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.

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/s9oFmyFZGL0
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!

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_N3nc
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

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.

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

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

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

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 hear:

• How the FDA’s current freeze on new regulations is reshaping device approval pathways

• What the shift from QSR to QMSR really means for your quality system

• Why De Novo submissions are both a blessing and a black box right now

• And yes… how a literal shortage of office supplies at FDA HQ ties into all of this

Whether you’re a regulatory pro, a QA lead, or just someone who enjoys watching bureaucracy unfold in real time, this episode will help you decode what’s happening at the FDA — and how to stay one step ahead.

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/5vQjrwYforY

Visit us at https://leanraqa.com/ for even more regulatory goodness and to learn more about our services.

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 claims, AI buzzwords, and “inherent use,” this episode reveals why context, punctuation, and phrasing can make or break your FDA submission.

You’ll learn:

• Why “should” really means “shall” in FDA guidance

• How to argue (and win) your case using the right regulatory language

• What “substantial equivalence” actually means (and doesn’t)

• Why saying your product uses “AI” might double your review time

• The hidden meaning of “general wellness” and “inherent use”

• How punctuation can change compliance outcomes

Whether you’re a startup founder or seasoned QA/RA pro, this is your crash course in how to speak FDA — without a translator.

Listen, laugh, and learn as Michelle and Tianna pour a cocktail and translate regulatory jargon into plain English.

Watch the video on YouTube: https://youtu.be/lCICbNHgt4I

In this episode, Michelle and guests take a deep dive into what’s really happening inside the FDA in 2025. From pre-submission strategies to the blurred line between wellness and medical devices, this discussion uncovers the latest regulatory trends shaping medtech.

What you’ll learn in this episode:

• How to structure effective FDA pre-submissions (Q-subs) for better feedback

• Why the FDA’s focus on “inherent use” claims is shaking up wellness and digital health products

• Real-world examples of recalls, labeling risks, and social media missteps

• Why startups and Fortune 500s alike struggle with regulatory strategy

• The rising demand for cybersecurity policies in medtech and service providers

• When (and how) to push back on FDA reviewers with evidence

If you’re in medical device development, regulatory affairs, or quality management, this episode gives you actionable insights to avoid costly mistakes and stay ahead of FDA expectations.

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/R0K9UsbxfLw

Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.

Subscribe to the leanRAQA Today podcast for even more bold,insightful conversations that make medtech regulation make sense.

Watch the video on YouTube:

Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.

📩Gota question or a topic for a future session? Drop it in the comments below!

Subscribe to the leanRAQA Today podcast for even more bold,insightful conversations that make medtech regulation make sense.

Watch the video on YouTube:

Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.

📩Gota question or a topic for a future session? Drop it in the comments below!

Visit us at https://leanraqa.com/ for even more regulatorygoodness and to learn more about our services.
📩Got a question or a topic for a future session? Drop it in the comments below!