Biodesign: The Process of Innovating Medical Technologies

It's very comprehensive and detailed in a well-structured presentation of the process of introducing a biomedical product or process into the market place. It's solidly based on the real-life experience of one of the authors, Josh Makower, a Successful serial entrepreneur. It also includes examples from the classroom at Stanford, where this book is used as the textbook for the senior design class. Important concepts are often illustrated with real cases from the field. Plenty of references help the readers dig deeper. It's not suitable for casual reading or for someone who just wants to get a quicky on selling an invention, but is excellent for entrepreneurs who are considering getting into the field and senior students who are training for an entrepreneurial career.

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.

This is the most comprehensive text I've found in the area of medical device development. I'm often approached by surgeons who are interested in inventing medical devices, and they often lack the business acumen and intellectual property knowledge to make the best decisions. Now I have a resource to direct them to so they protect their interests and drive their inventions to commercialization themselves, without having to rely on someone at a large corporation to give their invention a go/nogo.

A must-have for anyone desiring to develop a new medical technology. Can literally save you months and thousands of dollars providing the basic insights in how to get started. Systematically goes through the entire process from concept to commercialization providing sound advice from industry leaders with successful track records. This resource can literally help you develop your business plan as you think through the market need, and phases of development.

This is a great text to give an overview of the entire medical device development with the unusual emphasis on identifying and defining unmet clinical needs. It has been a work in progress for many years and has been validated many times over. A must have for every medical device entrepreneur.

This book is a great reference for any biomedical engineer that looks forward to design and develop a bio-product. Along side of Product Development book by Ulrich they are a great combination for learning about the process of product development.

A little too formulaic for many of the processes, and then it will completely brush over some complex processes that probably need more information. All together, the best available textbook on how to go from need identification all the way to business concept and beyond. I'd highly recommend pairing this with The Startup Owners Manual and Business Model Generation. Both books are the go-to textbooks for startup generation at the moment.

This book is an incredibly efficient way to become familiarized with all of the many facets of innovating in the medical device sector. It is a fantastic read for beginners and seasoned veterans alike. The case studies are terrific.