'Biodesign: The Process of Innovating Medical Technologies

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.