RAQA Today

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...

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 r...

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 aliena...

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 n...

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 co...

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 cl...

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...

In the Season 1 finale, Michelle and Ti challenge the traditional view of regulatory affairs as the “business prevention department.” Instead, they reframe regulators as strategic partners and proactive innovators who can drive compliance and competitive advantage. From shocking stories of last-minute compliance scrambles to major recalls that reshaped the industry, this episode reveals why being...

In this episode of Device and Conquer , we unpack the differences between the FDA’s inspection style and the EU’s notified body-driven approach. From classification rules and audit methodologies (QSR, ISO 13485, MDSAP) to unannounced FDA inspections versus Europe’s annual surveillance audits, we dig into what medical device companies really need to know before entering either market. Whether you’r...

Who really is the FDA and how do they regulate medical devices? In this episode of Device and Conquer , we break down the U.S. Food and Drug Administration’s role—from product classification and product codes to substantial equivalence, 510(k)s, de novos, and PMAs. Learn how the FDA oversees everything from tongue depressors to pacemakers and why regulatory strategy can make or break your product’...

In this episode of the NEW Device and Conquer podcast, Michelle and co-host Ti dive deep into the European Union’s Medical Device Regulation (MDR) — and explain why it’s much more than just red tape. The conversation begins with a fun recap of their “Real or Ridiculous” game, where they fact-check quirky device ideas like smart spoons for Parkinson’s, mood rings that claim to detect cancer, and ne...

What exactly is a medical device — and why does it matter if it’s regulated? In this premiere episode of Device and Conquer , hosts Michelle Lott and Ti Benson unpack the surprisingly broad world of medical devices, from smart thermometers and glucose meters to fertility tech and connected implants. You’ll hear: The difference between drugs and devices Real-life horror stories of unregulated (and...

What if your quality system could audit itself — and tell you where you’re overcomplying, underperforming, or about to get caught in a regulatory trap? In this episode of Lean RAQA Today , Michelle Lott sits down with Adam, founder of Ryden Solutions, to explore how AI-driven tools are changing the landscape of medical device quality management, audits, and regulatory compliance. From navigating 2...

Everyone wants that shiny FDA Breakthrough Device designation — but what does it really take to earn it, and does it actually make a difference? In this episode, Michelle Lott joins Monir El Azzouzi on the Medical Device Made Easy podcast to unpack the truth behind the Breakthrough Devices Program — from eligibility and benefits to the myths, statistics, and reality checks every medtech company ne...

Did you know that 60% of startups cannot survive beyond five years, and 75% will ultimately fail? Bringing a medical device to market is hard — but most startups make it much harder than it has to be. In this episode of Lean RAQA Today , Michelle Lott and Renae Franz reveal the most common mistakes medtech startups make from concept through commercialization — and how to avoid the “butterfly effec...

The EU Medical Device Regulation (MDR) has reshaped the European regulatory landscape — bringing new rigor, new challenges, and plenty of confusion. In this episode, Michelle Lott joins Etienne Nichols ( Greenlight Guru ) and Karandeep Singh Badwal to debate the real-world impact of MDR on medtech innovation, market access, and patient safety. From notified body bottlenecks to language barriers, i...

Everything you need to know about biocompatibility - in one podcast. From a webinar hosted by MedTech Leading Voice and featuring Michelle and Marina Daineko from Intrinsic Medical Group. LinkedIn: https://www.linkedin.com/in/michellelottraqa Website: https://leanraqa.com/ YouTube: https://www.youtube.com/@leanRAQA Instagram: https://www.instagram.com/leanraqa

Which market is best for your product - the EU or the US? The answer is not always straightforward, but Ronald Boumans, Nika Mendelev and I did our level best to answer your questions in this Master Class presentation. Michelle leads off with a review of FDA strategies and pathways. 15:34 - Ronald dives into the particulars of MDR and dealing with notified bodies. 27:15 - Nika Mendelev explains wh...

Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Some unethical third-party testing labs are sending their clients data mined from old 510(k) submissions - and passing it off as fresh data. So what's a medical device manufacturer to do? That was the topic of conversation this month when I chatted with Mike...

The good folks at Vistatec invited me to participate in their Life Science In-Focus podcast last month, where host Karen Tkaczyk and I chatted about the intricacies of regulatory affairs within the life sciences. We also discussed just how I ended up in the field, and the many challenges companies face when choosing regulatory pathways in the United States and Europe. LinkedIn: https://www.linkedi...

This is not last year's eSTAR - a LOT has changed, and there are things you need to know before you try to submit your 510k. In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you planning a 510k or PMA submission. We'll review the eSTAR 5.0 platform and what you need to know to use it effectively –the good, the bad, and the ugly. The ne...