scanning System Development	491	(4)
Testing of Anesthetists	495	(3)
Apnea Detection System	498	(2)
Cancer Clinic Charting	500	(1)
EKG Analysis Techniques	501	(3)
EKG Analysis Module	504	(1)
Choosing the Correct Plastic Material	505	(5)
Choosing the Appropriate Material for Autoclaving	510	(1)
Choosing the Correct Cleaning Material	511	(6)
Homework Exercises	513	(1)
References	514	(3)
Future Design Issues	517	(12)
The NSF Design, Manufacturing, and Industrial Innovation Division	518	(6)
The National Institute of Biomedical Imaging and Bioengineering	524	(1)
The National Institute of Science and Technology	524	(1)
DARPA - Defence Advanced Research Projects Agency	525	(1)
Miscellaneous and Other Areas of Future Design Activity	525	(4)
Conclusions	526	(1)
Homework Exercises	527	(1)
References	527	(2)
Appendix 1 Chi Square Table	529	(2)
Appendix 2 Percent Rank Tables	531	(18)
Appendix 3 40 Inventive Principles, Engineering Parameters, and Conflict Matrix	549	(10)
Appendix 4 Glossary	559	(22)
Index	581