Biodesign

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

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.