All Sections

Chapter 1 - Needs Finding

1.1 Strategic Focus
1.2 Observation and Problem Identification
1.3 Need Statement Development

Chapter 2 - Needs Screening

2.1 Disease State Fundamentals
2.2 Treatment Options
2.3 Stakeholder Analysis
2.4 Market Analysis
2.5 Needs Filtering

Chapter 3 - Concept Generation

3.1 Ideation and Brainstorming
3.2 Concept Screening

Chapter 4 - Concept Selection

4.1 Intellectual Property Basics
4.2 Regulatory Basics
4.3 Reimbursement Basics
4.4 Business Models
4.5 Prototyping
4.6 Final Concept Selection

Chapter 5 - Development Strategy and Planning

5.1 IP Strategy
5.2 R&D Strategy
5.3 Clinical Strategy
5.4 Regulatory Strategy
5.5 Quality and Process Management
5.6 Reimbursement Strategy
5.7 Marketing and Stakeholder Strategy
5.8 Sales and Distribution Strategy
5.9 Competitive Advantage and Business Strategy

Chapter 6 - Integration

6.1 Operating Plan and Financial Model
6.2 Business Plan Development
6.3 Funding Sources
6.4 Licensing & Alternate Pathways