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5.5 Quality & Process Management - Videos
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THE PROCESS
NEEDS FINDING
1.1 Strategic Focus
1.2 Observation & Problem Identification
1.3 Need Statement Development
NEEDS SCREENING & IDENTIFICATION
2.1 Disease State Fundamentals
2.2 Treatment Options
2.3 Stakeholder Analysis
2.4 Market Analysis
2.5 Needs Filtering
CONCEPT GENERATION
3.1 Ideation & Brainstorming
3.2 Concept Screening
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
DEVELOPMENT STRATEGY & PLANNING
5.1 IP Strategy
5.2 R&D Strategy
5.3 Clinical Strategy
5.4 Regulatory Strategy
5.5 Quality & Process Management
5.6 Reimbursement Strategy
5.7 Market & Stakeholder Strategy
5.8 Sales & Distribution Strategy
5.9 Competitive Advantage & Business Strategy
INTEGRATION
6.1 Operating Plan & Financial Model
6.2 Business Plan Development
6.3 Funding Sources
6.4 Licensing & Alternate Pathways
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