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 eff…

Why 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.Par Michelle Lott

Question, 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.Par Michelle Lott

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…

As 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.…

Many 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.Par Michelle Lott

You 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…

The 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.…

MDR 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 implemen…

Upload 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…

What 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 al…

Risk 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 v…

Orthopedic 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, …

There'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.Par Michelle Lott

Similar 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.Par Michelle Lott

Do 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 i…

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 a…

When 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 bo…

Digital 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 …

The 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…

So - 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 yo…

So - 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 alon…

Which 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…

You'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.Par Michelle Lott

In 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 tha…

Six 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 proc…

It'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.…

This 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.Par Michelle Lott

We 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 a…

It 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 dev…

Whether 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…

More 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'…

Does 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.Par Michelle Lott

Determining 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.Par Michelle Lott

No 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 a…

Are 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 …

The 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 limit…

Robert 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 d…

In 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/mentoringPar Michelle Lott

Have 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 i…

Protective 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.…

You 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…

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.Par Michelle Lott