Simplifying MDR & IVDR Overcoming Regulatory Burdens and Achieving Sustainable Compliance

View need to change the view. So Hello, everyone. Welcome to today's webinar simplifying Mdr and Ivdr. Overcoming regulatory burdens and achieving sustainable compliance. My name is Sean Smith. I'm going to be your moderator today. The topic overview is incredibly pertinent as we discuss the complex world of Mdr. And Ivdr compliance we're gonna challenge some assumptions about high regulatory costs, lengthy review times and increasing product shortages. Our expert panel will provide comprehensive view of the current regulatory landscape and innovative digital solutions designed to revolutionize

the compliance process. Today's speakers. I wanna introduce them briefly, Christian yoner of owner of the Owner Institute in Germany Christian will discuss the burdens faced by companies and share yoner Institute strategies for modernizing the Mdr. And Ivr compliance process. You wanna slide back managing director of Berlin. Cert he will bring the notified body perspective and detail the importance of automating routine tasks to enhance compliance and patient safety. And Stephen Gilbert, who is from Dresden University of Technology, and Nature Portfolio

He is a professor of regulatory science. And he is gonna discuss some really interesting things that are happening with suites of devices. And the regulation of those, and so give you a glimpse of what's coming in the future in the not too distant future. And Then some housekeeping notes the recording and slides will be available to all registrants. If you would like a certificate of attendance, please drop your name and email address. I stress to include your email address. So I don't have to look it up we have to make these manually. So make my job a little easier. questions. We encourage you to use the chat and QA. Function to ask questions. But we have a pretty packed agenda, so we may not get to all the questions we'll try to follow up with you afterwards.

Don't forget to subscribe to Medtech leading voice.com do me a solid, and at the end of the call. There's gonna be a survey. Please do the speakers a favor and complete the survey and we're gonna introduce a couple of programs that I think you're really gonna want to hear about. So don't drop off early with that in mind, I want to go ahead and turn it over to Christian. Who's gonna start with the 1st presentation. You're free to share your screen, Christian, and take it away.

Awesome. let's do that. Can you see it, Sean? Can you see my screen perfect? So Hello, everybody just 90 seconds on who Yoda Institute is we are a company German base, but also with a Us. Subsidiary which only focuses on regulatory in metac. We help not only manufacturers, but also the legislators. EU commission FDA notified bodies in different tasks. And one of these tasks is also the transformation, basically making them fit for future. And this is exactly what we are going to talk about today. I'm personally, if you're interested in, I'm the founder of that team, we are meanwhile 170 experts for all the different

shades of regulations and all the different types of products. My background is in physics, computer science, automatical informatics. And I'm doing that awesome job since more than 30 years. I'm writing standards myself. We are also helping countries to write medical device law. I'm personally also an auditor and trainer of notified bodies, founded several companies. But the most important thing is, I really would like that. All manufacturers can survive this regulatory burden, and there is a big burden. And for that reason we have to think about commonly today. Okay, where does the future of regulatory affairs lie? So what is the perspective you have to know.

How do you know that you achieved a state which is fit for that particular future? So what characterizes that? And how do you get there? And in my 1st presentation I will take talk about the 2 1st points, and then I have another 5 min at the end, where I can give you a blueprint how to achieve this fit for future state in a way. So if you talk about the future, we have to start with the presence with the current situation. We just did a poll last month, asking, for example, how safe, regulatory, safe do you feel? And the results were desperating. Most of the companies have not enough, or even no regulatory safety or security. That means, if they submit their files, they don't know exactly whether the files will pass. If they have audits, they never feel secure, but that there are certain findings. So this seems to be a huge problem.

Another huge problem they face is the time to market in Europe. It takes meanwhile, rather years than month to to get this approval, to achieve these certificates. And this is very. You're encouraging, and this cost the companies a lot of money and they earn don't earn anything in this particular time. Frame. Biggest problem, though, is the regulatory, or are the regulatory efforts efforts for compiling documentation for the different markers checking these documents one time before submission, but also continuously. If there are any regulatory changes. So nearly everybody suffers heavily from that. And

the solution, basically hiring more people doesn't work. Since we are lacking this particular regulatory affairs expert. They are rather leaving the workspace. Then companies find new young hires. So these are, let's say, the big problems we really have to address. And unfortunately, to make things a little worse. we have now a lot of upcoming changes. And, for example, technology technology is going to change. And never again will technology progress so slow as it does today or the same, holds true for the regulations. We are monitoring several 1,000 regulations, and therefore we know the speed with which regulations are added or changed is still increasing. Yeah, think about AI. Think about cybersecurity. Think about other jurisdictions like, for example, in Asia.

and also never again will it be so easy to pass audits and reviews for a simple reason, the competency of your auditors and tech file Rabios is increasing, and the we call the Mdr puppy protection type is now over. And additionally, Regulators. Also, the FDA start to automate reviews. That means they have more time to really dig into your documentations. So this is the sad part. The good part is. we know how a bright future could like look like. So what we would like to achieve is that the computer does all the hard work, for example, searches. makes the searches for regulation, compiles all the approval documents, checks automatically conformity. This would be really a dream coming true.

and we also would like to know at every point of time exactly what still needs to be done where we do have any problems with compliance, so that we can fix them and be, and even more important, remain compliant. So these would are the big dreams we have, and then also would be very nice if you can have instances. Approvals if you have more time. Yeah, not not this busy work, but really time to develop strategies and support the top management. This would be very helpful, and if you have everything under control also our live so that we really can go home and don't have to work over hours. What? What's happening right now? Very frequently. And we all want to be sure and safe as companies. Yeah, we would like to be competitive, and we also would like to have workplace safety. So these are our dreams.

And now the question is, how do we achieve that? How do we get to a shorter time of to market? How do we get this regulatory security? Yeah, more transparency, more compliance. How could we increase our efficiency? Yeah, shift from busy work to strategic strategic tasks? How do we make our workplaces more attractive? Yeah, more satisfying. And at the very same time also more safe. Yeah, these are our dreams. And if you want to get answers to these particular questions, we can look what other parties are doing. and I would like to mention a few of them. and the 1st one is the FDA. I just talked to them last night again.

and in particular to to Patrick Extel, who is in charge of the E-star program. and what the FDA currently is doing facing similar problems is they undergo a digital transformation. What they're doing is they transform from documents to data. This was also our topic last night. Thereby they harmonize also the international requirements. For example, with Easter they harmonized. Now the submission format between the Us. And health. Canada. Other countries are coming up also. Europe is, we are in the in the loop. They start automating revenues. Yeah, in order to increase or to accelerate the approval times, and also obviously to gain more efficiency within the authority. So that's their pathway. Of dealing, of answering all the questions I just was erasing.

What do notified bodies do? Johadislibuck will give us his personal answer. Another notified body said, we have to digitalize, and thereby we can triple our productivity. If we have structured data. Again, you hear structured data and thereby redundancy-free data. If we have direct links between the the requirements or checklist items and the objective evidence. Yeah, for example, particular test results, and if you can talk directly with the manufacturers, can directly ask back, they called it a context sensitive communication. Or also you could refer to that as a chat. What do we do at the Yoda Institute? 3rd example, we we one of our tasks, is to monitor regulations, and in the past we had 5 people. Had roughly 100 regulations for 12 manufacturers, and these manufacturers had the size, typically

tens to several 100. People. Meanwhile we have 7 people, but we are now monitoring more than 6,000. Meanwhile, it's even more than 6,000 through 200 regulatory documents, you see, with a very similar amount of people. They have 250 customers meanwhile, and they are huge corporations with several 1,000 people. So that means we increase productivity. And again with automation. So this seems to be really one important key to the solution to achieving all the dreams I just was talking about. And indeed we I show you now, and a prototype. I architect how that could look like. For example. we develop a real-time compliance system. I just talked about this regulatory intelligence where operational people are working, but also the top management where post-market processes are part of the system and also the the authorization approval processes, development processes.

But this system is obviously not alone. It's not isolated. It has to be connected to other existing systems, like Erp systems, for example, Alm and Plm system, they have to be connected. But in order to achieve end to end processes, we also have to include notified bodies and authorities, and there are 3 different ways of doing that. The 1st one is basically the let's call it the legacy approach, or the eighties approach. You just export the old Pdf files. Yeah, this is the Old world. notified bodies, which are a little more modern. They use directly a system like this one here or they have. And this is the FDA approach. There is a connection via an API to their particular review systems. So this could be now. And this is an example for such an blueprint or for such an it architecture.

And now the question is, how do you know whether you have the right approach? And I would like to give you some checklist or some things you can verify whether you're on the right path. Most important, obviously, that we achieve the goals. Yeah, a transformation is for no use. If you don't achieve the targets, and if we achieve the targets, or we most likely achieve the targets. If your approach satisfies 5 principles. Principle number one is your, you should have a data-driven instead of a document driven process. Yeah, this is why, since the notified bodies since the FDA, since everybody is heading towards that direction. Reason number one. Reason number 2, because on data, you can on with data, you can implement algorithms which do all the tedious work for you. And this does not work really with documents. So

point number principle number 2, the process have to be end to end, since otherwise you are ending up with data 0 with islands. And then you again have different sources of truth, and then you might have inconsistencies so that never should happen for that reason end to end processes and also to avoid inconsistencies. All these processes, approval processes. postmarket surveillance processes, regulatory monitoring processes and so forth. They all have to rely on the very same data for the sake of consistency, and algorithms have to implement the laws so that all the teachers work can be eliminated by automation

and only for, let's say, backwards, compatibility documents should be automatically created, compiled. And any solution basically, you are thinking about to implement should satisfy these 5 principles. So this is a very helpful checklist for you guys to make sure that your solution is actually fit for future. And that means, if you want to develop a system, don't develop. Start with a development, start with the regulatory requirements. This is what you have to have. and from the regulatory requirements, then you can derive the algorithms. Yeah, your test logic. Yeah, your compliance assessment logic. And from the inputs of the algorithms, you can derive the data. And there by the data model. And if you have the data model, then you can develop

such a system. And but this takes a lot of time we this is our mission for the last 50 years. So, to summarize my short presentation here, we saw that we are just now in an uncomfortable situation, and that we have additional stressors in terms of faster technology, faster regulations and more competent authorities and notified bodies. But we can compensate that we can get ahead of the curve if we do what everybody is doing, basically automate all these activities. And if you do that, if you want to come up with a solution. Then just make sure that all the 5 check boxes are checked. So, and that's it from my part. Thank you very much, and I'm handing back to Sean.

Hello, so you're gonna see a poll question. You know what to do with that? I'm gonna go ahead and hand over the reins to Johannes. Welcome, and we look forward to his presentation. The poll is gonna run for 1 min and 30 seconds. So that gives him time to share his screen and bring up his slides and.

Can you see my slides? Hear me!

We can see you and hopefully we'll see your slides. The share button is at the bottom.

Yeah. Let's say some ring. I'll.

There we go!

Yeah, yeah.

On earth.

Perfect, perfect. Alright, so what is Bill? And said? We are notified. Body. Actually, we were founded in 1,915 during the 1st World War we and we were one, if not the 1st laboratory for testing prosthetics. My personal background is from the machine industry. But I have lots of experience with digital solutions. As I was responsible for one of the 1st machines, laser cutting machines actively using AI, and it's very interesting to use the experience to address the challenges and play an active role in improving patient safety. Now, our perspective on automation. So currently, often we search for information.

and then we spend lots of time with communication in the communication with customers about the missing information. And then we also do conformity assessment. Now, that sounds all very logic, but it's really not something. It it doesn't match our ambition, because actually, we want to find information. And then we want to check that information especially related to the individual characteristics of the product. Because this is why we have experts to give you, and to give manufacturers meaningful reports of the audits with the claim that companies can come, become better and exist sustainable.

Because this is actually the basis sustainable organizations. This is the basis for patient safety. we have pre-graded resources resource bottlenecks, because we lose lot and lots of time. 1st of all. because we spend so much time with activities that add little value. Now we all know that clinicians already have a 50 HA week, and then on top of that, we ask them to do conformity assessments. But then they spent hours and hours with just looking for basic information. Just, for example. company, the the company name, or the the product name. And this is actually the case. Takes up to several hours. Then we have system breaks. So we have the customer documents. Then we do the assessment in a different document. We send it back to the customer and they have to bring it all together and

redo the whole process if some information was missing or wrong. And in the end it all has to be rematched, but in a very manual way takes time. And it's yeah, we have a lack of standardization. We don't even know of how to exchange information. Now there are approaches to that, but it's not that we say a company name is always transferred as company name. Sometimes it's just called company. Sometimes it's called company name, and it all takes so much effort to bring in it, bringing it all together. It costs time, it costs money. and last, but not least, we need a secure data exchange. Now, there are individual solutions which are secure, but it's always an individual discussion with the clients of what they prefer and what is actually safe, because your information, especially in the medical device industry, is often very sensitive.

and from our perspective up to 40% of the time is lost on simple tasks throughout the whole process. You search for information. It's a 1-on-one matching of the results of information, of requirements and of transferring information manually, automatically. And really, that's no fun for anyone, not for us, not for our customers. Now, it could be very simple. If you just look at very simple and abstract requirements. for example, the unique device and the identification number and the product name. And these are real examples. So basically, it's just ask for simple information. Please provide us the Udi, so we check it. They everything's fine. Please provide us product name. Now, the product. Name is sometimes mentioned 2 or 3 times.

but not in this exact same way. So is the product actually called health app, or is it called health application. Now it makes a difference, and it happens. And so you have to reject the document. For us, there are 2 major problems. One of it is that we have to do a complete document check. meaning client, or the manufacturer hands over the documents. Now we check every points, and then we provide you the results. For example, we say the Udi is wrong. You rework the whole document, and then you send it back to us. But we are forced, as we have, to check the whole document, to really check the whole document, which is time consuming because only the Udi has changed.

If you think that a little bit more digital? What could happen is that we just check the Udi, and I think it's very easy to understand of how much that would really advance the whole process. And the keyboard here is audit trail. So through digitalization, we would be able to have really a strict audit trail over the entire process. So we have the proof of which information was transmitted and changed when we have a traceability of which information has already been checked, by whom, also, for us internally, sometimes they're more than there's more than one assessor and most important. We have a lean documentation of the test results at the actual place.

So if we give you feedback. it's not basically, it's not a general feedback in a separate document. And then you have to look of where did I actually mention the Udi? But we will comment that exactly at the place where the Udi is wrong, and then you know what to change and can do it in seconds. The second problem is inconsistent information. Here we take again the example of the product name. So you have different chapters. And then sometimes product is called health app. And then you have just typos in it. It can happen. And it happens now thinking that in a digital way. You just have the product name at one place and uses in different chapters.

And this would again make it so much easier for us, because if you have the situation on the top. really have to check the whole document. Where is the product name mentioned? If we know that you only use one source. We've maybe checked 2 or 3 places where the name is mentioned, and then we can be sure and the check is done. And here. my, the, the key points are that we need a standardization of data. So for me, the perfect example are drop portals. You have your data on. Maintain it in one place, and wherever you apply to you, just hand over the same information. But you have one single source of truth.

And the advantage would be that certification bodies, notification bodies, or any other participant is always up to date, because it's very easy to transmit that information. Once you change it. You can communicate the change right away, whether it's internally or to external participants. and we really avoid trial and error faces. We have lots of them so often. The manufacturers need at least 2, sometimes even 3, rounds when they have to rework the whole documentation. And can they come back to us. We have to redo the assessment. What is also happening that is, is that sometimes it's really just slight differences, differences in words that are used.

That that make a huge difference of the end of the interpretation of maybe how the product should be used. If that happens, and an auditor might, interpret the use of a product completely different than, for example, a clinician. If we always use the same terms that won't happen and what it also allows is to facility changes and improvements. So your as you change the data only in one place, it's done very quickly. and for us. it's will also allow companies to really speed up innovation processes. Because what we experience today is that manufacturers are rather slow, even slowing it down because they're afraid to make everything sure or everything correct. They're afraid of doing mistakes, but

once it's it's it's you only have one place where you have to change data and not look through the whole document over and over again to make sure it's all conform and consistent. It's it's just not such a big hurdle to to improve things, yeah, or to to change your your product, your documentation, and to become better what we strive for as a notified body and certification body is especially exchange exchange between certification bodies, and that is taking place. But in the situation, as we have it in Europe, it always is always also important to note that. it's a balancing balancing act. We like to share an information, but we're all private companies. So there's also always a bit of competition. And this is why standardization is so important. Because then that part of competition is gone, and we make sure that manufacturers can all work with the same standard and avoid any kind of login effects

and and are still free to to search for the best certification body and notified body. The strive for strong partnerships, close cooperations with pioneers such as the owner Institute and other innovators, especially in the private sector. And but what is also important to mention is that leverage only takes place through 1st mover companies. So we need manufacturers. We need companies that really understand the benefits of digitalization and are willing to just try to go that step and and find out of how much we can speed up the process. Maybe 40% is just the beginning. What is also important is, of course, political and the support of private initiative

to support private initiatives. be but try to find new funding pools. What is important is the cooperation between the EU, but as Christian just mentioned, also between the EU and, for example, the between us and the FDA, because if we communicate, we can learn so much from each other. And it's not just between notified bodies, between consulting companies, but also and especially with manufacturers, because they are the ones who bring products on the market. And thing that I'm hope you now agree with me on the major effects of simply digitalizing information and assessment processes, and that you're motivated to join us in promoting and realizing the future.

Thank you very much, Johannes. I'm gonna go ahead and turn it over to Professor Stephen Gilbert. From Dresden University of tech technology, and rape.

So can you hear me? Okay. yep.

Yes. And can you.

And my! Can you see my slides.

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And present about.

Cool, are we? Okay? Not.

Yeah, perfect.

So I'll make a start. So so I'm you've already had the introductions at the start. I I won't introduce myself further just than to say that I'm I'm going to be presenting the section, looking ahead in digital health regulation. And more specifically. just to set this in context. christian and Johannes have mostly spoken about kind of doing it better in digital and AI approaches for quality management, for regulatory affairs for for ce marking. And and those are also relevant to health technology assessment, although that's not been their focus. And that's been relevant to all devices, not just digital devices.

Now, there's another area which I work in in this green circle, which is areas intersecting the development of digital devices. It's kind of in the title of my Research Institute. You can have said for digital health. So I'm going to focus on the digital side. I'm going to focus on both of these things together as they come together for digital devices. I hope this is of interest to all of the audience, even though not all of you probably work in digital health. But digital is increasingly important in many devices. So I'll zoom in on digital health technologies and the overall thesis of this presentation. And the argument I'm going to try and make and hopefully convince you of is that increasingly, digital health technologies are interactive

every year, certainly every decade, and certainly every year, and we're seeing it accelerate. The degree of interaction of these technologies increases. So this is not an entirely new concept, and I'll come back to that. Christian will have known this for 1520 years within the sector. It's not entirely new. Nothing is new under the sun. But I would argue that it's accelerating, and it's very importantly accelerating. There's a manner in which these technologies are increasingly grouped together within an intended purpose which is an intended purpose of a super super grouping of devices. where the intended purpose itself can only be delivered by bringing together a number of independent devices made by different manufacturers. And I'll come back to this. So why is this a problem?

Well, it's in many ways not a problem. If we have the regulatory science and the innovation in the ways of thinking and the good approaches in place in order to assess these devices. But at the moment that's not the the in place. So that's where we have a problem. So I'm gonna introduce the concept in further detail. And I'm gonna I'm gonna focus in a little bit on the hospital at home. Those of you in Germany may not know this concept so well. It's very well known in the Uk and in Switzerland, and the Us. And it came to the fore in Covid existed beforehand. And it's an example of a situation where multiple devices are brought together and those include things like

health sensors, usually not implantable but wearable. Patient support apps and platforms, many of which are medical devices, alert systems in the home and on the patient things like smart pill boxes, which are in this context of medical device and approaches for continuous remote monitoring, sometimes on the patient, sometimes at home. These things are all grouped together, delivered together in a platform that actually allows relatively, acutely ill patients to be released early from home, say with severe respiratory disease when they would normally be in the pot and in the hospital. So it's a very interesting use case, and it requires multi interoperability of multiple independent medical devices. And there were special circumstances during Covid that allowed the use of these. So this is one example of a suite

in this paper that I'm talking about. It was published last week on Tuesday or Wednesday of last week in Nature portfolio digital medicine, so that the link will be shared in the chat and in the notes, you can have a look of where we bring this concept together to show that there are multiple interacting concepts of these suites, so you can take some of the same sub medical devices which are using the hospital at home, and they can be used in a different setting, which is the home monitoring setting, much more chronic disease. Typically. But many of the individual wearables, alert systems are very, very similar, and they could actually be the same wearables, in some cases the same medical device. So you could have your smart pillbox used in a scenario where it's not in a critical setting, but more of a chronic disease. Monitoring. And there are other settings we discuss in the paper are the individual setting link to wellness, fitness, and individual monitoring and outside the home

telemedicine with many interacting systems, telehealth platforms interacting with many devices which support the telemedicine, including measurement of physiology when used in in a telemedicine situation with a remote doctor, the care home setting the hospital or clinic setting as another setting where you bring together suites of of devices. Why is this a problem from the side of regulation? So there's an acknowledgement at both sides of the Atlantic and internationally, that this may be required, and the MDR. Has sections on systems of devices, and there are requirements laid out there, and they're somewhat vague, and the and Mdcg. And in there in 2,023 released their Mdcg. 2023,

number 4, which sets out for medical device software, hardware combinations. And it talks about some of these use cases. and it doesn't say these things are not possible. It says they are, but the the manufacturer who brings these together. The person who brings them together must verify and demonstrate their safety, the compatibility, interoperability of the medical device and accessories as they bring them together into into combinations. Now this this kind of works. but it's not a very flexible or forward thinking way of regulating these suites. So you effectively have a situation where they are treated as an individual medical device when brought together, or at least very close to that.

And the question that's really asked in the papers, and I'll come on to where it's being asked by by regulators, because, it is asked me, being simultaneously asked by regulators, is, you know, is there? Is there a way forward, which is not the approach which has largely been up to this point, which is slightly to bury the head in the sand, to the respect that we may have something new that we may need to look at it differently. But it's also not the kind of digital exceptionalism. Move fast and break things. Anything goes. Regulation doesn't apply to tech. The challenge in the world is always to find the best and most optimal way of digital transformation and new new approaches which enable safe and efficient progress. And I don't think this differs in any way from what Christian and Johannes have have said, but it's focusing slightly more on the medical devices than purely the quality, management and and regulatory system for them.

So so one of the 1st points is, is, you know, recognition of the the challenge and of the problem. When we were writing the paper quite conveniently in in many ways. This gentleman? Who's the who's Robert Caliph, who's the Commissioner of the FDA was speaking at an event in in in Las Vegas, and actually to the tech industry to an extent. But medical devices, industry, and I'll just quote him directly. And he says, if you think about device development like sensors. if you do it one at a time you'll never put a whole suite together into something that fits together in the home environment. The the center for for devices and radiological health. Cdrh is working on a strategy of how to create regulatory pathways to help make this happen. Now, if one thinks about Robert Califf's history, this is not that surprising. He served as the Commissioner of the FDA for a number of years. He was then replaced with political change. At the end of his term he. He worked as a very senior consultant to the Alphabet Google Company for 5 years, and then he was brought in for another term as FDA Commissioner. So this there was reasons why he's he's thinking about these things.

And really, this is, you know, setting the context of the paper I mentioned that this is, there's nothing new under the sun. Many of the things we talk about in in systems. I I just kind of give some some actual, some some sections from the Owner Institute website, which I've looked at over many years and and covers this area of systems and procedure packs and the nature of certain part of things being medical devices and not being very medical devices. This is covered, I think one of the best resources is on the Uniro Institute website of of considering the history of this. You know, it's not an entirely new thing.

But there are new considerations, and there is a new regulatory willingness to, at least in the the Us. To acknowledge that it it no longer could do to kind of a patchwork approach. As to how we bring these together as devices. So that's slightly, it's a recurring thing. So if we go slightly in the direction of of solutions. So we have a second paper in the series of 2 papers which which will come out on Tuesday. You know. If you ask Sean for the link. He will. I'm sure we'll share it with you after Tuesday, when it when it comes out, and the second paper looks a little bit more on the solution on the solution side. Now.

if I was saying, we can solve this entire problem within 2 papers. That would, you know. And even if we're considering what the FDA is doing in this space. I would be wrong. Clearly we can't. But we talk about some of the directions to recognition of the the problem approaches which allow conditional approval with wider intended use allowances at the moment. The intended purpose, the intended use, is seen as absolutely sacrosanct. It's kind of the Holy Scripture of regulation, that it must start from a fixed, intended purpose. Other things could move. You may adapt your device, but you will never adapt your intended purpose. So there may be room for more flexible thinking in this alongside, flexible monitoring which I'll come back to.

There certainly could be situations that within regulatory sandboxes, which are a little bit of a catch. All solution to everything in the current regulatory world may at least be able to explore approaches towards this I'll leave off the financial risk side, because that's more on the reimbursement side. Also talked about within the the papers, and next week, when this comes out comes out you can look at this in detail. There are approaches within the reimbursed digital health applications, particularly on the French side, which are starting to acknowledge. embedded digital medical devices, therapeutics within the system, starting to acknowledge co-design acknowledging that a useful digital therapeutic is actually embedded with your care pathways with human in the loop, and they're starting to be within the French pacing system an acknowledgement of moving in this direction. I don't want to state that as as completely resolved.

if we consider, you know, these challenges in regulation. Obviously, you've regulation requires the the establishment of safety. It requires establishment of the intended purpose, cyber security, data, privacy, compatibility, interoperability, usability. and interaction across diverse policies in different countries. These are not easy to achieve, and there will not be straightforward solutions, but for some of these things that may be more straightforward than others. and for areas like cyber security within the wider area outside medical devices of connected digital solutions. The most connected digital solutions are not always the most insecure. There are ways of building approaches towards cyber security which allow, you know.

in the end, Google have better cybersecurity. Systems or apple have better cybersecure systems than those that are in some cases in the medical device, industry developed through the very many thousands of regulations we have. So more regulation does not always mean more cyber security in this space. A 3rd paper, which is in progress in this reviews the the further developments which have happened since we started working on this a number of months ago, which is the FDA kind of leading on. From what Robert Caliph was saying, they they launched their formally launched in april, April 23, rd their health care at home initiative. And this is actually where they set out their own program of exploring this space.

And I think it's a very, very exciting program. And it's really the FDA taking an initiative where they're no longer looking at the approval purely of an individual medical device, they're actually asking the question, what is the conducive environment to enable a digital future to enable a healthcare system which maybe, or perhaps is transformed to deliver greater equity. Now they mentioned the word equity 15 times within this short document, which is only 8 pages long. And it it really is a very ambitious approach. It's actually kind of tame saying, can we take that system level instead. If we look every device as an island, we purely have the role of saying Yes no to a device. We instead

say, what should the system develop like? How do we better? Instead of regulating in a manner in which we say we will actually encourage manufacturers not to be interoperable, because we'll put so many restrictions where they will develop their own approaches in islands, because it would be too complicated for them to get outside their island. How do we explore that? We bring those islands together? So you can tell I'm a little bit fan of this initiative, and that the 3rd paper in the series, addresses my my opinions in this. Obviously other challenges. This very much goes in the direction of of still describing, how does one

find out how to solve the problems? I do have one suggestion of a of a direction, of a solution. I'm just gonna quickly flick ahead. See if I have only one more slide after this, and only one and a half minutes left. But I do think there are certain fundamental questions that are asked by digital health technology and ais. So so digital health technologies and ais are not static things. You know, we artificially regulatory, constrain them to be static. But naturally, these technologies should and are inherently more adaptive. So they should respond to user needs. And a eyes can be flexibly responding to user needs with retraining so increasingly, even within European regulation, that is a knowledge that they don't need to be static, and they have a dynamic nature. They also, I hope I've made the argument that they are.

They have a system level interaction. And the argument is be quite clear that where you have system level interactions. You've got suites. You've got the performance of one medical device fitting into another. You need to have approaches to performance monitoring which acknowledge they're interacting in systems and the fact, their usability interacts in systems. And then in red, you have this massive paradox that we have in the situation. We're building out the interact. The adaptable. automated, interconnected, scalable systems. We're even starting to build into interoperability. And that's been slow and coming. It's been a huge challenge. But it's starting to come. But we're doing nothing whatsoever to build in scalable, dynamic, adapted, automated, interconnected, and even dare. I say, open approaches to post market surveillance.

Post-market surveillance is in islands, and it's closed, and it may be a controversial point. You know. How could manufacturers cope if postmarket surveillance was open. I've worked for many years in digital health companies. They have to cope in a world where postmarket surveillance is open. Anybody can give it on the app stores. If we move to a world where it's open, we actually allow all of us to move forward in a world where performance is no longer something we're scared of, and feedback is something we're not scared of, just to mention, because out of time this paper, where we discussed this at the end of 2023, and it's an initial work exploring approaches that would allow feedback and devices. If anybody wants the reference you can. You can ask Sean, and he could share it with you.

This is part of a grant just to say that this work was funded by the European Commission, that the papers are in collaboration with the National Institute of Health Care, excellence, Nice in the Uk. And the University of Oxford, and the Grant wider grant involves numerous partners.

Thank you so much. Excellent presentation. I'm gonna go ahead and switch back to Christian. And please stay tuned. I will be back at the end with some final remarks. and everyone, please make sure that you complete the survey as well Christian. You want to take over the.

Yes, I do. I do. Do you see my screen?

We're still seeing the grants from

So then he has to stop it.

Here we go!

I have! I've stopped.

What's up? Okay? Awesome. I like this.

Present.

Very much for different reasons. But one of the reasons was, Johannes was clearly showing what are the challenges notified body is facing, and how similar they are to the challenges manufacturers are facing. And Gilbert basically gave us another proof how the complexity of technology and also regulatory oversight is increasing. And this was exactly. This is what we have to be prepared for. and what I would like now to add for a few minutes only is we made an experiment how to get how to make companies fit for future, and I would like to report from that very particular experiment, and just observe it, and look whether you find something helpful for you guys. Yep, possibly you can use it as your blueprint for making you fit for the future as well.

So the the experiment we did was we had 10 companies in a cohort and 2 in a private group, so to say. we had all types of medical devices. Also, ma Ivd devices in vitro diagnostic devices, all sizes of manufacturers. The smallest one had just 5 employees. The biggest one several 1,000 was a single digit 1 billion revenue a company and no restrictions to classes. Yeah, we we didn't have Class one but class to a class to B class 3. So everything was in this cohort. and the task was, how do we get from the actual state to the target state? That means from we have a lot of deviations and have to make a lot of improvements to certainty. How do we get rid of all this manual work and can automate? How can we get from a personal overload situation

back to that, we have time for important tasks. Yeah, for example, to shift from being a document transfer station to be a strategic partner, a regulatory strategic partner, especially important for products. Steven was just mentioning and yeah, shifting from uncertainty to real time compliance, and from a state which I would call eighties to what we could call fit for huge. And this is the transformation. And then the program. You realized there are 2 major traps we definitely have to avoid trap number one. If you have an unclear or an arbitrary target image where you would like to go to, or if the requirements aren't unclear, you have no chance.

Second is, if you try a big bang approach, you will most probably fail, since you just have too much complexity. Basically these results. We could have read them also in other papers. But they are definitely true. And how did we overcome those? So the 1st one. How did we get to a very clear picture? So what we really did? We wrote it down. What are your requirements? What is the approval. Time, you would like to achieve. How many iterations? What are the priorities of your goals? What is part of the transformation process? Yeah. All processes, all departments, all locations, all products. We narrowed out that very much down. We had very clear processes and responsibilities in that particular project, and we had a very clear

it. Outlook how that is going to look like. So this was just written down. Second trap was big. Bang, yeah, too much complexity. What did we do we cut the program into 6 sprints, every sprint lasting a quarter? Yeah. So that means it's an 18 month program. And we even got further. We sliced every quarter into single weeks. And every single week, basically at the very same structure we have on one day, typically Tuesday. we have our meeting, and then we discuss the results. From the previous week. We given you homework. Yeah, we've given you insights. What needs to be done in the next week. Now we get. Give them also certain guides, then they do their tasks. Example would be, they document part of their technical documentation in the digital system. They specify their target state, let's say, for risk management file.

they. So with the results. And what we do all the time, we give individual feedback so that everything is compliant if it's transferred to the digital solution. So no garbage in garbage out the every manufacturer has 100% certainty. What they transferred is now definitely compliant, and I just show you in in a minute how's how structured this approach was. So, for every single week we had a clear agenda, and the interesting thing is, the program lasts. Now we are end of quarter 3, and we are still on track by the day. We never had the deviation anytime. So it's really for me, even kind of surprising. But we managed that. It's really we are really completely on track. And today. And then yesterday we had basically the retrospective of that sprint. And next week we start with sprint number 4

and there are several elements to make that possible. Or, yeah, the 1st one is this precise roadmap. The second one is this weekly expert sessions, where we additionally give or make conformity assessments. So we check every new piece of data which is entered. We have a software basically to collect all this data where we have the data models and algorithms being implemented, we give them blueprints, how to connect other systems, to integrate them with that particular solution. So that we achieve these end-to-end processes. We give them a combining materials, examples, sheets, instructions, and so forth.

and every company has a personal companion. Since. This has a lot to do with trust. Since you're opening yourself, you're showing your non conformities, and we have to discuss them. We have to get over them. And this personal environment is also a very important factor. We just yesterday made. Let's say the revenue, asking, for example, just saying examples. How satisfied are you? What you see is, they are satisfied, or even very satisfied. Keep in mind, this is a German. a scale. So the grading in term, typically, if you're fully satisfied, it's neutral. Yeah, not complaining is the highest form of appraising. But in that case they are really, very, very happy. So that means just to return. If you want to make such a transformation, an idea would be copy that kind of blueprint. This approach with this

sprints, with these weekly sessions, with this continuous approach, with the algorithms, the matching software, your personal partner. And then you have a high probability that this transformation is going to be successful. Yeah, that's it already. What I wanted to share. And now I'm handing over already back to saw to basically share some last thoughts. new products, new ideas. And yeah, so it's up to you.

So to move to the next slide. The 1st program. Right? So I'm excited. They're introducing a English cohort for the fit for future program. And all we're asking you to do is to pre register either with the chat or email me privately, or you can email info@yonerinstitute.de or you can just use the survey after the call which is, gonna introduce this program as well as another one. and we'll follow up with you offline. There's no. you know. Obligation. It's just an expression of interest. Preregister but launching the 1st English cohort, which is gonna work exactly the same as the German one did.

And it's a fantastic opportunity to get it on the ground, for in the next program which I'm equally excited about is what we're calling the EU Star regulatory executive management program. And this is for individuals who are looking to up their regulatory executive management skills to understand what it takes to take your organization to the next level. This is going to be online self study course. With 15 min daily sessions. That you can do at your own pace. And yes, there will be a certificate involved in that as well. So if you're interested in that, you know, I'd really like to hear from you. You can do it in the private survey after the fact, you can add to the chat. But you know, really rolling out this program for the 1st time, and wanna get response to it. If you think this sounds interesting, you know, by all means let me know and

like, we, we want your feedback on these programs. So thank you to the speakers for your valuable time for sharing valuable information with all of us. As well as everyone who attended there were, you know, many, many people on the call today, and I know that your time is valuable, and we really appreciate that. So yes, let's keep this going, and the survey should pop up on your screen. So we look forward to seeing you again soon. Thank you. Everyone want to say goodbye.

Yeah. Eca. yeah, I want to say goodbye. It was a huge pleasure to to meet everybody. I see that there are some unanswered questions in the chat. We will do that right away. But we really would like to keep the time. It was a huge pleasure, so it was an excellent hosting moderation. I'm really totally thrilled and happy. Thank you so much. Thank you.

That's great, and thank you for the invitation, and thank you for the attendees.

Thank you, Steven. Okay, wonderful. Thank you all. I'm gonna sign off. Thanks.