BUZZ

Here’s a sample of what innovators, academics, and industry executives are saying about Biodesign: The Process of Innovating Medical Technologies and the process that it teaches…

Letters from Fans

I was formerly on faculty at Johns Hopkins, where I spearheaded the medical device program, and a practicing clinical Interventional Radiologist In 2008, I left for the private sector to directly pursue entrepreneurship.

Using your Stanford Biodesign Model, my cofounder, Jim Chomas (PhD, Biomedical Engineering) and I started the process of starting a company. We focused around the 3 step process of Identify, Invent and Implement. After multiple ideas/needs, we formed the company around a single clinical need and then developed the technology.

I just wanted to let you know how well this process has worked. Our company, Surefire Medical, Inc, was started with just the two of us in 2009. Now our company has >25 employees, FDA cleared product and generating sales. Along the way, we have had a great time.

I just thought you should know the positive impact that you have had on us.

Aravind Arepally, M.D., FSIR
Chief Scientific Officer
www.surefiremedical.com

I haven't gotten a chance to thank you directly for releasing the BioDesign book. I carried it with me everywhere for about six months before I started pitching for my seed round (which I secured Jan 2012). It is truly a handbook as to how to start a medical device company - not sure what I would have done without it! I hope to see you again sometime soon.

Surbhi Sarna
nVision CEO

I can't begin to thank you enough for the amazing work you've done in your Biodesign book. As a practicing anesthesiologist with over 25 yrs clinical experience, it has helped formalize the development of several of my businesses.
John Stocking, M.D.

Everything you ever wanted to know about medical device entrepreneurship and more.   Paul, Josh and Stefanos have led an A class team of experienced device company builders to produce a reference document to guide an aspiring device entrepreneur through all the challenges of getting an idea to market.  These are tough times.  Whether you’re a physician with an idea, an engineer or a businessman, this is a unique and powerful resource.
- John Abele, Founder/Chairman of Boston Scientific

Biodesign is a handbook for medical device entrepreneurs based upon the key premise that  innovation is a process and skill that can be learned.   Furthermore, the key to medical device innovation is getting the clinical need in correct focus.  This book will walk the student through the innovation process from how to properly define the clinical need all the way through getting the company funded and developing a quality product.  Important topics like the FDA regulatory process, patents, ethics, quality and manufacturing are addressed.  I don’t know of any other text that has the wealth of practical and usable information on the entrepreneurial process as Biodesign. This is a much needed ‘how-to’ book written by people who actually have done it many times themselves.   No thirty-thousand foot views necessary or appropriate here. Each chapter has a ‘getting started’ section that will help guide the budding entrepreneur through the necessary steps.  This book should be required reading for anyone wanting to develop a new medical device or to start a new company in the medical field.
- William Brody, President of the Salk Institute and Former President of Johns Hopkins University

The chapters are thoughtfully organized. With an excellent blending of scientific information, clinical problems, and examples of solutions, including case studies, the book has succeeded in accomplishing its goal of being very practical. The ending of each chapter with a “getting started” section can greatly facilitate the reader to get started with the information on valuable resources. The mirroring of materials on a website with active links is another wonderful feature. This allows the readers to gain rapid access to the FDA website, etc.  This book of Biodesign will be the standard in this very important field. It will be of great value in the education of undergraduate and graduate students in biomedical engineering and related fields, as well as for industrial scientists and university faculties who educate/train young bioengineers or want to pursue the process of innovating new medical technologies themselves.
- Shu Chien, Professor of Bioengineering, UCSD

There is practical material in these chapters that can make the path to implementation clearer, particularly for the physician or engineer who may have seen only parts of this process before.   It is also important that the first third of this book focuses on how to get the clinical need right.  There is nothing more critical in the innovation process than starting with a truly significant patient need.
- Thomas Fogarty, Founder or co-founder of more than 30 companies and member of the National Inventors Hall of Fame

This is a must read for device entrepreneurs. I only wish I had such a roadmap when I was starting out in my career. Biodesign: The Process of Innovating Medical Technologies is a wonderful guide with lucent case studies that illustrate the critical steps necessary for the translation of ideas into commercial solutions. It is the Gray's Anatomy of device innovation.
- William Hawkins, Chairman and CEO of Medtronic

Biodesign: The Process of Innovating Medical Technologies is direct, clear and simultaneously sophisticated yet practical as it unravels the many issues related to successfully navigating the entire biodesign path from concept to final product launch.  I highly recommend that anyone seriously interested in developing an entrepreneurial venture in the medical products field read this book. It is likely to spare budding entrepreneurs a lot of trial-and-error and painful on-the-job training. In the fast paced world of medical product development, it would be a shame not to take advantage of the practical lessons so well organized and articulated in the text.
- Dean Kamen, Inventor and Founder/President of DEKA Research and Development

In Biodesign, the Stanford team has assembled a treasure trove of methods for medical device innovation. The book is certain to become an invaluable reference for students, instructors, and practitioners alike.
- Karl T. Ulrich, CIBC Professor of Entrepreneurship and eCommerce, The Wharton School

Innovation for its own sake is of no use to patients—it must be focused, purposeful, and effective. Regrettably, innumerable innovative ideas with the potential to advance human health are lost because the innovators lack the business or procedural know-how necessary to bring a medical device to market, or because they fail to identify areas of true need, ultimately wasting talent, time and investment on concepts that provide little practical value to patients and health care providers. This comprehensive text provides clear guidance through every step of the biodesign process, from identification of market need to successful entrée into a complex, competitive marketplace. The authors of this book—faculty in Stanford's Biodesign Program— have done innovators a great service in shaping the study of biodesign and training students to put this knowledge into practice. The editors’ expertise is self-evident, and, with this book, is now accessible to anyone serious about succeeding in biotechnology.
- Miles White, Chairman and Chief Executive Officer, Abbott

 

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