RAQA Today

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!

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 a “regulatory rebel” means understanding intent over letter, pushing back when it matters, and building trust across teams.

Key takeaways:

• How proactive vs. reactive compliance impacts company culture and patient safety

• Why draft guidance matters (and how to use it to influence FDA thinking)

• The ethical and strategic case for regulatory professionals as innovators

• What Michelle and Ti would change if they ruled the FDA for a day

Perfect for regulatory pros, quality leaders, and anyone ready to challenge the status quo in medtech.

Season 2 coming soon!

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’re a startup navigating your first clearance or a seasoned RA/QA pro, this is your crash course on how regulators (and auditors) think—and why it matters for your compliance strategy.

Watch the video version on YouTube: https://youtu.be/JbuFPVBuB-4

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’s success.

Watch the video version on YouTube: https://youtu.be/nw9f7r5aWqE

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 next-gen implants.

From there, they unpack the real-world implications of MDR, explaining what the regulation means for companies, innovators, and ultimately, patients.

(MDR content starts at 7:06 if you don't want to listen to "Real or Ridiculous")

Key highlights include:

• The challenges and importance of achieving a CE mark under MDR

• How MDR impacts both startups and established medtech companies

• The balance between innovation and compliance in Europe’s regulatory landscape

• Practical insights on how companies can prepare for MDR scrutiny

• The ripple effect on global markets, investors, and patient safety

Whether you’re a regulatory affairs professional, a medical device startup, or just curious about how Europe is shaping the future of healthcare innovation, this episode breaks down complex regulations into an engaging and accessible conversation.

Tune in to learn why MDR is reshaping the medtech industry — and how you can stay ahead.

Watch the video version on YouTube: https://youtu.be/lJIGfF4wECQ

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 unsafe) products that changed the industry

• How the FDA, EU, and other regulators define and oversee devices differently

• Why regulations aren’t just “red tape” — they protect patients and level the playing field for innovators

Plus: a rapid-fire game of Real or Ridiculous — can you guess which products are actual medical devices and which ones we made up?

Subscribe to Device and Conquer and join us each week as we untangle the messy, fascinating, and sometimes ridiculous world of medtech regulation.

You can also watch the video version on YouTube: https://youtu.be/vBdgGz38Ewk

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 225+ regulatory requirements to surviving 30 audits a year, Michelle and Adam share real-world lessons, laugh at regulatory absurdities, and imagine a future where AI helps—not hinders—compliance.

In this episode, you’ll learn:

• How AI and automation can streamline QMS maintenance and audits

• Why large medtech companies struggle with harmonizing multiple quality systems

• How Raiden Solutions is pioneering continuous gap analysis and compliance intelligence

• What the QMSR transition means for FDA inspections in 2026

• Why global “harmonization” is unraveling — and how Brexit, MDR, and AI are complicating things

• How regulators (and AI) are already scanning 510(k) data for fraud

• The line between useful automation and overengineering your processes

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/EICxX3h-7_UVisit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

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 needs before applying.

They discuss how this program — and its sibling, the Safer Technologies Program (STEP) — fits into the FDA’s pre-submission framework, the most common reasons applications are rejected, and why only a fraction of “breakthrough” devices ever make it to market.

Here's what else you’ll learn:

• What the FDA Breakthrough Device Program is — and what it’s not

• Key differences between Breakthrough and Safer Technologies (STEP) programs

• How to prove your device treats a life-threatening or permanently debilitating condition

• Why early data, prototypes, and patient advocacy are essential for success

• What the real benefits (and limits) of designation are

• Hard stats: only ~12% of devices reach market authorization

• How to make your submission persuasive — and avoid the “rose-colored glasses” trap

Whether you’re an early-stage startup or an experienced RAQA professional, this conversation demystifies one of FDA’s most talked-about programs — and shows you how to navigate it strategically.

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

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

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 effect” that can turn a minor oversight into a million-dollar failure.

From creating a traceability matrix that actually prevents design disasters to aligning your regulatory, quality, and business strategy, Michelle and Renae share practical frameworks, real-world cautionary tales, and actionable advice to help startups save time, money, and credibility on the path to FDA clearance and market success.

In this episode, you’ll learn:

• Why most startups are only 20% done when they think they’re 80% ready for FDA

• How to use a trace matrix to prevent downstream compliance failures

• Real-world horror stories: cold-weather power cords, overdrawing donors, and untested adhesives

• How early regulatory strategy affects design, documentation, and market selection

• How to avoid the “Porsche vs. Ford Focus” problem in medical device design

• What to know about 510(k), de novo, and PMA pathways (and what each really costs)

• Why unsubstantiated marketing claims can derail your entire launch

• Commercialization strategy 101: distribution, sales models, and hospital adoption

• Protecting your IP and product cost structure before it’s too late

If you’ve ever thought “we’ll deal with regulatory later,” this episode will convince you otherwise — with humor, humility, and decades of hard-earned insight.

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/94gm5sP0EDUVisit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

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, inconsistent interpretations, and the myth of increased safety, the trio unpacks what MDR is really doing to the industry — and what manufacturers can do to survive (and thrive) under it.

Here's what you’ll learn:

• How MDR differs from MDD — and why it’s not a total overhaul

• Why software, AI, and post-market surveillance have become regulatory pain points

• The 12–18 month reality of CE marking under MDR

• How to select the right notified body (and why language matters)

• Why documentation ≠ device safety — and integrity still matters most

• The “significant change” rule: what triggers recertification

• Why smaller companies are struggling to stay in the EU market

• Practical steps to build a quality culture and navigate MDR effectively

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/Kgbmh0neJpE

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