Biodesign

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