Course Content
Lesson 1 – Securing the Hull (IP & Licensing)
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6 Topics
The Invention Disclosure Process at MUSC
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Assessment | The Invention Disclosure Process at MUSC
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Intellectual Property
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Assessment | Intellectual Property
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Licensing: Existing Company vs. Start-Up
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Assessment | Licensing: Existing Company vs. Start-up
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Lesson 2 – Anchoring Your Idea (Idea Validation)
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8 Topics
Does My Idea Have Commercial Potential?
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Assessment | Does My Idea Have Commercial Potential?
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Why Will Users Adopt My Solution Over Existing Options?
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Assessment | Why Will Users Adopt My Solution Over Existing Options?
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Who Is My Customer?
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Assessment | Who Is My Customer?
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Does the Market Opportunity Justify Investment?
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Assessment | Does the Market Opportunity Justify Investment?
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Lesson 3 – Building the Crew & Choosing the Vessel (Team Formation & Structure)
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10 Topics
Company Formation Basics
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Assessment | Company Formation
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Incorporation: LLC vs. C-Corporation
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Assessment | Incorporation – LLC vs. C-Corporation
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Developing Corporate Documents
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Assessment | Developing Corporate Documents
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Forming Your Team
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Assessment | Forming Your Team
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Major Business Resources Start-up Companies Need
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Assessment | Major Business Resources Start-up Companies Need
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Lesson 4 – Regulatory Currents (Regulatory Strategy)
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14 Topics
Section 1: Why Regulatory, Clinical and Reimbursement Pathways Matter
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Section 2: Laboratory Diagnostic Tests
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Assessment | Laboratory Diagnostic Tests
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Section 3: Key FDA Pathways – Drugs, Biologics and Medical Devices
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Assessment | Key FDA Pathways – Drugs, Biologics and Medical Devices
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Section 4: Cellular and Gene Therapies
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Assessment | Cellular and Gene Therapies
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Section 5: Clinical Evidence & Trial Design
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Assessment | Clinical Evidence & Trial Design
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Section 6: Coding, Coverage & Reimbursement
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Assessment | Coding, Coverage & Reimbursement
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Section 7: Digital Health Regulatory Pathways
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Section 8: Putting It Together – Design with Success in Mind
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Assessment | Putting It Together – Design with Success in Mind
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Lesson 5 – Pitching from the Helm (Pitch Development)
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4 Topics
Why Is Storytelling So Important?
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Assessment | Why is storytelling so important?
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Building an Effective Pitch Deck
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How Do I Tailor My Pitch To Different Audiences?
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Lesson 6 – Funding the Voyage
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9 Topics
Types of Funding for Start-ups
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Assessment | Types of Funding for Start-ups
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Setting Realistic Early Milestones
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Assessment | Setting Realistic Early Milestones
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What Investors Want to See
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Assessment | What Investors Want to See
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Using Funds Wisely
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Assessment | Using Funds Wisely
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Worksheet – Funding & Milestones Planning
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