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 Brainstorming
3.2 Concept Screening

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

5.1 IP Strategy
5.2 Marketing and Stakeholder Strategy
5.3 Regulatory Strategy
5.4 Clinical Development Strategy
5.5 Reimbursement Strategy
5.6 Competitive Advantage

6.1 R&D/Engineering Plan
6.2 Clinical Trial Design
6.3 Sales & Distribution Plan
6.4 Operating Plan & Milestones
6.5 Financial Modeling & Proxy Validation
6.6 Business Plan Development
6.7 Funding Sources