Hardware Podcasts

206 - Will AI Decide Your Next Drug/Device Approval?

Let's Combinate · 17 Sept 2025 · 31m

What this episode covers

Dominick Romano, founder of Drainpipe.io, explains how AI can be regulated in pharma and medtech by applying ICH guidelines and process validation to AI systems. He argues that pharmaceuticals are uniquely suited for AI because both deal with 'combinatorial problem sets' involving infinite inputs and outputs, requiring rigorous validation to prevent hallucinations in regulatory dossiers. Romano details how AI can accelerate dossier preparation by reducing millions of working hours in data acquisition and how regulators might use AI agents to speed up review processes, provided the technology is proven safe and accurate by the companies themselves.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Drainpipe.io
Also
ICH, FDA, ECTD, WHO/ITU

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