Biodesign: The Process of Innovating Medical Technologies

Book cover for Biodesign

Biodesign: The Process of Innovating Medical Technologies

By Stefanos Zenios, Josh Makower, Paul Yock, Todd J Brinton, Uday N. Kumar, Lyn Denend, Thomas M. Krummel
Cambridge University Press, 2009

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.

Selected 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
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
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
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