#464: Why LLM Unpredictability is a Liability in MedTech

Global Medical Device Podcast · 13 Jul 2026 · 53m · Episode 464

What this episode covers

Tyler Harmon, CEO of Iaso Automated Medical Systems, explains why the inherent randomness in Large Language Models (LLMs) makes them unsuitable for safety-critical medical devices compared to deterministic algorithms like Convolutional Neural Networks (CNNs). He details how Iaso uses non-LLM machine learning to detect Acute Respiratory Distress Syndrome (ARDS) in ICU patients and advocates for treating third-party AI stacks as Software of Unknown Provenance (SOUP). Harmon also outlines the need for a dedicated Machine Learning Management System (AIMS) within Quality Management Systems to govern AI governance, hallucination risks, and data integrity.

Mentioned

Companies
Iaso Automated Medical Systems, Google, AWS, Apple, Drager, Fisher, Johnson & Johnson, Georgia Tech, Blue Goat, HIS AI
Products
ChatGPT, Claude, Amazon Alexa, Site AI, Gemini
Also
PubMed, Medline, Google Scholar, IEC 62304, ISO 27001

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