Biodesign
The Process of Innovating Medical Technologies

A step-by-step, full-color guide to successful medical technology innovation with a new focus on value-based innovation and global opportunities.

Paul G. Yock (Author), Stefanos Zenios (Author), Josh Makower (Author), Todd J. Brinton (Author), Uday N. Kumar (Author), F. T. Jay Watkins (Author), Lyn Denend (Author), Thomas M. Krummel (Author), Christine Q. Kurihara (Author)

9781107087354, Cambridge University Press

Hardback, published 2 February 2015

952 pages, 255 colour illus. 67 tables
28.3 x 22.5 x 4.2 cm, 2.6 kg

'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

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.

Subject Areas: Semi-conductors & super-conductors [TJFD5], Transistors [TJFD3], Electronic devices & materials [TJFD], Circuits & components [TJFC], Biochemical engineering [TC], Nanotechnology [TBN], Human biology [PSX], Cellular biology [cytology PSF], Biochemistry [PSB], Medical imaging [MMP]