What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing with regulators can be challenging and emotionally draining. Win in the U.S. and EU marketplace by delegating all things regulatory to a grief counselor.
In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Michelle Lott, Founder and Principal of leanRAQA. Also, she served a four-year term on the FDA’s Device Good Manufacturing Practice Advisory Committee (DGMPAC).
Michelle is on a mission to help smaller companies with regulatory strategy, planning, submissions, audit preparation and remediation, due diligence, quality systems, and compliance.
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Some highlights of this episode include:
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Why new clients work with Michelle: It’s easy to find a competent regulatory person, but how many are you going to enjoy working with and able to make you laugh when you really feel like crying?
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Even with the adoption of EU MDR, people are still in denial when it comes to those with certificates that expire in May 2024 and think they still have time to get certificates reissued.
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Several small companies, as well as large corporations, are choosing to not go to market or withdraw products in the EU because of the lack of value and revenue.
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The cost, clinical data, and limited number of notified bodies are some of the biggest challenges for those in the EU versus U.S. market.
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Companies should perform a market analysis to determine if their revenue model will support year-over-year costs and third-party fees to stay in the EU market.
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The impact to quality in the European healthcare system could turn the U.S. into a destination for medical tourism. It could happen if an analysis is not done by the government or competent authority.
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A quality management system (QMS) has to have an ISO 13485 certification in the EU. The U.S. doesn’t require a QMS until a product is put into commercialization and meets performances, standards, and expectations.
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According to Michelle, the five stages of regulatory grief are denial, anger, bargaining, depression, and acceptance.
Links:
Regulatory + Quality Assurance (leanRAQA)
FDA - Device Good Manufacturing Practice Advisory Committee (DGMPAC)
European Union - Medical Device Regulation (EU MDR)
FDA - Quality Management System Regulation (QMSR)
The Greenlight Guru True Quality Virtual Summit
Greenlight Guru YouTube Channel
MedTech True Quality Stories Podcast
Global Medical Device Podcast Email
Memorable quotes from Michelle Lott:
“If you don’t have a relationship with a notified body yet, you’re already almost too late. You just can’t make any commitments to or marketing plans for the EU right now, in terms of timing.”
“The first thing is to do that market analysis, and then, if they decide that Europe is still something that they want to do, second, you need to get in line with a notified body.”
“There’s no such thing as grandfathering underneath the EU.”
“There were 18,000 certificates issued under MDD, and only one percent of those have made it all the way through MDR.”
“To properly prepare technical documentation, it is truly a cross-functional effort and it’s going to require a lot of very in-depth expertise.”
Would you like to participate in an AMA (Ask Me Anything) session with this speaker? Head over to community.greenlight.guru and use the access code TrueQuality2022 to see what AMA’s are coming up.
Transcript:
Etienne Nichols: Hey everyone. Welcome back. Today we're going to be talking with Michelle Lott. Michelle Lott is the founder and principal of Lean RAQA Lean RAQA. She and her team have supported over a hundred companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services, and what she calls grief counseling.
Because dealing with regulators can be emotionally draining, her clients delegate those things to her so they can focus on winning in the marketplace. Michelle has served a four-year term on the FDA Good Manufacturing Practices Advisory Committee, otherwise known as the DGMP.
As we all know, we love her acronyms.
She holds a Bachelor of Science in Chemistry from Troy State University and Certified Executive Leader in Regulatory affairs from RAPS and the Kellogg University.
Today we talked a little bit about the differences in the US versus the EU and the regulatory pathways and some of the pros and cons and some of the hurdles that you'll have to go through with each one of these different markets.
Hope you enjoyed today's episode. We'll see you next. Hey everyone. Welcome back to the Global Medical Divides Podcast. This is Etienne, your co-host. With us today is Jon Speer, the host of the podcast as well as the founder of Greenlight Guru.
And also, with us today is Michelle Lott. We're gonna be talking about some of the challenges of the US versus EU and your go to market strategy, how that impacts investments and so forth.
But before we get into that, Michelle also has a podcast. Would you want to talk about it just briefly before we, I mean, so we don't forget?
Michelle Lott: Yep. So, my own podcast is RAQA today and you can find me, you know, Apple, Spotify, you know, all the places where you get your podcast.
Etienne Nichols: All right. You know, I see you on LinkedIn sometimes. You make maybe complex, maybe not complex, I don't know, it just depends on your perspective. Different regulatory topics. Really kind of fun.
And I assume you probably do the same with the podcast. So.
Michelle Lott: Yeah, you know, I tell when I get new customers and they're like, well, why should we work with you? And I say, well, you know, it's easy to find a competent regulatory person.
But how many are you going to A, enjoy working with, and B, are going to be able to make you laugh when you probably really feel like crying.
Jon Speer: Michelle, we've known each other for a few years, but my favorite thing that you did was leading up into the EU MDR go live, and you had the T minus, you know, X number of days and all these sorts of things.
And I think it was super helpful because I think a lot of people sat on the sidelines thinking, oh, I got plenty of time, blah, blah, blah, or they're going to delay it.
Are they going to push? And of course, they did because of COVID but, you know, without that reminder, I have to wonder how many folks would have been struggling, you know, with their new MDR adoption.
Michelle Lott: Well, and, you know, I had the T minus going, but now I have the T plus going because I feel like people are still in denial, you know, in two separate ways.
Like, the first is the people who have certificates that expire in May of 24, and they think that they still have enough time to get their certificates reissued. And it's like, okay, if your technical documentation isn't turned in, in full in December, you're not going to, you know, have a continuity of your CE mark in any form.
And then there's still people.
I thought this was funny. I lost business that I was quoting on because the potential client went with a consultant that could guarantee that they would have a C marked by May of next year.
And they hadn't even talked to a notified body yet. They hadn't even, like, made a phone call. And I'm like, I can't even guarantee you I care how to get somebody to look at your documentation before May of next year.
Jon Speer: Right. How did that turn out? Did you happen to hear the. The. The result by. I'm just curious.
Michelle Lott: No, that was just last month. So, I'm like, okay, great, you found somebody that lied to you. You know, basically.
Jon Speer: Oh, good luck. Right.
Etienne Nichols: So, yeah, at least they'll get their money back with that guarantee. Oh, my goodness.
Michelle Lott: Maybe.
Jon Speer: Wow.
Etienne Nichols: Well, so I'm curious. So, we got the T plus. Now, are there any T minus dates that we should be thinking about or. Obviously, this is the big one, the T plus.
Michelle Lott: Yeah. It's just that if you don't have a relationship with a notified body yet, you know, you're already almost too late, and you just can't make any commitments to or marketing plans for the EU right now.
In terms of timing, I've talked to.
Etienne Nichols: A few companies that they've looked at the EU MDR requirements, and they've actually made the strategic decision just to let their CE mark go and they're just going to pull out of EU.
Have you seen things like that and any comments or thoughts?
Michelle Lott: Yeah, so I have seen, you know, a lot of small companies, they just are choosing not to go to market in the EU.
But then I've even heard that companies, you know, as large as Nestle are withdrawing up to 20% of their product lines that are, you know, almost like commodity products because the value and the return on revenue is just not there to maintain MDR.
Etienne Nichols: What's the main thing that holds people back? I mean obviously it's a big documentational challenge, but what would you say? I don't know if you could pick one or probably half a dozen.
What are your thoughts?
Michelle Lott: I think it's the cost and also the clinical data challenge. You know, it used to be that the FDA had the reputation of requiring a lot of clinical data being more difficult to get to market than a notified body.
And under MDR that paradigm has shifted to where, you know, companies are bringing their product to market in the US first because of the burden of the clinical data in the EU.
I mean I have a client that makes wound drain catheters. It's just a silicone tube with a hole in the end. That's it. They were up classified to Class 3 under MDR, and they have to have full out clinical trials for a product that's been on the market 40 or 50 years.
Jon Speer: Holy cow. I mean that's crazy to think about. I mean to go to class three. I mean, I agree with you. I think the clinical aspects are really causing a lot of challenges for folks.
How are you seeing companies address that though? I mean, because I think for a lot of folks this is like of all the requirements of MDR, this is probably the newest part of MDR that maybe, you know, they had bits and pieces of, but generally they didn't have the whole post market clinical follow up and all those things once you get to market.
I mean some of those products obviously require clinical data to get to market. But what are companies doing? How are they addressing this in an effective way?
Michelle Lott: I think that the companies who have got, you know, kind of newer or novel technology where they were going to have to do a clinical trial for one purpose or the other are in better shape than those with that long standing, you know, technology that's been on the market for decades.
I think that a lot of those commodity products still haven't Figured out how they're going to cross that bridge because you can't, you know, us, you can use real world evidence.
That's not a thing in Europe.
And they don't really consider like your complaints or lack thereof to be. It's just a small portion of what they consider clinical data.
Etienne Nichols: So, you alluded to the timeline or being able to or not being able to get your CE marking with the guarantee. What do the timelines look like right now?
Michelle Lott: So, the actual review is taking the better part of a year or more, so 12 to 18 months. And then once you get through your review, it's still taking another six months or more to get your certificate issued or by the notified bodies and the competent authorities.
Etienne Nichols: Okay, wow.
Jon Speer: I know leading up to the EU MDR, one of the big challenges then, and I suspect this is still the case, but very limited number of notified bodies.
I mean I can remember, you know, just being a few months out and I was like, there was still only right around 10 notified bodies. How many notified bodies?
Michelle Lott: I think up to 28 now, you know, and that's down from, you know, almost 130, you know, that were originally designated underneath the MDD, so.
Jon Speer: So, there's still a bottleneck there, right?
Michelle Lott: 100%.
And the competent authorities aren't getting notified bodies designated.
You know, you would think that as we were getting closer to the certificates expiring that they would be, you know, kind of pushing the notified bodies through to accommodate the certificates and make sure that, you know, Europe doesn't lose access to important products.
But that's just not the case.
Etienne Nichols: So, what do companies need to be doing right now? I mean, I guess if somebody doesn't have that put together, there's a drop-dead date.
Michelle Lott: Yeah. So, if you want to go or to stay on the market, I think that's the first decision is to do a market analysis to find out if your revenue model is going to support the year over year cost.
Because you've got notified body fees that are recurring, you've got authorized representatives and now you have to have a UK authorized representative, an EU authorized representative, a Swiss representative. You might have to have Northern Ireland if you don't have the right combination of marks and representation.
And so just the third-party fees alone are exorbitant. So, the first thing is to do that market analysis.
And then if they decide that the Europe is still something that they want to do, the second, you need to get in line with a notified body.
Most, if you're not already an existing client, they're Just not taking new applications. They'll say, you know, call us back in a year and see where we're at.
Jon Speer: So, I'm curious, you know, let's say I'm a company that has products on the market and you know, I'm a little late to the game but you know, I'm like following Michelle's advice, I'm going to reach out to my notified body or what have you.
And they're like, well, here's our timeline and it's, when I add it up, it's going to be, you know, beyond that, May 2024. Is there any recourse or is there any like, you know, if I'm in the queue with my notified body, can I present some sort of, you know, information or documentation to the competent authorities that says, hey, we're working on it, can we keep our products on the market or is it just going to be, you know, either you got it or you're out of the market?
Michelle Lott: You know, I think that that's the big unknown and that's where everybody I think is still speculating a lot.
The competent authorities haven't published any type of thinking or transition plan beyond that. The certificates are just not going to continue to be, are not going to be viable and they haven't published any ideas on what are they going to do with the product in that limbo period either.
Like, are we just going to all of a sudden in 2024 have Europe without, you know, important life sustaining devices? I mean, you know, as simple as a wound drain catheter is, you know, try having an open-heart surgery without one.
Jon Speer: Exactly. I mean, I think that's like, to me like the bigger, I'll say gotcha. I guess for right now it doesn't seem like anyone from more the competent authority side of things is looking at the impact on the quality and the health care system in Europe because of this.
And it's like there's got to be, surely someone somewhere has done some sort of analysis that says, hey, this is the potential issues that we could see in Europe. I mean, I hope anyway because you know, then you can see, can you imagine the United States becoming a destination for medical tourism?
I mean, that's pretty happen, right?
Michelle Lott: Yeah, yeah.
You know, the problem is I don't know if anybody in the actual government did the analysis. You know, I'm sure there's healthcare agencies and you know, an industry has done their own analysis.
But the government in Europe got such a black eye after the PIP scandal and you know, they were already in discussions about the medical device regulation. But when PIP happened, you know, they got a black eye for not protecting their own patient populations.
And so now they've just gone to the opposite extreme in an effort to try to prove their patient population aren't getting pigs basically for the rest of the world.
Etienne Nichols: But so, one of the things when I see these companies pulling out of the EU just saying, hey, we're just going to let it expire, it's not impossible. You know, I have some conversations with other people who say, well, once you do EU MDR, you'll never go back.
So, I'm curious where your opinion is. You know, you're a little closer to the true regulation. What is your opinion of the actual regulations?
Michelle Lott: I think if you're going to bite the bullet and do MDR, I think probably other geographies are going to be a breach in comparison.
You know, short of maybe, I think Japan is still pretty rigorous, but, you know, definitely to get MDR CE mark, I think will definitely set you up well to enter the US and Australia and some of the other markets.
It's just the sustainability of it. And you know, and that's another big difference with how products come to market and the US is that, you know, it's a linear flow.
You put your submission in 510(k) De Novo PMA, it goes through their review process, and it comes out, and your device is cleared. And unless you make changes that require you to do a new submission, you don't go back through that process.
But in the EU, you're going through that process, you know, with your quality management system into an extent product changes annually and then a full recertification every three years.
Etienne Nichols: Wow.
Michelle Lott: There's also no such thing as grandfathering underneath the EU, you know, so like if a technical standard, say, you know, 60601 for electrical safety changes from the time you first got your product authorized, you have to redo all that testing. So it's a living system.
Etienne Nichols: So, you do have to follow the updates to other international standards. Okay, interesting.
Jon Speer: Well, Etienne, I think you started off by saying something along the lines, sort of comparing and contrasting EU versus us.
Is my memory correct? Yeah, it's only been a few minutes ago.
Etienne Nichols: So, the challenges of the two. Yeah.
Jon Speer: All right, so we talked a lot about the EU side of things, I guess. What are some thoughts? How would you compare and contrast that with FDA?
Michelle Lott: So, there's a couple of things that you have to keep in mind is, you know, we just talked about the kind of a more linear submission process.
But then the other part of that is the quality management system, which is where you guys really play and help out, you know, and you have to have an ISO 13485 certification for your quality management system, which is yet another fee and certificate and hoops to jump through things to maintain.
And those are, you know, annual.
And if you have critical suppliers, that certification body will be going in and auditing your critical supplier’s quality management system as well.
And all of this has to kind of all come together at the same time.
Well, in the US they don't even really require a quality management system until you put your product into commercialization.
And so, I see all kinds of startup companies that don't have design controls, that didn't follow a process, you know, and they were having to reverse engineer their entire documentation once they put a quality management system after their submissions in place.
So, it's just very much more of a living. You know, you're going to maintain a lot of certifications, you're going to maintain a lot of testing and you're going to have to keep your product.
You know, you might have to redesign your product as you go as well in Europe to make sure it can past these changing performance standards and expectations.
Etienne Nichols: So, it sounds like even though it's a little easier to go through the FDA, you could potentially have a better product coming out if you started going the EU MDR process, potentially based on the design controls and the reworking of some of the documentation after you go to market. Is that kind of accurate what I'm hearing?
Michelle Lott: Or your product is going to be living and it's going to be considered whatever the EU has turned to be state of the art because that's how they define state of the art is with technical performance standards.
I think it's very interesting. When ISO 14971 was updated in 2019, they added a definition for state of the art for the first time.
And guess what? State of the art is not state of the art. It's like by this we do not mean the most technologically advanced or progressive, we mean generally recognized as safe.
Jon Speer: Yeah, I mean some of these terms are definitely interesting when you apply them in the medical device industry because, you know, a standard, by the time a version of a standard is published, it's definitely not current, most up to date way of doing things per se. I mean, that standard probably took a couple of years at least for that to be revised.
So yeah, sometimes there's things that are, you know, state of the art from a standard perspective. Which you know, is the opposite of that definition for sure.
There are some things about the EU MDR. I mean the fact that there's an, we'll say an attempt to implement these policies so that you treat your products as a living thing.
Right. I like that part of it. I like the total product lifecycle approach. I mean I'm a big fan of making sure your design controls and your design history file and your risk management file always are a current representation of your product.
But you know, it's that flip side that the way in order to do that or to demonstrate that is a little bit onerous, you know, so it's like how can we find that balance in between.
Michelle Lott: Yeah. And the ongoing cost of, you know, staying up with those performance standards as well, you know, so that's yet another layer of cost and expense.
You know, I think you’ve mentioned my LinkedIn and you guys have probably also seen the different stages of regulatory grief that I talk about.
You know, I think a lot of companies are still in the denial stage and I think that until we get into MDR where MDD and MDD certificates don't exist anymore and have that is the reality.
I think that there's going to be a lot of companies that continue to just denial and hope is not a regulatory strategy, you know, but they seem to be running their businesses like it.
Etienne Nichols: My own personal question. So, I'm curious how you walk people through those different stages of regulatory grief.
Michelle Lott: It's a lot of hand holding and there's just a lot of. I use what I call a submission risk matrix for those areas that you know, I can't get the client to, you know, stomach or buy or they just want to, you know, take the risk and let's see what happens, you know. And like so I'll keep this running list of these things that we can't, you know, get agreement on and ideas for them for a potential mitigation and you know, what can happen with their submission.
And we all have to at least, you know, agree to disagree on those points.
But like just for instance, biocompatibility under the MDR and under changing expectations with FDA, there's no such thing as a well-known material anymore.
Like you are going to have to do significant testing on your own device, and you can't just say this is made out of silicone and silicone's been used in medical devices for 50 years but still have clients who insist on hey, let's write a rationale about.
These are well known materials, Jon, you.
Jon Speer: Know, you’ve been doing helping companies with this transition now? Well, ever since I assumed it was announced that this was going to happen. I hope you got some success stories or, or at least some examples of instances where the company like they did it, you know, and this is how they did it, this is how they went into it. I guess share some of those insights with folks so that they can see it's, you know, it's easy to push it off and say, oh, you know, maybe something will change.
I'm hoping. Right, but like you said, hope's not a strategy.
For those that are being proactive about this. What are some things that you've seen go really well?
Michelle Lott: Well, and first, let me just even put some context around how many MDR certificates are even out there.
Only 1% of the certificates that were issued under MDD have been through. Those same people have got MDR certificate. So, we're not talking about there's not this huge amount of people with success stories because, so few have gone through it at all.
And I think that there were 18,000 certificates issued under MDD and only 1% of those have made it all the way through MDR.
So, you know, I think it's just, it's not going to be fast if you do it. You have to like really own it. You know, you can't rely on rationales.
I think the people that, you know, almost treated their product like this is brand new and almost started scratch with their testing, you know, I think have succeeded much easier than people who were trying to, you know, just ride that wave of well, we've had a CE mark forever.
It's not going to really be that different, you know, that did much more than just update their GSPR checklist and call it dart.
So yeah, I think it's going to be the testing, the not making rationalizations, not making justifications and having everything done when you turn it in and not waiting for the notified body to tell you that something's inadequate or turn something in in advance of your testing being.
Etienne Nichols: Completed or updated and as opposed to.
Michelle Lott: I'm sorry, this is a good one.
Etienne Nichols: Yeah.
Michelle Lott: You know, it takes a village now to write a submission.
It used to be your regulatory people, you know, would go in a hole and you know, they would come out, you know, with maybe engineer and the clinical person.
But now to write, to properly prepare technical documentation, it is truly a cross functional effort and it's going to require a lot of very in-depth expertise in things like biocompatibility, sterility, packaging.
So, you know, It's a very much of a. It's going to take a village now. It's not just a reg. You're not going to be able to silo your regulatory people.
Etienne Nichols: So at least one of the things that I'm kind of taking away from this is there's definitely a more robust testing requirement.
So regardless of whether you're 304, stainless steel or silicone, you're going to have to start really be thinking and focusing about biocompatibility, cytotoxin, things like that, or at least an assessment of those.
Okay, interesting. What other things would you say are stark contrasts, that if you haven't, maybe you could get by without it in the FDA. You're not going to get by without this in the EU MDR. Anything else come to mind? And it probably depends on the device.
Michelle Lott: I'm sure that. Sorry, what'd you say?
Etienne Nichols: Well, I. It may depend on the device too, I suppose, but, yeah, those are the.
Michelle Lott: Biggest things that we've already covered.
Etienne Nichols: Okay.
Michelle Lott: I think that, you know, a big difference in how that you have to approach not just the regulatory agencies, but your strategy is in your fundraising.
I see, you know, two mistakes that people are still, you know, I'm in a lot of angel groups and I'll still see pitches that, oh, we're going to go to Europe first.
I'm like, 2017 called and wants this regulatory strategy back.
Or I see people that are pitching, and they are saying the right things, they're aware, you know, of that they're going to bring it to market in the US first. But then I'll hear their investors say, oh, 20 years ago I had a huge exit because I had this great, you know, European business and why aren't you going to Europe?
And I'm, I'll call investors out. I'm like, you are just, you know, giving this person bad advice that's going to cost you to lose your money.
Because again, you know, 20 years ago called and wants his strategy back. It's just not a thing.
Jon Speer: Yeah, there was a period of time a few months ago that I had a conversation with a few folks, both from US and EU, and basically what they said then, and I suspect that that's probably still very, very true now, is startups especially, they're not going to Europe first.
It's not the more favorable market. I mean, used to, like you said, you know, 10, you know, 15 years ago, Europe was a more predictable path because, you know, I could understand it a little bit more clearly. But it just seems strange that Today FDA is the more predictable path, you know, and who'd have thought that you know.
So, I do agree. I think all these startups, if they're thinking about, you know, and I guess folks, if you're listening and you're thinking about going to market in Europe first, you might want to reach out to someone like Michelle because she can help educate and inform you of the perils of that thinking. So, beware.
Etienne Nichols: Yeah, one of the other things I'll just throw out since we're maybe talking advertising for example, for Michelle specifically, we're actually going to have a panel at the True Quality conference in San Diego where we actually talk about the go to market strategy, EU versus the US Michelle's one of the highlights of that panel.
I couldn't tell you who else is on that panel right now but definitely check that out. We'll have the link in the show notes. You can look a little bit more into that.
Michelle Lott: I have this conspiracy theory about that. It's like a macroeconomic model because if you think about the people in that are large enough that sit down at the tables with the regulators and are part of you know, the companies that are sitting there helping to drive these changes, it's not the small to mid-sized companies that are defining the future of regulations.
It's this behemoth that already control large parts of the market. Well, they don't do their own innovation anymore. They're not doing their own for the most part design and development.
They acquire startups and their technology and that's how they build their product portfolios. Now well before you know, a company would have this global commercialization strategy to get its valuation up and now if the regulations prevent you from being able to go into a global commercialization strategy and the valuation of your company is based off of a US market share alone, you know, what does that do for your multiple and your exit strategy? And all these companies can get these startup companies for virtually a song compared to what they might have if they had a true global presence.
Jon Speer: Sadly, that's so true. I think it's now more than ever challenging to be a startup in the medical device space. I mean, you know, I've been in this space since 98, so I guess that's 24 or so years.
You know, I can remember back in the day, you know, maybe, let's go probably 15 or maybe 20 years ago that there was decent amount of funding available for startups at that point in time.
But that's not non-existent. But a lot of that, that's Gone away or it's being invested much later in the company's maturation process. I mean the cash cover, seed funding and things like that, seed capital and that sort of thing is harder and harder to come by.
So that friends and family and you know, the early angel or two round has to carry a company much, much further. And now it's compounded by, you know, this new twist from a regulatory perspective where essentially, you know, most companies, not all, but they look at the US and Europe almost as a 50, 50 market share, you know, of their total opportunity. And now you cut part of that off. I mean that's another handicap against the startup. So, I'm sure startups will survive and they'll figure it out.
But you're right, I mean there's a lot of cards that are against them right now.
Etienne Nichols: So, my question about that though is to go back to your conspiracy theory, Michelle. If these behemoths are the ones influencing the regulations, which I totally agree, and they are making it more difficult for the startups but then if they acquire these startups, let's say at a discounted rate, they still have a lot of legwork to do to get that product to those other markets.
Or is there a piece I'm missing here?
Jon Speer: That's the point, right, that's the point, you know, to play along with the conspiracy theory is it is, you know, if I'm 800-pound gorilla making the rules and I make it so difficult for you to follow those rules.
But I like your technology, I'm going to get a deal on that because you can't survive long enough to make it into those markets. Whereas I have the capital and the resources to make it so now.
So, and I have Brian's will, you.
Michelle Lott: Know, I'm already doing it. We already have the quality management system that's compliant with MDR. We already have our ISO certificate. Don't worry, you're pretty little head about those things.
Yeah, but I'm not going to pay, I'm not going to pay you for them either.
Etienne Nichols: Well, I guess the startups need to band together somehow. I'm not sure how it's going to work but follow Michelle on LinkedIn.
Jon Speer: Actually, a good idea. What if all these startups could like form some sort of alliance or something, you know?
Michelle Lott: Yeah, it's a pipe dream of mine that one day like I want to start like an advocacy group for startups and small companies and be that voice and have them organize and you know, I've kind of started doing it to a point in the US with, you know, just trying to get people organized around comments on key guidance documents and putting them on the Federal Register.
And so, you know, I think it's just really important that they have the, you know, you have your say. It's the same thing. If you don't vote, you shouldn't get to complain against about public policy.
Jon Speer: Right.
Michelle Lott: Well, if you don't tell the FDA when they're asking for comments, if you don't participate in that, should you get to complain about what comes out of it?
Jon Speer: I think here's another thing that when I share this statistic with folks, oftentimes they're very surprised.
Like 80% of medical device companies globally have 50 or fewer employees.
I mean, that's the overwhelming majority of companies would be considered small companies.
And to your point, the companies that are making the rules, I mean, there's like 10 of them. Right. And they're so frigging large that 2%.
Michelle Lott: 2% of all medical device companies are those big boys.
Etienne Nichols: Yeah.
Michelle Lott: FDA calls a company large if they have over 50 employees. That to FDA is a big medical device company.
Jon Speer: Right.
Michelle Lott: It's not a big company, but it's a big medical device company.
Jon Speer: Right. So, you know, I want folks listening because there's at least an 80% chance that if you're listening, you're probably work at a small medical device company, 50 or fewer employees.
We need to all band together and have a voice. I mean, follow Michelle, you know, to her point. There's guidances that are published often draft guidances, you know, or Federal Register where FDA is soliciting comments and feedback.
You have that opportunity to chime in. You don't have to work for one of the 2% very large companies to do so. But if you don't say anything, the big boys, they have teams of people that. That's all they do is focus on that. And if you don't chime in, others will be making the rules for you to follow.
Michelle Lott: And just so everybody knows how these comment period works, is the FDA has to respond to every comment left in the federal registry. It's not that they can just read them and say, that's nice to know, or that's something to think about.
They have to like actually articulate comment by comment a response to it.
Etienne Nichols: I didn't realize that. Interesting. Yeah. So, I mean, I can just think of a few draft guidances that are still out there. I think the QMSR and the cybersecurity, which I know there's a lot of discussion around right now. So yeah, that's a lot of opportunity.
Michelle Lott: QMSR comment period is open until I think the third week of May, May 24th or so.
Etienne Nichols: Very cool. Any other thoughts or comments you'd like to just give the listeners or recommendations before you see them in live? Of course.
Michelle Lott: But yeah, so on my website I have got a market analysis tool and a regulatory pathway assessment.
And if you are thinking of going to Europe or staying there and you have not done that, you know, download those, give me a call, put some time on my calendar, and let's talk about it from, you know, first a business perspective, but then a regulatory perspective to see if this, you know, is something that makes sense for you.
Etienne Nichols: Awesome. We'll include those as a link in the show notes as well. Very cool. All right, well, Jon, anything to add?
Jon Speer: No, I'll get.
Michelle Lott: I look forward to seeing everybody in person.
Etienne Nichols: Me too.
- We can get back together. I'm really excited.
Thank you all for listening. You've been listening to the Global Medical Device Podcast with Michelle Lott. Check the links in the show notes. We mentioned a few different things throughout the episode.
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