Regulatory Intelligence Is Only the Start

Good morning! Nice to see everyone. Okay. So, today, what is it, April 3rd? We have a guest speaker today, Priya Bhutani, CEO of RegDesk. She's gonna be talking about regulatory intelligence is only the start. I don't remember the full title of it, but you guys do, so keep me honest. While we're, letting everybody in and promoting people to speaker, if you want to be promoted to speaker, just raise your hand. Virtually, and, Francesco will promote you. I have a couple of announcements, And, feel free to say hello. So first of all, how many pet lovers do we have in the audience? Give me a heart, thumbs up, something like that.

The reason for this is, Andre Domino's, product has made the semi-finals rounds of the coolest thing made in New Jersey, so that's 16 companies. And, there's online voting. I'm gonna put it in the chat. First, show some love to the post that I just did on LinkedIn. Follow the voting link, vote for Andre, vote for him as many times as you can between now and, April 6th, because his… His product helps old pets, like old dogs, walk better, move better, and And then he's gonna get it approved for human use. So, it's exciting, it's fun, check it out. I'm gonna put the link in.

The next thing is the International MedTech Safety Conference, June 2nd through 5th. I'm helping promote this conference, I'm not getting paid to promote this conference, there's no…

Risk management. It's not… it's not just med tech, but specifically risk management, right, Leo?

Yeah, so I'm speaking at it.

Yeah, me too.

Oh, cool.

So we have a number of speakers, also participating, so show your support for them. The good news is, I have a discount code. So, if you want to go virtually, you can save $200 off that, and I think the code is good for $200 off the live attendance. There's also a startup code for $250 off, or $50 off a day pass. So I'm going to put all those discount codes in, in… into the… into the, into the chat file. So, if you want to take advantage of that, or if you know somebody in the Boston area, particularly a med tech startup, that you would like to share, this

discount code with. It's gonna be a great conference. I went last year in Amsterdam. It was really, really good. There were a lot of great speakers. James Pink, who spoke last week, is going to be speaking at it, as well as, Leo, Michelle, and a number of our other regulars. If you're on here, please. Chime in.

James has quite a story.

You certainly don't.

A very personal story.

And then the last thing I'd like to draw your attention to, I'm gonna put in, next week's speaker and everything like that into the chat, but, is a post that I did, yesterday, about, In-silico testing. How many of you are familiar with in-silico testing? And, you know, on a scale of 1 to 10, 10 being, I know everything about it, and 1 being, you know, I, you know, I know what it means. So, at any rate, this, this company, has come out of stealth mode. They're, looking for conversations, looking for investors. They're doing cardio and neurological in silico testing, which, to just frame it really briefly, is, like, pre-inhuman, preclinical, and even, even pre-animal.

testing. They take, real-world evidence, data, and they… they do predictive modeling off of that, but it allows them to create, virtual patient populations, for, hard-to-reach groups. And so, if anybody knows anything about running clinical studies, the hardest part is patient recruitment. So, this really gives, particularly, companies working on, cardio and neurological devices, a heads up. And not only that, the FDA and the EU are both warmly embracing in silico testing, pushing it, I would even add.

is, being a priority. So, yeah, show some love to that post. I will be, Putting that in there. I'm seeing a number of… people joining in. So, yeah, all that said, I think we're in good shape, and I, you know, we got a fair number of people on the call. Again, if you want to be promoted. So, I'm excited about today's topic. I… I met, Prior, at, the Regulatory Intelligence Conference in Baltimore. We had an interesting conversation, and I wanted to, continue it, so I invited her to come and speak. I think they have an elegant, sophisticated solution.

And I look forward to learning all about it today. Hope you do too.

Thank you, Sean.

Priya. There we go. You can see your… your… yeah.

Yep, perfect. So today's agenda, what I'll be focusing on is tell you a little bit about our RegDesk story, how we came about, the current reality of what clients are expressing to us as their big problems. And then, really, the focus is on beyond intelligence. We think of Wrike Intel as the… the only issue, but there's… there's just so much more, and there's… Regulatory teams need. tools beyond just the reg intel, and how do you leverage RegIntel to make it more actionable and perform and optimize Intel, and what RegDesk is doing to transform regulatory affairs, to modernize regulatory affairs, and then finally, just wrap up questions.

So a little fun fact about RegDesk is that we actually started at a Google hackathon in Philadelphia, and pitched the idea there, and it sort of took off from there. And we… this is our executive team, and this is our link where you can find information, but for me personally, I started my career as a new product developer engineer working for a very large medical device company, and I transitioned into regulatory affairs. As many regulatory affairs people do, they usually come from other fields. And while in that role in regulatory affairs is when I had an eye-opening moment where I realized that companies of all sizes, regardless of

How many regional teams they have, what resources they have abroad. they all struggle with global expansion. And the other realization I had was the lack of technology that exists for regulatory affairs teams. Especially when I… we started Reddesk a decade ago, there was really hardly any technology, and… the entire medtech industry relied primarily on consultants, which is great, but also heavily on their distributor network, and it's been fragmented, it's been… using… they're essentially been using spreadsheets to manage all of their regulatory operations, and that is what actually was the impetus to get Reg That started, and…

The… our main objective from the very beginning has been to introduce technology into regulatory affairs space. We often do surveys, and also as we converse with clients day in, day out, these are some of the highlights at least the top three issues that are expressed to us all the time. One is, you know, how do we stay current on changes? Well, the problem is that regulatory teams, it's not that they are not receiving change… they're not really… it's not that they're struggling to have intelligence. I… one of the bigger problems is that regulatory teams are actually drowning in regulatory intelligence, meaning alerts, the notifications.

That they're receiving from authority websites, a lot of regulatory databases, trade organizations, Consultants, social media, even newsletters. They have a plethora of information. The problem is it's really passive monitoring. It's generalized information, so they have to sift through all of this to understand which aspects apply to them, their products. And then disseminate that information accurately across the organization. And… Beyond that, so you have, like, intel, but what health authorities are demanding of them is the gap assessments. They are saying, well, you know there's an update to a change, let's say, in Brazil, but then have you performed the impact assessment to understand how that change impacts your product?

And what that impact is. And that… Process is quite fragmented, and a lot of teams do it very manually, and it's quite time-consuming. And RegDisk has figured out solutions around that, right? So for us, it's really about the custom reporting, it's about providing you Reg intel that is relevant to your division, your product line. And then providing a lot of the workflows where clients can perform those impact assessments. And I'll go more into, sort of, how Reddesk is structured. Another big problem that clients have expressed to us is about the renewal deadlines. And despite, again, the size of the organizations, there are many very large organizations who frequently miss

Renewal notifications. And what we mean by that is you have to track your registrations, you have to track them at the SKU level, and if you're doing it through Excel sheets, you're really not receiving any notifications through Excel stating that, hey, by the way, you have these 5 renewals that are upcoming, and it's very easy to miss out on these renewal deadlines because you don't have automated notification system. So this not having visibility to critical dates across teams is another issue, so your regional team, perhaps, is responsible for it, but then you at the headquarter office have no idea what renewals are upcoming, and whether your distributors are even keeping up to date on those notifications. There's just a lot of scrambling, a lot of react…

Reactiveness within regulatory teams that leads to avoidable risks and penalties. And with RegDesk, we are… because it's a software platform, it's easy to build, integrate a lot of these alerts and automations, that way clients don't miss out on renewal. So our system will start… usually, typically sends alerts and… for renewal notifications at least a year in advance. Because if you realize today that you have a renewal coming up next month, sometimes that 30 days is not sufficient, you may have to start 60 days prior, or 6 months prior, every country has their own rules around how soon you need to apply for that, or notify the authority regarding the renewals.

Lastly, it's about, you know, where is the submission? And it seems… Silly to even… share that client's… actually, this is one of their struggles, or even something as simple as not being able to find the right version of a document. These are real-world problems, these are what regulatory teams are facing day in, day out. It's because data's fragmented. If you don't have a centralized platform in place for regulatory, data is scattered. You have regional teams managing their own data. Once we had a client where each regional team was managing their own data, they had their own structure, they all had different product attributes that they were tracking.

Not only that, it actually became more complex because each regional team also was tracking their data in their regional language. So then how do you centralize that? So they had to actually translate that data. Somebody at corporate had to come up with this master Excel sheet and have every regional team now transfer their data into that master sheet. And it's, again, very manual, but these are real problems, or the current systems are, even if when they have a system, is using such old technology that if they have 100 FDA supplements, or 500, let's say, it's impossible for them to find the right supplement, unless you remember the exact title of it. But, you know, technology's much more advanced. Can you actually do

better data query, where you can find the right document. And it's… it's bringing all these pieces together, bringing more transparency and trans… and visibility across global teams. for them to work more efficiently. And that's what RegDust provides. For us, it's really about providing this one source of truth for our regulatory teams. Where they can track their registrations, they have a unified dashboard where they can see where the submissions are globally, so international landscape in every country, and all the different teams can collaborate together. The problem is that when intelligence…

One question before we.

Oh, yes, of course.

So you go on, sorry. So I want to put… I want to put this out to, the audience and ask, you know, that you either use emojis or words or, you know, even open your microphone and… and talk. You know, this idea of old technology, I find… increasingly ironic in the med tech industry, being a, you know, a technology-based industry, and yet the embracing of technology, particularly in regulatory and quality, being… being slow to uptake this. You know, I have the… I don't think that it's for a lack of desire, to be more technologically advanced. I think that it is, oftentimes a question of getting the budget

To make the investment in the technology, but I would like to hear. from people who have experience with this, because I think it'd be educational, not just for each other to, you know, know that you're not alone, but also for Priya to understand the mindset of You know, people who are working as head of regulatory, and, what their challenges are, and, Yeah, so if anybody would like to comment on that, Perhaps Carrie.

Her is muted.

I muted. No, that… I've been consulting for years, and that just seems to be the overall… it tends to be with most companies, especially the smaller ones, it's the budget constraints.

One other thing… So I'm gonna chime in, carry over you amazingly, is in contracting with the bigger companies, they are so anti-AI, it's incredible in the contracts. It's crazy.

We're seeing a shift now, Leo, you're… you're right. I… we were even at…

The big companies.

Yes.

the Fortune 500s in the contracting, but the clients themselves use the AI. But they say the consultants can't use the AI. It's like, well, you're defeating the purpose.

Hmm.

That, that's interesting, that's interesting perspective, yeah, good to know, because we don't do any consulting at all. We… pretty much, we have a software tool that we license, and that's the… that's all we do is… is the licensing of the software, no consulting. We've been very clear about that, so that's interesting, because you're right, they are using AI internally, many of them, but it's interesting that they don't want consultants to leverage AI. It's… that is… yeah. And budgets, by the way, is a true struggle. Their regulatory teams are cost centers. Now, they tend to have budgets for consulting.

services, but for systems like the software tools, they don't typically have a budget, and we have experience where clients will try to get a budget, gets declined year one, year two, it gets declined again, and now the third year they're coming back. And now we are also seeing a shift where now their leadership executive teams are saying, why don't you have a rim, which is The irony is that those executive teams are the ones who never really approve the budgets. But the budget seems to be an issue, and I think that's where The med tech companies, as technologically advanced as they are with their products, but they are very slow to adopt.

Technology for their internal operational purposes, especially on the regulatory affair side.

And I think that makes the work for every consultant on this call even harder, because when they can't find a single source of truth. when, they're dealing with, you know, a hodgepodge of resources and documents, and oh wait, I sent you the wrong one, and oh wait, I sent you the wrong one, you know, which… I personally am guilty of on a regular basis, then… then… then I think, that becomes particularly challenging. Do you… do you work, with consultants at all on, you know, like, affiliate program, or, you know, having them walk your product in to their clients and show them? I've never… I haven't asked you this.

We don't. We don't, because the way a RIM platform works, and the way we have our systems designed, is really for the user to be the medical device company itself, because the way you use it is we… or rather, in order to use the platform, we need product information, we need to understand the company's product name, the SKUs associated with that product, because if you're doing an actual submission, or other than RegIntel, but any other activities you do, it is product or product-specific, and a lot of times, consultants don't have access to that data because clients own that data. In fact, we don't typically even work

with regional teams, usually the system is established by the headquarter office, or the corporate office, and then… then regional teams get to come on board, but it's very seldom when we have sold, let's say, a big, let's say, medical device company and just selling it to their Latin America team, but then the rest of the world doesn't use it. That also doesn't happen. We have been approached by consulting companies, it's just that we would have to completely reconfigure our platform, and we just haven't had the time and resources to do that. So that's the only reason why we don't typically work the consulting… or the consultant route.

Oh, no, you misunderstood my question. My question was, if somebody on this call brings you a lead…

Okay.

For a customer, would you work with them to bring their customer on board, too? See what I mean?

Yes, of course. Of course, we can certainly… yes, of course, we would certainly entertain that. If a company… we work primarily with mid to large. In fact, we also work the other way around. A lot of times, we may get an inquiry from a very small organization or companies that are just starting off, and the platform's just an overkill for them at this time. As we, a lot of times, will recommend consultants to them, because they… Somebody hand-holding and doing the work for them would be far more valuable than a self-service tool.

My other thing is… this is totally… Splitting my… not just that, but most, management doesn't see the benefit of quality regulatory until it's, reactive. Just… I think.

You're absolutely right.

until the FDA walks in, and they're like, well, why don't we see this? We need regulatory… Intelligence, and then they… then they see the benefit of this.

You're absolutely right. And, Carrie, that's, yeah, on point there, because we have had clients who have come to us because they had… they had issues with health authorities, they had a bunch of…

under control.

communities.

I know.

And that's what led… that's what, right, lit the fire for them to then seek a solution, and for companies to say, okay, now, fine, we'll invest in a Wrike Intel platform, but otherwise, yeah, they'll say, well, we have resources, and we have our own regional teams and distributors, and I was going to talk about the fragmentation that you get from even The current process, but yeah, you're absolutely right.

Yeah.

Okay, I'm done my detour, you can continue.

Back on. Sorry, Priya.

No, no, this is good format. We're talking about intelligence, and the problem is when intelligence is not operationalized, we still have all these issues. A lot of delayed submission, increased inspection findings, costly remediation, late compliance responses, etc. And it's really about taking the intelligence and making it actionable, as I mentioned earlier. So a lot of the passive monitoring sources, right, the alerts, the newsletters, relying on local distributors, just the general industry updates, etc, and repositories. Just don't cut it, because there's still a lot of work that Is required to get to what the health authorities want.

they don't care how many newsletters you're subscribing to. They want to know, were you aware of this update that impacted your product, right? So it's that precision and specificity. How does the change impact your product and your portfolio, and what are you doing about it? And have you taken the correct action? That's really what the intelligence comes down to. And the new way of Executing intelligence is really the impact assessments, which are typically done offline in most cases, and in fact, most REG Intel platforms don't have They'll just provide the intel, but they don't allow teams to perform the impact assessment, so they don't make the intel actionable.

And that's really what's key with RegDesk. We actually started our company off as Reg Intel platform, and very quickly just built upon that, and built a rim, from… from that. And so, for us, it was… it really came down to… we started with, again, Intel, right? So we… we could do… we could give clients the updates, we have comprehensive checklists of requirements, we try to build… early on in our days, clients were expressing their frustration with the existing RegIntel tools, and how generic they were, and they just gave high-level summaries. So we thought, well, let's do it differently. What if we were to sit and read the laws, which was a crazy idea, but we have still continued to maintain that, where our team reads the laws, and we give you the checklist of requirements. We tell you exactly what you need to do, that way you don't have to bother with reading the legislation, understanding what

the key action items are from there. You don't have to worry about the translations, we will do it all. And that's sort of what we have done. But then soon, again, we realized that the intel piece is valuable, that… but that doesn't complete the… circle for them, they need to perform the impact assessments, they need to have ownership execution, and then the intel really needs to tie into ARIM if teams have that. At RegDesk, we have what we consider four key major capabilities, or pillars. And those are plan, build, track, and maintain. So we are a comprehensive, but our aim is to be this one centralized

platform where teams can do the planning. The planning involves regulatory intelligence, as well as standards management. This is where, as I mentioned, we provide comprehensive checklists of requirements. We keep clients apprised of what's changing around the world in real time. Clients can also get updates on changes to standards, but also then perform those impact assessments. And state which… Specify which products or product families within the portfolio are being impacted by that change, and then have workflows within the platform to perform the impact assessment. And the way regulatory teams work, or regulatory affairs, rather, is like a domino effect. There's so much impact, so a change happens that can impact your product. Now, based on your assessment, the impact could be significant, meaning what if you have to retest, do retesting because the standard changed completely, or you have to do re-registration? Now.

That typically leads to change assessment, trigger. When you… once you have a regulatory strategy plan, then usually that gets fed into, now, the building piece, which is, for us, is submission and content generation. We have noticed clients struggle with content generation. Now, not in the country of origin, but when it's global. And also, there's a lot of redundancy of effort. The same information for UMDR is now utilized in 10 other countries, or 50, 60 other countries, and you're sitting there copying and pasting information. We built some AI tools. One of them allows… it's called our AI Submission Generator, where we provide country-specific templates

Clients can build their submission within the system itself using the template. Once they build one submission, the AI learns the content, and it can then auto-populate your subsequent applications, saving significant amount of time. Alternatively, if clients have… are working with, let's say, their distributors in different countries on registrations, and they don't plan on handling that themselves. But with distributors, it's sort of this black hole where you give them information, time goes by, but you hardly ever receive updates from them. So this tool gives more transparency and visibility, because you can see in real time what the distributor is doing. Are they reviewing the documents? They get to actually review the documents and sign off on them right within the platform. So that's one of our popular modules.

So this is the build component of our system. The third is the track, because once you build a submission, you want to now track the registrations. there needs to be… our platform's relational, each module talks to each other, that way you don't have to manually go initiate a tracking. The system tracks it automatically. Our big focus in tracking is really reporting, because ultimately, it's great you're tracking, and it's great you get a notification that, hey, by the way, there's a renewal upcoming, or, oh, by the way, you know, in a week you have health authority response. That… that is due…

But outside of that, there are a lot of reports, and this is something maybe open for discussion if anyone has had experience with it, but really, reporting, we've also noticed, takes a significant amount of time. Clients typically spend hours upon hours, weeks, to aggregate data from different teams, and then they put it together in an Excel sheet and generate reports. But it's never real time, because something might have gotten updated from the time they started gathering the data. And for us, the focus reporting is taking a lot of these key reports, KPIs that clients generate or have to generate multivariable, or they want to know, well, what SKUs in

let's say if a sales and marketing asks, well, what SKUs or what products are approved in Brazil, can you generate a quick list for them to show them which SKUs, where it's approved, when it's about to expire? So a lot of those types of reports are pre-programmed within the platform, our goal being saving clients time. And lastly, the maintenance piece for us is really focused on change assessment, more so than post-market, and change assessment's also a massive task. Some… for especially large organizations, they have specialized task force and teams that essentially just manage change assessments.

The goal here is to provide clients with workflows where they can understand what the regulatory impact would be if their existing product or product family goes through one change, or maybe multitude of changes, what that impact looks like, and then performing that action within the system. That way, you close that loop, and then when you have a change assessment, you also want to track it, and then it leads back into tracking. So if I had different arrows, the system really talks to each other, and that's also what makes it powerful. The way we have organized our… our system, the plan, build, track, maintain is by building what we call modular modules, so our system's modular. You can pick and choose the modules, you don't have to purchase the entire system in its entirety. You can say, I just… for us right now, the goal is the planning bid, or we want to plan, build, and track, but we have change assessment being managed through our PLM, no problem at all.

But the base of our platform is really the products, product information. That's the only way the system works. That's every Abram system. You need to know… you need to understand the product structure. And then the hierarchy of products and the attributes are, once they're in the system, we train our… the regulatory teams on it. We then… then clients can utilize the different modules, the reg intel standards for planning. We have also an AI form builder, where we have provided clients with templates for GSPRs and DOCs, and you can actually go in, and you… you actually fill out your GSPR within the system, and then the AI learns a lot of your information from standards. It just auto-populates, so we're trying to streamline and get… eliminate this… this effort of this administrative work or the repetition. That's really the goal there in… in the use of AI.

So the way we're transforming the regulatory, or the RIM space, rather, is that a lot of the traditional RIMs that exist, there are not that many that are focused on medical devices. We are seeing more and more pharma RIM companies they're trying to retrofit their pharma rim to suit medtech, but that's been an epic failure in… for the most part, because they're very different worlds, and you can't intertwine the two. But also, a lot of the existing technology is pretty old. In fact, some of our clients have used the older technology, and they've still struggled, and they've stated, you know, it still takes them many, many months, almost a year, to build a submission from scratch. There's no single dashboard, the system doesn't really talk to each other, or it limits

How they can interact with… outside business partners, there's a lot of still work that is required for regulatory teams to perform outside of the system, and then essentially redo the work and input that data back into the system, and that frustrates teams more than anything else. is when they have to repeat the work. They don't want to do it twice, and… or the RIM systems are very limited, where they'll have one or two major functionalities, and again, the rest of the work is done outside, then you don't have one centralized tool, you're just have too many disparate tools still, and what we are doing with RightDesk is that transformation. We're…

We are mapping out where are the… which tasks clients, or rather, regulatory teams end up working on the most, what's the most time-consuming for them, and we build our solution out of it. In fact, actually, we never intended to be a RIM, we just organically fell into the category. From day one, we were very quite… Client-centric and driven, so what we have done well is we have listened to our clients, we understand what problems they have, and then we build solutions around it. That's… that's how we build BrightDesk, and why it stands out from a lot of the existing RIMs, because we weren't… we didn't try to improve what was out on the market. We built everything from scratch just based on client feedback.

So for…

I would ask, right there, like, how many people on this call have experience working with, a RIM, or, with a platform, and what… what… what struggles they've had with that, you know, if that's, you want to put it in the chat, or… or whatever. But the, you know, I mean, the thing that I wanted to add… to what you're saying, and I agree with everything that you're saying. You know, I was… head of marketing at the Gray Sheet, and also at InfoDesk, and I… my experience… with this is that…

And I think this is a good framework for the audience to understand it, is that we'd always be focused on, oh, well, we have this many regulations, or we have this many products, or we do this many things, or, you know, we cover this many, And it was the aggregate, but really what we were selling in both cases was an insurance policy. Nobody wanted to read the entire grace sheet, but if your boss asked you for something, you knew you could go and get it. And the same thing was true with InfoDesk. Not everybody wanted to read all of the information that was pushed to them. However, when push came to shove, it came down to, you know, being…

Knowing that you know the answer when you go back to your desk, knowing that you can get the correct answer. So you talked about the reporting function, and the ability to service other departments within the organization. I thought that was very interesting. And And… and then this… this aspect over here are one-click audit exports for FDA, I knew UMDR. You know, I think that this is… directionally moving, you know, absolutely, and it sounds great. So, that was my only comment. Sorry to interrupt.

No, that's perfectly fine.

You know, I guess my question for you, Priya, is, The product that you're discussing today brings a lot of efficiency, makes things go faster. And allows for the processing of information to be so diligent that it raises quite good expectations for organizations in terms of the performance, you know, bringing products to the market, etc. With that comes a certain level of pressure on other organizations. I'm thinking quality assurance, product development. So they… they also would have to sort of come up with

Similar approaches, for, you know, basically, providing that same level of efficiency. Now, my concern is not so much about efficiency, but also about quality of the data that's generated, because with these processes, we're going to be generating also more data. So, my question to you is, I see the efficiency part of it. But the work that is also needed to make sure that the quality of the data that is generated. It's also, data that is worth you know, submitting to regulatory authorities, that part is also important. So, I wanted to get your reaction on my comment.

Yeah, you're absolutely right. It's really about the… the quality of the data, because a true RIM… now, Gartner… Gartner invented this term called holistic rim, and the reason why they call a RIM a holistic, or what defines a RIM as a holistic, rather, is that a RIM solution, so, for example, Red Dust RIM, then it can talk to different systems, so the integration's the key. And in order to have a successful RIM, you must… that RIM company, the solution must integrate with the QMS. with document management system, maybe the clinical trial system, whatever the systems that exist, ERP is a common one, that it should talk to integrate with that. So, with our platform, I can speak to that, that we do integrate with those. Now, the quality of the data is…

We provide workflows, but this… Quality of data has not been an issue, because our system isn't generating that, it's really the client's data that's going in the system, so they're responsible for the data that they add, right? So if they're creating an application for EUMDR, then it's their product data that gets inputted into the system, and clients have control of what data goes into the system. Our system gives them the template, and it can render the information or the submission into different formats, but ultimately, the actual content of the data, the documents, are coming from clients, the company, and the users itself.

But speaking of the results, one of them regarding the submissions, we've had… our AI submission generators really taken off, and clients have reported reduction in submission bill time from 8 months to about 2 weeks, which is massive. And clients also appreciate the real-time visibility that they can have across global teams and geographically as well. We have had other clients report 70% reduction in document hunting time, because if you can have advanced search query that is smart, that can actually read the content within the document, then it's easy to find the right content very quickly, within seconds.

We have clients also use our platform for a lot of the audits, because With the reporting and everything all in one system, it's really easy to generate reports for audit purposes, and we have had clients report that they've had 40% experienced 40% faster FDA audit completion, and then, most importantly, renewal deadlines is why some… a lot of companies even think of the idea of having a RIM, and to not have to worry, what Sean was mentioning about the insurance. We… I find tracking is really the insurance, so that you can make sure that you don't miss out on that renewal, because once you miss out on the renewal, your product's off the market, the risks are just

Too significant to take that lightly. And sometimes a small investment in a tool that can prevent those renewals that Miss… misses on those renewals is well worth the money. I didn't want to leave without talking about, sort of, the future of RegDesk and what we're working on. So, for us, it really comes down to Making our intelligent rim more intelligent, and more intelligent to make the user's life easier. Not just to launch cool AI tools because they're cool, we're quite intentional about that, that if the AI tool does not make their life easier, but it's cool, then we're not going to work on the cool stuff. We're going to work on what's really important.

Couple examples being we launched an EI translation tool. So, yes, it's fine, we can provide you with unofficial translated legislations and have a tool on the back end, but we actually launched a tool that our clients can use. They can upload any document in any language, and then the system will just translate it for them. Another one, a big request and actually demand from the market was regarding standards, where companies would come to us and say, great, you can help us manage our standards, but then can you let us inform us and perform this review when a standard changes and inform us what has changed in the standard? That's impossible for any RAM provider to do, because we don't have access to standards. However, we built a tool, AI-driven, where AI performs this assessment, so you

can upload version 1 of a document, and then the version 2, and the AI runs it An assessment, and actually spits out a report where it informs exactly what are the actionable items from it, what you should be made aware of, which is great, so it reduces that workload. So these are the types of AI tools we're working on. We are another change, a shift in RegIntel is that specificity, where initially, when we built RegI Intel, it was not product-specific. It was, you know, based on product. classification, etc. And we alert our clients daily, but now they're saying, well, alerts aren't enough. Tell me, just sift through all of that, just tell me what's needed for me, what impacts me. And that can only be performed using AI, so making… we're working on our AI Gentec tool, which will be launched soon, and as part of that is to make the intelligence also more intelligent, meaning

Making it more specific, allowing us to provide very specified curated reports for different businesses, etc, and then also allowing companies to run reports, so if you want to perform any regulatory intel function, meaning you may want to compare labeling requirements, or you may have very specific reg intel questions, then the AI can actually give you a report, and it can process all that information very quickly for you. Our big, outside of Agentic tool is really our maintenance module. We currently focus on change assessment we want to add. PSURs, CERs, annual reporting to that. There's a lot of requests for… for those templates as well, so that's really what we are focusing on.

And just to wrap up, I mean, for a RIM platform, it's not easy. These are long sales cycles, and it's a cross-functional, complex sale where a lot of teams are involved, and they have to all take responsibility and have to work in unison in order to successfully implement ARIM within the organization. So regulatory affairs, obviously, they're the users, and they are the ones who are performing and testing, and they will… they're the ones who provide data, etc. But IT teams are highly involved, especially if you are an AI-driven platform, then the… they want to manage the SSO, the security, the IT teams, usually you need approval from them. You have to

get the clearance from them, cybersecurity teams are now involved, there's all of that. But we also find that for a RIM to be successful, unless you have executive sponsorship… now, you may get sponsorship from the angle of, yes, the budget's approved, and you can you know, implement the platform. But when I say sponsor, meaning they're really there supporting, because implementing is a RIM platform, or a software solution of this size is usually requires… it's change assessment within the organization. It's… it's change management, not assessment, sorry. So change management, where you are changing the behavior and the patterns in which users are used to using. So if they're used to using

Word document to build submissions, and now you'll make asking them to build submissions using this wizard. It's a change, and it takes time, and it's… it's hard to implement and get the… entire organization to use a platform unless the executive team is pushing on it, and they are communicating, and they're just as involved in their message to their users, because a vendor can only do so much, and we find that executive sponsorship is really, a lot of times, the key driver in how successful a RAM platform Would be at any given organization. This is a quote from, the head of chief regulatory officer at Medtronic. For them, the RIM was really a strategic transformation, and she's phrased it the best, right? This is a strategic transformation that'll allow us to get the most out of our new technology, giving each of us time

back to focus on the most impactful work for our company and our patients. Because if the regulatory teams are bogged down doing administrative work, or chasing down distributors, that's a waste of their time. There's so many other strategic tasks that they should be working on that take the back burner, because all this other time… other tasks are very time-consuming. And so, for them, this was one of the main reasons why they decided to go with the RIM.

That's awesome.

I appreciate everyone's time today, and I'm obviously open to discussion and questions, and also, I like the format of this webinar. This is my first time joining, so I like that it's an open discussion, so I will definitely walk away learning a lot from everyone here.

Thank you for that, and thank you for your, presentation and preparedness. I appreciate that. I'm sure that others do as well. There were a number of questions. Does, RegDesk RIM also support EUMDR and IVDR? That was…

Yes, yes it does. We actually are probably the leader in the IBD space, meaning in terms of the number of diagnostic companies using our platform.

That's… that's great. How do you, michelle asked, how do your… how do you deal with copyright issues with the standards?

We don't, Michelle, because we don't have… we don't provide standards. So we are not… all we do is we aggregate the names of the standards, but we don't have any other information about… so we don't purchase standards or try to purchase standards. So clients can upload a standard that they have purchased into the system, but that would be only accessible to them, but yeah, so we don't have any copyright issues as such. We're just data mining the.

The client… the client owns the copyright, then.

Yes, yes, I mean, that's their standard, right?

They say, how do you… this still doesn't make sense, because most… all the standards that you purchase now are limited to one single person, and they've got all kinds of ways to, like, lock it down so that only one person, the person that bought it, can view it. Like, how do you handle that?

They don't.

We don't handle that, so that's clients… Yeah, but what I'm saying?

Is that the client… Has to violate the terms of the copyright of the standard to even be able to upload it into your platform.

And they don't have to upload it, they're not required.

how do you do a gap analysis? So we don't, they can…

they can use it, so that person who has the copyright can go in, because we have no purview into under… we have no view… we have no visibility into knowing which individual… which individuals within the organization have copyrights on the standard. That… we are a self-serve tool. We give them the option to upload a document, they don't have to. They can perform gap assessment outside of the system and then upload it, but if they want to use our AI comparison tool, it's on them. They can… that person who has the copyright, they can upload the document in there and get the report out of it. So, yeah, we… there's no way for us to control the copyrights of standards, because that's their internal document.

Excellent question. Do you have situations where a company uses external consulting help regarding the use of RegDesk?

Possibly. Again, we… we work primarily with mid to large enterprise companies, and they control their users through single sign-on, and they can have internal, external business partners, so I would imagine they many times use consultants, but those are… consultants are usually added by the The administrators who are, yeah, the clients themselves.

So it's up to the client.

It's up to the client, yes, they can have any type of user… Using the system, and they get to control what level of access each user has within the platform.

Nancy asks, how do you see companies evolving from reactive regulatory intelligence to a structured governance model integrated with quality systems and product lifecycle?

That's a great question. I… it would be one… Getting tools in place and not relying on the old model, which some companies still have, which is they… some… they'll have a Reaganel team, for example, in-house, and that team is subscribing to all these newsletters, and they're perhaps members of trade organizations. They get this intel, but it's very, again, generalized, high level, and then they create a newsletter, internal newsletter, that they disseminate across different businesses, and then it's… each business's onus to look into… delve deeper into that generic intel to extract what's relevant to them, and they have to do all the work. That model is frustrating to hear because it just doesn't work. I mean, now the technology's so advanced, there are a lot of reg intel tools out there. But then, I think.

for what you're asking for, it needs to be that the reg intel is integrated within the RIM, and that's why clients like our platforms because, right, Intel's not stand-alone for them. Our intel actually converts into workflows. You… you leverage the intel to then create workflows to then perform the impact assessment, so that closure is absolutely needed, either through integration or having a RIM that… that has that component. And then where, let's say, once you perform the impact assessment, etc, if it needs to feed into your somehow, then that integration. So, integrations, and it all needs to be just integrated into one

One… one flow, that's the only way that it works.

That's great. You know, comment, and then question from Jeff, and so my comment is, you know, over the last two years, I've watched a lot of people's eyes opening to the power of of AI. Has that spurred interest in, In your product, and adoption, and embracing the idea that, oh my god, we've been doing this, you know, backwards for so many years.

Yes, and if you had asked me this two years ago, I would say teams are still trying to learn what a RIM is on the MedTech side. and now they know what a RIM is, so that's a big advancement. But now, interestingly, even conservative companies, when you demo the platform, the questions that they receive are all AI-associated, where they'll say, well, can the AI do XYZ function for me? So now they want AI to do a lot of their administrative work, where they want AI to, for example. if you do a submission, so they're saying, great, yeah, I can do my sub… meaning, do my submission as in not submitted, but, you know, prepare this… the application for me, but then when I get the… once it's submitted and the back and forth I have with the health agencies.

those deficiency letters, can you… process those, can AI learn what mistakes I have made, and then prevent me from making mistakes with future submissions, right? That's smart. And that's what they're demanding now, is that bit. And as I already shared with you with Reg Intel, too, it was generic before, but now they're saying, no, no, no, give me what's relevant to me, otherwise I don't have time for this. So it's… that is what the expectations are now, which is quite exciting, and one of the clients we just onboarded, their entire… motto within the organization is the shift is all about modernization, and I… we love it because it very much aligns with our vision to

to make a RIM more intelligent. It's not just about giving you a basic technology and a spreadsheet-type-based platform.

So that brings us to the… well, pretty much the top of the hour, but, there was one last question that I think, and that's the one from Jeffin. With the current general-purpose AI models being made increasingly available, how is RegDesk Rim more reliable or safer than these models?

Well, we already, as a RIM platform and providing services, it's about data, encryption, data, privacy, so we already have a lot of that in place, and now you can actually train the AI bots on the EU AI policy, GDPR, and a lot of the rules and regulations that are out there, so that you work within that scope. Which is pretty neat, what AI can do now. So it can actually learn the framework in which you can work. But clients are open, I mean, and also having a proper AI policy in place, being more transparent about which AI tools you're using, and it's not just about using the tools. No one's trying to reinvent

ChatGPT, etc, right, or Claude. No one's doing that, but it's… it's taking the business AI models, and then training them for your purpose. That's really what everyone's doing. And so clients are open to some of those AI tools, as long as you're clear with them what you're using and… and within which purpose. And again, with AI, you can have a decent percentage of accuracy, but it's also about the disclaimer that you want the regulatory teams to still review the data, and then making it modifiable that if AI is predicting that based on these changes, this is your regulatory impact, then this is what… so AI is suggesting it's a new registration, but SMEs might think, no, no, no, it's just a notification, no problem, you can change it, document it. So, making the data modifiable, but yeah, having a lot of these perimeters in place. As a RIM provider, we have to have all of those in place, and so that's… that's…

what we're doing.

Beautiful, that makes perfect sense. Okay, well, we're out of time for this week. First of all, I'd like to thank, Priya for coming. And sharing, sharing, reg desks with us. I learned a lot today. I hope you did as well. carry… Do you have your hand up?

I just want to say one thing, with this, copyright deal. Hmm. The way RIM does this, by them providing a means to compare the standard. If one person compares the standard, they're just providing an output to the report. One person's doing the output. It's an output report. That's not an infringement of the copyright. The report is a report. That's not an infringement of one person comparing the output. The report goes to what they need to do to compare it, and that's it, so… That's my opinion. Okay.

Thank you, Carrie, you answered it better than I did.

Thank you, thank you for that.

Alright.

I would like to remind everybody… well, first of all, I'd like to thank everybody for your time and attention today. It's, important, and, and I appreciate… I appreciate all your thoughtful comments. If we didn't get to, your question, I will, send them to Priya, all the chat file, and, the Q&A, so that, perhaps you, can follow up. individually. A reminder that next week we're gonna do PMCF surveys under MDR, with, Marcus from Purdy Pasco. That ought to be interesting. The following week,

Pure Global, and then the week after that, Leon Dorn, one of my favorite AI ML, softwares, the medical device guys, is gonna come on and talk about some hard lessons that he learned. With, 510K submission for, software as a medical device. I think that'd be super interesting. And, stay tuned for… Or more. Thank you, everyone.

Thanks, everyone. Bye-bye.

Bye.