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Biodesign: The Process of Innovating Medical Technologies [Hardcover]

Stefanos Zenios , Josh Makower , Paul Yock , Todd J. Brinton , Uday N. Kumar , Lyn Denend , Thomas M. Krummel
4.9 out of 5 stars  See all reviews (14 customer reviews)

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Book Description

September 25, 2009 0521517427 978-0521517423 1
Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. A three-step, proven approach to the biodesign innovation process - identify, invent, implement - provides a practical formula for innovation. The experiences of hundreds of innovators and companies, in the form of case studies, quotes and practical advice, offer a realistic, action-orientated roadmap for successful biodesign innovation. Real-world examples, end-of-chapter projects, and Getting Started sections guide the reader through each of the key stages of the process and provide a template to create their own new medical devices. Addressing common medical, engineering, and business challenges to develop well-rounded expertise, this book is the complete package for any biodesign entrepreneur. The text is supported by valuable resources, including up-to-date industry changes: found at

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Biodesign: The Process of Innovating Medical Technologies + Change by Design: How Design Thinking Transforms Organizations and Inspires Innovation
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Editorial Reviews


"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, Boston Scientific

"This is a must read for device entrepeneurs. I only wish I had such a roadmap when I was starting out in my career. Biodesign: The Process of Innovating New 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 New 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."
Dean Kamen, Inventor and Founder/President of DEKA Research and Development

"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, M.D., Ph.D. UCSD

"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, Former President, Johns Hopkins University

"Whether you're a physician with an idea, an engineer, or a businessman, this is a unique and powerful resource."
CHI Bulletin

Book Description

Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.

Product Details

  • Hardcover: 806 pages
  • Publisher: Cambridge University Press; 1 edition (September 25, 2009)
  • Language: English
  • ISBN-10: 0521517427
  • ISBN-13: 978-0521517423
  • Product Dimensions: 11.1 x 8.7 x 1.5 inches
  • Shipping Weight: 5.2 pounds (View shipping rates and policies)
  • Average Customer Review: 4.9 out of 5 stars  See all reviews (14 customer reviews)
  • Amazon Best Sellers Rank: #90,812 in Books (See Top 100 in Books)

Customer Reviews

Most Helpful Customer Reviews
17 of 17 people found the following review helpful
By Gavin
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.
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10 of 10 people found the following review helpful
5.0 out of 5 stars Fundamental resource for medical device engineers September 30, 2009
By Erika
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!
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6 of 6 people found the following review helpful
5.0 out of 5 stars Filling a Big Void in Medical Technology Innovation January 3, 2010
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.
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Most Recent Customer Reviews
5.0 out of 5 stars Comprehensive and real-life experience-based
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. Read more
Published 4 months ago by Cmdr Bill
5.0 out of 5 stars Nice explanations and examples of Biodesign Innovation
I am new to the biomedical field and read this book on my own to learn. I thought it did a nice job providing examples of designs that are currently out there. Read more
Published 11 months ago by James
5.0 out of 5 stars BIODESIGN
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. Read more
Published 21 months ago by ongoingresearch
5.0 out of 5 stars A must read for any medical device entrepreneur, or hopeful
This book is an incredibly efficient way to become familiarized with all of the many facets of innovating in the medical device sector. Read more
Published on June 3, 2012 by Michael
5.0 out of 5 stars Useful resources...
This is a great resource, devoting many pages to how an inventor thinks of new innovations and develops those ideas. It also has great case studies of successful device companies. Read more
Published on April 21, 2012 by Fortran
5.0 out of 5 stars Must Have for Medical Device Entrepreneurs
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. Read more
Published on September 13, 2011 by Evan Anderson
4.0 out of 5 stars A great book for a biomedical engineer
This book is a great reference for any biomedical engineer that looks forward to design and develop a bio-product. Read more
Published on October 28, 2010 by Arash Momeni
5.0 out of 5 stars Primer for Medical Device Design, Experimentation & Commercialization
This is the best printed resource for helping physicians and entrepreneurs invent, prove & commercialize new medical technologies. Read more
Published on December 9, 2009 by ZMed
5.0 out of 5 stars A must for any medical device professional
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... Read more
Published on October 22, 2009 by Eric Heinz
5.0 out of 5 stars If you are a medical device designer you need this book
This is a book that compiles the most up-to-date and relevant knowledge, gained by real experience, on how to innovate medical devices, by luminaries in the medical device field. Read more
Published on October 10, 2009 by Theodore Kucklick
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