Course Content
Lesson 1 – Securing the Hull (IP & Licensing)
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3 Topics
4 Quizzes
The Invention Disclosure Process at MUSC
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The Invention Disclosure Process at MUSC | Assessment
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Intellectual Property
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Intellectual Property | Assessment
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Licensing: Existing Company vs. Start-Up
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Licensing: Existing Company vs. Start-up | Assessment
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Lesson 1 | Securing the Hull (IP & Licensing) | Founder’s Assessment
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Lesson 2 – Anchoring Your Idea (Idea Validation)
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4 Topics
4 Quizzes
Does My Idea Have Commercial Potential?
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Does my idea have commercial potential? | Assessment
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Why will users adopt my solution over existing options?
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Why will users adopt my solution over existing options? | Assessment
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Who Is My Customer?
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Who is my Customer? | Assessment
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Does the Market Opportunity Justify Investment?
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Does the market opportunity justify the risk and investment? | Assessment
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Lesson 3 – Building the Crew & Choosing the Vessel (Team Formation & Structure)
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5 Topics
5 Quizzes
Company Formation Basics
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Company Formation | Assessment
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Incorporation: LLC vs. C-Corporation
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Incorporation – LLC vs. C-Corporation | Assessment
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Developing Corporate Documents
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Developing Corporate Documents | Assessment
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Forming Your Team
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Forming Your Team | Assessment
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Major Business Resources Start-up Companies Need
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Major Business Resources Start-up Companies Need | Assessment
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Lesson 4 – Regulatory Currents (Regulatory Strategy)
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8 Topics
6 Quizzes
Section 1: Why Regulatory, Clinical and Reimbursement Pathways Matter
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Section 2: Laboratory Diagnostic Tests
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Laboratory Diagnostic Tests | Assessment
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Section 3: Key FDA Pathways – Drugs, Biologics and Medical Devices
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Key FDA Pathways – Drugs, Biologics and Medical Devices | Assessment
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Section 4: Cellular and Gene Therapies
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Cellular and Gene Therapies | Assessment
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Section 5: Clinical Evidence & Trial Design
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Clinical Evidence & Trial Design | Assessment
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Section 6: Coding, Coverage & Reimbursement
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Coding, Coverage & Reimbursement | Assessment
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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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Putting It Together – Design with Success in Mind | Assessment
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Lesson 5 – Pitching from the Helm (Pitch Development)
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3 Topics
1 Quiz
Why is storytelling so important?
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Why is storytelling so important? | Assessment
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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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5 Topics
4 Quizzes
Types of Funding for Start-ups
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Types of Funding for Start-ups | Assessment
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Setting Realistic Early Milestones
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Setting Realistic Early Milestones | Assessment
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What Investors Want to See
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What Investors Want to See | Assessment
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Using Funds Wisely
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Using Funds Wisely | Assessment
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Worksheet – Funding & Milestones Planning
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