*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.
Table of Contents
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
Authors
Joseph Tranquillo Biomedical Engineering Department, Bucknell University, Lewisburg, PA, USA.
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.
Jay Goldberg Department of Biomedical Engineering, Marquette University, and the Medical College of Wisconsin, Milwaukee, WI, USA.
Jay R. Goldberg, PhD, PE, is Professor of Practice in Biomedical Engineering at Marquette University and the Medical College of Wisconsin. He teaches graduate and undergraduate courses involving new product development and medical device design, including senior capstone design. His experience includes development of new products in urology, orthopedics, GI, and dentistry. Prior to moving into academia, he was Director of Technology and Quality Assurance for Milestone Scientific Inc. (Deerfield, IL), a start-up dental product company. Dr. Goldberg is a co-creator of the BME-idea national student design competition and Chair of Industry Involvement for the Capstone Design Conference. He is a Consultant to the Gastroenterology and Urology Therapy Device Panel (FDA Medical Device Advisory Committee), and as Chair of the ASTM International Subcommittee on Urological Materials and Devices, led efforts to develop and revise industry standards for ureteral stents and Foley Catheters, respectively. Dr. Goldberg writes a quarterly column on senior capstone design courses for IEEE Pulse magazine and has published two books on using senior capstone design courses to prepare biomedical engineering students for careers in the medical device industry. In 2012, he was awarded the Engineering Education Excellence Award by the National Society of Professional Engineers for relating engineering education to professional practice. Dr. Goldberg is a Fellow of the National Academy of Inventors and the Biomedical Engineering Society. He is a licensed Professional Engineer in Illinois and Wisconsin and has six patents for urological medical devices.
Robert Allen Department of Obstetrics & Gynecology and Women's Health, Albert Einstein College of Medicine, New York.
Robert H. Allen, PhD, PE is Research Assistant Professor of Obstetrics & Gynecology and Women's Health at the Albert Einstein School of Medicine, where he directs training of obstetric providers in managing mechanically difficult deliveries. Prior to that he was the founding Undergraduate Program Director of the Center for Bioengineering Innovation and Design within the Department of Biomedical Engineering at Johns Hopkins University. Prior to coming to Hopkins, Dr. Allen developed and directed team-based design programs since 1984; first at the University of Houston, then the University of Delaware and subsequently at Hopkins. Over this time, he has mentored over 250 design projects, many for the disabled population, with more than 40 teams or design students capturing national and international design competition awards. His research interests include the mechanics of birth, injury prevention and design education. He has authored or co-authored over 60 journal publications, over a dozen book chapters, and has generated over $4M in external support for research and teaching. A retired professional engineer, he is an inventor on three issued patents, and several pending ones, and co-founder of Birth Injury Prevention, LLC, a Maryland-company dedicated to improving maternal-child health.
