Design of Biomedical Devices and Systems, 4th edition

Paul H. King is an Emeritus Professor within the Department of Biomedical Engineering at Vanderbilt University. He has been an active instructor and practitioner within the medical device industry over the past 35 years. He is a Fellow of IEEE Engineering in Medicine and Biology Society. Richard C. Fries is a professional medical device designer who has been active in the industry since 1978. He has authored three books in this field and holds over twenty patents in related medical device technologies. Arthur C. Johnson is an Emeritus Professor within the Department of Biomedical Engineering at the University of Maryland. He has actively taught courses in medical devices and human factors related to medical devices over the past 20 years.

Introduction to Biomedical Engineering Design. Fundamental Idea Generation Techniques. Process Analysis Tools., and Evaluation Methods. Design Team Management, Reporting, and Documentation. Product Definition. Product Documentation. Product Development. Hardware Development Methods and Tools. Software Development Methods and Tools. Human Factors. Industrial Design. Biomaterials and Material Testing. Risk Analysis--Devices and Processes. Testing. Analysis of Test Data. Product Liability and Accident Investigations. The FDA and Devices. FDA History and Relevant Non-Device Regulations. Biological Engineering Designs. International Regulations and Standards. Intellectual Property: Patents, Copyrights, Trade Secrets, and Licensing. Manufacturing and Quality Control. Miscellaneous Issues. Professional Issues. Concept to Product? Appendix 1: χ2Table. Appendix 2: Percent Rank Tables. Appendix 3: 40 Inventive Principles, Engineering Parameters, and Conflict Matrix. Appendix 4: Glossary.