Hardware Podcasts

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

Let's Combinate · 22 Jan 2025 · 34m

AI in practice: one real use of AI described

What this episode covers

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precedents for products like auto-injectors and on-body injectors, while noting limitations such as redacted data and unpublished supplement reviews.

AI in practice

Where this conversation describes AI being used to build or deliver a product. Part of the AI in practice tracker.

Running the companyRhizome AIsearch time reduced from hours of manual Google searching to real-time answers in seconds

The team built a specialized search tool that downloads and indexes the FDA database, applies OCR to scanned documents, and uses an algorithm to answer natural language questions about regulatory precedents in seconds.

“So over the last few months, last year, really, we've been working together to refine this search capability where you can just ask a question. It will figure out what you want. It will go into the downloaded complete FDA database that's been indexed, optical character recognition, applied to it because a lot of these are images.”

Doug Mead · Hear it at 9:34

Most relevant to

early-stage companies

Topics

Mentioned

Companies
CP Pathways, Rhizome AI
Also
Drugs@FDA, Chet Mistra

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 24m

    #345: Using AI In MedTech

    Wade Schroeder, Medical Device Guru at Greenlight Guru, discusses the state of AI in MedTech, highlighting that 65% of professionals distrust AI data accuracy due to unknown sources. He explains how Greenlight Guru’s Risk Intelligence tool uses Bayesian statistics and natural language processing to pull data from the FDA’s MAUDE database, helping engineers address the 'cold start' problem in risk management. Schroeder also introduces the 'Digital Guru,' an AI bot trained specifically on FDA regulations to ensure compliance and trust, contrasting it with general models like ChatGPT.

    AI & machine learningQuality & yield
    7 chapters

  • Global Medical Device Podcast · 15m

    #460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead

    Etsy Nichols discusses the evolving FDA regulatory landscape for AI-enabled medical devices, highlighting the establishment of the Digital Health Center of Excellence and the shift toward rigorous documentation over algorithmic sophistication. She outlines five guiding principles for AI/ML-based Software as a Medical Device (SaMD) and emphasizes the critical importance of Predetermined Change Control Plans (PCCPs) in bridging US and EU regulatory requirements. Nichols argues that QA/RA professionals must combine regulatory fluency with AI literacy to navigate these complex systems effectively.

    Medical & health devicesCertification & compliance
    1 chapters

  • Global Medical Device Podcast · 49m

    #350: The Evolving Landscape of AI in MedTech

    Eric Henry, a regulatory expert at King & Spalding and strategic committee member for the AI Global Health Initiative, discusses the evolving regulatory landscape for AI in medical devices with host Etienne Nichols. They explore the distinction between 'locked' algorithms, which are currently supported by the FDA, and 'adaptive' algorithms that modify themselves in the field, noting that the FDA's Predetermined Change Control Plan (PCCP) still requires human intervention for changes. Henry emphasizes the critical role of the Federal Trade Commission (FTC) and its 'algorithmic disgorgement' power, while advising companies to focus on robust design controls and engage with public-private partnerships like the Coalition for Health AI to navigate harmonization challenges.

    Medical & health devicesAI & machine learning
    8 chapters

  • Global Medical Device Podcast · 50m

    #410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures

    Regulatory expert Mike Drues joins host Etienne Nichols to critique the FDA’s MAUDE database, arguing that widespread late reporting and poor data hygiene undermine its safety mission. Drues highlights that nearly 30% of reports are late, with major manufacturers like Medtronic, Becton Dickinson, and Dexcom accounting for a disproportionate share of violations. The discussion covers the legal risks of non-compliance, the misuse of MAUDE data for competitive analysis, and recommendations for modernizing the system with AI-driven cross-referencing and tiered reporting urgency.

    Quality & yieldCertification & compliance
    8 chapters

  • Global Medical Device Podcast · 42m

    #323 The Combination Products Handbook

    Susan Neadle, principal consultant and president of Combination Products Consulting Services, discusses her peer-reviewed book, The Combination Products Handbook: A Practical Guide, published by CRC Press. Neadle explains how she collaborated with FDA officials, including John Barwiener, and industry experts from companies like Johnson & Johnson, Novartis, and Pfizer to create a consolidated resource for the complex niche of combination products. The episode details the book's structure, covering regulatory strategies, CGMPs, risk management, and human factors, while highlighting the challenges of harmonizing terminology between pharmaceutical and medical device sectors. Neadle emphasizes the importance of holistic thinking and integrated development to ensure patient safety and regulatory compliance across global jurisdictions.

    Medical & health devicesCertification & compliance
    9 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.