Description

Specifically designed as an introductory text for students in biomedical design tracks OR as a hands-on reference for those entering the field!

Analyzing product conception through to delivery in actual industry examples, this reference considers pertinent issues in the industrial design process exactly as they would arise in real-world applications divulging valuable trade secrets of topics like materials selection, safety, prototyping, premarket testing and validation, liability, and learning from failure.

Introduces new concepts in hardware and software design, including the use of computer-aided tools to predict and document safety-related design issues.

Design of Biomedical Devices and Systems

discusses product definition, development, marketing, verification, and validation

elucidates the QFD process

assesses accident reconstruction and forensics

covers professional engineering licensure

addresses codes of ethics

contains numerous end-of-chapter homework exercises


and meticulously examines

the cost of finding problems in the field versus during preliminary testing

differences in designing for manufacturability versus assembly

how current regulations and standards impact the design process

viable idea-generating techniques and ownership protection

usage of software packages for web pages, medical databases, progress reporting, and process documentation

regulation for human and animal experimentation


Exploring effective methodologies to predict device reliability, Design of Biomedical Devices and Systems is an essential resource for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project managers; biomedical technicians; medical device manufacturers; and upper-level undergraduate and graduate students in these disciplines.

Introduction to Biomedical Engineering Design
Fundamental Design Tools
Design Management, Documentation, and Reporting
Product Definition
Product Documentation
Product Development
Computer-Aided Design
Human Factors Issues
Industrial Design
Biomaterials and Materials Selection
Safety Engineering: Devices and Processes
Prototyping and Testing
Quality Control and Improvement, Reliability, and Liability
The Food and Drug Administration
Licensing, Patents, Copyrights, and Trade Secrets
Premarket Testing and Validation
System Testing
Regulations Tracking
Manufacturing and Quality Control
Product Issues
Professional Issues
Miscellaneous Issues
Design Case Studies
Future Design Issues
Appendix 1 Chi Square Table
Appendix 2 Percent Rank Tables
Appendix 3 40 Inventive Principles, Engineering Parameters, and Conflict Matrix
Appendix 4 Glossary
Index