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Summary Objectives:

• Understand the funding process, trends and landscape

• Understand the anatomy of the pitch- an investor view

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

• Lessons learned and practical strategies for raising capital

• 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

• Understand the current state of AI in healthcare, including key technologies, applications, and market dynamics

• Learn about the regulatory frameworks and ethical considerations unique to AI-based healthcare solutions

• Identify viable business models, buyer ecosystems, and clinical workflows for AI-enabled tools

• Gain insight into FDA pathways for AI/ML-based medical devices, including Software as a Medical Device (SaMD)

• Understand how to validate, deploy, and scale AI solutions in real-world healthcare settings

• Explore partnerships, alliances and how to build platform ecosystems for scale

• Review emerging risks and challenges, such as data bias, privacy, explainability, and provider trust

• Take-home Toolkit: Buyer persona builder 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

• Understand how investors look at market size and fit

• Learn how to analyze competitors, incumbents, and adjacent markets to avoid being boxed into legacy positioning

• Learn how to create competative fencing and positioning

• Build compelling positioning and messaging that declares a bold new market vision

• Develop a category narrative that aligns product, brand, and investor story into a unified go-to-market strategy

• Gain tools to establish thought leadership, educate stakeholders, and claim space in crowded or emerging markets

• Develop a product differientation checklist

• Learn how to use “declaring your market” as a growth lever for capital, recruitment, and partnerships

• Take-home toolkit: Market declaration worksheet and competative fencing do's and dont's template

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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 roadmap or “playbook” tailored to their product and business goals

• Take-home tool kit: Commercialization playbook framework

• Understand how to design a business model that evolves with market feedback, regulatory shifts, and customer demands

• Explore how to localize or tailor business models across geographies, care settings, or stakeholder groups

• Review real-world case studies of healthcare startups that successfully adapted their model to unlock scale or avoid failure

• Develop strategies to align pricing, partnerships, and distribution with shifting buyer incentives

• Review frameworks to establish a customer success and operations organization

• Understand what launch metrics shoud be tracked to monitoir customer success

• Create a roadmap for iterating and refining their business model during clinical, regulatory, or funding milestones

• Take-home tool kit: Day 1 Launch playbook framework

• Understand the mindset and role shift required to move from scientist or technical expert to effective growth-stage CEO

• Learn how to build and lead an organization beyond the early product and prototype phase

• Identify leadership blind spots common to technical and clinical founders and how to overcome them

• Develop skills in strategic communication, delegation, and team building for scale

• Learn how to prioritize fundraising, go-to-market strategy, and execution over daily problem-solving

• Understand how to attract, retain, and manage talent and advisors while shaping company culture

• Build a personal leadership development roadmap aligned with company growth milestones

• Take-home Toolkit: Delegation planner, What type of CEO am I template, founder-CEO reading list