NEEDS FINDING
1.1 Strategic Focus
1.2 Needs Exploration
1.3 Need Statement Development
NEEDS SCREENING
2.1 Disease State Fundamentals
2.2 Existing Solutions
2.3 Stakeholder Analysis
2.4 Market Analysis
2.5 Needs Selection
CONCEPT GENERATION
3.1 Ideation
3.2 Initial Concept Selection
CONCEPT SCREENING
4.1 Intellectual Property Basics
4.2 Regulatory Basics
4.3 Reimbursement Basics
4.4 Business Models
4.5 Concept Exploration & Testing
4.6 Final Concept Selection
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 & Stakeholder Strategy
5.8 Sales & Distribution Strategy
5.9 Competitive Advantage & Business Strategy
BUSINESS PLANNING
6.1 Operating Plan & Financial Model
6.2 Strategy Integration & Communication
6.3 Funding Approaches
6.4 Alternate Pathways
Stage 4 – Concept Screening
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