Biodesign (2^nd Ed., Revised edition) The Process of Innovating Medical Technologies

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 ebiodesign.org. Readers can access this material quickly, easily, and at the most relevant point in the text from within the ebook.

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.

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™ angioplasty/stent system, which is now the primary system in use worldwide, and the Doppler-guided access system known as the Smart Needle™ and PD-Access™. 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