Biodesign: The Process of Innovating New Medical Technologies [Hardcover]

I am a recent graduate of the Stanford Graduate Student of Business and have worked in the life sciences industry for many years. While at the GSB, I took the 2-quarter BioDesign class which used a beta version of this book as its text. The course - and text - has a rather ambitious aim, namely to explore the medtech entrepreneurial and innovation process and to do so in a cross-functional, comprehensive, and hands-on fashion. As one of the more popular courses at Stanford and one that has resulted in numerous new VC-funded start-ups, I think they have succeeded in this goal.

More so than entrepreneurialism in other industries, starting a new business in medical devices requires bringing together many disciplines and functions, including engineering, medicine, and business. This book takes this comprehensive view of the process. You'll learn about:

* Medical - learn about the clinical trials process for medical devices (e.g. 510k / PMA) ... learn how to put together a clinical development plan & clinical trials plan

* Engineering - learn about prototyping, produce concept definitions, R&D strategy

* Business - learn about doing a market assessment ... how to put together a reimbursement strategy ... how to do a marketing & business plan ... how build your financial models

But more than just looking at the individual disciplines, this text looks at the innovation *process*. That is, it walks through idea/concept creation and screening, researching new clinical need areas, and important early due diligence (i.e. IP searches, researching unmet medical needs, doing a stakeholder analysis). Then, once you have your concept it takes you through developing your early prototype and putting together a development and business plan. Next, it discusses how you will want to go about pitching this to VCs and obtaining funding to implement your product. And finally, it touches on operation issues and exits once your product is launched.

The book is highly readable and is accessible to a wide range of backgrounds and knowledge levels. This is because it was designed to be a text for a course that was taken by b-school students, engineering graduate students, and med school students. Additionally it is very hands-on, and discusses the tangible *things* that need to be done as you go through the start-up innovation process, and includes numerous case studies. Some chapters are rather dense but these can be skimmed until you actual need to reference the material.

On caveat is that, while I think this text can be relevant for people that are interested in innovation and start-ups in biotech or other areas of life sciences, it is clearly targeted to medical devices & medtech.

Being a successful entrepreneur in medical devices requires a thorough understanding of each of these steps in the innovation process and all of the cross-functional disciplines that are involved in bringing a new innovation to market and to patients. This textbook understands this and tackles this topic with that principle in mind.

As a medical device engineer with experience at both small and large companies, I was skeptical whether one text could be considered a go-to reference for medical device design. After a year of of experience with the beta version of this text, my doubts were allayed. The text is thoughtfully and logically laid out in a step by step approach to designing medical devices. One particularly unique aspect of this book, is that it provides a well-balanced blend of medicine, business and engineering in its approach. This is largely due to the extensive experience of its authors and their collaboration in its creation. The case studies provided in each chapter provide "hands-on" examples of the key information. For me, I found these sections the most interesting and the most inspiring to read. I found myself reading the case studies first and then going back through the rest of the chapter text to pull out additional information.

As I have found with only a handful of my engineering texts ( admittedly, I have shelved my Vector Calculus and PChem texts), I find myself constantly pulling this text off my shelf and referring to it--particularly for the extensive list of resources that are included at the end of each chapter. It has taken so much of the guess work and internet searching out of the equation!

There are so many unknowns and potential pitfalls in the development of medical devices. This text is a key tool to entrepreneurs who would like to avoid and/or prepare for as many of these unknowns as possible!

Stanford University has been a leader in facilitating the creation and development of medical technology companies. A unique relationship has existed for a number of years between academic medical center and its engineering, science, and graduate business schools. The University also benefits from its location in the heart of Silicon Valley. In recent years, the University has created a noteworthy BioDesign Innovation program focused on the process of innovating new medical technologies by integrating faculty from its various colleges and experienced medical technology entrepreneurs.

Authors Stefanos Zenios (Charles A. Holloway Professor), Josh Makower, MD (co-founder of Stanford's Biodesign Innovation Program), Paul Yock, MD (Director of the Stanford Biodesign Program and the founding Co-Chair of the Department of Bioengineering), Todd J. Brinton, MD (Clinical Assistant Professor of Medicine), Uday N. Kumar, MD (Associate Director, Curriculum of Stanford-India Biodesign), Lyn Denend (Research Associate), and Thomas M. Krummel, MD (Emile Holman Professor and Chair in the Department of Surgery, and Co-Director of the Stanford Biodesign Program)in "Biodesign" have taken the essence of the Stanford program creating a roadmap accessible to all on recognizing market opportunities, mastering the design process, and developing medical technology business know-how.

This readable and easy-to-read book includes a three-step, proven approach to the biodesign innovation process, experiences of hundreds of innovators and companies, in the form of case studies, quotes and practical advice, real-world examples, end-of-chapter projects, and Getting Started sections that will guide the reader through each of the key stages of the process and provide a template to create their own new medical devices.

Biodesign fills a big void for medical technology entrepreneurs, venture capitalists, universities, and, even, global medical technology corporations. At what may appear to be a high price for a book, "Biodesign," will, for those in medical technology innovation, prove to be a bargain.