From Risk to Signal: AI, FDA Insight, Venture Capital, JPM Reflections & Live Startup Evaluation
Program Overview
Location & Logistics
Waltham, MA
🅿️ Free on-site parking available
Session 1 — FDA Reality Check: How Risk Is Evaluated Early
(By Former FDA Expert on Digital Health Center of Excellence)
A practical discussion on how FDA evaluates early-stage medical devices and digital health products through the lens of risk, function, and evidence.
Topics include:
How FDA evaluates risk and classification pathways in practice
What has (and hasn’t) changed in recent digital health / SaMD guidance
Where teams commonly overreach early on claims, evidence, or timing
Assumptions that create regulatory friction later
Focused on patterns and judgment — not regulatory advice or submission guidance.
Session 2 — Capital Allocation Under Uncertainty
Mark Zheng
(Strategic Partner, VU Venture Capital · Founder, TopContenders Network)
An examination of how investors form judgment in AI and deep tech when outcomes are uncertain and timelines are long.
Discussion themes include:
How early-stage risk is evaluated in power-law markets
What distinguishes companies that can generate 10×–100× outcomes
Why market size, timing, and structure often outweigh early traction
Common misalignments between founder narratives and investor judgment
A discussion-oriented reality check — not a fundraising or VC mechanics session.
Session 3 — Post-JPM Signal Forum: From Insight to Action
A moderated discussion extracting signal from JPM Week conversations and translating it into next steps.
Focus areas:
What JPM conversations led to real follow-ups
What diligence questions repeated across meetings
Which signals point to execution-ready opportunities
How founders can better interpret JPM feedback
Moderator: Morse (Co-host)
Session 4 — Startup Evaluated Showcases
A structured, signal-focused evaluation of selected early-stage startups.
Each team:
4 min — Context & problem framing
4 min — Live Q&A
4 min — Direct feedback
Designed to surface clarity, assumptions, and readiness — not polished pitches.
🤝 Why Attend
Gain a clearer understanding of how FDA risk, evidence, and early assumptions are evaluated
See how venture investors form judgment under uncertainty in AI and deep tech
Learn how to translate JPM Week conversations into concrete next steps
Observe how startups are evaluated live in a structured, signal-driven format
Engage in thoughtful discussion with founders, operators, investors, and ecosystem leaders
This forum is designed for participants seeking decision-level insight, not tactical instruction.
⚠️ Disclaimer
📸 Photos and video recordings may be taken during the event and used for promotional purposes.
📝 Program topics, speakers, and schedule are subject to change without prior notice.
⚖️ This event does not constitute investment advice or a solicitation of investment. All discussions are for informational and educational purposes only.
🔒 By registering for and attending this event, you consent to the sharing of your registration information with the event organizers and event sponsors for event-related communications and follow-up.