이 팟캐스트 소개 🔗
Podcast by Michelle Lott
진행자:
업데이트 빈도:
weekly
평균 오디오 길이:
32 minutes
게스트 인터뷰
영어
미국
에피소드 93 개
2018년 9월 18일부터
episodic
최신 에피소드 🔗
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 tec…
이전 에피소드 🔗
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 mis…
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 cove…
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 13485:201…
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…
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 eq…
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…
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 …
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-awa…
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 conversatio…
면책 조항: 이 페이지에 포함된 팟캐스트와 작품은 Michelle Lott에서 가져온 것입니다. 이 팟캐스트는 소유자의 재산이며 Listen Notes, Inc.와 제휴하거나 보증하지 않습니다.
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