Biodesign

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.