Outcome: Gain clarity and confidence on how investors see you and what it takes to earn a “yes.”

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• Understand the funding process, trends and landscape

• Act as an investor to understand their perspective on founder pitches

• Lessons learned from 100+ company evaluations

• Learn how investors score your company for investment with an investor scorecard template

• Get real time peer feedback on current pitch 

• Present pitch to broader group for overall feedback

• How to find the best fit investor and develop a funding roadmap

• The fundamentals of a deal and how to protect your interests as a founder

• Take-home toolkit: Investor scorecard template

Bringing a regulated healthcare product to market is hard—but the earlier you understand your FDA pathway and evidence requirements, the faster you can de-risk development, impress investors, and accelerate time-to-market. This workshop-style masterclass gives founders the practical tips, real-world insights, and hands-on templates needed to map their FDA route, outline early clinical evidence, and build a regulatory–clinical roadmap customized to their company. You’ll walk away with actionable tools, insider guidance, and a high-level milestone plan you can use immediately in fundraising, partnerships, and commercialization planning.

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What You’ll Learn

FDA Pathways Made Simple — What Founders Need to Know

• Quickly identify your correct FDA pathway (510(k), PMA, De Novo, IND/NDA, EUA)

• Understand how to communicate with the FDA (pre-subs, Q-subs)

• Learn insider tips to avoid the delays and mistakes that cost startups months

Navigating the Clinical Trial Landscape — Fast, Lean & Effective

• Understand the clinical evidence required for your product type

• Learn how startups design lean, resource-efficient studies

• Discover how to plan IRB submissions, site selection, and recruitment on a budget

Real-World Regulatory & Clinical Insights (Guest Expert)

• Hear the most common founder pitfalls directly from regulatory & clinical leaders

• Learn what FDA reviewers and clinical teams really expect from early companies

• Ask questions and get live feedback tailored to your product

Building Your Regulatory & Clinical Milestone Roadmap

• Map out the critical milestones investors look for

• Align regulatory and clinical tasks with your business model and funding timeline

• Create a clear, founder-friendly roadmap you can use immediately

Founder Workshop: Drafting Your Evidence & Risk Plan

• Develop your high-level evidence plan tailored to your company

• Identify key risks, dependencies, partnerships, and accelerators

• Leave with a 90-day action plan that moves your product toward approval

Outcome: Learn how to build a credible commercialization strategy that helps your business show it is investable and scalable.

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• Understand the key phases of commercialization in healthcare and life sciences — from validation to scaling

• Learn how to translate clinical and technical value into compelling market and customer value

• Learn how to identify and prioritize target customers, early adopters, and champions within complex healthcare ecosystems

• Explore different sales channels, pricing models, and partnerships appropriate for their product type and market stage

• Understand how to de-risk commercial execution by building the right team and how to acquire the best talent

• Discuss customer segments and acquisition strategies

• Create a clear, actionable commercialization “playbook” tailored to your product and business goals

• Take-home tool kit: Commercialization playbook framework

Outcome: Gain investor-grade evaluation that can be exposed to investors actively seeking new healthcare and life science ventures.

Scorecard report includes evaluation and recommendations across 8 dimensions

1. Founder teams

2. Market size and growth rates

3. Product innovation/ IP/ Regulatory Pathway

4. Competitive positioning, strengths and risks

5. Business Model, commercialization, pricing, scalability

6. Traction

7. Funding roadmap and feasibility of current and future rounds

8. Exit viability

Outcome: Walk away with a professional, investor-ready pitch that commands attention, builds trust, and can drive follow-up meetings. You will have 3 practice pitch sessions:

1. Initial Pitch with peers

2. Pitch refinement with investors and experts

3. Final formal pitch at showcase with investors

Outcome: Get expert recommendations for a investor-ready funding roadmap that demonstrates financial clarity, builds confidence, and positions your company for successful fundraising.

• Review of current funding raise along with future capital needs

• Refine key assumptions, timing, and milestones to align with investor expectations and market realities — ensuring your plan tells a story of disciplined growth and credible execution.

Outcome: An enhanced, investor-ready data room designed for fast, confident due diligence — helping you close funding rounds quicker and with greater credibility.

Includes formal Data room review across 6 dimensions and recommended action plan for set up and/or enhancements

1. Corporate & Legal

2. Intellectual Prop

3. Financials

4. Clinical & Regulatory Compliance

5. Product & Technology

6. Market & Growth