RAQA Today

Michelle Lott
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Podcast by Michelle Lott

  1. 26 de mai.

    From Innovation to Adoption: The Realities of Medical Device Market Entry

    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 customer.” Topics include: Market assessment and competitive positioningThe impact of Europe’s transition from MDD to MDRClinician usability failuresUnknown clinical problems and slow market education cyclesA practical discussion for MedTech founders, regulatory professionals, commercialization teams, and healthcare innovators navigating the gap between invention and adoption.

    From Innovation to Adoption: The Realities of Medical Device Market Entry

  2. 08/12/2025

    Building a Better Market Pathway: Aligning Regulatory, Reimbursement and Commercialization Teams

    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 regulatory, reimbursement, and commercial strategy must be developed in parallel; how misaligned claims create expensive detours; what payers actually look for (hint: not FDA clearance); when coding fails; how reimbursement timelines stretch into years; and how to pick the right regulatory pathway without blowing your budget. Packed with real examples—including companies that lost funding because they misunderstood CPT codes and companies that reached market faster by stair-stepping claims—this episode gives founders, CEOs, and RA/QA leaders a roadmap for reducing rework, avoiding FDA surprises, and accelerating revenue.

    Building a Better Market Pathway: Aligning Regulatory, Reimbursement and Commercialization Teams

  3. 02/12/2025

    How to be the Regulatory Person Everyone Actually Likes | Device & Conquer | S2:E6

    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 alienating coworkers.Be sure to like and subscribe for even more insights on medical device regulations, compliance, and quality systems (it will be fun and not painful, we promise). Watch the video on YouTube: https://youtu.be/s9oFmyFZGL0Visit us at https://leanraqa.com/ for evenmore regulatory goodness and to learn more about our services.📩Got a question or a topic for a future session? Drop it in the comments below!

    How to be the Regulatory Person Everyone Actually Likes | Device & Conquer | S2:E6

  4. 18/11/2025

    How to Build a Quality System That Doesn't Suck | Device & Conquer | S2:E5

    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 you actionable, real-world strategies to streamline your QMS without sacrificing compliance. Whether you’re a three-person startup or a 20,000-person organization, you’ll learn how to avoid bloated SOPs, empower teams to own their processes, and build a culture where quality is a partner—not the “business prevention department.” Includes horror-story “QMS Confessions” you won’t believe. Be sure to like and subscribe for even more insights on medical device regulations, compliance, and quality systems (it will be fun and not painful, we promise). Watch the video on YouTube: https://youtu.be/b947AW_N3ncVisit us at https://leanraqa.com/ for evenmore regulatory goodness and to learn more about our services.📩Got a question or a topic for a future session? Drop it in the comments below!#FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance #PreSub#QualitySystems #submissions #commercialization #startups #productlaunches#businessdevelopment

    How to Build a Quality System That Doesn't Suck | Device & Conquer | S2:E5

  5. 17/11/2025

    Due Diligence for MedTech Investors: What You Really Need to Know Before Writing That Check

    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 up with venture capitalist and serial entrepreneur Mudit Jain, PhD, (Treo Ventures) to walk investors through the realities of evaluating medical device opportunities. With over 30 years of combined experience, plus unicorn exits, hundreds of cleared devices, and several cautionary tales under their belts, their conversation is a gold mine for investors entering this space. Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense. Watch the video on YouTube: https://youtu.be/Y_QojHiu4dQ Visit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

    Due Diligence for MedTech Investors: What You Really Need to Know Before Writing That Check

  6. 11/11/2025

    Why Picking a Predicate Can Make or Break Your 510(k) | Device & Conquer | S2:E4

    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 strong predicate comparison table, what features FDA expects you to include, how to evaluate post-market data, and when older or newer devices make sense. Michelle and Ty also unpack the latest FDA thinking on predicate age, recalls, and draft guidances that are reshaping the regulatory landscape. Whether you’re new to regulatory strategy or refining your next submission, this conversation offers practical insight—and a few laughs along the way—into making your predicate selection bulletproof. Watch the video on YouTube:  Be sure to subscribe to the Device & Conquer podcast for bold, insightful conversations that make medtech regulation make sense. Visit us at  https://leanraqa.com/ for even more regulatory goodness and to learn more about our services. 📩Got a question or a topic for a future session? Drop it in the comments below! #FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance#PreSub#QualitySystems #submissions #commercialization #startups#productlaunches#businessdevelopment

    Why Picking a Predicate Can Make or Break Your 510(k) | Device & Conquer | S2:E4

  7. 03/11/2025

    How to Build a 510(k) Without Losing Your Mind | Device & Conquer | S2:E3

    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. They also cover the difference between traditional, special, and abbreviated 510(k) pathways, the myths around timelines, and why “just throw money at it” never works when you’re waiting on biocompatibility results. In this episode, you’ll learn: How to structure your 510(k) as a cohesive “story” What FDA reviewers actually look for (and what confuses them) The role of risk management, human factors, and performance testing What the eSTAR template really does — and doesn’t — simplify When to use special vs. traditional 510(k) submissions How to avoid common rookie mistakes and review delays Why patience, precision, and planning matter more than fundingWatch the video on YouTube: https://youtu.be/1XuGuLRsFyY Be sure to subscribe to the Device & Conquer podcast forbold, insightful conversations that make medtech regulation make sense. Visit us at  https://leanraqa.com/ for even more regulatory goodness and to learn more about our services.📩Got a question or a topic for a future session? Drop it in the comments below!#productlaunches#businessdevelopment for even more regulatory goodness andto learn more about our services.📩Gota question or a topic for a future session? Drop it in the comments below!#FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance#PreSub#QualitySystems #submissions #commercialization #startups#productlaunches#businessdevelopment

    How to Build a 510(k) Without Losing Your Mind | Device & Conquer | S2:E3

  8. 28/10/2025

    How to Submit a Pre-Sub (like a Pro) | Device & Conquer | S2:E2

    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 concur?” You’ll learn: How to use pre-subs to guide your FDA reviewer’s thinking What makes a strong vs. weak pre-sub question The difference between protocols and data (and why it matters) The risks of vague, open-ended questions Why IFUs and labeling now drive early FDA interpretation How FDA feedback lives forever — even from 10 years ago Listen in and learn how to master the FDA pre-sub process and get insights that will help you move your device forward. Watch the video on YouTube: https://youtu.be/XIJ2SAyAF9w Be sure to subscribe to the Device and Conquer podcast for bold, insightful conversations that make medtech regulation make sense. Visit us at https://leanraqa.com/ for evenmore regulatory goodness and to learn more about our services.📩Got a question or a topic for a future session? Drop it in the comments below!#FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance #PreSub#QualitySystems #submissions #commercialization #startups #productlaunches#businessdevelopment

    How to Submit a Pre-Sub (like a Pro) | Device & Conquer | S2:E2
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Sobre

Podcast by Michelle Lott

Informações

  • Criado por
    Michelle Lott
  • Anos de atividade
    2021 - 2026
  • Episódios
    67
  • Classificação
    Livre
  • Copyright
    © Michelle Lott
  • Site do podcast
    RAQA Today