From Risk to Signal: FDA Insight, Venture Capital Judgment, JPM Reflections
Schedule
Thu Feb 26 2026 at 12:30 pm to 05:00 pm
UTC-05:00Location
500 Totten Pond Rd 1st floor | Waltham, MA
About this Event
Program Overview
🕧 Doors open at 12:30 PM. Light lunch will be served prior to the start of the formal program at 1:00 PM.
​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.
Where is it happening?
500 Totten Pond Rd 1st floor, 500 Totten Pond Road, Waltham, United StatesEvent Location & Nearby Stays:
USD 32.78
