“This is the best printed resource for helping physicians and entrepreneurs invent, prove & commercialize new medical technologies. Creating medical innovations which make it all the way through clinical proof and as successful products are the greatest contributions we can have beyond our own hands. However, the process is complex and products are often commercial failures even when they are effective. This book helps to explain why. I run Innovation Grand Rounds, a forum for medical innovation among MIT, Harvard Medical School, MGH and other teaching hospitals, hosted by the Center for Integration of Medicine & Innovative Technologies (CIMIT). My AccelMed blog also provides information and case studies on medical device invention & commercialization [...] Kudos to the authors for compiling practical advice across the entire lifecycle, from validating the clinical need, to early prototyping, to navigating clinical & regulatory roadmaps. It will be a standard text for medical school and biomedical engineering programs focused on innovation.”  Medical Ventures 12 2009