Jan 26
44m 59s
In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming session at MD&M West, focusing on the critical intersection of generative AI (GenAI) and quality assurance. While many AI applications exist in MedTech, GenAI presents unique challenges because it creates new data—text, code, or images—rather than simply classifying existing information.
Ashkon breaks down the specific failure modes unique to generative models, most notably "hallucinations." He explains how these outputs can appear legitimate while being factually incorrect, and explores the cascading levels of risk this poses. The discussion moves from simple credibility issues to severe safety concerns when AI-generated data is used in critical clinical decision-making without proper guardrails.
The episode concludes with a forward-looking perspective on how validation is shifting. Ashkon argues that because GenAI behavior is statistical rather than deterministic, traditional pre-market validation is no longer sufficient. Instead, a robust quality framework must include continuous post-market surveillance and real-time independent monitoring to ensure device safety and effectiveness over time.
"Hallucinations are just a very familiar form of failure modes... where the product creates sample data that doesn't actually align with reality." - Ashkon Rasooli
"Your validation plan isn't just going to be a number of activities you do that gate release to market; it is actually going to be those plus a number of activities you do after market release." - Ashkon Rasooli