Podcast by Michelle Lott
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Brilliant technology is not enough. In this episode, Renae Franz unpacks the realities of medical device commercialization — including regulatory strategy, reimbursement, clinician adoption, usability, and market validation. Through real-world medtech case studies, the conversation examines why technically strong products fail when they ignore workflow, reimbursement, or the “voice of the…
Most medtech teams underestimate the work before FDA submission—and overestimate what happens after clearance. In this episode, regulatory expert Michelle Lott, commercialization strategist Renae Franz, and reimbursement specialist Fernanda Nusbaum unpack the leadership blind spots, strategic missteps, and easily avoidable financial risks that derail medtech companies every day. You’ll learn why…
A practical, lightly spicy guide to becoming the regulatory person teams actually respect—and want in the room. Learn how regulatory and quality professionals can build trust, lower resistance, and communicate across cross-functional teams without becoming the “department of no.” This episode covers communication habits, emotional intelligence, conflict navigation, and how to say no without…
Because your QMS should be a safety net—not a set of handcuffs. In this episode of Device and Conquer , Michelle and Ti break down how to build a quality management system (QMS) that doesn’t suck —or suck the life out of your MedTech team. From the shift to FDA’s new QMSR aligned with ISO 13485:2016 to risk-based thinking, supplier controls, and right-sizing your documentation, this episode gives…
If you’re thinking about investing in medtech, congratulate yourself—you’ve chosen one of the most exciting, innovative, and occasionally stomach-churning sectors out there. But between regulatory hurdles, clinical workflow quirks, and the fact that even great ideas can wither in the wild, medtech due diligence is…well, a sport. In a recent webinar, industry veteran Renee Franz (Lean RAQA) teamed…
Choosing a predicate device can make—or break—your 510(k) submission, so it's important to choose wisely. In this episode of Device and Conquer , Michelle Lott and Ti Benson break down one of the trickiest parts of the FDA clearance process: how to select a predicate that passes the “substantial equivalence” test without raising new questions of safety and efficacy. You’ll learn how to build a…
Building a 510(k) isn’t just about filling in forms — it’s about telling the FDA a story they can’t say no to.In this episode of Device & Conquer , Michelle Lott and Tianna Benson unpack what really goes into preparing an FDA 510(k) submission — from substantial equivalence and predicate devices to the eSTAR template , testing requirements , and why your submission is basically a regulatory novel.…
The FDA pre-submission (Q-Sub) process can save you time — or sink your submission. In this episode of Device and Conquer , Michelle Lott and Tianna Benson explain how to Pre-Sub like a pro. They explain when to use a pre-sub, how to structure your questions, and what to expect from FDA’s new eSTAR electronic template. Plus: insider tips on labeling, clinical protocols, and the art of “Does FDA…
The FDA state of the union in 2025 - deregulation, QMSR, and a toilet paper shortage? Listen in as Michelle Lott and Tianna Benson tackle the wild world of FDA policy shifts and what they mean for medical device manufacturers. From the administration’s sweeping deregulation mandates to the long-awaited transition from QSR to QMSR, they connect the dots between chaos, comedy, and compliance. You’ll…
Think you speak English? The FDA might disagree. In the Season 2 kickoff of Device &Conquer , hosts Michelle Lott and Tianna Benson break down the unique language of the U.S. Food and Drug Administration — a dialect every medtech professional needs to understand to survive regulatory conversations. From decoding words like “should,” “non-binding,” and “substantial equivalence” to navigating…
