Biodesign

'Biodesign is on the forward edge of one of the most exciting new frontiers of health care. This impressive and engaging work provides a thorough look at the innovation process. But this is certainly not just for the scientific innovators: it is a must-read for anyone in any aspect of health care today.' Alex Gorsky, Chairman and CEO, Johnson & Johnson

'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

'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 editio...

Paul Yock is the Weiland Professor and Founding Co-Chair of the Stanford Department of Bioengineering, with a joint appointment in Cardiovascular Medicine and courtesy appointments in Mechanical Engineering and Operations, Information, and Technology in the Graduate School of Business. He founded and directs the Program in Biodesign, a unit of Stanford's Bio-X initiative that focuses on invention and technology transfer related to biomedical engineering. He is internationally known for his work in inventing, developing, and testing new devices, including the Rapid Exchange(TM) angioplasty/stent system, which is now the primary system in use worldwide, and the Doppler-guided access system known as the Smart Needle(TM) and PD-Access(TM). Dr Yock has cofounded several medical technology companies, including Cardiovascular Imaging Systems, acquired by Boston Scientific. Stefanos Zenios is the Charles A. Holloway Professor at the Graduate School of Business, Stanford University and the director of its Center for Entrepreneurial Studies. An innovative educator, he was the first to introduce courses on the interface between medicine, engineering, and management in the MBA curriculum, and he is the lead architect of Startup Garage, a popular experiential elective on forming new startups. His pioneering research on maximizing the benefits of medical technology to patients when resources are limited has influenced policies in the US and Europe. Dr Zenios is the co-founder of Konnectology.com, a website funded by the National Institutes of Health to help kidney patients find transplant centers. Josh Makower has dedicated his life to the creation of medical technologies that improve the quality of life for patients. He is the CEO and Founder of ExploraMed Development, LLC, a medical technology incubator, through which he has founded several healthcare companies, including Acclarent, acquired by J&J, TransVascular, acquired by Medtronic, EndoMatrix, and GI Reflux, acquired by C. R. Bard. He is also a Venture Partner with New Enterprise Associates, where he supports investing activity in the medical device arena. Dr Makower holds over 200 patents for medical devices in the fields of orthopedics, ENT, cardiology, general surgery, drug delivery, and urology. He serves as a Consulting Professor of Medicine at Stanford University Medical School and co-founded Stanford's Biodesign Innovation Program. Todd J. Brinton is a Clinical Associate Professor of Medicine (Cardiovascular) and Consulting Associate Professor of Bioengineering at Stanford University. He is also an interventional cardiologist at the Stanford University Medical Center and the Palo Alto VA Hospital. His clinical practice focuses on general cardiovascular disease and complex coronary interventions. Dr Brinton is also a clinical investigator for new interventional-based therapies for coronary disease and heart failure. He has served as the Fellowship Director for the Biodesign Program since 2006, thr...

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.