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Medical Device and IVD Global Market Entry Strategies | LSI Europe '22

Speakers

Peter Bowness

Peter Bowness

VP, Regulatory Affairs, Europe, MCRA
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John von Benecke

John von Benecke

CEO, Locate Bio
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Glenn Stiegman

Glenn Stiegman

Senior VP, Clinical and Regulatory Affairs, MCRA, MCRA
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Erica Conway

Erica Conway

VP, IVD Regulatory Affairs, Europe, MCRA
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Integrating regional approaches into a global market entry strategy.

Transcription

Erica Conway  0:10  

Thank you very much. Warm Welcome to the panel. Today we're going to be discussing medical device and IVD global market entry. And in particular about integrating regional strategies. I'd like to first of all, welcome to the panel, my fellow macro colleagues, first of all, Glenn Stiegman. He's the Senior Vice President of Clinical and Regulatory Affairs for MACRA. And then on the end, we've got Peter Bowness, who's the vice president of Regulatory Affairs and operations for Europe. Very warm welcome, today to joining us is John von Benecke, from Locate Bio, who's bringing innovative ortho biologics to the market to join this discussion today. So in particular, we obviously the current situation is that there's a lot of challenges people are facing at the moment, both the regulatory framework as well is also changing, which is perhaps needing a change in regulatory strategy. But actually, what is the reality? So in Europe, there's been a lot of changes, in particular at the moment that have affected planning, and how does this impact your global strategy in bringing a medical device to market. So I'm going to start off then by setting the scene, given the European perspective. So there's many face many challenges at the moment, in particular, in Europe, a lot of uncertainty. And that's bringing a lot of complexity in regulatory burden to medical device development. And also we have the backdrop of Brexit. And here in the UK, again, sort of impacting how devices are going to have to think about coming to market. So in particular, in Europe, we have the transition from the medical device directive to the make medical device regulation. And that transition, as you know, we are more than five years on from the publication of the regulations. And yet still, there's significant infrastructure that's developing or missing. In particular, we have huge very much still in development stages. And there's been a lot of discussion, and we're hearing a lot from manufacturers about concerns of notified body capacity, and how that's how that's affecting them. So real good question for us to discuss today is right, whether actually that impending deadline of May 2024 for the medical device regulation, will that actually see all safe medical devices coming to the market, under the regulation? Just touching on the UK, then the UK, UKCA legislation, currently under redrafting. So there's a lot of uncertainty, again, in bringing devices to the UK market that needs to be considered at the moment, the UK is accepting the CE mark until the end of June 2023. So, you know, again, we're having to think about planning and how we bring devices to the market. There was a consultation on the new UK framework, the output of that consultation has been published, which gives us a little sense of the direction that things are moving in, again, a good discussion point for today. But there is ultimately a lack of clarity. And that, again, is impacting manufacturers. So for diagnostics, the new IVD regulation, actually there's been a significant change to diagnostic developers. And in particular, devices have been reclassified. So this is actually quite huge. And that change from directive to regulation really wasn't going to happen in five years. So much. So a new regulation was published at the beginning of this year to change the transition provisions. Again, the infrastructure for the IVD regulation is still evolving, they still have lots of questions. We don't know about high risk devices, how companion diagnostics are going to come to the market effectively. And in particular for diagnostics, that concept of clinical evidence is quite new, and quite a shift for manufacturers to think about the UK legislation, we're getting a sense of, actually the direction that that is going in. And in particular, we see, yes, there's movement towards the EU framework, but maybe looking more wider. It's international harmonization. We all are very familiar with self test COVID-19 assays. And actually, in the UK, there's been a very specific approval process for COVID-19 assays. And again, this experience may influence future legislation. So overall, then the European Framework, this regulatory change is seeing that manufacturers innovators, those bringing new devices to market have to really think about their planning, and potentially pivot and adapt what they're doing. So I'm going to hand over to Glenn now to give us a perspective of the US market.

 

Glenn Stiegman  6:07  

Thank you. Thank you, Erica. So first, I wanted to sort of set the stage, what we've seen in the past 20 or so years, I was at FDA for for many years. And I can tell you that just about every company that came to me would say, Hey, we've been CE marked for a decade. And coming from FDA, oftentimes, we would say, well, we don't care, you're still going to need to evaluate it and follow our regulations. But the trend at that time as as much as a decade ago, and maybe as early as five years ago, that everyone would focus their marketing and commercialization in Europe, and then move over to the US and they had gathered their clinical data there, get an understanding of their indication their patient population, how to properly study their technology, and then come to the FDA. Now, if you talk to companies, they're completely changed that around and looking at the US and the FDA first and then moving over to the EU. And we're consistently seeing that trend, as we meet with companies at LSI here, and LSI in the US, we're continuing see their focus first on the at the FDA in the US and then moving slowly over to Europe or other even other markets such as Japan, and AIPAC. Now the FDA is goal really, and this is not a fancy language that I chose this is from their website is to facilitate the development and regulatory evaluation of innovative medical devices. And so when they're getting on slotted with, you know, the trends and technology advancements that we see today, that, you know, they need to come up with practices that are able to streamline these products and get them in the hands of physicians, and caretakers, such that the patients can benefit from them. So how do they how do they do that? Well, there's a number of different programs and some of these everyone has seen, and come to love. And I'll start with the global harmonization. And given that we're going through or on the back end of a pandemic, some of these are actually utilized. A lot of these are sort of conceptual in nature, or are not maybe utilized as much as they should be on the device side. They're really starting with the drug side and moving slowly over to biologics and devices. You know, certainly the international medical device. Forum is one outlet that people are trying to collaborate together internationally more than the harmonization. And as you go through the FDA webpage, you see the collaborative communities. You know, these are bringing together various stakeholders trying to unify and be consistent with the way they regulate. Same with the mutual recognition agreements, where they're getting actual agreements between different parties to better regulate products. But again, mainly pharmaceuticals and drugs in these in these efforts. Now, the FDA Partnership Program is something that I've actually had to deal with myself on various products, we actually helped a company with a drug coated stent. And given the pandemic, we had the FDA actually reached out to other regulatory bodies TGA and Australia, PNDA and Japan, where this product was actually already on the market and utilize their auditing system and some of their overview and review practices to help the FDA actually get that product approved. So it actually works, but again, because they had a drug component, they're able to utilize utilize that program. The single audit mdsap That's a very popular program. We have a lot of comp buddies get through that. And it just eliminates the the auditing that a lot of companies do, again, trying to harmonize from area to area across the globe. And then real world evidence and real world data. That is something that's obviously a hot topic, FDA is continuing to come out with a lot of guidances on this, their acceptance of it can be a little bit sporadic. I can't say that they're just blanketing a yes to real world evidence, they oftentimes will poke holes in it to a point where you're all of a sudden running another randomized controlled study, but it is an outlet to learn. And if you work with the agency, then you can get make some headway with getting your device approved. Now, the US initiatives we're probably a little more familiar with, obviously EUA has emergency use authorizations, that's, you know, sort of the buzzword of the year last year, with COVID. And the vaccinations and some of the personal protection devices that were that were approved. The breakthrough device program is is also a very beneficial pathway, or at least it has been in the past. I think the FDA is continuing to see an onslaught of breakthrough opportunities, and submissions, and they're trying to filter that process a little bit more in denovo 510 K's while those have been around for years and years and years, I think as technology advances, especially with the digital health technologies and products, where they are low risk, but they are also filling a gap where you know that nothing existed before, we're doing a lot more to novice and FDA is seeing a lot more to novice. And then And then following up with the medical device development tools. Again, yet another opportunity for companies to work with FDA to qualify various tools to assess and better regulate various products. And then education, digital health, cybersecurity, and then safety surveillance. So all of these programs are in place that the FDA uses, how it affects all of our lives, it remains to be seen some of these we see pretty much daily, others are more theoretical in nature and sound good on a website. Now, our approach to this process, especially from a global perspective, Erica gave us a good overview from the EU perspective. And so when we approach a client or have a client approached us, we try to develop sort of a global plan. And we really start with sort of the user need, like what what do you actually need? Again, some people want to solely focus on the US. Others want a global plan, they want to understand how can we run one clinical study? How can we do one thing one time, and it fits within the MDR and with FDA, and with other other markets? So first, you have to understand what is needed from a preclinical perspective. Cybersecurity is a big one. biocompatibility is another big one that we're consistently, let's say bickering or negotiating with FDA, as to how to get past that particular point to engage the FDA on the actual regulations. So understanding how this how your product is regulated in the US how its regulated, and per the MDR is critical, because that's going to set the stage for not only your preclinical evidence, but also your clinical data, which is that that third step? And how do you get that, you know, what is your plan of action? Are you going to run? Gather real world evidence from the EU? Are you going to start an IDE in the US? How is that going to transpire to get the information that you're going to need for a US marketing application or a technical file? And then considering reimbursement within the scope of that from day one? You know, figuring out what is the reimbursement pathway if it's a me too product, as I already have a code in the US what is the reimbursement in Europe, formulating and figuring that into your clinical study design is critical to be success from the commercialization standpoint. And then last but not least the quality system, sorrows, the Forgotten child out there, you know, the quality systems in Europe and in the US. they correlate pretty well but not not one to one. So ensuring that you have the right quality system in place as you begin marketing, your technology. Look, thanks. Turn it back over to Erica.

 

Erica Conway  14:35  

Yeah, thank you very much, Glenn. So just to start that panel discussion, Glenn. So then sort of following on from your slides. So what are you seeing as the key challenges to bring in devices to the US market?

 

Glenn Stiegman  14:51  

You know, I think you know, technology is advancing so unbelievably quick, especially in the digital health world and a lot of a lot of companies here are in the digital UCHealth imaging type space as well as neurologic space. And, and oftentimes, that's a little bit foreign to the FDA. So you really have to be able to communicate effectively on what patient population, you're treating what you're trying to create. So they give you the advice that you need to push forward. Some people jump over that expecting the FDA is all knowing. But really, they're they're learning at the same time you're teaching. So you really have to take a step back, think about it, like you're explaining it to maybe your child and say, here's what we're trying to do step by step by step. And then you can start building on that experience to formulate a good plan.

 

Erica Conway  15:42  

Yeah, it's really, really good point. And so, John, you're bringing the perspective of innovators, you've got lots of experience in bringing innovative technologies to market. And you've, you've been doing this for a number of years, right? So how have you seen changes in legislation, we're talking about, you know, the US thinking about new innovation, and they can adapt very quickly. How's that impacted your strategy and bring in devices to market?

 

John von Benecke  16:16  

Yeah. So I've been fortunate enough to be involved in two med tech startups that have gone to incredible exit events. And their strategy is almost directly contrast to the strategy we're executing it Locate Bio so their strategies are the first exit was maybe 10 years ago, and the last one, maybe three years ago, their strategy was very much Europe first, it was seen that you needed a small amount of money, it was less onerous, you could get prove to the investors that you could convert science into a product or product into regulatory approval and establish early commercial traction. And then your growth phase came when you unlock the US and the acquisition happened shortly thereafter. Now, for us at locate, buy, the exact opposite is true. Now, I think it does depend on the specific product. And for us, you know, if you're talking about a class to be implantable, Europe has become incredibly challenging. It's always been a smaller, less attractive market opportunity. But it did make sense if you could raise a certain amount of money and had an unknown milestones, whereas now it's recovered in this form. So for certainly for us, we're pretty much exclusively focused on the US for all of our pipeline for all three products.

 

Erica Conway  17:26  

And so touching on Europe then. So I think, John, you've touched on there about the fact that the change in legislation is increasing that burden. So Peter, from the X notified body perspective, we've both been at a notified body. How do you see the current situation of medical device directive to regulation? We're not We're not far from that deadline. So what's your perspective on the impact on that?

 

Peter Bowness  17:58  

The complexity, I think, is the biggest change. So the regulation itself is inherently much more complex. And as the the requirements are much more onerous, there's a lot more sort of things, milestones that manufacturers have to meet and that the notified bodies have to assess. But you couple that with the capacity crisis is that is the probably the best way of describing it. It's a capacity crisis in the regulatory system in Europe, where the notified bodies are so overwhelmed. There, they were learning themselves, many of them have already just been designated, you know, BSI, they've been around now designated for a few more years. But even there, the processes are developing, that's further compounded by the fact that every time a new MDS eg guidance document comes out, you know, that it has to be retrospectively applied to ongoing application. So suddenly, manufacturers are having to comply, you know, potentially for a submission that they've put in 12 months earlier, they now have to change that process. So it's always this constantly shifting goalposts, which adds so much unpredictability to the system. And like I said, couple that with just the inherent complexity increased from MDD to MDR. And from IBD to IBD, you know, it's just this perfect storm of, of, of regulatory disaster in the in the making.

 

Erica Conway  19:13  

So I think there's two points there that we can pick up on, first of all, capacity. And, you know, as people are bringing new devices, the audience here is about innovation, new products. What's the impact then on? You're talking about notified body capacity, actually, their view at the moment is about switching directive certified devices, these are already on the market. You know, John's talking about switching strategy to us, is that impacting getting innovative devices to the market? I think,

 

Peter Bowness  19:49  

for the most part, innovation has essentially stopped in Europe during the transition period. The because of those capacity constraints and because of existing relationships between notified bodies and manufacturers. of legacy devices, they have to focus on that transition for their existing client base. So new companies coming in. And I've experienced this directly by putting out inquiries to notify bodies on behalf of companies and the responses, "We're not taking clients, we don't have the capacity right now, we can't even engage with them to talk to you", you know that it's just this closed door. So innovation has essentially stopped in that regard, certainly, from a regulatory perspective, because there's just no access, you can't access that regulatory process anymore, because they're notified bodies don't have the capacity to take that on. So that's definitely having an impact. And we can see that not just with Locate Bio, but across all of the manufacturers we've spoken to today. And yesterday, they have literally shifted, they say, well, we can't access Europe, we're not going to try it. There's no point anymore, we'll go to the US. And when things are a little calmer, when the dust is settled after the transition period, maybe in 2025 2026. We can we can reevaluate it. But at the moment, it's stifled everything.

 

Erica Conway  20:55  

Yeah. So I think we can come back to discuss that a little bit more. So just going back to your perspective, then John, on bringing innovative devices to market? What's your view on the new regulation? So this was brought in on the back of hip, fraud? What what do you see is the impact of the regulation now to in the future for the European market?

 

John von Benecke  21:25  

Yeah, I mean, I have a fairly disappointing view, I think on on that, you know, I think it's right, there's criminal acts, which they've now created a bunch of more legislation to try to solve. I mean, the point about being a criminal is you don't particularly care what the law says. So I'm not too sure. That's the right method of improving that. And I think innovation in Europe will suffer as a consequence of that, you know, and all med tech startups are only as good as their next funding round. So we're always looking to our next funding round. And the one thing you want to be able to do is, make sure you achieve the next value creative milestones that you can unlock the subsequent funding round. And I think you've now got this fog in Europe, which is a combination of uncertainty and everyone's uncertain, you've got the resource crisis, not only at the notified bodies, who I think have been punished through this transition, as well. But also, you've talked to any my peers, their most valuable resource are totally the internal regulatory people, because they're so scarce now. So it's, it's hit both the notified bodies and industry about being able to access those. So you know, it's very fortunate that you can rely on people like Mikra, and get fractions of people's time to complement it. But you know, I think innovation in Europe will suffer for, for quite some, some length of time, I think, relatively few products, new products, suddenly the innovative ones weren't becoming, and I think a lot of the existing products will come off the market, because the economics of keeping them on the market simply don't work.

 

Erica Conway  22:56  

So I think we should come back to break through in a moment. And I'm just gonna touch before we move on to that, because I know that companies out here, it's all about innovation. So let's just come back to in a moment. But Peter, I just want to go back very briefly on that capacity because it affects everybody. A lot of and a lot of people in the room about getting a notified body if they've got it. You know, planning is key planning ahead. Recently, MDCG, so the medical device coordination group brought her to a recent guidance if you haven't seen it, 2020 to 14, forgot my numbers, looking specifically at notified body capacity, and actually what what could be done, right, because 20 months is not a long time in medical device approval processes. What do you what's your view on whether you think, elements in that guidance, or is that going to work? Or is it actually too little too late now?

 

Peter Bowness  23:59  

I mean, the context to that particular the MDC 20 2214, is the European health ministers went to the MDC EG and said, We cannot have a situation where all of these devices lose their certification in May 2024. Fix it. The MDCG's response was to issue this document, the bulk of it seems to be pointing finger at the notified bodies and say work more efficiently. Well, the notified bodies are working as efficiently as they can, considering the requirements that the MDCG themselves are imposing, and given the complexity of the legislation. So in itself, just saying do better, isn't helpful. Now, there are some interesting provisions in there. The main one is a maybe a little bit of an allowance for notified bodies to issue certificates provisionally or to interpret maybe less clinical data but have robust post market clinical follow up to fill that bridge because that transition away from equivalence, which is now incredibly difficult under the regulation has left a lot of manufacturers exposed to not having sufficient clinical evidence. So perhaps that Probably the most concrete item in that document to give the notified bodies just that little bit more flexibility. But the other one, the other one that was interesting, was just a comment that if a new MDCG document comes out or new guidance comes out midway through a conformity assessment process, they don't necessarily have to apply it to those ongoing applications. So that will reduce the complexity a little bit. But I feel like this is very much tinkering around the edges. Now, I think it is too little too late. We're 20 months away. And they need to do something to fundamentally address that pending sort of cliff edge, you know, a manmade healthcare disaster in Europe that is encroaching, nevermind innovation and what's coming next, which is bad enough. But taking those legacy devices and the potential for those to fall off the market is is horrifying. And this MDCG document does not go anywhere near far enough to address that problem.

 

Erica Conway  25:49  

And of course, one of the issues that was always the case when the new regulations came out was the Commission said, these are no regulations. There's no grandfathering. And actually, this comes back to a little bit about actually, if we could accept that we're transitioning from one to another, it might actually help the capacity, but I think just that complete absence of ability to see grandfathering is okay. You know, yeah, and

 

Peter Bowness  26:18  

There's a lot of decisions that compounded this, for example, you know, for drug device combination products, and for devices that use THC susceptible materials. The Commission's position was you have to repeat that consultation even though the drug hasn't changed even though the source material hasn't changed. There's a repeat requirement. Now this is further complicated by Brexit because the MHRA, as a competent authority probably conducted about 70% of drug device evaluations, and of TSE evaluations. So there's no capacity in the competent authority system to take on those repeat consultations. Because the MHRA has stepped away now know a lot of the other competent authorities HPRA in particular, are trying to boost their capacity. But again, it's not fast enough. They're complicated processes. They're complicated devices, you can't just bring somebody in and train them up in three months. It takes a long time. So that's just adding little decisions like that have added to that complexity and the difficulty with that transition. Where if there's no change in the drug, if there's no change in the source material, why repeat that the legislation governing drugs, the legislation governing, TSE susceptible animal products hasn't itself changed? So why repeat? So there's, you know, compounding issues that are avoidable? Had decisions gone a different way.

 

Erica Conway  27:27  

Yeah. So so I'm going to come back to break through devices, because I think everybody here wants to know about innovation. So Glenn, significant experience at the FDA, and continuing to understand what's happening at the FDA, what's your view on how successful that breakthrough designation, pathway has been for medical devices in the US?

 

Glenn Stiegman  27:52  

No, I think you know, of all the initiatives FDA has undertaken for this harmonization, but also from the getting good technologies on the market, or at least, putting them on a little bit of a pedestal, while they're continuing to study them. Not yet reached market, the breakthrough program has been one of the most successful. Now with that, you know, the FDA, or at least CDRH, the device side of the FDA is quite expansive, quite diversified. So the FDA is interpretation of what his breakthrough has been a little inconsistent. You know, we've successfully argued and and for those maybe in the audience that don't know what the criteria for breakthrough designation is, you know, a product that has the expectation to be more effective, and irreversible, or debilitating condition. And really, there's a lot to that. And there's other criteria you have to meet. But that's really sort of the tagline of, of the breakthrough program. And there's a lot in there, you know, the expectation, the more effectiveness and the irreversible and debilitating condition, all can be argued in front of the FDA. Now, the FDA has welcomed the breakthrough program, for the most part with open arms. But what comes with the breakthrough success and the granting of a breakthrough designation, is a sprint discussion with FDA, which means you're getting in front of FDA, communicating with them more frequently than you would through the Q sub process, which is, you know, a 75 to 90 day process. The sprint conversations can happen within 30 to 45 days. So you're engaging them you're creating this alliance with FDA, which usually always ends in a successful outcome. But given the FDA is open armness, if that's even a term of accepting breakthroughs, they overwhelm their system. And then you get to a capacity crisis, like Peter was talking about, where they're making these promises of a sprint conversation within a certain timeframe, and they can't commit to that anymore. So we're seeing a lot of our breakthrough successes have sprint conversations, but they're on the timelines more of a pre sub at this point, which is unfortunate. And they've also sort of taking taken a step back, just because you have a breakthrough for a certain indication means, okay, they've accepted that as an irreversible and debilitating condition, and does your product meet the other criteria, and oftentimes, we can be successful. But now they've taken a stricter view on that definition. So while we were being tremendously successful in the, in the program, now we're starting to see some pushback saying, Well, wait, you know, and I don't know if that's an impact on change in definition of what they see as breakthrough. Or they just realize, Oh, my God, we're gonna have to now follow up with these front conversations, and we just don't have the capacity.

 

Erica Conway  30:48  

So, so coming back them from the perspective of the innovator, then John, so how, what sorts of things would you like to see, in terms of future framework? You talked about shifting that perspective, from the US to Europe? What's, what's your view?

 

John von Benecke  31:04  

Yeah, and I think just just to echo some of Glenn's points, MPSAP helped Locate Bio secure to breakthrough device designations. And I think there's something was a subtle shift in the FDA perspective, when engaging those conversations, which is more collaborative than perhaps in the other way, in terms of what I would love to see. And I think all of my peers, who are chief execs of innovative companies would like to see, you know, if you've, if you've gone to the trouble of getting a regulatory approval with a highly competent organization like the FDA, then it seems to me that it ought to follow that provided your indications the same, the homogeneity of the patient population between territories is the same, you know, that she does, we'll read across, right, we shouldn't have to then reinvent a completely different technical assessment. So you know, mdsap has has been a good first step around quality systems. What we now need to see is that replicated from a technical assessment perspective, and that just resolved so much of the thinking, and strategizing early Medtechs have to do which is, you know, the thinking about, well, what's the more attractive market? And can I get there? And where's the uncertainty because it will open up incremental market opportunities for the same effort. And I think that's the key for for innovation.

 

Erica Conway  32:28  

And so, thinking about that thing, coming to Europe, Peter, we've got the changes CMDR, which we've spoken about, there isn't really a provision in there is there in the same way, in Europe. So what's your view on whether that might be a possibility in the future, we've got an open, blank page in the UK is that, you know, somewhere perhaps could be a foothold. To get onto the market,

 

Peter Bowness  32:57  

I certainly don't get the impression that your European Union is prepared to flex on their requirements, you know, the, they've always been very black and white, you've had that legislation since 2017. Get on with it. This is this is the deal. The UK certainly has an opportunity, as they develop their own to either recognize what they consider to be complementary, or mutually sort of quality pathways from the US or from Europe, or from Switzerland, or from Japan, that gives them that advantage to be a little bit flexible in that sense. I'm not sure Europe will follow. But possibly from as you mentioned, the consultation on the UK future of the UK legislation certainly implied that it was going to be relatively closely aligned to Euro to the EU, the MDR. So there's a potential there for maybe a mutual recognition agreement between the UK and Europe, if we can get over some of our political differences at the moment. But that's going to be done down the line in the future. I don't think there's anything in the short term that we're going to see to allow that kind of Global Innovation alignment, which will really help you know, certainly in the UK, definitely helping the EU given that that sort of barrier to innovation, that the MDR is representing the UK is where the opportunity lies to recognize these global pathways. I don't see the EU following suit anytime soon.

 

Erica Conway  34:15  

Yeah, and and I think the first page of the consultation with the MHRA, they don't want to stifle innovation. They want to have legislation that can can respond. And so it seems interesting that they're looking at domestic assurance, which would allow the recognition like you say you do it once you put all the hard work in and perhaps an add on to get to the UK market, but certainly far off in Europe. We've got a couple of minutes left, we should probably just recognize just coming back to John's point about there are initiatives if you're interested, the IMDRF have got working groups looking at a global technical review program. So maybe that's something that will happen in The future but it probably isn't moving as quickly as everybody everybody wants it to. So any final, final questions amongst the panel,

 

Peter Bowness  35:10  

Less of a question more of a comment, I think the one positive outcome that we're seeing a little shift in from the European Union of late, there was there appeared to be a slight step back from the use of international standards. And the fact that they weren't quite aligned to the MDR, the the European Union seems to have listened quite well, to the stakeholders involved in this and to the standards organizations around Europe and the world. And there's the reengaging, I think more much more fully and completely with that standards process, which is good, because it means those international standards will still form the core of a lot of the technical requirements underpinning the MDR, and ivdr. So again, those are international. So they're recognized in Japan, they're recognized in the US, they're recognized in the UK. And now they're definitely recognized for Europe as well, which is a huge benefit from that harmonization.

 

Erica Conway  35:59  

I'm just going to let Glenn give perhaps some of our closing comments. What do you see is the future direction from the US perspective, we've heard obviously, the direction in Europe?

 

Glenn Stiegman  36:14  

Well, I think, you know, I think in general, I'd like to see the continued push for the global harmless harmonization, I don't know how successful it will end up being, you know, from the FDA perspective, I do think they're making strides to you push innovation quicker. But as, as they continue to push as fast as they can. Innovation is knocking on the door even harder. So where's the give and take and you know, it and think people I mean, some of the some of the technologies and products I've seen here are just mind blowing. And, and for the FDA to wrap their head around that. And especially if it goes across multiple centers, and the complexity associated with that, the FDA tends to get themselves all bound up in a ball not knowing really how to regulate this, how to advise companies to do that. So, you know, I think just the the engagement, the interactiveness. And the partnership, you have to go to the FDA with in the level of transparency and a lot of companies, you don't necessarily that they're apprehensive to go in with such open arms and such transparency. But I think to get success, you got to partner with someone that knows what they're doing. And they'll make strides and then you you plow your own ground. And, and really set your own rules at that point.

 

Erica Conway  37:43  

Okay, John, you've got 30 seconds to tell us a cut. If you were giving two pieces of advice to the innovators out there. What would it be,

 

John von Benecke  37:52  

I think, invest heavily, very early on to understand the regulatory clinical and reimbursement framework. That's something for small startups that they won't have all those expertise. So go and find other companies that you can work with, like Mecra who can bring that and I think just be focused, focus on the simplest way to get to your next investment, I would say,

 

Erica Conway  38:14  

yeah, thank you very much. Thanks very much, everyone. Thank you.

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