The Medical Device Innovation Handbook is a concise introduction to medical device innovation. It is widely used as the first textbook in the study of the field. The book was developed by its authors with support experts in business, in physiology, in education, and in design, and by the world-famous Earl E. Bakken Medical Devices Center at the University of Minnesota.
The Medical Device Innovation Handbook is unique in that it introduces its readers to the entire spectrum of elements required to make an innovative new medical device come to a successful end result: producing good therapeutic results for patients and commercial success for its inventors. That is, the book covers the design process, the development process, research in disease states, business assessments, market research, prototyping and bench testing, patenting, clinical trials, Good Clinical Practice, regulatory pathways, insurance reimbursement lanes, and obtaining funding to bring the products into commercial production. No other book attempts to cover the entire life-cycle of medical device development.