Shows
RAQA TodayBuilding a Better Market Pathway: Aligning Regulatory, Reimbursement and Commercialization TeamsMost 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 p...
2025-12-0840 min
RAQA TodayHow to be the Regulatory Person Everyone Actually Likes | Device & Conquer | S2:E6A 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/s9o...
2025-12-0217 min
RAQA TodayHow to Build a Quality System That Doesn't Suck | Device & Conquer | S2:E5Because 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 lea...
2025-11-1815 min
RAQA TodayDue Diligence for MedTech Investors: What You Really Need to Know Before Writing That CheckIf 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, h...
2025-11-1758 min
RAQA TodayWhy Picking a Predicate Can Make or Break Your 510(k) | Device & Conquer | S2:E4Choosing 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...
2025-11-1119 min
RAQA TodayHow to Build a 510(k) Without Losing Your Mind | Device & Conquer | S2:E3Building 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 bioco...
2025-11-0320 min
RAQA TodayHow to Submit a Pre-Sub (like a Pro) | Device & Conquer | S2:E2The 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 thinkingWhat makes a strong vs. weak pre-sub questionThe dif...
2025-10-2816 min
RAQA TodayFDA Strategy 2025: Policy, Pressures and the Path to Medtech Clearance | Part I | leanRAQA Today | S5:E6The 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 pathwaysWhat the shift from QSR to QMSR really means for your qualit...
2025-10-2223 min
RAQA TodayHow to Speak FDA (Without a Translator) | Device & Conquer | S2:E1Think 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 guidanceHow to argue (and win) your...
2025-10-2121 min
RAQA TodayInside the FDA: Pre-Subs, Wellness Devices & Cybersecurity Challenges | leanRAQA Today | S5:E5In 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 feedbackWhy the FDA’s focus on “inherent use” claims is shaking up wellness and digital health productsReal-world examples of recalls, labeling risks, and social media misstepsWhy startups and Fortune 500s alike stru...
2025-09-2546 min
RAQA TodayRise of the Regulatory RebelIn 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 safetyWhy draft guidance matters (and how to u...
2025-09-2339 min
RAQA TodayFDA 101: Audits, Classification Rules and EU MDRIn 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....
2025-09-1527 min
RAQA TodayFDA 101: Understanding the OTHER Regulatory GiantWho 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
2025-09-0823 min
RAQA TodayEU MDR - More then Just Red Tape?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...
2025-09-0333 min
Let's Talk Risk! with Dr. Naveen AgarwalLTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSRThis is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Don’t wait. You need time not just to update your procedures, but to generate the records FDA will expect to see the day they walk through your door.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal and Michelle Lott from Lean RAQA discuss the upcoming Quality Management System Regulation (QMSR) for medical devices, emphasizi…
2025-08-2901 min
RAQA TodayWait, What - There are Rules?!?!?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 devicesReal-life horror stories of unregulated (and unsafe) products that changed the industryHow the FDA, EU, and other regulators define and oversee devices differentlyWhy regulations aren’t just “red tape”...
2025-08-2616 min
RAQA TodayQMSR, AI Reviewers and the Value of a Good FDA and Internal Audit | leanRAQA Today | S5:E4What 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 epi...
2025-06-2736 min
RAQA TodayWhat You Need to Know About FDA Breakthrough Devices | leanRAQA Today | S5:E3Everyone 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 fra...
2025-06-1623 min
RAQA TodayMedical Device Product Development: From Concept to Commercialization | leanRAQA Today | S5:E2Did 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...
2025-03-1348 min
RAQA TodayEU Hot Takes: MDD vs MDR | leanRAQA Today | S5:E1The 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...
2025-02-0645 min
132 Problems: Revisiting Mormon Polygamy155: The Lott Family Bible - Proof of Joseph's Polygamy?Please consider supporting this podcast: Venmo: @Michelle-Stone-24Patreon.com/132problemsLinks:Lott Family Bible: https://catalog.churchofjesuschrist.org/assets/7226d36f-b3a5-4c0e-9d0c-33d87d46ffb4/0/3Joseph F. Smith Reminiscence (re Cornelius Lott): https://catalog.churchofjesuschrist.org/assets/dcbc02ae-b054-44d8-9381-de93c8cb9a37/0/20 Like a Fiery Meteor (Biography of Joseph F. Smith: Paperback: https://amzn.to/4hDXHOxKindle: https://amzn.to/3PWMcFZ Nauvoo Sealings, Adoptions and Anointings: https://archive.org/details/nauvoo-sealings-adoptions-and-anointings/page/188/mode/2up?q=corneliusLetter from Rebecca Fausett’s Father: https://www.familysearch.org/tree/person/memories/KWV9-MFC Sealing Letter re...
2025-02-021h 51
RAQA TodayBiocompatibility for MedTech ProfessionalsEverything 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
2024-12-0652 min
RAQA TodayCE Certification vs FDA Submission Strategy: Which is Right for You?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 whether you really need to choose one or the other.
32:10 - the Q+A session begins.
Link to the full presentation on YouTube: https://youtu.be/4wyZzVibiAY
2024-10-0149 min
RAQA TodayASCA, CLAP, Fraudulent Biocompatibility Data and YouBiocompatibility 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 McGrew and Sandi Schaible from WuXi AppTech.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
2024-09-2430 min
RAQA TodayA Conversation with Vistatec's Life Science In-Focus PodcastThe 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.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
2024-05-1321 min
Life Sciences - In FocusLife Sciences - In Focus Ep 03 - Michelle Lott, Lean RAQAIn this Life Sciences In-Focus podcast episode, host Karen Tkaczyk sat down with Michelle Lott, the founder and principal of Lean RAQA, to discuss the intricate world of regulatory affairs within the life sciences sector. This conversation not only shed light on Michelle's unique journey into the field but also explored the challenges and nuances of navigating regulatory pathways in the United States and Europe.
About the Host
Karen Tkaczyk
Director of Sales for the Vistatec Life Sciences Division. Karen is an accomplished chemist and translator with extensive experience in the drug, medical d...
2024-04-3023 min
Project MedtechEpisode 179 | Michelle Lott, Principal and Founder at LeanRAQA | FDA and MDR UpdatesIn this episode, Michelle Lott at LeanRAQA and Duane Mancini discuss the QMSR, FDA e-start program, 513g vs. presubmission meeting, MDR update and so much more.
2024-04-2235 min
RAQA TodayeSTAR 5.0 - What You Must KnowThis 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 new features, including premarket approval content and updated cybersecurity documentation and dive into the simplified EMC questions, revised sterility section, and new biocompatibility testing options - we...
2024-04-1932 min
RAQA TodayThe Benefits of 3rd Party FDA ReviewersWhy would you use a 3rd party reviewer for your submission? How does a 3rd party reviewer function? How is it different from working with the FDA?
I sat down with my good friend Shawnnah Monterrey from Beanstock Ventures to answer all your pressing questions about using 3rd party reviewers.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
2024-03-1237 min
RAQA TodayeSTAR 5.0 Q+A with Patrick Axtell from the FDAQuestion, questions, everyone has questions about eSTAR 5.0, so I sat down with the FDA's Patrick Axtell to answer the most pressing ones I've received.
From file size to eSTAR type to biocompatibility - we cover it all.
2024-02-2033 min
RAQA TodayFractional or Full Time Quality Support: Which is Right for You?When is it better for a medtech startup to hire a fractional quality professional, and when is it time to hire full-time?
This is not necessarily an easy question to answer, and there can be a lot of factors impacting the decision.
In this joint podcast with Mitch Robbins, we discuss the challenges and opportunities of today's topsy-turvy QA hiring market, and why many companies are opting for fractional QA professionals rather than full-time employees.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
2024-02-0722 min
RAQA TodayMedical Devices, Cloud Computing and Cybersecurity with Randy HortonAs medical devices become more connected, concerns about security increase, leaving manufacturers - and regulatory staff - uncertain as to the best path forward. Listen in as Michelle and guest Randy Horton discuss industry needs and what the FDA plans to do to ensure the safety of connected and AI-driven devices.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
2023-11-2927 min
Let's Combinate - Drugs + Devices106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle LottOn this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them!
If you'd like to hear more about Michelle checkout episode 031, 077, checkout Michelle's Blog @ LeanRAQA.com and Michelle's Podcast RAQA Today.
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and...
2023-10-2433 min
RAQA TodayThe Business Benefits of QualityMany manufacturers see quality as a necessary evil, a box to be checked just to placate the FDA on the way to market launch. But it can be SO much more.
In this episode, Ti Benson and I discuss how quality can actually be a business benefit and not simply something to be endured.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
2023-08-1112 min
RAQA TodayThe Joy of Document ControlYou may think document control is boring, but wait until you hear these stories:
Red-lined post-it notes. Uncontrolled copies passed around during inspections. Master files stored on a desktop instead of in the eQMS system. Secret file cabinets in locked closets full of uncontrolled, red-lined specifications documents.
Oh, the joy of document control!
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
2023-08-0915 min
RAQA TodayMake Quality Make $en$e: Management's Role in QualityThe best leaders know that quality is much more than a box to be checked, or a necessary evil to be endured along the road to FDA (or MDR) approval.
This is the third in a series of conversations talking about quality and how it can actually benefit a company, and even give you an advantage over your competition.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
2023-07-3137 min
Let's Combinate - Drugs + Devices077 - 8 Databases and How To Use Them with Michelle LottOn this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them!
If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today.
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Dev...
2023-03-2222 min
RAQA TodayMDR By The Numbers: Leveraging New Data for Implementation PlanningMDR has been puzzling me for a few years now, and it's getting worse, not better. In this webinar hosted by Greenlight Guru, we look at the data gathered from recent MDCG guidance documents, industry and notified body surveys, and personal interviews with stakeholders (including notified bodies) who shared their first-hand experiences with implementation (spoiler alert: it ain't pretty).
2023-03-101h 18
RAQA TodayEUDAMED Update: January 2023Upload to EUDAMED is a requirement of MDR, but adoption has been slower than anticipated. Manufacturers are reluctant to invest in the time required to upload their product catalog, and the platform itself has been plagued with issues. Listen in as Richard Houlihan lifts the curtain on why industry has been reluctant to embrace EUDAMED and what the future might hold for both sides.
2023-02-2151 min
RAQA TodayFrom the Front Lines of EU Medical Device RegulationWhat happens when two regulatory consultants sit down for a chat about MDR?
A lot of distressed head shaking, for sure and an equal measure of what-were-they-thinking eye rolls, but we also dug into the meat of the proposed extension and what it might mean for industry.
Monir El Azzouzi and I chatted last month about MDR, and while we didn't solve all of the EU's problems, we did touch on some of the biggest challenges facing manufacturers.
2023-01-311h 00
Let's Combinate - Drugs + Devices069 - EU MDR Extension with Michelle LottOn this episode, Michelle Lott discusses the EU MDR Extension that was formalized by the European Commission and what it means for industry.
If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today.
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and...
2023-01-2517 min
RAQA TodayRisk Management - Beyond the BasicsRisk management can be difficult to understand, even for seasoned quality and regulatory professionals, because there are SO. MANY. ACRONYMS.
I mean, there's FMEA, uFMEA, ISO, FDA, PMA to name a few.
We discussed acronyms and more at the November meeting of the Dallas ASQ - Section 1402, so if you're ready to go beyond the basics and right into the very heart of risk management, then this is the podcast for you.
2022-12-1354 min
RAQA TodayTrends in FDA Initiatives and the Impact on Orthopedic DevicesOrthopedic devices may qualify as medical devices, but they have very different regulatory requirements. So different that the FDA created a new office to manage orthopedic devices - the Office of Science and Engineering Laboratories (OSEL) - and ensure their safety and efficacy. OSEL was created to accelerate patient access to innovative devices, as was the Orthopedic Devices Program. In this podcast, Michelle walks through the important work that OSEL is doing and the regulatory specifics you need to know when preparing the submission for your orthopedic device.
2022-11-1538 min
RAQA TodayFree FDA Communications with the FDA? What you Need to KnowThere's the pre-submission, of course, but did you know there are other ways to get FDA feedback without breaking the budget? In this episode, Michelle reviews three pathways that can help startups save some cash while working their way through the commercialization process.
2022-11-0850 min
RAQA TodaySplit Personalities of QMS Audits for FDA, MDSAP and ISO 13485Similar but different is a good way to describe how FDA inspections and MDSAP and notified body audits compare. On the surface, they appear to be looking at the same things, but dig a little deeper and the differences in agenda - and outcome - become plain.
2022-10-3150 min
RAQA TodayUsability Testing and the FDADo you know how your end users will use your device? Are you sure?Do you know how end use will differ between demographic groups? Do you know why this is important, and how usability testing fits into your risk assessment?
Shannon Clark has been doing human factors/usability testing for some time, and she can tell you exactly why usability testing is required and the impact it can have on your final product design.
2022-10-2532 min
RAQA TodayIs your State of Affairs for MDR State of the Art?If you're struggling to determine whether your devices qualify as state of the art - and how that can impact your submission strategy - then check out this presentation I did with my friends at Greenlight Guru in August.
Etienne Nichols and I sort through all the acronyms - SOTA, SOC, MDR, MEDDEV, IVDR - and try to shed some light on what MDR says about state of the art, what it doesn't say, and how to determine your best path forward.
2022-10-171h 03
RAQA TodayMDR, FDA and Other Regulatory RealitiesWhen submitting a medical device for regulatory approval, it's always better to just dive in, accepting the fact that it's going to take a lot of work and require a lot of patience before you feel the glow of market clearance or approval.
There are just SO MANY things to consider, and remember, and document, and SO MANY regulations to refer to on both sides of the Atlantic.
In this edited version of a Greenlight Guru podcast from earlier this year, I discuss the roadblocks that exist on both sides of the Atlantic with Jon Speer and Etienne Nichols...
2022-09-2235 min
RAQA TodayDigital Health: The Future of Medicine and Medical DevicesDigital health technologies are exactly new, but they did get a huge boost from COVID and will define how we deliver healthcare in the future.
Digital health includes telemedicine, software functions that allow providers to monitor patients remotely, apps that track medication use and provide user-configured reminders for improved compliance - and more.
In this podcast, we dive into the whys and the hows of regulating digital health while still managing to bring products to market.
2022-09-1343 min
RAQA TodayThe End of the COVID-Era EUAsThe end of the COVID-era emergency use authorization (EUA) is rapidly approaching - do you know what's next?
Earlier in the year, the FDA laid out their proposed plans for transitioning devices marketed under and EUA or FDA enforcement policy - then went radio silent.
They still haven't released their final guidance, so what's a manufacturer to do?
In this podcast, we'll review the proposed FDA recommendations, suggest the type of feedback industry should provide to the FDA, and discuss actions to take if you are a manufacturer with an active EUA.
In other words, we'll laugh, we'll cry, we'll...
2022-09-0642 min
RAQA TodayCrash Course in FDA SubmissionsSo - you have a product, and you have a submission ready to go to the FDA. You're all set, right? You know how the e-Submitter works, you know exactly what FDA Form 3514 is for, and you know the best questions to ask the FDA during your pre-sub?
If you've answered NO to any of these, then listen in as Michelle explains what you need to do to help your product move smoothly through the submission process and on to premarket approval.
2022-08-3125 min
RAQA TodayFive Steps to Bring a Medical Device to MarketSo - you're a hot new startup with a snappy new medical device.
Now what?
Do you have an intended use statement? Do you have the 𝘳𝘪𝘨𝘩𝘵 intended use statement? Do you know for sure that your product qualifies as a medical device? What about your predicate device?
There are a lot of potholes along the road to market clearance or approval, so come along with me as I explain what you need to avoid derailing your go-to-market plans.
2022-08-2329 min
RAQA TodayDesign Controls and Risk ManagementWhich comes first - design controls or risk management? Both - because the two are inextricably linked. In this podcast, we'll take an in-depth look at both design controls and risk management, the waterfall design process, how/where risk management fits into that process - and vice versa - as well as discuss the ISO and 21 CFR 820 requirements for each stage of the product life cycle.
2022-08-171h 19
RAQA TodayBreakthrough, de novo, or PMA? FDA Submission Pathways for Novel DevicesYou've developed a novel technology and want to bring it to market in the US. Now what? Can you submit as a breakthrough device, or is the de novo route a better choice? How are they different? How are they similar?
Breathe - and listen in as Michelle walks you through the options.
2022-08-0947 min
Let's Combinate - Drugs + Devices031 - "The Five Stages Of Regulatory Grief" with Michelle LottOn this episode of the podcast, I was joined by Michelle Lott of Lean RAQA. Michelle and I discuss:
- Her background starting at a manufacturing site and moving into QA and RA
- Being Outspoken and Honest
- What she's observed between large and small organizations
- Her Experience being an industry rep on the FDA Device GMP Advisory Committee
- Regulations vs. Guidance's and how they come about
- The 5 stages of regulatory grief
- QMSR Harmonization
- Audit Preparation
...
2022-05-041h 19
RAQA TodayThe Aftermath Of MDR - Part IIIIn this final segment from 𝗧𝗵𝗲 𝗔𝗳𝘁𝗲𝗿𝗺𝗮𝘁𝗵 𝗼𝗳 𝗠𝗗𝗥 webinar, we discuss what you should and should not do when preparing for your certification, then segue into what you need to consider when building the business case for (or against) pursuing certification.
This one runs a bit longer than 15 minutes because it includes most of the Q+A session, and that has some juicy tidbits you don't want to miss.
2022-01-2520 min
RAQA TodayThe Aftermath of MDR - Part IISix months into MDR and manufacturers and notified bodies are clashing over differences in opinion and fighting over their respective interpretation of the standards in pursuit of product certification.
In this second installment of a series, I share three real-world examples of what actual clients faced when going through the MDR certification process.
You'll want to listen and learn from their experiences, so you'll be better prepared for your boxing match with your notified body.
2022-01-0615 min
RAQA TodayThe Aftermath of MDR - Part IIt's no longer a secret that MDR has morphed into an unmitigated disaster for the medical device industry - and Michelle has the goods to prove it. In this first in a series, she spills the beans on notified body readiness, the roadblocks that have been causing the most trouble, and the FDA's long-term plan to become the easier pathway to market.
2021-12-1615 min
Project MedtechEpisode 71 | Michelle Lott: Principal and Founder at LeanRAQA | Regulatory Strategy and its Place in a Medtech Startup Business Plan
In this episode, Michelle and Duane discuss discuss her focus on startups, when to get a regulatory strategy done, why regulatory strategy is crucial and should be a part of your business plan, why you need to be careful when building your website, when it makes sense to use a stepwise regulatory approach, benefits to a De Novo pathway, could the US move towards MDRish regulations, and more.
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LeanRAQA Website
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Project Medtech LinkedIn
Project Medtech Website
2021-11-2948 min
RAQA TodayEUDAMED, MDR and Even More Madness with Richard HoulihanThis is the second part of my conversation with Richard Houlihan, where we delve into the current status of the EUDAMED database, the intricacies of the data entry process, and why the EU competent authorities are not your friends.
2021-11-2320 min
RAQA TodayEUDAMED, MDR and Other Madness with Richard Houlihan - Part IWe all knew that MDR would change the medical device industry forever, hopefully for the better. But as manufacturers grapple with redundant requirements and notified bodies struggle to attract and retain the qualified staff mandated by the new regulation, it becomes clear that MDR is not just changing the medical device industry - it's requiring an entirely new mindset.
2021-11-0316 min
A Lott Of Help with James Lott JrYou Can't Make This S**t Up with Abuse Survivor/Author Michelle MaysMichelle Mays was born into an abusive family in the Midwest. As she and her siblings cling to survival, the balance of family ties is weighed against alcoholism, drug abuse, abandonment, and despair. Hope dawns in the form of foster care, only to be deferred by multiple placements and a system not equipped to support the children it's meant to protect.Through powerful vignettes of a life disjointed, Mays's story is a journey of hope that is echoed in the experiences of thousands of children in the court and foster care systems today.Dumpster Doll is...
2021-10-2643 min
RAQA TodayThe MDR No Good Very Bad Day: Go To Market Challenges in the EUIt used to be that Europe was the first choice when bringing a product to market. Relaxed regulation meant a quick approval and the chance to earn some money while waiting for FDA approval. That's not the case anymore, and thanks to MDR, there are new challenges and roadblocks - not to mention a LOT more expense - involved in bringing a medical device to market in Europe.
2021-10-1512 min
RAQA TodayThe FDA No Good Very Bad Day: Common Regulatory MistakesWhether you are an investor or inventor/founder, there are some things you need to avoid if you want your FDA submission to succeed, some common regulatory mistakes that a lot of startups make.
These common misconceptions about the FDA submission process can cost you time and money and extend your go-to-market timeline, so it's worth knowing how to avoid them.
2021-09-2914 min
RAQA TodayEmpowering Female Entrepreneurs and Investors with Faz BashiMore and more women are investing in medtech startups as the next phase of their professional development.
It's a key career move that can fuel further business growth while establishing women entrepreneurs as experts and investors to be taken seriously.
But all investors need to know what to look for when gauging a pitch from a startup, because it's not just about the cool new science or the revenue projections.
My friend and mentor Faz Bashi taught me a thing or two about investing, and has been working to educate and empower other women looking to take this important professional...
2021-07-1327 min
RAQA TodayHow A Strong Regulatory Strategy Can Boost Your Business with Stephanie SchullDoes regulatory strategy really impact your business strategy? Yes! Stephanie Schull, founder of kegelbell, explains how defining the regulatory strategy for her fledgling business early on helped promote her product both to investors and distributors around the globe.
2021-05-1819 min
RAQA TodayFDA Submission Pathways with EIT Health AlumniDetermining which FDA submission pathway best applies to your medical device or product can be daunting. Listen in as Michelle explains how to decide if your product qualifies for a 510(k), PMA, de novo or 510(k) exempt submission - as well as the basic requirements for each.
2021-04-011h 17
RAQA TodayAll You Ever Wanted to Know About Risk Management with Edwin BillsNo matter the risk management question, Edwin Bills will likely have the answer. He's been involved in the medical device quality and regulatory space for many, many years. Give him a tricky compliance situation or example, and chances are he has been there and done that, maybe more than once.
Ed sat down with Michelle to talk about ISO 24971, MDR and the risk of radiation exposure in a sun-filled hospital room.
2021-03-1244 min
RAQA TodayRegulatory and Reimbursement - Similar but DifferentAre regulatory and reimbursement at all related? Does one influence the other? Or are they more like oil and water, both necessary but not really something you should mix?
Michelle and Nic Anderson answer questions about how regulatory and reimbursement issues can impact a product's go-to-market strategy, and how these two seemingly disparate areas actually may overlap in a variety of medical device scenarios.
2021-03-0438 min
RAQA TodayFDA Device Downclassification - This is Not Good NewsThe recent FDA device downclassification decision is not good news - for industry or for patients. Several devices on this list - namely ventilators - have benefitted from close FDA scrutiny during the 510(k) submission process. They are safe precisely because they have been so closely regulated, not because they are simple to use and present limited risk to the patient.
This podcast combines three different interviews into one narrative about the FDA decision, the reasoning behind it, and the action we need to take to keep ventilators and other devices under the careful watch of federal regulations.
Link to...
2021-02-2526 min
RAQA TodayInside a Notified Body with Robert DostertRobert has years of experience working for notified bodies, and provides a peek behind the curtain at the North American division of Norway's DNV GL Presafe. Hear what they have going on now, what may be coming up in the future, and how a notified body determines how to best manage a client project.
Note: You didn't miss anything, and your headset did not malfunction. We removed all references to other notified bodies from the podcast, but decided not to annoy you with the delete beep.
2021-02-1719 min
RAQA TodayEntrepreneurial Roundtable with Elena KyriaIn this clip from Elemed's Entrepreneurial Roundtable series, Michelle sits down with Monir El Azzouzi, Stefan Boelleininger and Elena Kyria to talk about the benefits and challenges of running your own business.
You can hear the entire discussion at http://www.elemed.eu/mentoring
2021-02-1116 min
Medical Device made Easy PodcastWhat is the QA RA Mindset with Michelle Lott
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Michelle Lott and I are discussing our Experience in the Quality and Regulatory affairs area. We will help you define what is compliance and how we think it should be applied. Michelle had also some good and bad experiences that she is sharing with us.
Who is Michelle Lott?
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on...
2021-02-0900 min
Medical Device made Easy PodcastWhat is the QA RA Mindset with Michelle LottIf you are thinking that you are the only one that has issues as QA RA, then listen to this episode. I hope this will help you to understand that there is a certain mindset to have when you do this type of job. The post What is the QA RA Mindset with Michelle Lott appeared first on Medical Device made Easy Podcast.
2021-02-0936 minMedical Device made Easy PodcastWhat is the QA RA Mindset with Michelle Lott
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Michelle Lott and I are discussing our Experience in the Quality and Regulatory affairs area. We will help you define what is compliance and how we think it should be applied. Michelle had also some good and bad experiences that she is sharing with us.
Who is Michelle Lott?
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on...
2021-02-0900 min
RAQA TodayVentilators, Components and Accessories - Choosing the Right FDA Pathway for Your ProductHave you ever struggled to understand the regulatory difference between a product, an accessory and a component?
Have you ever driven yourself slightly mad trying to determine the best FDA submission pathway for that product, accessory or component?
A group of medical device manufacturers asked those very same questions during a presentation I gave in the fall of 2020.
The answers apply to more than just ventilators, so there is something in this video for just about everyone.
If you want to view the video version with the slide deck, check it out on my YouTube channel: https://youtu.be/e-UTXSFwHaw
...
2021-02-0326 min
RAQA TodayAre You Ready for MDR - Part IISecond half of the conversation with the SoCal chapter of Opthalmic World Leaders.
2021-01-2925 minRAQA TodayAre You Ready for MDR - Part IMichelle was invited to speak to the Southern California chapter of Opthalmic World Leaders (OWL) and familarize them with the basics of the approaching MDR transition.
2021-01-2925 min
RAQA TodayPPE, Masks and FDA Regulations in the Age of CoronavirusProtective gear is still in high demand, and absolutely everyone is making masks. In this April 2020 clip from Joe Hage’s weekly COVID-19 call, I discuss the requirements for each type of mask, the constantly changing regulations, and the reason why that homemade mask may not offer up any protection after all.
2021-01-2912 min
Career Diaries by ElemedSPECIAL EPISODE | The story of Elemed | Elena Kyria, CEO of Elemed and Michelle Lott, Founder of Lean RAQA SystemsKey takeaways:The secrets and success of a WOMEN-LED businessHow Elemed’s Mentoring Academy was a GAME-CHANGERHow to use your passions and skillset to SUCCEEDElemed’s EXCITING story and why you should start your own businessAbout Michelle:Michelle Lott is founder and principal of Lean RAQA Systems (leanraqa.com) where she has supported more than 100 companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services and grief counseling – because dealing with regulators can be emotio...
2021-01-2933 min
RAQA TodayRegulatory Requirements and the "Simple" Surgical MaskYou have a raw material supplier. You have a marketing strategy. You have a sales funnel. But what you don't have is a clear understanding of the regulatory requirements for this new surgical mask you're making.
Now what? Do you even know where to start?
Michelle sits down with a client facing this dilemma and walks her through the regulatory process and requirements for a "simple" surgical mask. (Hint - there's no such thing).
2021-01-2211 min
RAQA TodayRAQA Today Becomes leanRAQA Today: What's Next?Mitch Robbins is moving on, and Michelle Lott of lean RAQA will be taking over the podcast! Mitch and Michelle chat about transitioning the podcast, what's ahead for the Anthony Michael Group, and what the leanRAQA team has in store for 2021.
2021-01-1326 min
Scary ThoughtsScary Thoughts #82 - "Is this how you thought it would all end?" with Michelle Tea, Meg Elison and Lawrence English Writer Michelle Tea, writer Meg Elison, and composer Lawrence English join us for a trio of COVID-19-era conversations. We ask them each, "Is this how you thought it would all end?" All three guests have great perspectives on the apocalyptic vibrations affecting us all, but are any of us truly ready for the end?
2020-10-091h 02
Career Diaries by ElemedThe benefits & challenges of being a RA/QA consultant | Michelle Lott, Founder of Lean RAQA SystemsKey takeaways:Learn the BENEFITS of being self-employed from an experienced consultantWhat is BRAND CONSISTENCY and why you need to be aware of thisHow to become an independent SUCCESS and start your own businessHow to GROW in the RAQA industryAbout Michelle:Michelle Lott is founder and principal of Lean RAQA Systems (leanraqa.com) where she has supported more than 100 companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services and grief counseling – because dealing with regulators can be em...
2020-08-0353 min
Flicker EffectHigh Fidelity, Birds of PreyDavid, Bobby, Jascha, and Michelle discuss Hulu's High Fidelity series, Birds of Prey, the new Batsuit, and much more. Learn more about your ad choices. Visit megaphone.fm/adchoices
2020-02-281h 13Medical Device made Easy PodcastHow to register your Medical Device through 510k with Michelle Lott
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510k is a famous way to register your Medical Devices in the US. It is so famous that even if you don’t need it, you will ask to go through it. In this episode, Michelle Lott, Founder, and Principal at LeanRAQA will help us understand everything about 510k. And she is also providing a Slide deck to help you understand all about the FDA process.
We will discuss the different types that are existing:
TraditionalAbbreviatedSpecial
We will also discuss the way to use standards to confirm that your product conforms to...
2020-01-1300 minMedical Device made Easy PodcastHow to register your Medical Device through 510k with Michelle Lott
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510k is a famous way to register your Medical Devices in the US. It is so famous that even if you don’t need it, you will ask to go through it. In this episode, Michelle Lott, Founder, and Principal at LeanRAQA will help us understand everything about 510k. And she is also providing a Slide deck to help you understand all about the FDA process.
We will discuss the different types that are existing:
TraditionalAbbreviatedSpecial
We will also discuss the way to use standards to confirm that your product conforms to...
2020-01-1300 min
Flicker EffectMidway Soars, While Doctor Sleep SnoresThis week we discuss the slow box office weekend, but more importantly, how David and Michelle saw movies! They've got thoughts on Jojo Rabbit, Parasite, Doctor Sleep, and more! Time to start the show! Learn more about your ad choices. Visit megaphone.fm/adchoices
2019-11-121h 05
Flicker EffectTerminator Won't Be Back?Well, we're covering Terminator: Dark Fate, which sounds ironic in retrospect. Plus, David and Michelle bite into the new Apple TV+ show - Morning Show. All that and more in this week's episode! Music: “Whistle” by BenJamin Banger, on Instagram @BenJaminBanger and at https://www.benbanger.com Learn more about your ad choices. Visit megaphone.fm/adchoices
2019-11-051h 11
Flicker EffectStar Wars Tickets, Riddler CastingThis week, David and Michelle discuss the latest news including the casting of the Riddler, the Star Wars: The Rise of Skywalker ticket sale, and more! Learn more about your ad choices. Visit megaphone.fm/adchoices
2019-10-2245 min
Flicker EffectJoker: Spoiler ReviewNow it's time for the rest of the crew to talk about Joker! In this episode, Kevin Fuentes joins David, Jascha, and Michelle to have a spoiler-filled discussion of the latest DC film. Learn more about your ad choices. Visit megaphone.fm/adchoices
2019-10-101h 16Medical Device made Easy PodcastRegister your Medical Device in the US with Michelle Lott (FDA)
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The challenge for Medical Device companies is to understand the different pathways to register their products in a certain region. On this episode, we will focus on the US FDA regulation for Medical devices.
To help us, I invited Michelle Lott from LeanRAQA. She will let you know what are the different steps to consider when you are trying to register a Medical Device in the USA.
We will talk about the product classification, the different registration procedures (510k, deNovo, PMA) and also about the Quality Management System acceptable by the...
2019-09-3000 minMedical Device made Easy PodcastRegister your Medical Device in the US with Michelle Lott (FDA)
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The challenge for Medical Device companies is to understand the different pathways to register their products in a certain region. On this episode, we will focus on the US FDA regulation for Medical devices.
To help us, I invited Michelle Lott from LeanRAQA. She will let you know what are the different steps to consider when you are trying to register a Medical Device in the USA.
We will talk about the product classification, the different registration procedures (510k, deNovo, PMA) and also about the Quality Management System acceptable by the...
2019-09-3000 min
Flicker EffectD23 2019David, Bobby, and Michelle discuss all the big news out of D23, including the Disney+ announcements, the latest from the MCU, The Mandalorian, and more! Learn more about your ad choices. Visit megaphone.fm/adchoices
2019-09-071h 32
Flicker EffectBonus Ep - Spider-Man Out Of The MCU?In this special bonus episode, David, Bobby, and Michelle discuss the breaking news that Spider-Man may be out of future MCU films. Learn more about your ad choices. Visit megaphone.fm/adchoices
2019-09-0742 min
Flicker EffectHobbs & ShawThis week , Michelle and David are going back to Cali as they revisit Once Upon a Time in Hollywood, plus Bobby talks about Hobbs and Shaw and The Farewell. Also, someone else has checked out Star Wars Galaxy's Edge. So go ahead and hit play to find out who. Music: “Whistle” by BenJamin Banger, on Instagram @BenJaminBanger and at https://www.benbanger.com Learn more about your ad choices. Visit megaphone.fm/adchoices
2019-08-061h 08
Flicker EffectMen in Black: InternationalMIB: International is out in theaters, and we're talking about it. Plus, did The Satanic Temple gain new fans in David and Michelle after watching the indie documentary 'Hail Satan?' Find out in this week's episode! Music: “Whistle” by BenJamin Banger, on Instagram @BenJaminBanger and at https://www.benbanger.com Learn more about your ad choices. Visit megaphone.fm/adchoices
2019-06-181h 15
Flicker EffectGodzilla: King of the MonstersThis week, David and Michelle discuss John Wick: Chapter 3, Game of Thrones: The Last Watch, Godzilla: King of the Monsters, and much more! Learn more about your ad choices. Visit megaphone.fm/adchoices
2019-06-061h 32
Flicker EffectEp 282 - Lego Movie 2, Super Bowl, and HamiltonIn our latest episode, Jascha shares his Super Bowl experience, David and Michelle discuss The Lego Movie 2 and their first experience seeing Hamilton, and much more! Learn more about your ad choices. Visit megaphone.fm/adchoices
2019-02-121h 10
Flicker EffectEp 274 - Ralph Breaks the Internet, Creed IIDavid, Bobby, and Michelle sit down to discuss Ralph Breaks the Internet, Creed II, the new Lion King trailer, and of course a little more Fantastic Breasts: The Crimes of Grindelwald talk has to happen. Learn more about your ad choices. Visit megaphone.fm/adchoices
2018-11-301h 17