Streamlining Regulatory Intelligence New Tools for Success

Hey? Good morning, everybody, and welcome to streamlining regulatory intelligence with the Owner Institute today I'm really excited that we're gonna be introducing their regulatory radar. Here with Stefan Gossel and Dr. Interesting and I thrilled to be here with the 2 of them. I while we're while we're warming up. Let's go ahead feel free to drop into the chat where you're dialing in from what country love to know. And a few housekeeping notes. Feel free to use the chat function vigorously. During during this webinar. We welcome your questions and comments. And we'll try to respond to them.

as as we are as we are able, Switzerland is in the house. That's fantastic. So again, the reason that you've been invited to this webinar, and I'm very excited about this is this is med tech leading voices. First. private invitation, only webinar and we reached out to select subscribers and and other members of the Med Tech community to help yoner Institute introduce their regulatory radar product to a larger audience. It's been used extensively, but mainly in in Germany. For a while now. And I am really excited to learn all about it, and to see it in action. And I hope you all are too.

Again. If you have questions or comments, please feel free to put them in the chat along with where your calling in from? There will be only 2 poll questions, and then there will be a 6 question survey, following the thing which you will either show up on your screen or you'll receive it in the in the Follow up email tomorrow. This session will be recorded. And the recording will be available to all of you who registered. So without further ado, I'm going to introduce Stefan Stefan. Take it away. Yeah, share your screen.

Yeah, thank you for your introduction. So I'm Stefan Gusill. I'm the member of the board at the Owner Institute, and I've I've been doing like 25 years digital transformation of heavily regulated industries now. And yeah, I'm happy to be here and introduce our regulatory radar or regulatory Intelligence Platform. So, Andrea. do you proceed.

Yep. Thank you. Stefan. Yeah. Andreasik is my name. also from the younger Institute. I've been working there for 7 years now, and I'm the lead of the digital solutions department. So we provide different digital products to our customers. And one of them we are going to introduce today regulatory radar my background is medical engineering, but I have also strong background and regulatory affairs. clinical evaluation. All the things that regulatory affairs experts have to deal with. So yeah, welcome to today's session.

Okay? So should I, just jump right in.

Yes, go ahead and share your screen. Let's let's do this.

Okay, perfect. So here we go. Yeah. So okay, so welcome to streamlining regulatory intelligence. So first, to set a bit the context. So this is the total pages published of regulations. Just a trend. And, as you can see, the trend goes upwards, it's not surprising. And so it never again will be as few as today. And I think this is important to understand. So this won't stop. This will never stop, and it will only go up next thing like technology growth curves you. You all have seen them. And so never again will technological innovation move as slow as it is moving today.

and in the last, like 24 months with the Gen. AI trend. It's it's difficult to even imagine how this will go on. And this is a tweet from yesterday. And someone said, Okay, there's a new Llm from Meta, from Facebook, and it's the best ever. And then Microsoft just released a better one, and it's open source and it's free, and you can deploy it on your platform. So never again will product release cycles. Be as slow as they are today. And I think this is something you really have to get a grap on. And so it's it's difficult to imagine. But things will just speed up.

And so the strategic context of all of this is. most of you will have new competition from Google, Meter, Apple, Amazon, and so on. And we would see new technologies in an either even faster, accelerated way, like Jen AI. Data driven drug development of medical technologies, personalized medicine, or VRAR, call it XR, and so on, and so forth. And somehow you have to cope with it, and what we are seeing is the time of standalone products, is probably over, and we would see solutions, and we would see solutions of solutions. And in the regulatory context

there is, isn't even a concept for for solutions. So it's all about products, single products. And so this will even drive complexity further. In this space we see a divergent, regulatory landscape. So we are from Germany, obviously, as you can hear, and so we are. In Europe, and Europe is having the worst regulation ever, at least in the metic space with the Mdr. And it's completely diverging from what FDA is doing and so on. And so this is also a pain. And this won't be this, this will even continue to diverge. And we don't find the right people. And probably you also have some problems with labor shortage. So it's difficult to find

the right people with the right skills and so on. So something we have to do on this and everything in regulatory affairs starts obviously with regulations. So you need to understand the regulations and the landscape, and what is evolving. And so what is regulatory intelligence all about what most people don't understand. Regulatory intelligence is just a part of your business intelligence, and everyone is spending millions on business intelligence. and most of the companies are not spending even close budgets to this in regulatory intelligence and like business intelligence.

Let's say it's a set of strategies and technologies. So it's take, it's not only technologies. And it's not only strategies, it's both. And what you want to do is you want to analyze your business informations. and you want to transform them into actionable insights. So it's all about actionable insights. And it's not about a newsletter or a couple of newsletters. What we see today as regulatory intelligence or regulatory radars, is you? You you you get some newsletters and you just get information. But what you really want is actionable insights and those actionable insight they have to inform business decisions.

And then. if that loop is closed. you have a regular or a business intelligence in this case. And so regulatory intelligence is the same. And what what you are driving is business decisions, obviously, but also regulatory decisions. So you're driving your regulatory strategy, and in in which markets you go when, when you go in which markets how to go to market, and so on, and so forth. And this is what regulatory intelligence is about. But why do you need it? I think if you're excellent in in your regulatory intelligence, you you just can move quicker with more determination.

So what we see is in, especially in large global companies. A lot of people are working on regulations, but they are not aligned. They don't know each other. They don't know what the others are doing. They don't know what they decide or what they decided last year, and why they decided they have no track record. They have no tools to analyze, and so on, and so forth. And if if you have excellence in regulatory intelligence. You can anticipate. You can act faster, and you can act with the coordinated effort, and you can bundle your resources. and that's pretty much what regulatory intelligence is about. And I think

you need a strategy. And you need the right technology. And for us. the right technology is an open platform. That allows you to move your processes across your global departments and to align all those departments and to to understand what's going on to monitor what's going on to monitor the performance and to have a dashboard to understand what's going on. And yeah, that's pretty much what it's about the session today. And yeah, I would hand over to Andrea.

Before we go into that, I'd like to launch a quick poll question right launch just to get an idea of. Oh, you know where companies are right now in terms of their regulatory intelligence. Any integration within company while we're running the poll question. I'd like to. Just you know. Ask Stefan. You know, we had talked with Christian extensively about the necessity of integrating regulatory intelligence into the entire business process. From end to end, and you know that it doesn't exist in a vacuum and I think one of the things that intrigued me the most about our discussions was the concept of integrating regulatory intelligence into the strategic business

decision making process and the advantage that it would have for companies that that. Take on that challenge. any comments.

Yes, yeah, completely fully agreed to this. What? What we see? So either companies have no regulatory intelligence in place or no, no processes. but even when they do, they lack kind of a dashboard for the management to understand the implications of those thousands of updates a year. So it's not possible that the board is discussing tens or hundreds or thousands of of regulatory updates, but it's possible to to chunk up to condense it, and then discuss a strategic direction. How how you go about regulations, regulatory affairs, and how do you align all these aspects into your business strategy, and I think

maybe it sounds a bit strange, but I think if you have excellence in your regulatory intelligence, it can be a competitive advantage that is difficult to copy for your competitors. And so there's a term regulatory capture which is a bit wild. But in the end, if if your if your capabilities are really good in that space, it helps you to differentiate. And in in today's or tomorrow's world. I think it's becoming increasingly difficult to differentiate in this space, and this is one component of a differentiating strategy, I think. Yes, I agree.

Fantastic. We're gonna turn the presentation over to Andrea now. Thank you.

Sally. Yes. so welcome to this presentation about the regulatory radar which I'm going to deep. Dive a little bit into it now. In the next few minutes. maybe a little bit on the history of the regulatory radar. So about 7 years ago, when I started at the Unit Institute as a consultant myself, and also my colleagues. We all had the need to get all the information about new regulations, about changes of regulations, and we all needed that for our consulting projects, of course, and we were also in the need for having some kind of

tool or platform to manage all the incoming information. And we also started with excel as a first tool. But obviously only after like 2 or 3 months, this is was not handable anymore. So we really started about started to think about a data model that is reliable, that is sustainable. And that can help us to manage all the regulation data that is coming in. And we set up the database for that. And this was basically the birth of the regulatory radar. So over time, we saw that many of our clients face all the the same problems like struggling with handing all the information, keeping track of

who is preparing. What change, who's implementing a measure on a change and so on. So after a while, we decided to provide our solution also to our customers. And this is why, we now have the opportunity to show you the regulatory radar as a customer solution. Stefan already talked a lot about what is the what the problems are of regulatory affairs, or what are the challenges in regulatory life, science, industry today? So we have an increasing complexity of the products, the technology, we have the divergence in the regulatory systems between the Us. Between Europe, between China, lack of skilled workers, we have increases in a time to market, especially in Europe. That's a big problem at the moment. Because the approval processes are that long. And Stefan also talked already about the

new and very fast competitors that we see coming up. So we believe that a key element in staying ahead of the competition is really to have timely and specific information, or, as Stephan said, actionable insights into all that to react appropriately and very, very quick. So this is where the raiders jump in now, and what we can especially help you with the raiders is in the first start to prepare and evaluate a regulatory spread. Achieve that you have for that you need for a product. So imagine you want to go on a new market with your product, you can get all the information that you need from

what regulations do exist on a certain topic, on a certain market. Things like that. You can research in a regulatory intelligence tool. And then again, of course, you can. monitor all the regulations, all the information that is coming from all the databases or different sources. and really tailor it to your needs, so that it's really specific for you. We don't want you to get a lot of noise. We want you to get the really relevant information. So you can really start working on the things that are mostly relevant for you. What really helps inside a regulatory intelligence tool is that you have a

a process set up to assess and implement all the changes, because monitoring is only a one part of the story. You have to do something with the information, and we saw many teams that struggle with how to evaluate the information and objective transparent way, and then to implement those changes and keep track of how the the changes are implemented in the company could be change of a product, change of an process, something like that. And what Stefan already mentioned is also work together as a team. So the situation where 2 departments get the same information about the regulation and start implementing changes. Here it would be really helpful if those changes are aligned. If you have a holistic approach to implementing those new information into the the products and the processes.

And last, but not least. a tool like that helps you to identify bottlenecks in your compliance process and based on that, manage the resources that you have. So this is especially helpful for the management team, of course, to see where we do. We have bottlenecks, maybe certain market or a certain product group that there are many changes that came up on that market, and they cannot be handled in time, so they can see very quickly where they have to put their priority on. So those are the 4 use cases that our platform really helps your team with. If you look at the regulatory radar as of today, we monitor about 6,000 regulations worldwide in about 120 countries.

And this is covering various scopes from the regulated life science, industry, such medical devices, pharmaceuticals, biologicals, but also topics as data security, where which are a little bit more vertical topics. We monitor all kinds of regulations. So we monitor standards, but also guidance documents Regulations act. So you get the full landscape landscape of regulations in the tool. and we can easily extend this data with almost any scope, because what we did we established a real suitable data model that we can adapt to all the other scopes out there. So this data model really helps us to make the tool suitable for all industries.

What are the different sources that we actually monitor in the tour? So, on the one hand, we have, of course, all the official standard resources and database. So, for example, the Iso standards, or CLSI. Standards also the FDA guidance documents, all the databases that are available there. We build callers that check those standard resources basically every night and inform us about any change that happened on that day. You also monitor news websites. So that's from authorities, from governmental institutions, from regulatory affairs, associations. Those are also monitored. And we also

put this information into our tool. So especially for those things that are in preparation, like drafts or upcoming consultations, things like that. So we get the information really early in the process. For some countries. We also have international partners that help us to provide the information from there's countries, so especially Japan or or China. So countries where we also have the the language as one of the challenges there. We also have our experts, our local experts that inform us about any upcoming regulation there and then, of course, all of our internal experts, our consultants. They are part of

standard committees. They are also part of regulatory affairs, associations. They work in the consulting project. So they also provide all the information and based on the data model we established. We can put all this information together in one tool. So we have the possibility to inform or to to have the information very early. when even there's the idea of a new regulation, basically coming up, and this is where we can help to provide the information just in time. So you have enough time to adapt your processes or product to that upcoming change. We also monitor databases as safety databases like

the FDA recall FDA more database or so the and visa Ddb from systematic databases. Additionally, the literature databases. So that's especially for clinical literature pup made Google scholar, but also Cochrane, that we can monitor there and then some special databases like in this database for cyber security topics. Those are also included in the in the, in the scope of our solution. When we look at what I just told you what the 4 use cases are that the the rate is happier. I want to get into those a little bit more detailed. Now.

I just want to show you some slides on that, and then we jump directly into the tool so you can see it in the live system. But just to get that, you get an impression already. So how does this support for the setup strategy work? This is based on our data model. As I told you, we have a data model, and all the regulations in our tool are tagged with several labels like the product carries that we stick the market, that this regulation is for certain topics like cyber security or artificial intelligence, things like that. So with the help of that tagging system, we can provide filters, we can provide any

algorithms that really find the things that you need, especially for your strategy, for your product or for your new market access. So this is really helpful to set this up to your specific needs. The second use case was the monitoring itself. So what we do. I told you we have all those different sources for our information, and we integrate all these information into our database. So whenever we get an information about a change or upcoming new regulation. We verify this manually that this is really a true change, or a true

new regulation. We do a pre assessment here. So this is also done with the help of our experts. Basically decide is this relevant is for for what manufacturer is is this relevant? We do provide a little description of what has changed, and if it's applicable, we also provide some next step for recommendations for you. and then this is reported to the customers. This is how it looks in the tool, but I will show that in a few minutes. So. as I said, this is the one part of the story. The second part is then in the company or in the client itself. At that site you have. Decide. how do you have to react to that information.

So basically, what we found for almost all our customers, what they usually do is like an initial assessment. So they quickly have a look on it. And they decide, okay, this is relevant. This process might be impacted. This product might be impacted. And they just do like a quick assessment on that. And then this is handed over to the experts, and they usually do a detailed assessment. So maybe biological evaluation. Or we need a new safety report on electrical safety or something like that. So that is part of the detailed assessment. And the result of this detailed assessment usually is a list of implementation tasks. So what has to be changed? What has to be added? What has to be reworked? For example.

this is part of the implementation process, and then you have to track, of course, that those tasks are really done. So this is really like then the workflow we saw at, I would say, 95 of our clients. And this is why we decided to set up this workflow exactly like that in the tool. If you do, all these assessment steps in a really structured way, like in the tool. You then can use those structured information for the dashboard. because this you need the structured information to provide those insights. And here, in those dashboards you can quickly identify bottlenecks. For example, you can see what is over to you what is really urgent. What is in progress? Is there a special market that needs attention? Is there a special product that needs attention? So you get really very quick and precise information on

how healthy your compliance process is at the moment, and where you have to set up your next priorities, maybe shift some resources or seek for external help in a special area. This is something you can do with the insights from those dashboards. Again, this relies on using a structured workflow or structured data in the workflow in the assessment phase. Okay, that was just a little intro. And now we will go directly into the tool. and I'll show you. So here we are start at the dashboard. So maybe what you need to know is what is an action item. We've already heard a lot about action and actionable insights. An action item is some.

Is any change that we discovered in our monitoring process. or any new regulation that came up? We decided to call this also action items, because well, the client has to get into action. At that point we inform you about those changes on a regular basis. and you are the the key or the key screen in that tool is the oversight of all your action items that are in progress at the moment. So here you have an overview of all information changes new regulations that are relevant for you.

So what you can already see here is that each each line is one action item. And you can see the face that this action item is in. For example, the initial assessment, or it's in the really really early stage of evaluation could also be that it's already in detailed assessment or in in already in the implementation phase. So this is really showing you what is currently going on. You also see how this is rated, for example, is it really urgent? Is it critical? Is it maybe not that relevant? Is it still an enough time to to work on that you can see which regulation is affected which market is affected, and then already some labels on which kind of products are affected which processes might be affected here.

What you can also tell is, if there's already some activity. Is somebody already working on that? Who's responsible? And who's the account of a person for that? So really, just a first overview of what is going on in your regulatory update process. So let's take a look at some at one of these action items. Maybe I the newer one. You I think most of you will know the Mdc. Documents. So if you open this action item, this workflow I talked about pops up. And now we have here all the information that we provide to you. So you have the site, some meter information again, the market, maybe some internal deadline that is already set.

also the persons that are responsible to work on it. Things like that here you also have the description of what has changed. You have links to the documents that is affected here in this action. Item, the evaluation is already done. That's why this is checked. Somebody said, Okay, this is potentially relevant for our process. That's why we have to work on that An internal deadline is already set. and the initial assessment is now to start. So that would be the first phase. So now here you have the questions that the tool leads you through. For example, is experience mandatory? Is this a local

a regional or global impact? You can also select which processes might be affected. So those are pre-populated in the system for the clients. So we can say, the risk management is affected, probably, and the product group? Why is affected? And then can you also say if there is a risk to the patient? Or if there's a risk to compliance? And then you can send this for review to the account. But person. So we always have, like a 4 eye principle here. so that it's really also audit safe. and this person will then decide. Yes, everything is as set, or we have to change something and send it for the detailed assessment. So that would be the next step. So we really have this dedicated workflow in the system which gives you structured answers to

to those questions. And this leads, then, to the possibility of having this performance dashboard that we already talked about bit smaller. And here you can, for example. Now see, we have 3 currently overdue items. Those are in. 2 of them are in the initial assessment. One of them is in the evaluation phase. We also can see that we have 6 that are not critical. We have one that is really relevant. We have 8 that is potentially irrelevant. You can here use the filtering like filter for some special markets, or if you have a look here at the European market, for example.

there, is it. then? This would only give us the results for Europe. And then we now see, okay, we have 3 critical items in Europe. Probably it would be a good idea to prioritize those now before other. Maybe not that relevant action items in other countries can also filter for processes areas. So it really shows where you need the next step to take to get into compliance again. That's the idea. Behind this dashboard. What you can also do is have a look at all the regulations. Of course, in the tool. This is again the starting point where you can say, Okay, I have

a topic I'm interested in, for example. I want to see everything about cyber security. Then you could. look here, for all the cyber security issues in a special country. So you get an idea of what regulations exist for a certain market. And you can you have a starting point to work with in the beginning and decide if that's a good approach to go this way, or if another country might be easier to access in the beginning, and then build upon that strategy there. So this really helps you to find your way through all the regulations in a certain topic and a certain market.

Last, but not least, I want to give you just this really sneak preview on something we work on. So of course we all hear a lot about those AI topics, and we also started working on that. So we have a feature here which is in the Beta phase, I would say at the moment, so here you can upload your own resources like any kind of documents like, for example, the FDA guidance or Mcg guidance whatever you have can also use your internal documents, of course. and then you can start asking questions on those topics that are part of the context, or that the the the regulation that you uploaded from

can answer. for example. So this is what we are building here. This is also helping to start where to look for regulations, where you have input which regulations might give you some answers to your questions. Things like that. Yes. So that is basically it what I wanted to show you. There is some more features, but of course I don't give you too much information in this demo. It would be a little bit too overwhelming. Probably I want to summarize, maybe. what you've seen. So what we have here is a tool that really gives you regulatory oversight.

Do you want to do the pool first?

No, you can keep talking just. I just wanted to get this poll question in. It'll just take a minute to run, and then they'll be able to see the slide.

Thank you. So what we have is a tool that really provides regulatory oversight, which really helps you to maintain, improve the compliance and shorten just the cycle time of the changes. We have a transparency here, because everybody in the company can look at all the information, all the data you can work together, eliminate redundancies. For example, you can. If you have an action item for your user group, you can also think about sharing it with another user group, because it might be interesting for them. So you can inform them about that. We have this coordinated workflow. So it's really streamlined. It's single source of truth. All the data is there in the tool.

and it can help you with your resource management through the early recognition of any bottlenecks. And last, but not least. you also have the possibility to reduce costs for multiple tools, because we have here all the different sources put together into one tool. And as you've seen, this is an end to end solution from setting up monitoring and keeping track of all the implementations. So thank you.

Now we're gonna switch back to Stephan, who's gonna share some useful information on your owner Institute. I'd like to add that. You know, there's gonna be a trial offered that. You'll receive information on as well. In the follow up email with the slides and presentation. So stay tuned for that tomorrow in about 24 h.

Perfect. Thank you. So maybe you don't know the Owner Institute and I think we are pretty special as a company, and so just a few words. Why, we are special. so we are regulatory affairs only so we do nothing else. We are the regulatory nerds, and we just live regulatory. So I think this is not very often the case. And so our core is met. Tech obviously. But so now we are covering the whole life science industries and just some Logos. Maybe you know the one or another.

And at the moment about 150 of those companies are using the regulatory radar for their regulatory intelligence. And it's pretty much from the smallest startup to the biggest enterprise. And honestly, what we are right now. Very interested in kind of our ideal customer profile is a global enterprise with a complex set of. let's say, products and product variance, and so on. So a complex product portfolio in a lot of different markets.

and who are interested in, let's say, co-developing our platform further and do some experiments, maybe with AI, maybe with workflow or integration or whatnot. And so we have one of those ideal customer profiles. and they are onboarding 1,000 users. which may sound a lot. But they have like 100,000 employees. So it's about 1% of their staff, which is about right for regulatory, I think, or maybe it should be even higher. And here you can see the larger the company, the bigger the value is in coordinating all those

efforts and people and processes and products and markets and whatnot. And so, this is what what we are. yeah, especially looking for. But nevertheless, there are different. Let's say. variations of the product. So you can only buy a monthly report, and that's pretty much it, or you can go full circle what you have seen here. So and this webinar is about. Let's say the Enterprise edition of all that. Yeah, it's. And so our background is, we literally helped many thousands

organizations to master the global regulatory affairs over the last 20 years. So, as I said, we are kind of nerds in this space, and so I think we are kind of a Wikipedia for regulatory affairs for the industry, and sometimes we have the golden source, so the golden truth. And so we are supporting the whole ecosystem. So manufacturers obviously, but also notified bodies and authorities and regulators. And so we are training the notified bodies. Which is a point. Yeah. And we are working with service providers. We are working with Academia. So, for example, the Harvard Mit center for regulatory signs. We are working with them, and so on, and so forth. And this

brings with it that we have kind of our sensors deep in the system. So we know kind of a lot at very early stages. And this is, yeah, it's it's good. If you have a regulatory radar. So most of the time. We are the first ones to know about upcoming changes or upcoming things. And we provide this knowledge who are customers within the regulatory radar. and what we are doing is active, regulatory science. Which is lacking right now to have better regulations. So this is a goal of us to to have better regulations

and to provide feedback to, to the regulators, to the authorities. We are obviously doing advisories or leadership training, and so on and so forth, and those digital platforms. and up to outsourcing. If you don't want to do things yourself. yeah, that's that's pretty much about yona. So we are from Germany. We are working on a global basis for for startups up to enterprises. So every size of companies. And we are. we are about data driven processes. So our vision is the real time compliance

on a global basis. And we think you cannot go real time compliance with documents. So we try to convert everything into data. and we are pushing topics like regulation as a code. which will be the next step. So we will have regulations as code and not as text. And you can you can process them automatically, and then you can automate the whole regulatory affairs processes. This is what we are pushing. And we are building platforms for this. And the regulatory radar is kind of the basis because it all starts with regulations. Obviously.

yeah, that's pretty much all about the Yona Institute. and I give back to Sean.

I just like to thank everybody for attending today. If you have any questions, feel free to send them to me. And you should all be able to contact me through Linkedin. If we're not connected on Linkedin, please connect, feel free to connect with Stefan as well as well as Andrea, and I would like to thank both of you. That was fascinating. I really love the opportunity to see it in action. And I wanna thank everyone who gave us their time today. This is first webinar. So please provide your feedback private webinar and

we will pay careful attention to your responses. Thank you very much, everyone. And I wish you all a great day and evening.

Thank you. Bye, bye.

Thank you.

Take care bye, bye.