Biodesign : the process of innovating medical technologies / senior editors, Stefanos Zenios, Josh Makower, Paul Yock ; associate editors, Todd J. Brinton, Uday N. Kumar ; principal writer, Lyn Denend ; specialty editor, Thomas M. Krummel ; web editor, Christine Kurihara.

Cambridge : Cambridge University Press, 2011, ©2010 (4th printing)

xxxv, 742 pages : illustrations ; 29 cm.

Machine generated contents note: Pt. I Identify -- Sect. 1 Needs Finding -- 1. Strategic focus -- 2. Observation and problem identification -- 3. Need statement development -- Sect. 2 Needs Screening -- 4. Disease state fundamentals -- 5. Treatment options -- 6. Stakeholder analysis -- 7. Market analysis -- 8. Needs filtering -- Pt. II Invent -- Sect. 3 Concept Generation -- 9. Ideation and brainstorming -- 10. oncept screening -- Sect. 4 Concept Selection -- 11. Intellectual property basics -- 12. Regulatory basics -- 13. Reimbursement basics -- 14. Business models -- 15. Prototyping -- 16. Final concept selection -- Pt. III Implement -- Sect. 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 -- Sect. 6 Integration -- 26. Operating plan and financial model -- 27. Business plan development -- 28. Funding sources -- 29. Licensing and alternate pathways.

Includes bibliographical references and index.