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The Process of Innovating Medical Technologies

$79.00 ( ) USD

  • Date Published: May 2011
  • availability: This ISBN is for an eBook version which is distributed on our behalf by a third party.
  • format: Adobe eBook Reader
  • isbn: 9781139064675

$ 79.00 USD ( )
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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: May 2011
    • format: Adobe eBook Reader
    • isbn: 9781139064675
    • contains: 106 b/w illus. 79 tables
    • availability: This ISBN is for an eBook version which is distributed on our behalf by a third party.
  • 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

  • Resources for


    Stefanos Zenios, Josh Makower, Paul Yock, Todd J. Brinton, Uday N. Kumar, Lyn Denend, Thomas M. Krummel

    General Resources

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    Here you will find free-of-charge online materials to accompany this book. The range of materials we provide across our academic and higher education titles are an integral part of the book package whether you are a student, instructor, researcher or professional.

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  • Instructors have used or reviewed this title for the following courses

    • Advanced Biomaterial Design
    • Analysis of Emerging Technologies
    • Bio-Innovations and Opportunities in Medicine and Engineering (BIOME)
    • Biodesign
    • Bioengineering Design Clinic
    • Bioengineering Design Project: Development
    • Bioengineering Senior Design
    • Bioinnovation for Surgeons
    • Bioinstrumentation by Design,
    • Biomaterials and Advanced Biomaterials
    • Biomechanics
    • Biomedical Device Analysis and Design
    • Biomedical Device Design
    • Biomedical Engineering
    • Biomedical Engineering Design and Innovation
    • Biomedical Engineering Senior Design
    • Biomedical Engr Industrial Practices
    • Biomedical Product Development
    • Biomolecular Engineering Design I, ll, and llI
    • Biophotonics design
    • Biosolid Mechanics: Modeling and Design
    • Biotechnology Entrepreneurship
    • Bringing Biomedical Devices to Market
    • Business of Biotech
    • Clinical Applications for Biomedical Device Design
    • Clinical Bioengineering
    • Construction Methods
    • Design of Circulatory Devices and Artificial Organs
    • Design of Medical Devices
    • Discovery to Markets
    • Early-stage commercialization of biotechnology
    • FDA and ISO Requirements for the Development and Manufacturing of Medical Devices
    • Foundations for BME Design
    • Fundamentals of Bio-Nanotechnology
    • Graduate Innovative Design
    • Healthcare Innovation and Entrepreneurship
    • Healthcare Systems Engineering
    • Introduction to Biomedical Engineering Design and Discovery
    • Medical Device Design and Development
    • Medical Device Design and Engineering
    • Medical Devices
    • Medtech Innovation Projects in Orthopaedics and Wound Healing.
    • New Product Design and Business Development
    • Product Innovation Lab
    • Research Practicum in Pharmacy Administration
    • Senior Biodesign
    • Starting New ventures
    • Technology and Medicine
  • Authors

    Stefanos Zenios, Stanford University, California
    Stefanos Zenios is the Charles A. Holloway Professor at the Graduate School of Business, Stanford University. His pioneering work on maximizing the benefits of medical technology to patients when resources are limited has influenced policies in the US and Europe. He has quantified the ethical implications of technology allocation choices on patients and society as featured in the Financial Times and At Stanford University, he was the first to introduce courses on the interface between medicine, engineering, and management in the MBA curriculum. Dr Zenios advises medical device and biopharmaceutical companies on health economics and outcomes studies for marketing and reimbursement strategies. He is also a co-founder of Culmini Inc., a company funded by the National Institutes of Health to develop web-tools that help patients and families with difficult choices.

    Josh Makower, Stanford University, California
    Josh Makower is the founder and Chief Executive Officer of ExploraMed, a medical device incubator. He is also a Venture Partner with New Enterprise Associates, a Consulting Associate Professor at Stanford University Medical School, and a co-founder of Stanford� Biodesign Innovation Program. Dr Makower has founded several medical device businesses including Moximed, Vibrynt, NeoTract, Acclarent, TransVascular and EndoMatrix. Up until 1995, he was founder and Manager of Pfizer� Strategic Innovation Group. He holds over 50 patents in various fields of medicine and surgery, an MBA from Columbia University, an M.D. from NYU, and an S.B. in Mechanical Engineering from MIT.

    Paul Yock, Stanford University, California
    Paul Yock is the Director of the Stanford Biodesign Program and the founding Co-Chair of the Department of Bioengineering at Stanford University. He is known internationally for his work in inventing, developing, and testing new medical devices, including the Rapid Exchange� balloon angioplasty and stenting system, which is now the principal system in use worldwide. He also authored the fundamental patents for mechanical intravascular ultrasound imaging and founded Cardiovascular Imaging Systems. In addition, he invented a Doppler-guided access system known as the Smart Needle� and PD-Access�. Dr Yock holds 55 US patents and has authored over 300 papers, mainly in the area of catheter-based interventions and technologies. He has been elected to membership in the National Academy of Engineering and has received several prestigious awards, including the American College of Cardiology Distinguished Scientist Award.

    Todd J. Brinton, Stanford University, California
    Todd J. Brinton is a Clinical Assistant Professor of Medicine (Cardiovascular) and Bioengineering (by courtesy) at Stanford University. He is an interventional cardiologist at Stanford University Medical Center and investigator in interventional-based therapies for coronary disease and heart failure. He is also the Fellowship Director for the Biodesign Program, and Co-Director of the graduate class in Biodesign Innovation at Stanford University. Dr Brinton completed his medicine, cardiology, and interventional training at Stanford University. He holds an M.D. from the Chicago Medical School and a B.S. in bioengineering from the University of California, San Diego. He is co-founder of BioParadox, Inc., a venture-backed medical device company and serves on the advisory board for a number of early-stage medical device companies. Prior to medical school he was the Clinical Research Director for Pulse Metric, Inc., a medical device start-up company.

    Uday N. Kumar, Stanford University, California
    Uday N. Kumar is the founder and Chief Medical Officer of iRhythm Technologies, Inc., a venture-backed medical device company focused on developing new devices and systems for the detection of cardiac rhythm disorders. He is also the Associate Director, Curriculum of Stanford-India Biodesign and a Lecturer in Bioengineering, and has served as an Adjunct Clinical Instructor of Cardiovascular Medicine, all at Stanford University. In these capacities, he mentors, advises, and teaches students and fellows about the biodesign process. Dr Kumar completed a Biodesign Innovation fellowship at Stanford, cardiology and cardiac electrophysiology fellowships at the University of California, San Francisco (UCSF), an internal medicine residency at Columbia University, and his medical and undergraduate education at Harvard University. He was also Chief Medical Officer and Vice-President of Biomedical Modeling Inc., a medical start-up company.

    Lyn Denend, Stanford University, California
    Lyn Denend is a Research Associate at Stanford University� Graduate School of Business, where she has authored numerous case studies for use in graduate-level and executive education programs in areas such as strategic management, international business, supply chain management, healthcare, and biodesign innovation. Previously, Ms Denend was a Senior Manager in Cap Gemini Ernst & Young� management consulting practice and Vice President of Operations for a start-up providing human resource services. She has an MBA from Duke University� Fuqua School of Business and a BA in Communications from the University of California, Santa Barbara.

    Thomas M. Krummel, Stanford University, California
    Thomas M. Krummel is Emile Holman Professor and Chair in the Department of Surgery, and Co-Director of the Stanford Biodesign Program, at Stanford University. He has been a pioneer and consistent innovator throughout his career, and has served in leadership positions in many of the important surgical societies including the American College of Surgeons, the American Pediatric Surgical Association, the American Surgical, the American Board of surgery, the American Board of Pediatric Surgery, and the American Board of Plastic Surgery. Over the last 14 years, Dr. Krummel has pioneered the application of technology to simulation-based surgical training and surgical robotics. For his work in this area, and developing a collaborative simulation-based surgical training system, he has received two Smithsonian Information Technology innovation Awards.

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