This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated.
- Provides updated material as needed to each chapter
- Incorporates new examples and applications within each chapter
- Discusses new material related to entrepreneurship, clinical trials and CRISPR
- Relates critical new information pertaining to FDA regulations.
- Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments
- Presents multiple case examples of entrepreneurship in this field
- Addresses multiple safety and ethical concerns for the design of medical devices and processes
Table of Contents
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.
Paul H. King is an Emeritus Professor within the Department of Biomedical Engineering at Vanderbilt University. He has been an active instructor and practiioner within the medical device industry over the past 35 years. He is a Fellow of IEEE Engineering in Medicine and Biology Soiety. 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 relarted medical device technologies. Arthur C. Johnson is an Emeritus Professor within the Department of Biomedical Engineering at the Universithy of Maryland. He has actively taught courses in medical devices and human factors related to medical devices over the past 20 years.
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