RAQA Today

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 implementation (spoiler alert: it ain't pretty).

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 future might hold for both sides.

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 all of the EU's problems, we did touch on some of the biggest challenges facing manufacturers.

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 very heart of risk management, then this is the podcast for you.

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, 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.

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.

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.

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 is required and the impact it can have on your final product design.

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.

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 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 - and share what you can do to make sure you don't end up with an MDR or FDA-induced hangover.

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 more. In this podcast, we dive into the whys and the hows of regulating digital health while still managing to bring products to market.

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 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 rail at the insanity that has been the entire EUA process.

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 your product move smoothly through the submission process and on to premarket approval.

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

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 each stage of the product life cycle.

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.

In this final segment from

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 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.

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.

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 an entirely new mindset.

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 device to market in Europe.

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 avoid them.

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'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 step.

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.

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.

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 and the risk of radiation exposure in a sun-filled hospital room.

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 actually may overlap in a variety of medical device scenarios.

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 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 the original post and instructions for submitting your comments to the Federal Register: https://leanraqa.com/regulatory-quality/fda-down-classified-classification/

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 did not malfunction. We removed all references to other notified bodies from the podcast, but decided not to annoy you with the delete beep.

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/mentoring

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 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 Enjoy!

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 and requirements for a "simple" surgical mask. (Hint - there's no such thing).

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.