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The Process of Innovating Medical Technologies


  • Date Published: September 2009
  • availability: In stock
  • format: Hardback
  • isbn: 9780521517423


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About the Authors
  • 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

    • A step-by-step 'how-to' guide for medical technology innovation shows how to approach the innovation process, minimize risk, and optimize success
    • Three-step, practical process - identify, invent, implement - and 'Getting Started' sections give readers the tools and resources they need
    • Compiles experiences of hundreds of innovators and companies in case studies, quotes, lessons learned, and practical advice
    Read more

    Reviews & endorsements

    "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

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    Product details

    • Date Published: September 2009
    • format: Hardback
    • isbn: 9780521517423
    • length: 806 pages
    • dimensions: 287 x 227 x 50 mm
    • weight: 2.35kg
    • contains: 106 b/w illus. 79 tables
    • availability: In stock
  • Table of Contents

    Part I. Identify
    Section 1. Needs Finding:
    1. Strategic focus
    2. Observation and problem identification
    3. Need statement development
    Case study
    Section 2. Needs Screening:
    4. Disease state fundamentals
    5. Treatment options
    6. Stakeholder analysis
    7. Market analysis
    8. Needs filtering
    Case study
    Part II. Invent
    Section 3. Concept Generation:
    9. Ideation and brainstorming
    10. Concept screening
    Case study
    Section 4. Concept Selection:
    11. Intellectual property basics
    12. Regulatory basics
    13. Reimbursement basics
    14. Business models
    15. Prototyping
    16. Final concept selection
    Case study
    Part III. Implement
    Section 5. Development Strategy and Planning:
    17. IP strategy
    18. R&D strategy
    19. Clinical strategy
    20. Regulatory strategy
    21. Quality and process management
    22. Reimbursement strategy
    23. Marketing and stakeholder strategy
    24. Sales and distribution strategy
    25. Competitive advantage and business strategy
    Case study
    Section 6. Integration:
    26. Operating plan and financial model
    27. Business plan development
    28. Funding sources
    29. Licensing and alternate pathways
    Case study

  • general resources

    View all resources
    Group Section Name Type Size Sort Order filter vars
    General Resourcesebiodesign.orglinkn/aSort Order general resources general resources general resources general resources

    These resources are provided free of charge by Cambridge University Press with permission of the author of the corresponding work, but are subject to copyright. You are permitted to view, print and download these resources for your own personal use only, provided any copyright lines on the resources are not removed or altered in any way. Any other use, including but not limited to distribution of the resources in modified form, or via electronic or other media, is strictly prohibited unless you have permission from the author of the corresponding work and provided you give appropriate acknowledgement of the source.

    If you are having problems accessing these resources please email

  • Authors

    Stefanos Zenios, Stanford University, California

    Josh Makower, Stanford University, California

    Paul Yock, Stanford University, California

    Todd J. Brinton, Stanford University, California

    Uday N. Kumar, Stanford University, California

    Lyn Denend, Stanford University, California

    Thomas M. Krummel, Stanford University, California

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