How-To Guide For Surgical Innovation: A Book Review


Book reviews, and reviews on literature regarding innovation in Surgery can be useful tools to help decide where to spend our scarce time.  Here, we review a very useful text book called Bio-Design: The Process of Innovating Medical Technology.  This book serves as a great template for how to innovate in the field of Surgery.


This text was published in 2009 and has contributing authors including: Stefanos Zenios, Josh Makower, Paul Yock, Todd Brinton, Uday Kumar, Lyn Denend and Thomas Krummel.  About 5 years ago, Dr. Krummel spoke near Center Valley, Pennsylvania, at the Lehigh Valley Health System.  It was there that I was exposed to just how process-oriented the Bio-Design system had become.  In short, Dr Krummel and his colleagues at Stanford demonstrated a nice pathway for how to evolve, rate and create companies out of the talented surgical residents and interdisciplinary teams they helped form.  This Bio-Design text mostly captures a sketch of that system and makes it a readily available template for other centers across the country.


One of the most useful portions of the text is its organization.  It is clearly organized from brainstorming and conceptual phase down to licensing and beyond.  Some of the more interesting facts that you can glean from the text include the idea that the Stanford system has this innovation pathway mapped to such a level that the staff maintains a computer database with which they attach ratings to different ideas and potential startup teams.


Why is this pathway so attractive?  There are at least two reasons:  (1) effective innovation can help more patients than we could ever help in our day-to-day work, and (2) innovation provides a non-patient volume-based revenue streams that is very effective.  That is, each of these medical devices has the potential to return multiples of investment.  Therefore, in years where patient care numbers are decreasing or have issues, these non-patient volume sensitive revenue streams are even more useful.


What I especially like about the process described in Biodesign is that it leverages human capital to a very full degree.  The text clearly conveys how the program achieves this end.  It highlights how this system takes motivated future/current physicians and plugs them into a process that gives them the ability to create their own medical devices and companies.  Again, they can leverage these companies to help more patients with amazing designs and devices than they could otherwise help in day to day practice seeing patients in the office.


Other hightlights of the book include thoughts and quotes from known innovators.  Dr. Thomas J. Fogarty, of Fogarty catheter fame, is one of the Stanford physicians and his comments throughout certain portions of the book are insightful and relevant.


The book also contains several directly useful tools. Some of these include sample non-disclosure agreements and other legal documents.  The FDA regulatory process, both for compassionate use and other pathways, is clearly explained such that even a person inexperienced to the process can come to understand some of the various regulatory issues and challenges in bringing a device to FDA clearance.  Of the various textbooks on medical device innovation and biodesign I cannot recommend this text strongly enough.  Its ease of use, clear organization and practical tools makes it an excellent primer for healthcare executives and clinicians who have an interest in the bio-design process and who have an excellent idea that they might want to bring to market.  If you have a moment visit  You will find the textbook available for download as a Kindle textbook or available for purchase as a hardback.


Note the author has no financial association with the publisher of the textbook, the various surgeons and clinicians involved, or any association with the university mentioned.