The Economics Nobody Taught You in Medical School

When the Algorithm Is a Device: AI, the FDA, and the Question Almost Nobody Is Asking

The AI tool you bought last quarter, the one bundled into your EHR upgrade, the one your hospital piloted on your unit. Was it cleared by the FDA as a medical device? Most physicians do not know the answer. The vendor's pitch deck almost certainly did not lead with it. And the answer matters, because once an algorithm crosses into FDA medical device territory, the rules that govern what it can claim, how it has to perform, who is liable when it fails, and what evidence the manufacturer had to produce before it reached your practice change categorically. In this episode of The Clinical Realist, Dr. Sarah Matt walks listeners through three questions: when is an AI tool a medical device, what do the three FDA approval pathways actually mean about the evidence behind a product, and what does professional liability look like when the algorithm is the one making the call. What you will take away: - When a clinical AI tool crosses the line into FDA-regulated medical device territory - What 510(k), De Novo, and PMA clearance pathways actually say about the evidence behind a product - Why the word cleared is doing enormous amounts of work in this industry - What changes for physicians, procurement teams, and health system leaders when the algorithm is making the call Book a Discovery and Clarity Session: https://calendly.com/sarahmattmd Subscribe to The Sarah Matt Briefing: https://drsarahmatt.com/newsletter-signup — Resources & Links: 📖 Get the Book: "The Borderless Healthcare Revolution" is available now on Amazon and major retailers. 💼 Work with Dr. Matt: Looking for a keynote speaker or strategic advisor? Visit: drsarahmatt.com 🔗 Connect on Social: LinkedIn: https://www.linkedin.com/in/sarahmattmd/ YouTube: https://www.youtube.com/@DrSarahMatt-ClinicalRealist [http://www.youtube.com/@DrSarahMatt] 📧 Subscribe to The Briefing: drsarahmatt.com/newsletter-signup   — Disclaimer: The views expressed on this podcast are those of Dr. Sarah Matt and her guests. They do not necessarily reflect the official policy or position of any affiliated institutions. This content is for informational and educational purposes only and does not constitute medical advice or a professional consulting relationship.

The Economics Nobody Taught You in Medical School

Medical school teaches you pathophysiology, pharmacology, and clinical reasoning. It does not teach you how the money actually works. In this episode, Dr. Sarah Matt breaks down the economic structures that govern every clinical decision, every technology purchase, and every AI pilot that dies in a committee room: who pays, who decides, who uses, and why those three people are almost never the same person. What you will take away: - The user / decider / payer split and why it explains nearly every failed health-tech deal - How the RVU system shapes physician behavior and silently resists AI adoption - Why value-based care is harder to execute than the architects planned for - The practical questions buyers, vendors, and physicians should be asking before any AI deployment If you want to understand why healthcare moves so slowly, start here. Book a Discovery and Clarity Session: https://calendly.com/sarahmattmd Subscribe to The Sarah Matt Briefing: https://drsarahmatt.com/newsletter-signup — Resources & Links: 📖 Get the Book: "The Borderless Healthcare Revolution" is available now on Amazon and major retailers. 💼 Work with Dr. Matt: Looking for a keynote speaker or strategic advisor? Visit: drsarahmatt.com 🔗 Connect on Social: LinkedIn: https://www.linkedin.com/in/sarahmattmd/ YouTube: https://www.youtube.com/@DrSarahMatt-ClinicalRealist [http://www.youtube.com/@DrSarahMatt] 📧 Subscribe to The Briefing: drsarahmatt.com/newsletter-signup   — Disclaimer: The views expressed on this podcast are those of Dr. Sarah Matt and her guests. They do not necessarily reflect the official policy or position of any affiliated institutions. This content is for informational and educational purposes only and does not constitute medical advice or a professional consulting relationship.

The Patient We Never Designed For (Live from Cornell Ithaca, Extended Cut)

Recorded live at Cornell Ithaca. This is the extended cut of Dr. Sarah Matt's keynote on the central design flaw in modern healthcare: a system optimized for an "average" patient who does not exist. When you build clinical workflows, EHR defaults, drug dosing tables, and AI training sets around a statistical mean, every patient outside that mean pays the cost in workarounds, missed diagnoses, and unsafe care. And most patients are outside the mean. In this talk, Dr. Matt walks through: - Where the "average patient" assumption shows up in clinical AI, and why it compounds bias instead of correcting it - The design debt baked into EHRs, order sets, and risk calculators - What health systems and physician leaders can do now to design for variance instead of pretending it away - Why the patient we never designed for is the patient most likely to be harmed by the tools we are deploying next Recorded live at Cornell. Audience Q&A included. — Resources & Links: Get the book: "The Borderless Healthcare Revolution" is available now on Amazon and major retailers. Work with Dr. Matt: Looking for a keynote speaker or strategic advisor? Visit drsarahmatt.com Connect on social: LinkedIn: https://www.linkedin.com/in/sarahmattmd/ YouTube: https://www.youtube.com/@DrSarahMatt-ClinicalRealist Subscribe to The Briefing: drsarahmatt.com/newsletter-signup — Disclaimer: The views expressed on this podcast are those of Dr. Sarah Matt and her guests. They do not necessarily reflect the official policy or position of any affiliated institutions. This content is for informational and educational purposes only and does not constitute medical advice or a professional consulting relationship. — Resources & Links: 📖 Get the Book: "The Borderless Healthcare Revolution" is available now on Amazon and major retailers. 💼 Work with Dr. Matt: Looking for a keynote speaker or strategic advisor? Visit: drsarahmatt.com 🔗 Connect on Social: LinkedIn: https://www.linkedin.com/in/sarahmattmd/ YouTube: https://www.youtube.com/@DrSarahMatt-ClinicalRealist [http://www.youtube.com/@DrSarahMatt] 📧 Subscribe to The Briefing: drsarahmatt.com/newsletter-signup   — Disclaimer: The views expressed on this podcast are those of Dr. Sarah Matt and her guests. They do not necessarily reflect the official policy or position of any affiliated institutions. This content is for informational and educational purposes only and does not constitute medical advice or a professional consulting relationship.

Sunk Cost, Vendor Lock, and the AI Tools Health Systems Can't Let Go Of

Most clinical AI governance frameworks tell you how to evaluate tools before you deploy them. Nobody talks about how to exit a tool that is not working. In this episode, Dr. Sarah Matt walks through the anatomy of sunk cost bias in health system AI: how it starts (month four or five, mixed performance data, a vendor who keeps resetting the clock), how experienced vendor account teams use it to extend bad contracts, and how to build exit criteria into your governance framework before you ever go live. What you will take away from this episode: - Why sunk cost bias in vendor relationships is a governance failure, not a behavioral one - How vendors use remediation roadmaps to reset your evaluation clock - What a real clinical AI exit criterion looks like: specific, measurable, time-bound, established before go-live - How to execute a clean exit without losing six months to organizational politics - Why the cost of staying with a bad tool grows geometrically — Resources & Links: 📖 Get the Book: "The Borderless Healthcare Revolution" is available now on Amazon and major retailers. 💼 Work with Dr. Matt: Looking for a keynote speaker or strategic advisor? Visit: drsarahmatt.com 🔗 Connect on Social: LinkedIn: https://www.linkedin.com/in/sarahmattmd/ YouTube: https://www.youtube.com/@DrSarahMatt-ClinicalRealist [http://www.youtube.com/@DrSarahMatt] 📧 Subscribe to The Briefing: drsarahmatt.com/newsletter-signup   — Disclaimer: The views expressed on this podcast are those of Dr. Sarah Matt and her guests. They do not necessarily reflect the official policy or position of any affiliated institutions. This content is for informational and educational purposes only and does not constitute medical advice or a professional consulting relationship.

The Q2 Governance Problem: When AI Goes Live Without a Safety Net

Most health systems that deployed clinical AI in Q1 are now six to eight weeks post-launch and starting to see the governance gap. Dr. Sarah Matt explains what the gap looks like in production, why retrofitting governance is more expensive than building it before go-live, and the four-step rapid governance build for organizations that are already live and need to catch up. — Resources & Links: 📖 Get the Book: "The Borderless Healthcare Revolution" is available now on Amazon and major retailers. 💼 Work with Dr. Matt: Looking for a keynote speaker or strategic advisor? Visit: drsarahmatt.com 🔗 Connect on Social: LinkedIn: https://www.linkedin.com/in/sarahmattmd/ YouTube: https://www.youtube.com/@DrSarahMatt-ClinicalRealist [http://www.youtube.com/@DrSarahMatt] 📧 Subscribe to The Briefing: drsarahmatt.com/newsletter-signup   — Disclaimer: The views expressed on this podcast are those of Dr. Sarah Matt and her guests. They do not necessarily reflect the official policy or position of any affiliated institutions. This content is for informational and educational purposes only and does not constitute medical advice or a professional consulting relationship.