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.
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.