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Why Startups Get Stuck Before First-in-Human and How to Fix It – Powered by 3PH Alliance/HRCRS

September 18, 2026 | 02:50 PM (EDT) - 03:35 PM (EDT)

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Speakers
Leanne Bakke
Co-Founder & CEO
BioSim Innovations
Jose Osorio
Medical Director of Electrophysiology - HCA Florida Miami | Founder and CMO | Founder and President
HCA Florida Miami | 3PH Alliance | Heart Rhythm Clinical Research Solutions
Srijoy Mahapatra
World Wide General Manager, Left Atrial Appendage Management
Abbott
Christopher Porterfield
Cardiac Electrophysiologist
Aurora Denver Cardiology Associates
Moderator
J. Peter Weiss
Cardiac Electrophysiologist
Banner University of Arizona Medical Center Phoenix (BUMCP)

Why Startups Get Stuck Before First-in-Human and How to Fix It

Roundtable 1
September 18, 2026 | 02:50 PM (EDT) - 03:35 PM (EDT)

Most MedTech failures happen before first-in-human, not because of bad technology, but because of the
wrong preclinical strategy. Startups often overspend on data that doesn’t reduce regulatory risk or move
them closer to clinical use. In this session, you’ll learn how to align preclinical, simulation, and regulatory
strategy to move faster with less waste.

Powered by 3PH Alliance/HRCRS