Winning in the EU Crafting a Bulletproof Clinical Strategy

Good morning. Good afternoon, everyone. My name is Sean Smith. Welcome. To today's webinar. I am pleased to introduce Leah Wetlaffer and Dr. Bettina Martin from the yoner Institute who are going to speak to us today about developing a bulletproof clinical strategy. This is an exciting topic, and it's very timely considering the struggles that people go through in preparing their clinical. Oh, for for Cr and Mdr, so with that I have a few housekeeping announcements. And they are. This webinar will be recorded and the recording will be made available by email tomorrow. At the same time. To everyone who is registered, you will receive a link and a passcode, allowing you to view the thing.

If you do not, you can go back to the registration page and just register and watch the thing. Secondly, the slides will be available, and those will be included in the same email. 3, rd should you like to have a certificate of attendance for today's event. Please include your name as you would like it to appear on the certificate and your email address in the chat button. Use the chat and Q&A buttons rigorously throughout this webinar. We're going to hold questions till the end. However, please submit them at any point during the webinar using the Q&A function. Lastly, this is part one of a 3 part series. I'm going to put details of the next 2 sessions along with registration links

in the chat button. As soon as I get done running my mouth. The last thing is there will be a poll at some point in the 1st 20 min or so asking you a few questions, and there will be a survey at the end. I do ask that everybody participate in that. And the final announcement that I have is I don't know how many of you saw it but recently yoner Institute has released a free version of their post-market radar tool. And that link is also in the chat. I encourage you to take advantage of this free tool because it's huge time saver, and you won't regret it.

That is all I have. I'm going to turn it over to our speakers today and thank you. If you have any questions. Please put them in the chat for me, and let's get started.

Thank you, Sean. And now I will share my screen. So I guess now you can see my screen screen, and I will start with a presentation so welcome to the Webinar today, winning in the Iu crafting a bulletproof clinical strategy, and, as Shawn already mentioned, my name is Leah Metlaufer, and my focus is since 8 years the clinical strategy.

Leah. They do not see your screen.

They do not see the screen. Okay, thank you for this information. This is this is a topic we can handle. So now, okay, so again, the name is Leah. Thank you for the information that the screen was there. And yeah, I'm a strategy. Strategic clinical affairs manager at Uni Institute since 8 years, and the focus is, of course, the clinical evaluation under Mdr. The Clinical Strategy. And we support clinical studies. And if you want to send me an email feel free to use the email address or

contact me via Linkedin. You can use the QA. Here and the webinar we are doing because of our mission. So the mission of the Una Institute is to help medical device manufacturers to overcome regulatory challenges and bring your products to the market faster, and therefore this isn't the only webinar we have. There are 2 more webinars. One is done, or it will be done by Bettina and the other one by my colleague Johannes. and there are more topics about clinical trials in the second one, and the 3rd will be about a step-by-step guide for clinical market access.

So but today it is all about the clinical strategy of clinical evaluations under Mdr. And so let's start with the topic. and I would like to start with a short story to introduce the topic. So a few years ago I was sitting with a director of a Medtech company, and he was so frustrated. His product already had market access in the Us. But getting Iu approval, felt like an endless hardly raised to him. and he said, it will be so complicated, too expensive, too unpredictable. And today his products are successful on the European market because he choose the right clinical strategy under Mdr. And that's what today is all about how to save, especially your time and your money with a clever strategy without getting lost in the regulatory jungle. Okay.

I will show you the 4 key success factors today that successful manufacturers use, and I promise, if you implement these principles, the path of the regulatory approval will be easier and more efficient. Yeah. there are some or number of stories, even under Mdr. Where manufacturers manage to bring their own medical devices to the market in Europe under Mdr. And all these manufacturers have certain things in common. They follow very clear rules and strategies, and especially with regard to the clinical strategy and clinical evaluation, because the clinical strategy can in turn decide how much money and how much time you, as a manufacturer, have to spend on the authorization of the medical device.

And do you know what the very 1st thing is these companies do when they have a new product idea? I will tell you they talk to each other, and this means that all the people from different areas come together and start by formulating the intended use. And do you know why large companies do this? Because they know exactly that if several departments are not connected with each other, then this can lead to problems at the final approval. For example, shortly before Ce. When the file is submitted to the notified body, and therefore the 1st key factor is, please start with the intended use.

And this is why the 1st key success factor is, start with the intended use. Because your clinical strategy will be based on the intended use. And if we have a look in the development process of the product, it will look like this. You have the product idea. And if you have the product idea, you will also start to identify your intended use, and then you should start to plan the clinical evaluation and the clinical strategy in your clinical evaluation plan, because you get information from your intended use

for the clinical evaluation planning. And then afterwards you put the information from literature search of the clinical evaluation plan back in the development plan of your prototype of the product. And if you know early in the beginning that you may need to collect clinical data because you planned it in the clinical evaluation plan. Then you are able to plan your clinical investigation very early. Do or run the clinical investigation save the time until the Ce. Mark and then put it in the clinical evaluation report.

If you don't do that in the very 1st very early beginning of the clinical strategy. Then you lost time. Because if you do not know that you maybe need to collect any clinical data, then you want to have the Ce. Mark. But the notified body will tell you that your clinical data is not enough, and then you need to go through the clinical investigation and lose a lot of time. and not only a lot of time. You will also lose a lot of money, because not only the intended use is very important to plan with clinical data or any other data. So if you have any clinical claims

which maybe need the collection of clinical data for the approval. Then this is also very important to know at the beginning of the product idea, because a clinical claim may be come from marketing which is not validated by your clinical affairs. Manager can lead to very high costs before you get C. Mark. and this is a topic you need to know, because this can lead to high costs and very much time before you get your Ce. Mark. And to get this a little bit more practical, let us assume that you are a manufacturer of a common coat pack. Okay.

the code pack is for contusion and pain reduction. So pain reduction is the benefit of the product. and the performance of the product which reached the benefit is cooling the temperature over 20 min to a temperature of 13 6 degrees. and therefore giving an enig effect coming from the cooling. And now this is your intended purpose or intended use from the medical device, and you need to show in the clinical evaluation which part of that needs clinical data or do not need clinical data. And therefore you need to identify

parameters to each of the performance benefit, and, of course, of the safety. And from these parameters you can transfer, if you need clinical data or non-clinical data, I will show you on the next slide. How it looks like in the clinical evaluation, for example. in the clinical evaluation and clinical planning, you will do it, maybe in a table, and here you can list the clinical performance and the cooling of the tissue which describes the clinical performance. Then the parameter is the temperature which is measured by, for example, non-clinical testing, and we have the specification or the acceptance criteria of 13 6 degrees after 20 min, which reach the energetic effect. And this comes from literature.

By the way, these 2 topics are given in the state of the art, or you get this from the state of the art. The parameter to your specifications. Okay. then, we have the clinical benefit. And this was the pain reduction in our cold pack, and from the state of the art. We know that the pain reduction is measured by pain, intensity, and the specification listed in the state of the art is a pain reduction of 30% after 20 min. And this is not only, or these 2 parameters are not the only ones you need to give more information on the clinical safety as well, and the clinical safety parameters.

and we know from the state of the art of our product that cold burns are a common risk from similar devices, for example, and the parameter could be the severity and the probability of that occurrence and the specifications you can also get from the literature. Search. Okay? And if you have this table coming from literature and coming from your intended purpose, then you can go through these parameters and think, okay? For which one I need the patient to measure the parameter

and to get the information on that. And I think it's really clear that only the pain, reduction, and the severity and the probability of occurrence of cold burns are needed to measure with patients or on patients. and this is because only the patient himself can feel the pain, and there's no clinical test set up for this. We can just easily measure the probability of Burns or other risks occurring in a larger population that actually use the product. This means that we get this data most appropriately from the Pms system, from similar products or from the literature research.

and in our example the performance validation can be often done by technical testing or non-clinical testing, as it is called by the Mdr. And an example to measure the tissue temperature or cold application ability. You do not need a patient and this means that we now know what we need or don't need based on the purpose of the information from the literature on the parameters. Okay, so start with the intended use and then get your parameters from the literature. Search to think about how or for what kind of parameter you need clinical data for the validation in the clinical evaluation. That's 1 part of the clinical strategy.

You need to use the right or the correct clinical data strategy because the notified body want to see the right strategy. And this is not going to be easy, and therefore I would like to give you more examples on 3 different products. So we have at 1st a bed pen washer. and the second one is a spirometer. The 3rd one is an implantable device, so an autopathic plate and I will go through these 3 devices with several clinical strategies which we have supported in the past. So

the 1st one, the 1st device is a device for, let's say, disinfection of bedpans and cleaning of them. and it has no completely no interaction with the patient. So only the medical staff is using this product. We have also no clinical risks. When we look in the clinic in the risk management. So no remaining clinical risks and the manufacturer do not do any clinical claim like our bedpan washer is saving lives or something like that. And we have a good product standard which is describing the performance of this device and the safety of this device.

And with this device we did the strategy with non-clinical data for the approval of the device. This is called the article 61, 10 in the Mdr. Meaning that you do not need any clinical data for the approval of your medical device in the clinical evaluation. Because of several topics. You do not have any interaction with the body and the product. You have no clinical risks remaining, and there are no clinical claims which need to be supported by clinical data like pain reduction.

and then the performance. So the disinfection performance is shown by the product center of the product, and therefore the performance and the safety is shown by non-clinical testing, and the benefit was shown by the state of the art information coming from similar devices or state of the art. Okay, then, we have the second one. The spirometer is used to measure the air volume coming from the lungs, and this product has direct interaction because the patient is blowing in this product.

and there were no clinical risks and no clinical claims made by the manufacturer. There's also a product standard for this product, and we we planned Pms. Measures for getting the safety information. and this product was approved under Mdr. With performance testing in the 1st time. But we were able to collect clinical data in the Pms phase. And we planned this in the Pms and Pmcf plan. Because, why? Why was this possible? We could show that this is a common technology, because there is a product standard which shows that the performance of that device and the safety is given.

We did the test from the product standards. and then we show that the design and the product, the product group itself, is very well described in the state of the art and the clinical benefit and the diagnostic accuracy as well, and therefore the notified body was fine. That we are doing this approval of the of the medical device without clinical data in the 1st step, but get more data to the safety afterwards in the Pms phase. And then we have the 3rd product, which was the implantable device. So this device is more for stability of the bone, and of course it is the direct interaction, because it is an implantable device. So we have clinical risks, and we have clinical claims but a little bit different to the other twos.

This product has a long market history, so this product is on the market. Since, let's say, 40 years. And we have Pms data available to the safety. And if this is given to your products, for example, that you have a long market history. You have a stable design in your product, no changes in the product design, and the state of the art is well described for this product group to performance and safety and benefit. Then you are able to go through Mdcg. 2026, which is telling that you can go the well established technology strategy. This is possible for devices which were on the market for a very long time and fulfill the parameters I already mentioned.

And yeah, this is the 3rd strategy I would like to show you without a clinical investigation to get the clinical approval. Okay. you know that there are a lot of strategies we can go. There are much more than I showed you today, and it always depends on the product and product history you have. And there are. there are different types of strategies which can be very cheap or very expensive, or very easy or heavy, and the easiest way, and the cheapest way will be the performance strategy. So, as I mentioned for the backpan washer, it was Article 6,110, and we know that a lot of manufacturers would like to go through this or with this strategy, but that this is not possible for every product.

Please remember, there was no interaction between the body and the product, and the performance testing was was able because there was a product standard. For example, okay, so article 61, 10 is not possible in every case. but it is very cheap and very easy. The second one is as well easy, but not cheap because it is very expensive. This is a clinical investigation. So clinical variation planning with clinical investigation very expensive because it costs a lot of money. If you need to do a clinical investigation. But it is easy to explain to your notified body that you will do a clinical investigation. Of course.

a little bit more difficult to explain. the strategy is the equivalent. Yes, I have no example today for equivalence, because equivalence strategy is not that accepted anymore? Yeah. The Mdr shows that equivalence will be able to do. But to be honest, there are only a few cases where we can use the equivalence even for implantable devices and class 3 devices. It will be very hard, maybe, not. Not

not possible, to go with this strategy. And then we have the well established technology under Mdcg. 2026, as I mentioned, to the to the bone plate. So the implantable device and this is very cheap because you do not need to have an investigation before you get your Ce. Under Mdr. But it can be very heavy to discuss this strategy with your notified body, because a notified body needs to. Very good. Understand the product and your strategy you're going through in the clinical evaluation.

Okay? Last, but not least we have a middle thing strategy, which is not that heavy and not that expensive, but also not cheap and not easy. This is the performance strategy and the the Pmcf. Investigation afterwards, which was shown by, for example, the spirometer and this could also be heavy. Because you have to make it clear to your notified body that also you need clinical data to prove safety, even if you do not see this necessity for the approval, but do see it for the Pmcf phase. So there are a few examples where a clinical review will actually go along with this strategy. But it is possible.

Okay, so again, use the right or the correct data strategy to make your notified body happy. And another key factor, success factor, will be the following. please be careful with your clinical claims, because clinical claims can cost you a lot of money, and I will give you some information to that. So remember the call pack, please. We have said, or we have said, that the intended purpose and the benefit is reduction of pain by contusion. And

this costs some money. Okay, then, your marketing is coming and say, Okay, please. I would like to have more claims for the marketing materials, and I would like to have, we are 10 more effective than nice. This means that you need to show that you or your product is 10 times more effective than ice, and this means that you need more data to prove that so more patients in the maybe in the clinical investigation. And then you need to compare this with your own product. And then you need to show that you are 10 times more effective in pain reduction than ice. That's not that easy. So please be careful with marketing claims

another claim could be. We want to say that instant wound healing is possible. Our cold pack stops pain faster than any other. So this means that you do not have that. You not only have one indication to show here in the claim, you say, okay, we can do wound healing with our cold pack. That's not so clever because you now need to show that you're able to heal wounds, and that your cold pack is better than every other cold pack on the market, meaning you need a follow up, maybe in the data collection.

And you need more patience to collect clinical data because you have one indication more, and you need to compare to all the other products on the market. And this will be very, very expensive. Okay, so please be careful with your claims, and then last, but not least. now, the opinion of your notified body. Not that easy. I know. But we have the situation that each of the notified bodies has a different interpretation of the Mdr. And a different idea how to applicate the rules of the Mdr. And not every notified body would have accepted the examples I showed with the spirometer or the implantable device I just placed.

and intensive exchange with experienced auditors and technical reviewers, as well as an understanding of regulatory discussions and perspectives among each other, has become more and more important than ever. and we have already worked with many notified bodies and our customers to successfully bring the medical device to the market and therefore know exactly which notified body would focus on which strategy and which product. Okay, no, you're notified body's opinion. And this is also just just one note. This is also

possible when you go through an structure dialogue with your with your notified body, because if you have evaluated your clinical strategy in the beginning of the development, then you can go with this topic to your notified body and talk to them about your clinical strategy. To be a little bit more safe in the approval of your medical device. Okay.

The quiz of the poll, if I may. You can keep talking. I'm just gonna it's 5 questions. If they're just answer these.

So summary. What have we talked about today? So the 1st key success, strategy is. please talk to the others in your company, especially to marketing, know what your colleagues want to have in the marketing materials, so that you, as a clinical affairs manager, can can evaluate them. So the second one was, start with the intended use and set your clinical strategy based on the intended use. And please transfer this in parameters and get to know which data you need, based on these parameters and then use the right clinical strategy based on the rules of the Mdr. And the Mdcg. Depending on your product and your product history. Of course.

please be careful with clinical claims. and know your notified body's opinion, and use the structured dialogues. They were very helpful in the past. Okay, so I'm very happy to have any questions to that. And yeah, maybe, Sean, you want to say something for the quiz. All sort of.

Well, while the survey is running, there have been a number of questions that have been submitted. and I'm just going to start with the last one, which is, would only performance data be accepted for products like tubing that carries medical gases, since they are not directly in contact with the patients, even though they may be classified as 2, a devices.

Tubing devices.

Tubing for carrying gas, medical gas.

Yes, I guess they have an interaction with a notified body, with the body of the, with the body of the patient. Sorry.

I would think so.

So if there is any interaction, then it depends on the product. So this needs to be proven. In this case, I guess, because any interaction, any indact, any direct interaction with a notified with the body, sorry with the body, needs to needs to verify.

It also might be an option if it's a part of a system only. Yeah. So if maybe the medical gases is the medical product and the tube is just a part of a system. This can then be only be on performance data. However, Leah is correct. If you have any interaction with the human body. It's not possible to do the the performance data route.

Okay, they clarified it. It's the tubing that carries gas to the from the tank to the insufflator.

The patient.

Up to the patient.

I think I think in this case, then, performance data could be enough. However, however, that doesn't mean that you don't have to collect Pmcf and Pms data. It can be that your clinical evaluation is on performance data. You can use Article 61. But then, in the end, of course, you still have to to show that your device is safe and safe on the market, and you have to collect Pms data which is defined as clinical data in the Mdr.

Yeah. Very important topic. For example. Some notified bodies are, okay. With the 1st step of article 61, 10, with a good Pmcf. Planning so that you're doing some surveys. and with your customers, or something like that.

Hmm! Very good. So the next question is concerning Band-aids Wound care. At what phase does a manufacturer need to start the clinical investigation for a wound. Care, Band-aid. From what I understood from the training, we can't use Article 6,110 if there's direct contact with the patient. So this is a similar question to previous 1 61, 10 would then be disallowed.

Yeah. Wound healing. What kind of product?

Band-aid, bandage.

Standard wound healing, maybe something with claims like reduction of infections or something like that. Then it's not possible. because you need to show that infections are reduced.

1st around healing.

Yeah.

Right? Understood. Okay, the next question is about a spirometer, for the spirometer is promise of Pmcf investigation adequate. Or do you need Pmcf data before you submit for Eumdr review. If Pmcf data, then how is it different from clinical investigation? How is Pmcf data collected? Okay?

But you know you want to do.

There are a few questions. And one question, I think the most important question is. Pmcf. Clinical study really differs from a clinical investigation for Mdr. These are other articles. I think the clinical investigation for Mdr. Is Article 62, 62 exactly, and the one for Pmcf. Studies is Article 82. And it really difference is not.

40, 74.

24. Sorry. And what is the really important thing about this is that if you do, Pmcf, you can't change anything of the intended use indications or contraindications. You just do this to collect data for your medical device. If you do a clinical investigation for Mdr, you can. Still. yeah, you, you can still prove change. You can prove changes in the intended use. You can add indications, and it's a lot more effort and documentation. This is one question. The other question is.

Hmm. The other question was.

Is is promise of Pmcf investigations adequate. Or you need Pmcf data before what means promise to Pmcf invigation. So you promise the notified body to to do it, and then you don't. I don't know for sure. If you plan a Pmcf. Investigation, you have to hand in a plan for this clinical investigation. And then the 3rd question is, how is Pmcf data collected? There are different ways to collect Pmcf data, because, for example, literature search is a Pmcf activity.

A questionnaire is a Pmcf activity. A clinical investigation is a Pmcf activity. It depends which activity you plan for that.

And Pmcf is based on on the parameters you are collecting in the Pmcf face. So if you're going to ask for pain reduction, then it is a Pmcf activity. And if you ask for any product, feedback quality or usability, or something like this, then you have only a Pms measure.

So this question is very interesting, and it may be a little bit hard to answer, but I'm going to ask it anyhow, if you can. Could you please discuss how the clinical strategy differs for medical device software? I assume they're referring to software as a medical device and direct contact with the human body is questionable.

Okay? So the differences between medical devices, standalone software and medical device not being a standalone software. the strategy for medical devices of a standalone software will be done via the Mdcg. 2021. This is a saying that you need to show that you have data on 3 parts. So part number one is the technical specification. Part number 2 is the scientific validity, and part number 3 is the clinical validation. So here are some some some important information, only

really only for standalone software. The Usability can be used for the clinical validation. The scientific validity is coming from the state of the art and show that the inputs and the outputs to the software are clinically relevant. And the technical specifications and testing is the software development process and integration tests, or when we are talking about AI, then the validation and the testing data sets. So this is the difference to the the other product. And then you need to do a gap analysis to the standalone software. If there is any gap, maybe in the

in the scientific validity or in the clinical validation with the Usability. Then you need to collect more more data which can be a clinical investigation before you get ce mark. And the product isn't on the market yet.

Hmm, okay, this is a two-part question assuming a medical device. Executes, as is use is used in a well-established clinical method, and it's possible that it's done within the state of the art performance and safety ranges. Further, it is assumed that the latter one can be shown by performance, validation, and compliance to be to a dedicated standard. Can then clinical investigation be avoided? And then there was a clarification. All of the above applies, eg. For radiation therapy accelerators. When the claim is just that a dose is provided

by the machine as described in the Ray Oncologist Yo.

Very long. Question yes.

So the question is, can a clinical investigation be avoided if they perform to the standards? If they've done all? Is there any way to avoid

Depending on the product history. So we need more information about that. So if there is a product standard that's good product center, often gives information to the performance and the safety. But then we have the intention to the notified body to the body. There was no interaction. Right sorry. I don't know what what's going on.

That's.

So there was no interaction to the body of the patient. Right? Okay. Then. Do we have any clinical claims? Is the question.

For sure. Yeah.

Is it less.

It says when a claim is just that it does provided by the machine as described by the rancologist, I don't know

Hard to say with that information.

Oh, He says, radio oncologist. Sorry for typos. So that's the claim. It's just that a dose is provided by the machine as described by the radio oncologist. I don't know.

So then is it? Is it? Is it a part of a system? Again the question, and for me the sounds.

He says it's simple. LINA.

Let's let's say, let's let's say it like that. If it's a legacy device and you could show it that it's a legacy device, then you might avoid it. But it sounds like it's a new device. So it's not on the market yet. and then I think you cannot avoid a clinical investigation like it's sounded like now, only if it's a device already on the market, and you might. You don't want to make a Pmcf. Clinical study or something like that, because you don't have enough clinical data or something like that. But it sounds like a new device.

Yeah, he says it's new, but doing the same thing like the other line X on the market. So is claiming equivalency. 2. But it isn't.

If you can click like equivalent. See? Then you can use the data. But however, Leah said, it's really difficult at the moment, equivalents, it's not like 5, 10 k. Any longer. It's really difficult to do equivalents in au at the moment. We can just recommend it to do it. If you have already a device by your own company, and you want to further develop it. And you have all the data and the technical documentation. Then then we say, Okay, equivalent can be done, but not if it's from another company, it's really difficult to do it. You need a contract with another company normally to get the whole technical documentation.

Somewhat similar question, could equivalents with the competitor device be accepted? For what class? 2. A device that comes into non-invasive contact with the patient. We have a competitor device for collecting technical information and for performing all of comparative preclinical testing to supportive equivalence. Again, equivalency question, very hard.

Hmm. So equivalence is possible under Mdr. For class 2. A competitor devices. When you can show that the intended purpose intended, use indications, and so on. So the clinical part is the same to the competitor. You need to show that you have enough access to the documentation of the other product. Then you need to compare the technical specifications so that the devices have the same, not not the same, the similar sorry, similar design, similar parameters, so performance and safety parameters, and so on, and then, if

if needed, so if there is an interaction to the body of the patient and the product, then you need also to compare the biocompart, the bio compatibility topics. So if there are some Legibles or extractables, these these amounts of legibles and extractables need to be the same. Not similar need to be the same. The materials need to be the same. and so on. And if you can show this, and have enough access to the other documents of the competitor, then you can claim the equivalence. But this will be very hard to support or to discuss with the notified body.

That's not an easy way.

Another option is that you do all the testing with the competitor device. if it has the same intended use indications and so on. If you don't have any access for the technical documentation, and and you do exactly the same biocompatibility for your device and the equivalent device. This might work, but we never tried it out with the customer, so we cannot say if this works with the notified bodies.

Let's shift gears to a literature search question. This might be a little bit easier. It is expected to do a literature search with the Pico scheme question, mark, or can it be based on comprehensive and in a reproducible way, ie. Including the use, search terms, or combination of search terms in used in the literature databases that should be declared, and why I have used them so.

I will recommend that you use Pico. And this is rule from the mdct 2020 13. So clinical review will always look to your literature, search searching for if you use Pico or not, and then give you a deviation if you don't use that. so use Pico.

Thank you. And the next question is, we're developing passive, battery-free sensors, passive battery-free sensors that can integrate directly into existing orthopedic implants. enabling remote, patient monitoring. If we do not change the external design envelop of the implants we integrate into and prove through bench testing, that we're not not a new worst case. Do we need to do any clinical studies post-market surveillance? Both Fdr. And FDA and Mdr.

So it sounds like the question is, they're putting sensors into a device that goes inside the body and want to avoid clinical studies.

Yeah.

My question is, Is there.

Is then there a battery in the implant? No, it says.

There we go, positive battery, free sensors that can increase battery, free sensor. I have no idea what it is.

He never.

Yeah, kind of hard to tell. Well.

I would, I would say again. you have a clinical benefit benefit because you monitor the patient. That means you have clinical claims. and then you have to do a clinical data route.

Maybe you have some data from a legacy device. I guess the devices on the market right.

I think the devices themselves are already on the market. And it says, no battery. Our sensor is working through inductive coupling. No battery inside.

So there is a significant change which maybe is clinically relevant. And then for this change, you need clinical data.

In all likelihood. Yes. Okay. Next question, does a new product development always change the intended use? Thank you.

There's the new product development. So not every time I would say so. If there are some changes regarding maybe the design. But the intended purpose is the same. Then there's no change in the intended purpose. However, you need to show that a new design performs well under the or or within the intended purpose. So you need to evaluate if the change is clinically relevant, as mentioned before, and if no give a justification. and if yes, there is the need to collect more data, maybe non clinical data to validate the performance, depending on the device and the change, and maybe clinical data

depending on the change you are doing.

Hmm.

Okay? The last question that we have time for is 2 questions, when is it too early to think about? This is beginning to think about it at the R. And D prototype stage, still in an academic lab. Too soon? If not, is it something we can and should try to convey in applying for non-dilutive funding.

I would say it's never too soon. or only for us to to do a literature search for the state of the art to go further. It's still good to do it.

Yes, and then, second one is, is it more difficult to develop a clinical strategy? And craft claims when there is no similar strategy already existing. We can draw similarities between a few other strategies, but nothing like this exactly.

It sounds like.

Disruptive new technology.

Hmm, yeah, this this is always really difficult. Normally, then, you should compare to the state of the art treatment at the moment. Well, for example, if you have, I don't know medical drugs. And but now you use a software, or you have a surgery stuff like that. You still have to compare to that. But it might be that you need new parameters for yourself, because the performance and the safety parameters from the state of the art are not fitting, but this is really rare. I have to say. I think we never had a case like that.

Okay, well, we had 54 questions submitted in the Q. And a. I would like to thank everybody for their participation. Today, I'd like to thank our speakers, Leah and Bettina, for an excellent job. I would like to remind everybody that a survey is going to pop up, and, if they please participate in it. It would be very helpful. Also those of you who requested a certificate. You'll receive that in a day or 2 from us. and if you would kindly share them on social media, that would be most appreciated. Thank you very much for your time and attention today. Thank you. Both speakers who would like to say goodbye.

Thank you. Have a nice day.

Bye, bye.