Electronic Instructions for Use: Capitalizing on the EU’s eIFU Rollout | Michael Kania (Meddevo)

Start. So, while everybody's joining, I just have… Couple more… Copy invitation link. Things.

Okay. So, while people are still joining, And I'm waiting… Then I just want to announce, that we're doing a webinar, Closing the Blind Spots, Designing Devices for the Real World. on September 18th. So, this is a really cool webinar, because we're gonna take real-world evidence in silico testing, and human factors, and combine them into a single discussion with

four amazing speakers, and this is quite possibly one of the most ambitious webinars that, we've ever tried to pull off, because it's not taking a single topic, and You know, running through the usual, but rather… . Weaving together these important topics and talking about how do we use this intelligence to, create Sorry, I'm trying to promote… Francisco Panelist…

And then make him co-host so that he can let everybody in, more… make co-host. Sorry, this wasn't done earlier. And, so that's great. That's gonna be on, September 18th at 10 a.m. Eastern Time. please join, I'll put the link in in a minute. So, while Francesco is letting everybody in, and everybody's still joining, I'm gonna start introducing our topic for today, and our speaker. And so, I'm super excited. This is a really current topic. I'm gonna start with 3 numbers. 6.4,549,000 and 1.9 months.

So that's 6.4 million euros in annual savings for large EU manufacturers, 549 euros for medium-sized companies, and just 1.9 months payback time. So, these are measurable impacts we're seeing from companies that implemented electronic instructions for use strategically. Here's another critical number. 87% of healthcare professionals prefer Electronic instructions when available. July 16th, in the EU, the legislation allowed them to do just that, to provide electronic instructions for use, to healthcare providers. And companies implementing EIFU are cutting operational costs by 80%, reducing regulatory update from

6 weeks to 2 days, and freeing up 27… Workdays annually for core business activities. Michael Kanya from MedDevo helps companies implement digital transformation at scale. In the next hour, he'll show you the specific steps to turn regulatory requirement into competitive advantage, whether you're managing 12 SKUs. with a 28,000 euro investment, or… 12,000 SKUs with transformational returns. This is about building an infrastructure that creates sustainable operational advantages for your organization and for regulatory agility. So this has direct impact on regulatory, it's not just, you know, about printing and paper. Michael.

I'm gonna turn it over to you at this point. I would like to encourage members of the audience to ask, intelligent questions. Don't monopolize the microphone. But, Michael, what… tell us what you're gonna walk us through today.

Yeah, so, I… I'm really excited because, the… in the last, years, we… we, did the digital transformation with, with our electronic technical documentation and our… clients are pushing us, I don't know, since couple of years in the direction of IQ management. And, it was like, okay, it's interesting for us, but we don't see the urge that our company needs to do something in that direction. And boy, was I wrong. And, we learned so much in the last months where we were developing, a EIView platform from ground up. And I just wanted to share with the audience today, and I hope we will get in some interesting discussions, about this journey and all these learnings that we had along the way, because it's not only about getting rid of paper, and,

I think that this is really interesting, how you can think further, and think maybe 2 years, 5 years, 10 years in the future, how this can evolve for, for the entire healthcare professional spectrum, that's dealing with this instructions for use. And, yeah, not only the numbers that you thankfully presented, Sean. But also, the usability of these platforms is very interesting. So, this is what we're gonna do today.

Great, let's dive in. So…

Okay.

Before you dive in, when you were a small child, Michael.

Yeah. What did you dream of when you were growing up? What did you dream of being when you were an adult?

This?

I dreamt about, being a pilot, actually.

An airplane pilot?

Yes, airplane pilot.

Nice. And did you ever get to fly an airplane?

Yeah, I did fly airplanes in, let's say, tryout sessions at an airport. It's pretty cool. So, I turned 40 this year, and my goal is to, get my PPLA license, maybe in the next one or two years, if everything works out, if I have the time. To do a license.

Do we have any other pilots on the call? Anyone else fly airplanes? I have not. Personally. Well, that's just to let us get to know you a little bit better before we dive into the highly technical business of electronic instructions for use. I'd point out that IFQ in the United States, is indications for use, and that's a very different…

Different topic.

Very different topic altogether, and it's interesting the way that the, EU and the U.S, use those topics. But, anyway, let's keep going.

Okay, so, I want to encourage everyone, if you have remarks, questions, ideas, so just unmute yourself and simply speak up, and then I'm looking forward for the discussions. Okay, so let's start. Let's talk about… paper iFuse. Let's talk about EIFuse, and how to get rid of the paper version here, because, of course, we want to save money. Sean, that was, there were very, very huge numbers, and I didn't even knew that, that the numbers are so high in that topic. So, let's talk about this as well, and let's… oh, who's that? That's Bob. Let me introduce you to Bob, and Bob is a healthcare professional.

that, you said 87% of those people, are preferring the electronic iFUE if it's available. But, we also see the feedbacks that sometimes they struggle. They struggle, because when do you actually read an instruction for use? it's not that often, I would say, as a professional, but if you want to read it, you, have situations. Maybe you are before a surgery, or maybe this is a, emergency, and what the people are struggling with is Really, really bad readability, for the instruction for use when on mobile phones. So it looks like, scrolling to the right area and pinching and zooming, and you know the zoom stuff on the iPhone when this is needed. So this is a huge problem. So, but before we dive into that.

I just wanted to, point out the, the, the topics. When can you get rid of a paper-based IQ? So. it needs to be for professional use, your medical device, so if there are any layperson involved, it's, it's not possible in the EU. You need to check… If… the use of an EI view does compromise user or patient safety, so it's a part of your risk management when you try to distribute that purely electronically. It needs to be accessible all the time, 24-7. I think it makes sense if there is no printout in the package, so it needs to be available 24-7. And, of course, like the paper version, you need to update it if there are updates, but you also need to keep an archive

and presented to the users. Maybe they have an older version of a device, and then they have to have the access to an older version of the instruction for use as well. If there is the urgent need of a individual. that say, I need a paper-based IFU, then, you need to provide it upon request. And this is funny, because when you are accessing that via a, let's say, desktop computer, most of the people also have Printers, so you can basically download it and print it out, but it's in the regulation that you need to send that over to them. You need to set up also internal processes, because you need to document how you manage the documentation, how you are dealing with that IT-wise, and from the quality assurance perspective.

And it's also necessary to, beside the availability, in terms of IT security, also to prevent that someone that is not authorized log into your portal, change things, or mess things up when the documents and the end users then got confused or get simply the wrong documents or the wrong information. And this is also pretty funny, it must be intuitive and easy, and you remember Bob, so it's not always intuitive and easy. So, in the last 7 years or so. we talked to manufacturers in regards of the electronic technical documentation, so this is where we're originally coming from, but we also heard about the EIFU, or iFew management. So, the first thing is, that comes to mind is saving money, as you also indicated, Sean.

on printing, storage, and packaging processes, because this is most of the time manual labor to box that IFU in the package. But it's also saving money on scrapping if you are doing a change, and then you need to scrap all the stuff that is in your storage. It's not only a waste of money, the printing, but it also costs money for For the scrapping itself. And what they said is also the saving money and time if you need to coordinate the changes of the IFUs. I wrote here iFew version versus the product version to match that in the production, but we also know manufacturers that have multi manufacturing plants all around the world, and then you need to manage and coordinate all the changes when there is a new iFew scrapping, and when do I need to put what in the packages. So this is also a huge lift.

From regulatory, but also from the shop floor management in the production units. Well, avoiding packaging problems, that was a surprise that I heard, last year, I think, due to a very, very large IFU, that was a really large booklet. And they shipped that in a container together with a sterile packaging, and they had problems with the validation, transportation validation, because the IFU was damaging the sterile barrier of the original product. So they are looking, very, very forward to, really replace the complete, a printed IFU and replace it by an electronic version. And by the way, it's not only that they can throw away the paper version, they also will smaller or downsize the packaging of the device, because the packaging of the device was larger due to the IFU, not the device itself. That was a really funny one.

Yeah, there is, of course, the urge to comply with EUMDR. We all know the passage that if you have a website as a manufacturer, and you have this instruction for use, then you need to also make it available on your website. So this is also a point And, not the last point, I think this is, should be, more on the top here of the list. It's the impact on environment situation and the burden on hospitals, because the Medical Mountains Association here in Germany, together with MedTech Europe, they also pointed out that, all the IFUs that were sent into hospitals They got stored in rooms, and they also need to be scrapped somehow, so there are costs and handling costs on the hospital side.

Okay, so… Let's have a closer look on that topic, not only from the paper perspective and the electronic perspective, but on the complete process. And… To start that, we need to zoom out a little bit where everything starts. And everything starts, of course, in the development process, where you have your R&D team and all the stakeholders that are defining risk management, defining the information that you need to manage, and eventually provide to your end users. You have the regulatory process that is providing also information about the pictos, and about information that needs to be placed on the label, and on the IFU itself.

You have the label department that are then managing this kind of information to put that on paper, or let's say in the InDesign, or some are using also Word files to design the IFUs, so this is a process. And then you have the approval of that. And sometimes this is also cycling back, because the people that approve the data upstream are seeing and reviewing the data on the final artworks, and then it's got recycled back, so this is also a topic for itself, but not for today. And then you have, eventually, the printing process and the storage and handling by the end of the day. So, we want to get rid of printing and storage handling, so this is totally clear, but

what to do. When we are using EIView, websites for that, then we have another burden on the regulatory department or the label department. It depends on the structures of the company, because you need to handle, as well, this stuff. So if there is something new in the development process, risk management gets revised, we have new warnings, and we need to place it on the iFew. Then you have to do the artwork, and then if it's approved, you have to manage that on the website itself. And don't forget about Bob, because he's still struggling in reading this, paper-based versions reading on his iPhone.

And that's why we started this process. We got punched by our customers and say, well, we are managing already so much digitally, and we don't want to do that the same way for the instructions for use. And they say, okay, we did our evaluation, and we will start to do something about it. And… what we ended up with is we started to rethink EIFU as the process, but we also started to rethink IFU as the medium how we use it today in these paper versions. And I want to show you both, processes that we went through. And we will start with the rethinking EI view process. So, it's clear we got rid of the printing and of the handling.

But what the people told us, and the manufacturers and experts, is they tried homebrew solutions by their IT teams and stuff like that. So, they had also the manual burden in managing the stuff, and it was also very expensive. EIFU platforms, as we started to look at it. seems also very expensive in return, what they are actually doing. I mean, they are doing… the management and the distribution of PDF files right now, so it doesn't sound like a really, really rocket science here, but despite of the fact that the technologically stuff is easy, they are very expensive. And we have a lot of small manufacturer clients that are also asking us, how shall we do… how shall we deal with that?

Because we don't want to spend that much money on a solution, but we want to get rid of the printed iFuse. And of course, the manual handling is something that was discussed, and There is Bob again. I think that Bob is really, really having a hard time in understanding what he's reading there in his eye view, so we're talking about the usability for healthcare professionals. Okay, so… If we want to get rid of this manual handling, we need to introduce a technology that is automating EIFU handling. And this is placed then not on top of the regulatory people or the label department. It needs to be placed directly at the approval step. So, when you are approving new instructions for use in your company.

then it needs to be a workflow that this is automatically handed over to the EIView platform that is then distributing this information. So, we're talking here about a complete autopilot setting, so this is the pilot stuff again, so autopilot stuff. when there is a new IFU released by the regulatory department, or however the regulatory workflow is handled in the company. So this is number one, how we are, rethinking the EIFU process itself. But, we don't stop here, because we have other options. Due to digital options that we have, the technology is evolving so fast nowadays. So, rethinking the iFuel itself, getting rid of

paper-based layouts and artworks for our end users. We want to have something like responsive designs, so when the healthcare professional is looking at it, it doesn't matter if this is a phone, if this is a tablet, or if the healthcare professional is sitting in front of a desktop computer. the content is presented in a nice way, searchable way, and stuff like that, so he gets, or she gets, very fast to the information they need in this moment. And we know sometimes it's maybe an emergency, and they need to get this information very, very fast. So, when we are looking at a print version of an instruction for use, we have a layout, and this layout is containing a lot of information, and most of the time, it got copy and pasted out of development documentation by the artwork team. Some are using maybe ALM, PLM solutions, where you have

content, and they try to automate that with, InDesign servers, XML, and stuff like that. Because all the stuff that we are looking at here now is kind of content where not only the R&D department, QM, or RA department and label department are interested in. We are talking here about single source of truth-like stuff. And that's why our clients started to nudge out and say, please do something about that, go in this direction. Because if we have a single source of truth about our devices and everything is in place, then we can take this information, automate it in a way that the user, the end user, the healthcare professional, basically.

is reading this information and don't have to pinch and look at, PDF files that were designed, I mean, many years ago, these tools were designed to print the stuff and not to, to put it on a screen, on a smartphone, so small screen. Not talking about Apple Watches, but… but iPhone-sized screens. So… when we are rethinking this, it's really important that we are engaging in a thinking where we can place the data in content. And if we have content, you can think about it, like, if there is A content change because of risk or a warning that is added to the data. and the development regulatory department will introduce that data here, then this data is already staged for publishing, on the EIView portal. So, if the approval workflows run through.

Then this information is revised and getting published to the healthcare professionals, and they can read it, and they can get maybe a notification or something like that, that something changed. And this is a really, really digital content-to-content workflow without having all these single steps in breaking the software and programs we are using, from ALMs to Word, from Word to InDesign, but from a really content-based, end-to-end process, delivering this information to the end user. And why I'm talking about, also about that, because the numbers Sean presented to us were really impressive. And this number is based on a workflow

that I showed earlier, where I have the information in a single system, and then translate it into the artwork, doing the approval, and then translate it into an IQ platform. So if this process is already giving you so much more resources, or enabling these new resources, or saving money, then going to a complete content-based EI through publishing will free up even more time. We know that from our clients that are using our ETD solutions, and they are reporting us more than 50% time advantage in technical documentation management. And if you take that number. and pour it here on the EI field process, you can feel, or you can think about, what is possible even more beyond the numbers that Sean presented to us.

Well, this would be, of course, a process that, everyone is dreaming of, and this will open up new possibilities, not only for the manufacturers and save Time and money, but also to enhance the usability or for the healthcare professionals. And I think this is something when 70 or 87% of the professionals are preferring the EI view, and got not presented in a really bad usability and readability of a PDF, but the information got presented to them in a nice way, with a lot of options to search and to browse and stuff like that. This will also enhance the happiness of using an instruction for use for the healthcare professionals.

So… So, yes, please.

I want you to breathe. Yes, I'm worried about your breathing. So I want to stop here and open it up a little bit to the audience and say, you know, do you see the benefit in this? For yourselves, or for your clients, or, you know, what have you. Also, there's an interesting question, which is. Would this… would this software that you're talking about coded for this data repository be treated as software as a medical device itself? My personal opinion on that is no, because it's not for the treatment, diagnosis, or cure of a disease. Therefore, it does not meet the definition of software as a medical device. I would defer to the regulatory experts in the room on that.

And then there were a couple comments, Daniel had a couple comments, which I'm gonna let him ask out loud, and… or comment. And then… Any other, any other, comments from… from the audience are… are welcome at this time before we go into the learnings.

So, so this is then, my first comment to your last statement is that The… that software, the information that we would provide would be an extension of the product labeling? So, someway, somehow, it would have to be regulated as…

Labeling as an extension of the label of the product.

So… so I… I would expect that we would have to do… All the, sort of. validation and verification work that we would do to predicate rule paperwork, because the IFU it may be in an electronic form. It's not accompanying the product, but it's intended to supplement the work that you do for the product.

Yes.

From my perspective, I would say that we definitely would have to comply With specific expectations for labeling, to say the least. The… this… this… so that's my comment. The second comment is… is really around the mindset that I have, that you've been talking, Michael, about the healthcare professionals, but a lot of IFUs are actually also intended for end users, the patients. Yes. For a number of medical devices. So, I was just thinking about, to what extent we could envisioned, eventually, an AI-based IFU, I would call it the IIFU, where there would be an interactivity between the patient

and the IFU, where I am not just reading the IFU, but I'm listening to it, and in listening to it, I may even, at a certain point, say, I need a clarification on this. Because I think the possibilities are just, you know, infinite. Any comments from you on that?

Yeah, sure. So, as we thought about the design of the Medevo EIFO platform, the LLM, or let's say, generally, AI, was, of course, a topic. and started from, okay, maybe we can have a chatbot so you can actually talk to that and ask questions and so on, to using Gemini or OpenAI models to have also the voice, part of that. And, I love that idea. And of course, in the beginning, you are, focusing on the, let's say, on the minimal viable things that you, that you want to, that you want to fix to, to, to the platform, that you are envisioned. But this is something that, we have on our, on our paper, on our list, because, we think that this is,

Breaking the barrier, or opening a new dimension for patients, or even healthcare professionals that simply want to chat with an instruction for use. And we think that multimedia, like, introducing also of videos and audio beside AI, is something that makes it really, really modern and a digital way to transport this information.

And the last point then, Martin, I'll let you go in a second. The last point is, I like the openness of the regulatory authorities, but we still cannot forget that there will be certain regulatory requirements associated with everything that we do, so we really have to make sure that not only we can Manage and command the technical aspects of what we want to do, but that those technical activities are actually compliant with the GXP regulations that will be applicable to those activities that we manage.

Yes. Aim into that.

Martin?

So if I've understood… if I've understood correctly, we're really talking about cross-media IFU. So… The issue really is, is that we need to… we're in a sort of world, a very fluid world, where people expect to be able to download something and see it. And we really need to be able to… and whether it's a talking IFU or a video IFU, whatever, we need to be able to make sure that we communicate somewhere, whether it's on the packaging or wherever it is. What device you can view it on. You know, the Apple Watch was a classical example, right? I think this is a classical labeling

we still have all the labeling issues, right? Like, when you go… when you have something draft, and you're submitting it, and you want to move from draft to non-draft as soon as possible, after you've got approval. Or you have the issue of RUOs in the market, and they're turning into IBDs, for example, but… and so those issues don't really go away, those challenges don't go away. But I think the key challenge in our fluid world is… communicating to the user, whether it's a tiny text underneath a QR code, or whatever it is. That gives them a guarantee that they know that there's at least one device out there that they can view this.

Michael, what do you think about that?

Yeah, so, especially the extended labeling, topic, I was listening closer, because I started 15 years ago at Fresenius and regulatory, in, in the label, department, and, I think that we have so many options today, and we are inventing stuffs… I mean, every day there is a new idea and gets developed, and the regulators will look closer to that, and as long as we are, taken into account, like, the ISOs and all the requirements that we have. then we can shape something, and we can wait for the regulators to, let's say, speak up if there is something that we need to do better in this direction. But when we are talking about the content-based, especially the thing that I'm showing here.

from the perspective of a EIFO platform, the platform is only there for the distribution of information. The validity or the integrity of the data, of course, needs to be preserved. So, when we are talking about this data. I am assuming that this data comes from an regulated or controlled environment. So, like, now I am approving a document to release it. I need to approve and release the data before it's got published. So I think that this is, an analogy, how we handle documents, and how we are dealing with and handling data by the end of the day. And it needs to be the same, like records, or the approval of records according to 21 Part 11. So this needs to be the same, and

If the data is coming from a validated system. and is handed over to an EIFU distribution platform that is also validated. Then I see this, I see it as a no problem. But if we are introducing this kind of multimedia thing, let's take maybe the idea of the chatbot. I don't think that you can use simply the general OpenAI or Gemini model for that, because Hallucination is still a thing among the AI. So, if the patient is asking something, you need to be 100% sure that the information that is going out is really the thing that the patient needs to hear, and not misusing the device, or misconfiguring the device, and this is a potential harm, but this should be covered by your risk management by the end of the day, I would assume. So,

I think this is a really, really interesting, area where he's stepping in, when we are talking about cross… media data that we want to transport to the professionals or to the patients. Of course, if it's layperson, you need to have also the printed stuff. But it's nice to play around these ideas. But this is opening more and more risk-related issues and stuff like that. So, I think that this is the beginning of a really interesting journey. About that topic.

Great. Luke, you had a comment or question?

I have 4 points. Hi, Michael, interesting presentation. As you know, as I know, that the thing with IFUs is that if everything else fails, read the manual.

So, to throw it away on the first occasion.

You mentioned correctly that upon request, at least the paper version must be available.

Boom.

Excuse me. But that means that either you have to have a very smart editing system that can spit out your electronic form for iPads and your paper form, or you're maintaining two different versions, which is not Very nice. So… I expect that in one of your next slides, you'll see a very clever editing.

System?

And also, at least for our product, the IFUs are on the critical component list from the… Yeah. From the notified body, that means that if you do make a change in it, you always have to at least… report it to the, notified body, or ask for permission, which is… which is very, very… at least it takes some time, and it takes some effort.

So, the danger of having a very agile system for editing your manuals very quickly.

Is that people are getting used to.

Editing it very quickly. Well, for each step, you still have to go to the notified body.

So I guess that's… that's a danger in… in… in using that. And there's a point I would like to mention, is that, at least in Unimet, there's an option for adding a URL for your product in there, which can.

Yes.

to your electronic eye view on your site, and if you could make a URL always say the latest version, or a landing page where you can choose your version for the… Yeah. for the, the IFU, that would make it very valuable. You, you scan your, your, your, your, your, your, UDI label on the back of your device, and you can instantly get a referral to your IVU, which would be very handy.

But.

The last thing I would like to mention is that, because there is so much regulatory burden, as Daniel Barreto pointed out, for us, it's, I guess, easier to make AI view that's a little bit fixed, that passes all requirements, and doesn't change too often. And on the side, have instructional videos on how to use your product. You still have to be careful with all your marketing efforts, because it's still… is considered labeling, I guess, but it gives you more freedom in how to express the things that are… are important, because in your eye view, there's this list of mandatory things that clutter up the things you really want to say.

Really, yeah.

production of video. You're more free to show what's really important and prevent the mistakes that people make. Usually with your product. Okay, there were 4 points. Can you comment on that, please?

Thank you, thank you. So, if this is okay, Sean, maybe I can show a practical example about this point, yeah?

Let's, let's move.

Okay, so before I will go on with the slides, let me simply share… something with you, because I think that we need to clarify on that. Can you see my entire screen now?

Yeah.

Okay, so.

But, yes.

But you can't see my screen.

Yeah, I can see it.

One second, I think I need to click on share. Now. Now you should see my entire screen.

Yep.

Okay, so… When we're talking about this database symbol here, what I talked about prior to you, look, thank you for those questions and remarks, I'm talking about a single source of truth manner. So, it doesn't matter if you are using our ETD tool for the electronic technical documentation, or you have other tools in place. So… when you are changing things, and, let me quickly bring up our ETD here. When you are changing things, everything is subjected to audit trailing. So when I'm looking here at a, at a product that I want to investigate here, I have here the 2.6 as a version, and maybe I changed something about the intended purpose, or I added intended users, or, as in my example, I added maybe a warning.

So, when we are at the process and adding stuff to our, to our product that is then reflected in the IFU, You have the regulatory process prior to that, so you are changing information in your product, and then you need to, of course, approve that information, and then give it over to your notified body for the approval, or for the review, or whatever. And at this point, when you got this information approved and everything is okay, then you move on with the process to hand over this information to the EIVU, or in nowadays, you would go to your artwork department and say, please update the IFU according to this project. So…

This is what I'm talking, single source of truth, because if I have that, then this change can be then reflected in the, in the iFew platform, where I have then my documents, for instance, for my infusion set, and I have my versions with all the, languages, the status, and everything. So, you have all the stuff then here, so it's really, really version controlled on the data side. and also then on the EIView site. So this… there is no, break in the process. And the second part of your remarks was, if I am managing this thing on content level, then of course, if I need to provide a iView, this content, since this is a responsive design solution, you can create an

A4 or letter size printout of the extraction for use for the persons, but still, still be in this content-based management of the information. So, there is no redundancy between creating a print version of an IQ and maintaining a content-based version of the iView. This is entirely taking place in one system, and there are no differences between this. And since you are talking about the UDAMet section, so… When you are managing the products, you have a evergreen link. Which is also, I read that in the comments here, also as a QR version. So, when you are looking at this.

QR code, or taking a link, you have an evergreen link that is taking the user, or the UDAMet user, to the area where the documents live. And when the user, and I do not have a QR code reader here on my desktop, but when I am scanning that. or clicking the UDAMet link, I will get here to this evergreen link to my product, and I have the overview of all my languages, and also the older versions, for what I talked about, the archive option that you need to have. In doing that. And then you can simply go inside that and then, looking at the stuff. So, this is, just as a practical example how this might look like, because I think it's too abstract when talking about data and how this is, connected or,

Yeah, how to imagine that when talking about this icon with this database here. I hope that was… Okay for you, look.

Yeah, yes. It looks a bit like a system we designed once for a ship towing company. They had boats, and they had crews, and they had, like, equipment on their boats, and they all had certifications and that kind of stuff, and diplomas, and they had.

Yeah.

database, and when they had to spit out what was available, they could… you could have it on an A4 with the current equipment, the current available crew, that sort of stuff. So it looks a bit the same. You have all kinds of regulatory required parts.

Yeah. He just, can…

Put it together the minute you like it.

Yes. It's like reusing, reusing of content.

You had a link to the, to the IFU via the… how do you call it, the URL? But is then the front end separated from the publishing end? Because you don't want to have, people going into your backend?

Of course, of course. So, you have a, complete backend area where the complete management takes place, where you have the print requests that the people are requesting from the site. audit logs and everything, and settings for the, workspace, for the public page and everything. So, this is a area where only, the administrators or the managers of that application have access, and then you have the public page. And the public page is completely separated, from this area, of course.

How do you do the version control? Like, say someone's printing, we want to make sure that, you know, sometimes, you don't have the most, you know, employees that pay the most attention, so they might just click on something. So how is that version control in place?

Yeah, so, we have here, when, one second, when… do you, do you mean the public, or do you mean the, the managers?

Both. So the… the public… I feel like you resolved that question with the public one, because you only have, like, you can just Enable it in the public side, but for the versioning control for the managers to make sure that they have the iteration.

So, it's not possible to upload the same version of the same document. The management takes place a little bit different than in a document management. Let's talk about, like, a SharePoint, because, IFUs are different, right? We have versions, and we have languages sometimes. That's why we came up with an idea that you are not uploading simply a document, but you are creating a document set. And this document set, where you say, this is my IQ, or whatever I want to publish for ABC, and then I can define for what kind of products this is applicable. And then I'm creating the set where I can add my files. I can add the English version, I can have maybe a version that is containing four languages, and this is everything then contained with versioning, with the publishing date.

And, I can also, bulk import stuff, so, and the system is then recognizing in the files, if this is a version 3, if this is a version 4, or the publishing date. And with that options, you can also then tell the people, tell the system what kind of languages are in there, if it's not automatically checked from the document. And with that system, you are managing it really, really, let's say. guided by the system, so you're not able to do that many errors in terms of version control, because the system will give you the heads up. And also, when we are looking then on the public side, we have a clear indicator when clicking here that this is an older version, and also when you are looking at that.

you get the information that this is an older version you are looking at. So, this is, let's say, risk-controlled by design of the system.

Okay, thank you. Follow-up question. I just completed this large Kappa program, Kappa project for a global med device company that's based in the U.S. that had, you know, multiple languages and everything for their IFUs. My, my question is, they use Agile, Oracle? And how… and they upload their… their IFUs into that. How does… is there an API, or how does this work with Agile, if any? Anyways…

Yeah, so… so, right now, what we are… what we are integrating is the EIFU connection to our ETD solution that I showed you, a couple minutes ago, so this is, this… no, this is this solution here. But, there will be a REST API so that, you can use, also Medevo EIFue platform without being Medevo ETD client, so… This is on our roadmap. It was not the first feature, but it is on our roadmap because we know that there is no one solution fits at all, so that's why there will be an API for that.

That's great. So… One thing that I would like to point out, is that, you know, a large reason for this group to exist is so that we can help each other, and, I firmly believe that products like this one, like Medevo, get adopted, when they're walked in the door by people that are already trusted, by the client. So, a lot of you are consultants on this call.

And…

you have the opportunity to say to your clients, I saw an interesting solution from an interesting company that could help you. Now, that gives you the opportunity to help Michael, but it also gives you the opportunity to help yourself. That… When we create a network of connections with one another, and we're able to provide introductions to people who are able to solve problems that, as a solo consultant or a consultancy, we're not able to solve on our own, we're able to, Provide a partnership network to one another.

And so, I would invite Michael to say, you know, is there any way that the people on this call.

can work with Medevo, can learn more about the products and solutions that Medevo offers, and and is there anything in it for them if they do? To put it real.

Yes.

Yes, I have it, I think, on the… on this or on the next slide. So.

since we are running, out of time, so I just don't want to miss that. So, let me briefly tell you about our learning. So, what we learned in this couple months, is that If there is a solution that we are building, it needs to be cost-effective, because a lot of solutions have, like, caps on documents and products when you are introducing that to them, so it's very, very expensive. So it needs to be cost-effective, and also affordable for small manufacturers. And you need to have a fast onboarding, no, no long projects and whatever, IT and so on, it needs to be really, really fast. and the best self-service. And it needs to have a high degree of automation already with the PDF stuff that we talked about, to have that automation already.

And it needs to be future-proofed in terms of content-based methods to go this direction, to content-based or cross-media, I like the word, cross-media distribution for the EI views or iFuse information. Well. If we… if we do that. then I think we can make the, not only the manufacturers happy in terms of cost saving, but also the healthcare professional. And now to the point that you pointed out, Sean, we have this EIFuel platform now on early access, so in a couple of days, there will be an early access to the platform, and we added a free forever plan for small manufacturers. So if you are a small manufacturer.

and only need to handle a couple of IFUs, you can go with the free plan, and there will be no string attached, so it's really, really free, and there will be no charges at all. And, for the early access people, we will have a thank you, which is a, promo code for, for the first 6 months to have it, for the paid plans. And, you can, you can reach this by medevo.com slash EIView. And what we also did is we created a partner program. This is the first partner program, let's say, for an individual product here, for the EIFU, which is EIFU-partner-program, and there you can apply to our affiliate program for the EIFU platform, because this is a product that is designed for self-service to

Really, really fast distribution, and in this program, we want to, share, this, this with our partners to, if they share it with their clients, and they become our clients. So, there will be also commission fees, or commission payments that we will, do. And beside of that, we have also a partner program for our electronic technical documentation for the ETD platform. So, if you're interested also to know more about the ETD solution, feel free to reach out to me or our team, and we can share information how the Partner Program is a little bit… more factors to the ETD Partner Program than for the EIView. The EIFU is pretty straightforward, and yeah, so that would be, what I have brought for you that are consultants or freelancers here.

That's awesome.

That's… that's it from my side.

So, do we have any questions, from the audience? I'm gonna, make a small reminder for those of you who are long-time regulars and had trouble logging in this week. We're moving from having a single login for all events to, individual logins. The way that Joe did it and the way that I do it are two different things. We're entering a new era. If you are a long-time member, you will receive, an email update from Zoom, your webinar is starting in an hour, it will have the link in it, you should use that link. You should not go to a 2-year-old link. And think that you're gonna get into this call, because that will not work. So, you know, be prepared for that change. I think it impacted attendance a little bit this week. And I know that I got some

panicky text messages, I can't get in, I can't get in. So, be aware that we're… doing this so that we can promote these better, we can get better attendance, and we can attract, you know, the best speakers possible, every week. With that in mind, next week we're going to be looking at another platform, that approached us… the regulatory compliance problem in a very different way, that's Houdin, and they are going to come and show us what they've been working on, and they've been working on some really interesting things, so I don't think you're going to want to miss that. Let's see, does anybody have any final comments or closing remarks for us?

Let's start with Michael.

Yeah, so, thanks, thanks for having me here, and for the opportunity to sharing this, development journey, that we've been through, and, Yeah, I don't have anything to add, because I said everything, but one thing I want to add, next Friday, Huden, I know Marcus for a couple of years now, and I think that this is really, really interesting, what they are doing, so don't miss that.

Thanks for the plug.

I'm gonna hit up… hit you up after this to schedule a call. Sorry, I just want to be aggressive and let you know I'm gonna reach out to you. Thanks.

Thanks.

Fate rewards the aggressive, Patricia, so thank you for that. And anybody else, you know, feel free to, drop a message in the chat, say I'm interested, and I will forward all the chat messages to Mr. Michael. Had an interesting comment from, one attendee, George, who wanted to know, you know, just… On a tangent, the, idea of the panel, what they wanted to think about the new AirPods 3 features, which will now have health features included, including heart rate. So this was on the idea of, you know, claims.

advertising, and what is considered a medical device. Probably a bigger topic, it's 12, but, if you have comments on that, please feel free to send them to me. And, yeah, I will hopefully see everyone next week. Bring a friend. Thank you.

Thank you so much, Sean.

Thank you. Take care.

Take care, bye-bye.

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