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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

• Understand the structure and function of the FDA and its regulatory pathways for drugs, devices, and digital health products

• Identify which FDA pathway (510(k), PMA, De Novo, IND/NDA, Emergency Use Authorization, etc.) applies to their innovation

• Gain practical knowledge of how to prepare for FDA interactions, including pre-submission meetings and Q-subs

• Learn how to avoid common mistakes and delays in the regulatory process for startups

• Understand how to align regulatory strategy with business models and funding milestones

• Discover tips and tools to streamline the approval process and accelerate time-to-market

• Learn the role of regulatory consultants, CROs, and how/when to leverage external partners

• Take-home tookit: Regulatory roadmap template, FDA pathway quick-reference chart

• Understand the purpose, phases, and structure of clinical trials across drugs, biologics, and devices

• Learn how to design a clinical trial strategy that aligns with regulatory, business, and investor requirements

• Identify the different types of clinical studies (e.g., interventional vs. observational) and when to use them

• Gain practical knowledge of trial planning, including IRB submissions, site selection, recruitment, and budgeting

• Discover common obstacles startups face in clinical research and how to overcome them with limited resources

• Learn when and how to engage Contract Research Organizations (CROs), clinical advisors, and academic partners

• Explore tools, platforms, and techniques to accelerate trial execution and data collection

• Take-home Toolkit: Clinical trial design checklist, regulatory/IRB prepareation check list

• 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 subject matter expert (SME) 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