Biodesign: The Process of Innovating Medical Technologies

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en Limba Engleză Hardback – 02 Feb 2015

This step-by-step guide to medical technology innovation, now in full color, has been rewritten to reflect recent trends of industry globalization and value-conscious healthcare. Written by a team of medical, engineering, and business experts, the authors provide a comprehensive resource that leads students, researchers, and entrepreneurs through a proven process for the identification, invention, and implementation of new solutions. Case studies on innovative products from around the world, successes and failures, practical advice, and end-of-chapter 'Getting Started' sections encourage readers to learn from real projects and apply important lessons to their own work. A wealth of additional material supports the book, including a collection of nearly one hundred videos created for the second edition, active links to external websites, supplementary appendices, and timely updates on the companion website at Readers can access this material quickly, easily, and at the most relevant point in the text from within the ebook.

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ISBN-13: 9781107087354
ISBN-10: 110708735X
Pagini: 952
Ilustrații: 255 colour illus. 67 tables
Dimensiuni: 225 x 283 x 42 mm
Greutate: 2.54 kg
Ediția: Revizuită
Editura: Cambridge University Press
Colecția Cambridge University Press
Locul publicării: New York, United States


Preface; Focus on value; Global perspectives; Process insights; Part I. Identify: Stage 1. Needs Finding: 1.1 Strategic focus; 1.2 Needs exploration; 1.3 Need statement development; Case study; Stage 2. Needs Screening: 2.1 Disease state fundamentals; 2.2 Existing solutions; 2.3 Stakeholder analysis; 2.4 Market analysis; 2.5 Needs selection; Case study; Part II. Invent: Stage 3. Concept Generation: 3.1 Ideation; 3.2 Initial concept selection; Case study; Stage 4. Concept Screening: 4.1 Intellectual property basics; 4.2 Regulatory basics; 4.3 Reimbursement basics; 4.4 Business models; 4.5 Concept exploration and testing; 4.6 Final concept selection; Case study; Part III. Implement: Stage 5. Strategy Development: 5.1 IP strategy; 5.2 R&D strategy; 5.3 Clinical strategy; 5.4 Regulatory strategy; 5.5 Quality management; 5.6 Reimbursement strategy; 5.7 Marketing and stakeholder strategy; 5.8 Sales and distribution strategy; 5.9 Competitive advantage and business strategy; Case study; Stage 6. Business Planning: 6.1 Operating plan and financial model; 6.2 Strategy integration and communication; 6.3 Funding approaches; 6.4 Alternate pathways; Case study; About the author team; Image credits; Glossary; Index.


'Since its first release, Biodesign has established itself as a unique foundation of expertise for medical device entrepreneurship. No other manual has been so popular and so influential, reflecting admirably the entrepreneurial values sustaining the Biodesign endeavor. [The] second edition, by the outstanding founding editorial team, preserves the highly praised detail, clarity and refreshing essence of [the] previous edition … an indispensable manual and reliable companion for all students and professionals, from business, medical or engineering arenas …' Professor Jacques Marescaux, President, IRCAD Institute, and Founder and CEO, Strasbourg Institute of Image-Guided Surgery
'I can't think of a more important place to turn creativity loose than in designing the future of healthcare. But it's a complicated scene - and it's easy to get lost in the maze of stakeholders, regulation, and financing. Biodesign lays out a clear and logical map to find and pursue opportunities for real innovation. One of the core messages in this new edition is that by placing the need for affordability up front in design process, innovators can more explicitly create technologies that bring value to the healthcare system. This is design thinking at its best!' David Kelley, Founder, Hasso Plattner Institute of Design, Stanford University, and Founder, IDEO
'A [must-read] textbook for anyone in academia or industry, in any country, who wants to innovate and deliver value to patients and health systems around [the] world.' Koji Nakao, Chairman, Terumo, and Japanese Federation of Medical Device Associations
'If you want to know how to come up with a both innovative and transformative technology in medicine, there isn't a better resource than this book by Paul Yock and his colleagues at Biodesign. Over thirteen years ago, the program at Stanford brought together transdisciplinary innovators - engineers, physicians and business experts - to not only design their formidable program, but to teach all the rest of us how to do it.' Eric J. Topol, Director, Scripps Translational Science Institute
'… this book on biodesign will be invaluable for any inventor or entrepreneur. It contains very useful information on such critical areas as design principles, regulatory issues, clinical trial strategies, intellectual property, reimbursement strategies, and funding - and it backs them up with interesting real-life experiences and case studies.' Robert Langer, David H. Koch Institute Professor, Massachusetts Institute of Technology
'This practical but comprehensive resource is keeping up with the rapid developments affecting medical device innovation. The authors draw on their own extensive experiences and insights, as well as diverse case studies, to present the full range of strategic and operational considerations to bring valuable new therapies to patients in the US and around the world.' Mark McClellan, Director, Health Care Innovation and Value Initiative, Brookings Institution