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

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

3.1 Ideation and Brainstorming
3.2 Concept Screening

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

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

6.1 Operating Plan and Financial Model
6.2 Business Plan Development
6.3 Funding Sources