Human Transcribed
Dominik Lysek:
With all the trends that we have in healthcare, we need to somehow accelerate the way that these products come to market and at the same time be sure that they have a positive effect and that the public really believes that.
Chai Nussbaumer:
Medical devices come in all shapes and sizes, and the rules for bringing them to the market are just as varied.
Micah Schweizer:
So how does this patchwork of global regulation shape what can actually be made?
Chai Nussbaumer:
In this episode, we're looking at medical device production around the world.
Micah Schweizer:
We'll talk with expert Dominik Lysek about what medical devices are, hear about some huge advances in the sector, and discover why the regulatory landscape could be changing very soon.
Chai Nussbaumer:
I'm Chai Nussbaumer.
Micah Schweizer:
And I'm Micah Schweizer. This is Balancing the Future from METTLER TOLEDO.
Chai Nussbaumer:
On this show, we explore the world of science and technology and the solutions transforming our lives.
Dominik Lysek:
So my name is Dominik. I'm a chemist by training with a PhD from the ETH. And then serendipity led to me being in a biomaterials company doing clinical research and also for a dental company. So those are the kind of redlines throughout my whole career. I then did a very short stint in a pharma startup before founding my own company, Credentis, where we developed a guided enamel regeneration system, a product called Curodont. Since then, I'm leading an electronic data-capturing software company called PharmaTrail, where we are trying to bring trust into the healthcare system.
Chai Nussbaumer:
And just to hone in on the term "medical device," can you please put our listeners all on the same page and give your definition?
Dominik Lysek:
Sure. So medical devices are pretty much anything that is used in medicine that does not have a metabolic or a chemical effect. Meaning we all know about drugs, drugs you take, and they do something with your body in the metabolic space. Medical devices are more physical. For example, because I come out of dental, a filling is a medical device because you just repair that tooth that has an issue. And these medical devices, as you can imagine, they span an enormous variety. They're about half a million on the market. They are from simple probes, metal objects to highly sophisticated robotics to biomaterials that are implanted in the patient's bodies. So we have something that really spans an enormous range, and that is also some of the issues that we are facing in that ecosystem or in that industry that whatever regulations, whatever laws they are, they need to cover all of those.
Micah Schweizer:
A half million of them?
Dominik Lysek:
Yes. Roughly about half a million different ones.
Micah Schweizer:
Now you gave the example of fillings, which hopefully I'm not the only one today in the conversation who has one or two, but can you give an example of some other medical devices that have recently solved problems?
Dominik Lysek:
Yeah. So all the AI supported diagnostics, for example. Again, let's come back to dental because I know that space. There are plenty of AI programs that read your x-rays to see that whether you actually need a filling or whether you may have an early lesion, and you can actually help regenerate that enamel. All these AI engines, they run under medical devices. And to give you a little bit of an outline because that is really where the world is changing at the moment at an incredible speed, the different areas in the world handle this very differently. For example, the US has approved close to 1500 AI-powered medical devices. The EU under MDD is not even at 300 yet. There is a whole innovation gap that at the moment also these devices are regarded high risk, so class three in Europe. Whereas in the US they are a majority of class two devices. They are regarded less risk and therefore are approved a little bit faster.
Micah Schweizer:
And so does that mean that depending on where one lives, one may or may not have access to new medical technology, new devices?
Dominik Lysek:
Yes. Back, until 2020, normally innovation came in medical devices via the CE label into Europe. And I know a number of American companies that first sought CE labels under the medical device directive, the old legislation. And I think we really had innovation on our side. Now anybody in the ecosystem has heard about the medical device regulation, the MDR, which is, for those of you not familiar with that, it provided such a high bar to bring a medical device on the market that now most European companies that have anything innovative go to the US and face the FDA preferably to facing MDR first. So perhaps as a little bit of an explanation, the FDA, 99% of the medical devices are cleared by the so-called 510(k), which is based on predicate devices. So meaning practically you are telling the regulator, "Look, I have this new device, but it's only incrementally innovative. It's not something completely and utterly new. I took something else and I made it a little bit better."
And the FDA hopefully provides you a clearance on that. And that clearance is worth forever unless it's revoked out of some reason. In Europe, it's practically everything that you now submit for a CE label to a notified body is regarded as a completely new device. And you have to provide clinical data for practically all of those. And that at first glance for an outsider might sound incredibly valuable because we know how it then works in the body, et cetera. But it is an incredible burden on the manufacturer because of clinical trial, it costs you two years, it costs you a bunch of money, and all that delays your go-to-market, but also it means you need to have a bigger business model in order to finance that ultimately. So the two pathways in the US and in Europe have gone very different ways.
Micah Schweizer:
And this seems to be a common story that the technology is outstripping the regulatory environment in many areas of life at the moment.
So if development is similar across the world, but the regulation is where you run into significant differences, then that affects where and how devices can be launched.
Dominik Lysek:
Yes. So because I also sit on the board of a number of companies, the pathway that I see most is you get your FDA clearance, and then you run a clinical trial in the US because there it's a post-market trial, which is then easier, lower regulatory efforts to run that. And you use that data, and hopefully that will be sufficient to get you European. And perhaps other there is something called an MDSAP, which then you can roll it out hopefully throughout the whole world. And then obviously China is another big market that people are looking at these days. But it's kind of where do you start? And that's also where you're going to launch first, and you're going to get your market access, and that market then profits from having those innovative products.
Micah Schweizer:
Because you have faster time to market in those places.
Dominik Lysek:
Exactly. By the way, also, the FDA has timelines, and they are pretty good in keeping those. Whereas the notified bodies, they don't give you timelines. That's a two-year project at the moment.
Chai Nussbaumer:
So you did talk a little bit about other major players in the world. Do you see as a future trend any other big players, such as maybe China, specifically in the medical device area?
Dominik Lysek:
Yeah. So I think China is definitely catching up. I looked at the numbers a little bit, and they are clearing about twice as many devices at the moment as we clear here. They have a way to catch up. And to be honest, I don't know the Chinese market very well. I would assume that a lot of low-regulated devices are out there, but if foreigners, especially foreign companies, come in and want to market their device, they need to have the Chinese FDA approval. And they are trying to really clear those at a very good rate in order to catch up. It's certainly a market that we cannot exclude. And at the same time, they're trying to bring their innovation out into the US and the European market because those are two very big markets.
Micah Schweizer:
Do you see any potential for harmonization in the processes in these major markets?
Dominik Lysek:
This is such a good question. I would love to see that. Actually, there was; before MDR came on in Europe, there was a trend within the FDA to actually go closer to the kind of CE label European assessment. Because MDR backfired so badly, it's actually now countries like Switzerland and the UK where there are political pressure there to actually say, "Look, if something is cleared in the US, why don't we just allow it here as well?" Because obviously the UK and Switzerland are not part of the European Union, so there is a little bit of leeway that they would have.
And I know it for Switzerland; there's been a political discussion about saying practically having our own regulatory approval for these products just simply for eight million people, nine million people; it makes hardly sense.
Chai Nussbaumer:
Yeah.
Dominik Lysek:
There is also in MDR 2.0, which has been submitted to the European Parliament end of last year; there is a little bit of a trend towards that kind of predicate if it's an established technology. And I'm really curious where the things like calcium phosphates would fall under that, ultimately practically saying if you are using components that have been used somewhere else similar to the predicate approach, you can have a little bit of a fast track.
Micah Schweizer:
Hey, Chai.
Chai Nussbaumer:
Hey, Micah.
Micah Schweizer:
Chai, since we're talking about major markets, do you want to hear about how long medical devices typically take to be approved worldwide?
Chai Nussbaumer:
Yes. Let's hear some stats.
Micah Schweizer:
Okay. As Dominik mentioned earlier, the FDA sets timelines. These vary depending on the class of medical devices, but on average, approval takes around 150 days.
Chai Nussbaumer:
That's pretty quick. And what about China?
Micah Schweizer:
There it's a bit complicated, but including the time needed to provide optional extra materials for review, approval can take anywhere from 12 to 18 months or even up to two to three years. However, if a device is particularly innovative, it might be fast-tracked.
Chai Nussbaumer:
And finally, what about Europe?
Micah Schweizer:
As Dominik said, there isn't a set timeline, so it's hard to say for sure. However, the MDR 2.0 regulation now being discussed in the European Parliament is considering a 255-day approval timeline. There are still some details to work out, and this could change as the regulation moves through the approval process.
Chai Nussbaumer:
And it also seems that MDR 2.0 will allow for types of data that aren't clinical, such as simulation or in vitro modeling, to be considered in the approval process. What won't change is the need for data with integrity.
Dominik Lysek:
We're coming for all the discussion that we had so far with all the regulatory. Why do we have regulatory? Because as a manufacturer, you are intrinsically biased. Let's face it, you want your product on the market-
Chai Nussbaumer:
Yes.
Dominik Lysek:
... and especially, you're a startup and you want to succeed. You don't want to come out and say my product is ineffective. So the regulator puts all types of levels on there in order to be able to show that your data is robust and has integrity. And therefore the public can then trust whatever you claim based on your product. So bringing integrity into that data is incredibly important. I think it's more important today than it ever has been because so much data is raised, so much data comes out of AI, where you really have very little audit trail for where it comes from. So we need to take an extra effort to make sure that the data that we use in order to show effectiveness has integrity.
Micah Schweizer:
And so this ties in then also to the trust that the end consumer has. It obviously has an effect on regulation as well if there's data integrity, but the end consumer also has to trust that the medical device that's being potentially put into one's body or that's analyzing results from a test is secure and is accurate.
Dominik Lysek:
Exactly. I think in everything that we do in the healthcare industry, we should always think about the patient ultimately. I mean, otherwise, I don't feel we have a right to exist as a company if we don't try to provide that. However, in many, many of the devices that we have, this is not a direct journey because a lot of that is B2B, meaning we are marketing to healthcare professionals. And in healthcare professionals also the marketing, you're trying to get so-called opinion leaders, key opinion leaders, that propagate your product. They need to believe your data as well because otherwise they will not go up on the stage in a conference and tell that your product works or has efficacy or is to be trusted. And again, the data that you provide to these key opinion leaders and to the profession in general, the integrity is absolutely vital.
On top of that, there is another thing that for somebody on the consumer side might not see that immediately, but because a lot of the startups want to get acquired by somebody larger and the large companies looking for innovation in these startups, it's also the companies that need to trust each other's data. Because I can tell you from my own experience, I went through many, many due diligences. We've gotten offers and some of them simply did not fully trust our data with their brand because that's what they are ultimately doing. Let's say if a large corporate buys a startup, they want to put their brand on it, but they need to know that this product is really helping and not destroying their brand. So if they want to do additional clinical trials, that's going to make it really difficult because they have a return on investment, let's say four years, two of those gone for another clinical trials. The value is going to be low.
Micah Schweizer:
So let's return to the conversation about regulations and also to product launches. Can you give any examples of changes in regulations that have helped drive positive change in the medical device sector?
Dominik Lysek:
So I mentioned the MDR, which I think the products that are cleared by the MDR are more trustworthy because you have to bring your own clinical data, et cetera. It has the big downside really that it's not clearing products fast enough. We have both in the US and in Europe, and I think even in China there are risk classes. And I think that is something we need to use a lot. Something that is of high risk should be regarded as such. Whereas if something is the 25th product that is pretty much the same, why does it take us two years to clear that if there clearly has been no issues somewhere else?
Micah Schweizer:
Do you have an example of something like that?
Dominik Lysek:
Yeah. For example, biomaterials, many of them, are made up of calcium phosphate. It's the same stuff that your bones are made out of. There really hasn't been much of an adverse effect for any of them. And the second part is, for example, any type of collagen products that mostly are still sourced by bovine or a porcine origin because you cannot synthetically build collagen in an economically viable way. Beginning of the 2000s, I lived in the UK. There was the big BSE crisis, and we put in this whole safety thing around it.
There've been a hundred tragic cases of new variant CJD where people got infected with that BSE human variant. None of them came via medical devices because medical devices, they control their sources. But we're still putting an enormous amount of obligations on the manufacturers and showing that their collagen, which is the same as 50, 100 other products on the market, still comply with all that. There, I think the US approach with the predicate devices where you can say, "Look, I am similar to this other, and I do my biocompatibility, and I show that I'm safe according to the regulation," is really much more the better way.
Micah Schweizer:
And just to clarify, BSE is bovine spongiform encephalopathy, right?
Dominik Lysek:
Yes, exactly.
Micah Schweizer:
But mad cow disease, in short.
Dominik Lysek:
Yes, exactly. Yes.
Micah Schweizer:
And who do you see as the primary beneficiaries if these processes become more efficient?
Dominik Lysek:
I think ultimately it's the patients because, as we discussed previously, there is valuable innovation out there, and we need to bring it to the market. And as long as it has a positive risk benefit ratio, the patients as a whole will benefit from that. And if I can't bring it to the market, I can't benefit from it. Obviously there is a whole economy behind it that will benefit as well. And I'm not denying that by any means, but ultimately it's the patient care that should be elevated.
Chai Nussbaumer:
Well, thank you so much, Dominik, for this great discussion. Do you have any final thoughts that you'd like to share?
Dominik Lysek:
Well, first of all, thank you very much for inviting me. I think the discussion that we had a valuable one because with all the trends that we have in healthcare, we need to somehow accelerate the way that these products come to market and at the same time be sure that they have a positive effect and that the public really believes that.
Chai Nussbaumer:
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Micah Schweizer:
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Chai Nussbaumer:
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