# 172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-01-22
- Length: 34m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/172---Regulatory-AI-Innovations--DrugsFDA-Database--Regulatory-Intelligence-Strategies--Human-Factors-Insights--and-Smarter-Submission-Approaches-with-Doug-Mead-e2tluk2

## Summary

Doug Mead, founder of CP Pathways and Rhizome AI, explains how his company uses AI to search the FDA's Drugs@FDA database, enabling faster regulatory intelligence for combination products. He details the transition from manual Google searches to a specialized tool that handles OCR and semantic search to interpret review memos, human factors data, and Type C meeting minutes. Mead highlights the value of understanding FDA precedents for products like auto-injectors and on-body injectors, while noting limitations such as redacted data and unpublished supplement reviews.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg#t=0) Introduction: Doug Mead and CP Pathways
- [1:15](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg#t=75) The Value of the Drugs@FDA Database for Regulatory Strategy
- [4:17](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg#t=257) Challenges with Manual Search and Google Indexing
- [7:23](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg#t=443) Developing the Rhizome AI Search Tool
- [14:52](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg#t=892) Practical Applications: Auto-injectors and Human Factors
- [20:28](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg#t=1228) Regulatory History and Reference Letters
- [25:22](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg#t=1522) AI Limitations: Redactions and Unpublished Supplements

## Topics

- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

early-stage companies

## Mentioned

- CP Pathways (company)
- Rhizome AI (company)
- Drugs@FDA (other)
- Chet Mistra (other)

## Related episodes from other shows

- [#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)
- [#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)
- [#350: The Evolving Landscape of AI in MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-04-350-the-evolving-landscape-of-ai-in-medtech) (Global Medical Device Podcast)
- [#410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-06-09-410-is-the-maude-database-broken-an-insiders-take-on-adverse-event-reporting-fai) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)

## Citing this page

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