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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-09-17
- Length: 31m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/206---Will-AI-Decide-Your-Next-DrugDevice-Approval-e388i9k

## Summary

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.

## Chapters

- [0:06](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval#t=6) Introduction: Regulating AI in Pharma and ICH Guidelines
- [1:01](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval#t=61) Pharma's Unique Risk Profile and Combinatorial Problem Sets
- [4:24](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval#t=264) Applying ICH Process Validation to AI Systems
- [10:20](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval#t=620) AI Use Cases in Regulatory Affairs and Dossier Preparation
- [15:54](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval#t=954) Ensuring Accuracy and Preventing Hallucinations in Submissions
- [16:56](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval#t=1016) Regulatory Agencies Using AI to Accelerate Reviews
- [21:36](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval#t=1296) Time Savings in Dossier Formation and Data Acquisition
- [25:44](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval#t=1544) AI in Quality Control for Biologics and GMP Integration

## Topics

- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Drainpipe.io (company)
- ICH (other)
- FDA (other)
- ECTD (other)
- WHO/ITU (other)

## Related episodes from other shows

- [#459: The Purolea Warning Letter & Validating AI in Medical Devices - What FDA Actually Requires](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-11-459-the-purolea-warning-letter-validating-ai-in-medical-devices-what-fda-actuall) (Global Medical Device Podcast)
- [#441: ICYMI (In Case You Missed It!) How Artificial Intelligence is Impacting the MedTech Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-12-441-icymi-in-case-you-missed-it-how-artificial-intelligence-is-impacting-the-med) (Global Medical Device Podcast)
- [Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-07-measuring-the-impact-of-ai-ml-technologies-on-the-current-medical-device-landsca) (Global Medical Device Podcast)
- [#460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-18-460-fda-ai-regulations-master-the-qa-ra-skills-to-stay-ahead) (Global Medical Device Podcast)
- [#345: Using AI In MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-22-345-using-ai-in-medtech) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.