Biomedical Engineering Design

*Textbook and Academic Authors Association (TAA) Most Promising New Textbook Award Winner, 2024* Biomedical Engineering Design presents the design processes and practices used in academic and industry medical device design projects. The first two chapters are an overview of the design process, project management and working on technical teams. Further chapters follow the general order of a design sequence in biomedical engineering, from problem identification to validation and verification testing. The first seven chapters, or parts of them, can be used for first-year and sophomore design classes. The next six chapters are primarily for upper-level students and include in-depth discussions of detailed design, testing, standards, regulatory requirements and ethics. The last two chapters summarize the various activities that industry engineers might be involved in to commercialize a medical device.

Joe Tranquillo Ph.D. is the Associate Provost for Transformative Teaching and Learning and a founding faculty member of the Biomedical Engineering Department at Bucknell University. At Bucknell he has served as the Director of the Teaching and Learning Center, Director of the Institute for Leadership in Technology and Management and co-founded the Bucknell Innovation Group and KEEN Winter Interdisciplinary Design Experience. Off campus Joe is the past chair of the ASEE Biomedical Engineering Division, co-organizer of the BME-IDEA meetings, founder and inaugural chair of the BMES undergraduate research track. He has delivered intensive teaching workshops on five continents and his work, conducted exclusively with undergraduates, has been featured on the Discovery Channel, TEDx, CNN Health, Google, US News and World Report, and the ABET National Symposium. He is an elected Fellow of ASEE, BMES, AIMBE and NSF Frontiers of Engineering Education. Joe has spent time at Trinity College, Duke University, University of Utah, Stanford University and is an international visiting faculty member at Universidad Catolica de Chile in Santiago, Chile.

1. Introduction 2. Design Teams and Project Management 3. Defining the Medical Problem 4. Defining the Engineering Problem 5. Generating Solution Concepts and Preliminary Designs 6. Selecting a Solution Concept 7. Prototyping 8. Detailed Design 9. Testing for Design Verification and Validation 10. Testing in Living Systems 11. Medical Device Standards and Design Controls 12. Regulatory Requirements 13. Ethics in Medical Device Design 14. Beyond Design: The Engineer's Role in Design Transfer, Commercialization, and Post Market Surveillance 15. Collaborating on Multifunctional Teams to Commercialize Medical Products