Intelligent RIM for Medical Device Manufacturers: RegDesk | SourceForge Podcast, episode #119

Hinzugefügt: 2026-05-30

[00:00:05]Hello everyone and welcome to the SourceForge podcast. I'm your host Bo Hamilton and today I'm joined by Priya Bhutani uh founder and CEO of Rakeesk, an AI powered regulatory information management platform built specifically for the medical device industry. Uh now while we think about the technology behind medical devices, I think it's fair to say that we tend to think about the devices themselves. Uh, but there's a whole other side of the industry that most people never see, and that's the software and the actual systems that get those devices approved and into the hands of the doctors and the patients who need them and rely on them. Um, and getting a medical device approved in one country is hard enough. Now, imagine doing it across 120 different countries, each with their own regulations. They have their own timelines. Uh, they require their own paperwork. And I think for a lot of regulatory teams, that process still uses many antiquated solutions like spreadsheets and emails and just a whole bunch of of manual work and effort and and when regulations change, which they do all the time, it it just means scrambling to update submissions that took months to put together in the first place. So, it can be a real headache and a real challenge.

[00:01:15]And my guest today saw that problem firsthand and decided to build a better way to handle all of this. So, I'm just really excited to hear about what Priya's company is doing in the space and just to dig into what makes global regulatory compliance so complex in the first place. So, without further ado, Pria, welcome to the podcast. Glad you could join us.

[00:01:33]>> Thank you, Bo. Thank you to SourceForge for this opportunity. Glad to be here.

[00:01:39]>> Yeah, I'm excited to to dig into this some more. So, um I think before we really get into riges itself, I do want to start with your background because I think it really helps set the stage. you you started your career as an engineer at Baxter, you moved into regulatory consulting and then you launched riges back in in 2014. Um, and that's really the uh sparknotes version of it. Um, what was the the moment you realized this company and your solution needed to exist?

[00:02:08]>> Yeah. Well, a fun point about a note about right descend hackathons. That's where it was actually incepted. But I had this idea prior to participating in the hackathon. We saw the the whole idea of hackathon is you build your minimal viable product and you prove that this that there's potential if anyone were were to invest further into this idea and we just over the weekend of sharing the thought and the idea behind Reges, we actually received a lot of feedback from actual companies and regulatory folks asking for signing up for whenever the platform would be ready. So it became it sort of validated the idea but the impetus really came from the drive from when I was uh when I transitioned over into regulatory affairs I recognized that companies of all sizes it didn't matter how big you were and how many resources you had around the world they all struggled with the same thing which was global expansion and another shortcoming was that They all rely on distributors or consultants. I mean there's just no technology. There's just no other way to go about expanding your products to international markets. It's quite limiting and that really was the reason for starting Red Desk. Our mission from the very beginning has been to modernize regulatory affairs to introduce technology into the process and that's that that's how we got started.

[00:03:59]>> Interesting. That's interesting to hear that you've you started from that that hackathon um which we've cover um hackathon related um kind of bug bounty programs over on um our sister site slashdot. So I'm pretty familiar with that and it's interesting to hear that your company was kind of bored from that effort. That was back in 2014 era.

[00:04:20]>> Yes. And there was this hackathon was specific to healthc care ideas. It wasn't generic though it was perfect.

[00:04:28]Philadelphia has a pretty solid healthcare scene and health tac in lot of hospital systems and this hack Google hackathon was specific to that which was quite relevant. That's why he participated in that.

[00:04:43]>> Okay. Very cool. And then I also have in my notes here since then you've you've been recognized as one of Inc.'s top 100 female founders which I think is really impressive. So kudos to that accomplishment. And then uh Rig has been named a gardener representative vendor for both regulatory information management and regulatory intelligence.

[00:05:01]I also want to get that out there. So you guys are doing some really um valuable important work. So just want to tell the listeners kind of how how much value you guys are are offering in this space. Um and I I bring up the origin story to set the stage. You know a lot has changed since 2014. I mean 12 years later um we're we're looking all these automations which of course I want to ask you about AI and how that's playing into the to what you guys are doing. Um, but uh before we get into that, for our listeners who might not be super familiar with this industry and maybe they've heard the term, you know, regulatory information management, but aren't sure what that really means, um, how would you just describe describe that term, describe what reges does?

[00:05:44]>> Yes. To a layman who has no familiarity with this space, we will for a moment shelf this term rim or regulatory information management system. To give some background, if you have a medical product and medical product has a definition that is defined and created by health agencies. Every country has its own health authority. For instance, in the US, we have the FDA. The FDA's task just like we are familiar with FDA dealing with medicines and getting drugs approved. Similarly, they also approve medical products, medical devices that you see at doctors, offices, hospital systems, anything that's diagnosing you that's and any medical equipment that you see. Everything is defined that classified as a medical device. These medical devices cannot be exported in countries around the world just because you have FDA approval. Every health agency requires that you submit so-called an application to them where you explain and describe what product you are trying to introduce into that market, why it's beneficial, what is unique about that product. You provide you have to also convince the health agencies in all the countries around the world where you want to sell your product that your product is safe and effective. Ultimately that's the goal that the product is safe and effective and you have to provide evidence for it.

[00:07:16]So these applications are quite lengthy.

[00:07:19]This is not a form that you fill out and then ship your product and the process is expensive. It costs thousands of dollars and it's lengthy. It can take several months to sometimes even two three years to get your one single product approved in a particular country where as in medical device manufacturer you're typically thinking global you are usually selling in more than one country and it gets to be quite complicated because rules and regulations are constantly changing and there are new legislations.

[00:07:53]It's an evolving landscape to say at least and then your products expire.

[00:07:59]There's a lot of compliance in the maintenance of the products that you approve on the market and it's quite a complex process and it also very technical because you're dealing with the rules and regulations and dealing with health agencies. Most of the companies had been using spreadsheets to manage this process. As I mentioned earlier, consultants, a lot of old traditional fragmented ways to to manage and get these products approved, their products approved in global markets. And this concept of RAM is a regulatory information management system. The idea is to introduce technology, a software solution that allows companies to manage their processes. So what's unique about our platform is the the technology aspect, which we'll dive into a little later, but what our platform allows a medical device company to do is one understand and keep apprised of all the regulations that are changing around the world. Then they can do regulatory strategy planning as to where they should bring introduce what product where it's fastest where it would take them more time. They can do all that planning. Then they can what we call the build phase. So they can actually build these applications leveraging AI through our platform track these registrations around the globe that they didn't know where each skew is be have been has been approved to then make the maintenance bit which is once your product's out in the market and if you make any change to that product let's say you change the design or label changes then you have to reassess what would be the regulatory impact if you were to make that change and that process is also all managed through our platform. So, we're an end toend solution that essentially digitizes regulatory operations.

[00:09:57]>> So, I imagine when you're you're you're working with uh companies, um the companies you're working with weren't necessarily using maybe purpose-built software before they they found you and discovered what Reagesk offers. Um, I mean, from from what I've seen, a lot of the regulatory teams, even at larger companies, they're still managing this stuff, like you were saying with with spreadsheets, with email chains, maybe there's like shared folders. Um, and then the teams themselves can be relatively small. So, that kind of adds to the, you know, the burden of everything and and when you have a system that doesn't work as efficiently as it should. Um, maybe you can elaborate on where those approaches start to really fall apart. If you have a medical device company and you have, let's say, thousand product SKUs, you're not typically selling every SKU in every country. You have certain SKUs that are specific to Japan and not certain ones, China and then Latin America. And you're doing that all through a spreadsheet, an Excel sheet that someone can go and change the formula on or somebody put be on vacation at forget to update the the one of the big challenges and the risk.

[00:11:12]It's not even the challenge, it's actually a risk to an organization is that once your products is approved, you're selling that product. If now that product is to be renewed in 5 years and that license expires because you were tracking it through a spreadsheet, then you have to take that product off the market and start the renewal process again. Or actually, not even renewal, registration again, which means now the profit and the income that you were generating from that product on the market, you're no longer doing so because the product has to be removed from the market. That's that's a huge risk to to an organization because the product has to be revoked. It can slow everything down. It it it's it's a P&L impact is what it is. That's one.

[00:12:02]Another is, for example, if you're not up to date on what's changing around the world because different legislators sometimes not even alerting you, you could subscribe to their newsletter and still not be aware that something changed that there's a new regulation or new guidance that you should be following and be complying to. Then when health authorities come and audit you, the first thing they ask is are you keeping up to date to change its regulations? And if you're not that that in itself is a non-compliance you know they'll that's a stamp of non-compliance now you have to address that issue and you have to have processes in place now.

[00:12:42]So there are a lot of companies go through audits and there's just a lot of compliance risk for doing it this haphazardy in a way and then this actually leads to companies constantly reacting as well because they don't have the right tools in place and everything is manual. You have regulatory PE folks who should be doing strategic work doing a lot of administrative work. Also there tends to be a lot of redundancy of effort as well where for example you have to submit these 10 documents to the health agency in Nigeria and now the Saudi government's asking for the same 10 documents. So you're constantly repeating the same amount of work rather than working in a smarter way leveraging AI. I mean now the technology is so smart that it can do a lot of misadministry work for you. So there just a lot of risk the companies expose themselves to just way too much risk missing deadlines missing renewals not be compliant.

[00:13:41]>> Yeah that that makes sense. I mean it's to your point about the reactivity and and I think a lot of people outside of the regulatory industry might not uh appreciate maybe just how uh reactive uh the work is. I mean, you got the you got the FDA making changes um on one side of the equation. You got the EU's rolling out their own requirements on the other.

[00:14:02]You have dozens of other countries have all their all their various compliances.

[00:14:05]Uh on top of that, um so it really creates this this burden back and forth um and constant sort of uh stop and start and um you're you're constantly having to like go back and and dot your eyes, cross your tees. Um that sort of thing. And I think also just the uh the scale and how how much of a a global challenge this is. You know, you're not tracking regulations in five or 10 countries. Again, it's 120 plus countries um each with their own authorities. So, it's it gets pretty complex and it's a it's a definitely a big challenge you guys have set out to to try and solve. But um how do you actually stay on top of all that u from a solution standpoint? Is that more of like a tech problem? Is it a people problem? um does it lead into this uh you know kind of the AI solutions you've devised? Um where's kind of the where does the problem lie?

[00:14:58]>> Yeah, the problem is in the process and the lack of tools that companies use to stay on top of regulatory changes. Most companies don't even have a regulatory intelligence team. their regulatory team in general doing all the work and then has the onus to keep on top of changes which means they are subscribing to newsletters. Now some bigger companies will had a rag intel team but they also many times lack tools what they do is they'll subscribe to newsletters and they attend conferences etc. They are hoping to get information that way and then what they do is they'll aggregate all this information. They'll say okay there's a change in China, Japan, wherever. Then they create a newsletter over the course of a month that they disseminate across different business units especially for a large company.

[00:15:58]Then it's the responsibility of each business unit to read that newsletter and determine what's relevant to them.

[00:16:07]On top of this, the actual expectation of a health authority when an auditor comes in is not just, hey, do you are you keeping up to date with changes, but what they're asking is great, you are keeping up to date with changes regulations internationally, but then have you performed an assessment to understand which products in your product portfolio will be impacted by that change? And then have you performed further assessment to determine what that impact is? Does that mean you have to now reregister? How does this change impact your products? First, if you are already delayed by the change is taking place daily and you have to wait for an entire month to receive the newsletter, that too is very generic and high level and you have to dig deeper. That's a lot of manual work and you're already behind. We encourage companies to find tools because now especially with AI we established regulatory intelligence very early on and we built hard platform on top of it. That's one of our big advantages. Most red solutions don't have integrated regulatory intelligence but we find that to be one of the key vital I would say modules or capabilities of our rim should be rag intel. How do you make any regulatory decisions without having the right intel? You need the intel first. We encourage companies to have tools because now what AI can do is one for even a system like ours, we alert our clients every single day. We let them know what's changed around the world because it gives them enough sufficient time to then act on that change and then we have workflows that allow them to not only get alerted on the change and receive notifications but actually perform the impact assessments that the agencies are asking for. That way when a when an agency comes they can show here are the changes these are the products that being impacted in these markets.

[00:18:16]this is the impact and this is our action I call to action for this that's the loop the compliance loop that you have to complete and that's what our system does so yes I mean you can only imagine the risk of doing it manually subscribing to newsletters versus letting AI especially with the gentic AI tools because it can also provide curated intel that can disseminate information so we can say okay this business you're focused on robotics and this business you're focused on and are delivery devices. So now you you require different intel and so you get curated reports leveraging technology and AI.

[00:18:56]>> Okay. So, let's talk about that that intelligence layer and then and then get into some of those AI features because you got you got this intelligence layer and you have this expert network of some 4,000 regulatory experts around the world which um we can we can unpack some more too but um I want to talk about the platform. I know a lot of like the traditional uh you know regulatory information management platforms they they've become these tracking tools. So you upload your documents, you log into your you log your submissions. Um and that's really the main functionality I would say, right? But then from what I understand, riges goes much further and actually guides teams through that process, integrates with other systems and and kind of starts to really work and control all the different uh mechanisms at play to get a to help a company get a a finer understanding and really work through the the problem and find a sol efficient solution. Um maybe you could talk about like how how Reges fits into that workflow that teams typically um handle and then what is what does Reges do differently than some of the other platforms out there? Like what's your main value proposition?

[00:20:07]>> Yes. So our main value proposition I would say the top three is one the technology infrastructure. We are using the latest technology we always have and we're constantly keeping up to date on the technological development and the backend infrastructure.

[00:20:25]Because of that, the second point is we have the most amount of workflows embedded within the system. The older technology platforms are limiting. They don't allow you to build build workflows on top of workflows. They had too many limitations and that's one of the problems. And then it also the older the technology the worse user interface and experience that you have that also impacts the value clients get out of your platform. And then the the the third is the rag intel. That's a a unique point to us to have integrated rag intel because our system is built on top of regel. So for example before you even take action to decide to submit a product in Saudi Arabia for example most companies would not know what exactly what are the most current requirements in that country right that's the first thing anyone would be to find out what do I need to do how do I do it and our assistant gives them that formula of exactly what's required when it's required here's the legislations and here are the guidances that support this if We give you everything that you need and then th that intel actually converts into workflows because now that you have the intel now let's get to action and start collaborating whether that's with your internal team or whether that's with your distributors external business partners to put together those submissions. Another point I want to make is that because we use the latest technology we have been a pioneer in the regulatory space to introduce AI. our systems system now is AI native platform where we're using Agentic AI to to help companies work in a smarter way. So it's what we tell our clients or any prospects who come to us is that if you're looking for a platform that is going to truly modernize your regulatory processes and that's your vision then we are the platform. and we are the best solution for you. Especially if you're mid to large enterprise company, that is what we do best. If a company is looking for the cheapest platform and it technology really doesn't matter with them. They just want to go one little step above a spreadsheet, then yeah, there are lots of solutions out there we can also support. But the the best alignment is companies and leaders saying, you know, I eat my teams leveraging AI. How do they work smarter?

[00:22:54]Can they build submissions faster?

[00:22:56]They've been manning these things, then that's where we are a leader.

[00:23:01]>> Okay. So, if you want the bleeding edge, you know, technology and you want to kind of be forward- facing, it's safe to say that you guys are the the the leading provider in that front. Um, and it's it's interesting to hear about some of these AI features in this industry.

[00:23:15]um because it doesn't I mean I know that with regulatory and the medical space you have to deal with a lot of regulations obviously but um a lot of privacy components um one security breach can really decimate a company.

[00:23:29]It's just like there's more um it's seems like it's inherently a little bit further removed from some of these newest uh from the newest technology um than other techfacing uh tech industries. Um so I want to I want to unpack that some more. I know that regggesk um can actually take data from a previous submission let's say and use it to sort of autopop populate forms for new markets. That's like one use case. Um, so you don't have to like go in there manually and and um every time a team files in a new country. Um, and then just like those little little automations can really uh accumulate and start saving some real time, right? Like the what's the typical like process timeline for um a submission? Is it like a matter of months? In some cases it weeks.

[00:24:20]>> So a submission preparation. So there there we call them four pillars. the plan, build, track and maintain. If we just focus on the building part, your your building submission submission preparation is also an arduous process.

[00:24:36]One, you need to understand what the requirements are for that market. Then you need to put together this application, right? You need to in have your sterilization report, your validation report. There's a lot of evidence that you have to provide for that for that product and it is quite redundant. So what are one of the ways and this is actually one of the biggest ROIs because it can take companies or at least our clients have reported savings of 35 plus hours per application that they generate which is massive. It can take several weeks. It can take a lot of hours to build these applications and our system saves them time and so once once we have the base application and we we have enough we don't even need the base application if we have enough data in our system to learn about your product and we have documentation then our system can leverage that data to autocopulate your sufficients for you.

[00:25:33]So imagine that let's say you did an EU European submission or you submitted an application for the FDA and now you want to go to India. Instead of now having to repeat that work all over again which is what companies do instead of that you'll just simply select India in our system and our AI will autopop populate as much of the application as it can for India.

[00:25:57]So within seconds you can have 60 to 80% of your application autopop populated.

[00:26:02]That's huge administratively because most companies especially if you look at mid to large their goal per year is typically 100 to several hundred applications that they have to submit and this accumulates right this compounds the same dates. So do you find that when you ha when you work with the team to integrate some of these um tools, these AI tools, um do they does the role of the team shift into kind of becoming a more judgment based and like their goal is is less like punching in numbers um and doing some of the redundant tasks to kind of reviewing what some of the agentic AI has has delivered for them. they they can become like like the they have to kind of review and check. Um and then if they have any time savings, which it sounds like they're, you know, able to save on average 35 hours per submission. Um are they able to reinvest that time into other areas that are more uh you know, productive or um rewarding, let's say?

[00:27:08]How how is how is that causing the shift?

[00:27:10]>> Yes. Because they're able to do more work. they're able to meet those deadlines, complete more work, have more strategic conversations. When you let's say you have a sufficient analic Saudi Arabia, for example, another and without the tool, you would have to reach out to the agent Saudi and say, "Hey, what do you need from me?" And then you wait because now to wait for them to tell you what they require, what documents, any once they send you your documents, you have no way verifying, right? you to go for spying the law on the Salvi health website. Then if it's in Arabic, you have to now translate that law, read it to decipher whether the requirements provided by your local regional partner is exactly what they require.

[00:27:58]Something's missing. No one has time to do all that work. So you receive the requirements if it's holiday there, it's a weekend there, year, you just so much time gets wasted. Whereas with our platform, it's within seconds you create workflows and and you're communicating. So because they also have the rake intel, they no longer ask the distributor what is required. They are proactic. They proactively tell the distributor this is what we think you need. Tell us just add on to this list if you need anything additional. Right? They're they're just so much more efficient and getting warped on versus being flung by and delays and the latency involved with all the bureaucracy and the holidays and the the outreach that they have to do their work. They are not hired to constantly follow up with the distributor because the distributor hasn't responded to them in 3 weeks or when they distributor comes back two months later complaining that so and so is missing from the from the documents and now they have to search. Like it's all this busy work instead of this administrative work.

[00:29:09]They're having strategic conversations and they're doing the reviews and and getting these submissions. Regulatory the last step to a company making money off that product. It's the last hurdle without getting regulatory approval. You could have the most innovative product.

[00:29:27]It means nothing. No company can ever generate any revenue from it because it's not on the market. So it's a critical role and the faster if you can enable with through proper technology enable regulatory teams to work faster get these submissions done faster learn from these submissions using agentic AI so that those same mistakes are not being made and they're continuously improving the process that's another area where AI is being generated it's it's well worth the investment for any organization to have such a tool Maybe you could also talk to uh speak to the um what you're doing to ensure accuracy and and the trust in the technology, right? Because I mean when you're when you're dealing with governments from all around the world, you're in this last there's a lot of pressure from companies to u you know get their medical devices approved um and and be regulatory compliance. Um and so and then you know it's it's a it's an important decision.

[00:30:29]um you want to make sure all the uh the right facts and information are being you know translated over and and communicated. Um so how do you solve that trust issue? Like do you notice teams um like apprehensive at all about incorporating any of the the tools? Um do you have a good kind of robust system to make sure everything is on track and and accurate?

[00:30:51]>> It it's a good question because I'll answer it in two separate parts. So one, let me address how dubious some folks are in certain teams and organizations about using AI. I would say if we were having this conversation last year, I would say yeah, they are just not ready for AI yet. Even though every conference is talking about AI and they hear about AI, they understand AI is ubiquitous, but they're just still not ready. There has truly has been a shift. I was telling this to my team that just in the past week or probably conversations with some prospective clients when you ask them what do you want to discuss they don't say AI but when the leader gets on the phone every question that they're asking is AI related can AI do you have AI that can do XYZ and can it do this and can it do that so subconsciously they are ready for it and I think they're trusting AI more in fact health agencies are using AI. So a lot of leaders are recognizing that if they are not using AI because AI is everywhere not just in regulatory that if they're not leveraging it they will really fall behind and many most companies are using AI in their daytoday they have approved AI platforms that they're allowed to use even I mean grandparents using AI now.

[00:32:19]So it's becoming a very common theme it's it's helping. So there the trust factor it's increased a bit more just because of their workforce and in their personal life. There's a lot of encouragement to use AI and they see positive results. Now the way we validate that and our AI is trustworthy.

[00:32:39]Well one we don't believe in the entire platform be just AIdriven that it's heavily AI driven. However with every step there is human in the loop. So we do they get to review the requirements if there are any changes that need to be made. It's all editable.

[00:32:58]It's not that the system automatically generates a submission and submits it to the health authority. They get to review it. They get to approve it. They get to modify it. All of that. So there's a human in the loop that that's very important to us and that's there.

[00:33:12]Second, the way our AI works is it's not a large that we aggregate all of our client data from every company and then learn from it. It's actually quite specific to each company's products and their documents because when you're building the submission for company X, you need to learn the information about company X's products, company Y's products and their documents would be learning from that would be irrelevant to to them because their test reports everything's unique to them. So our model is also based on that where the AI provides a tell based on their products their documentation that in combination with the the human in the loop and and also our regel though we leverage AI there is a human factor it's human curated so that eases a lot of those stress and anxiety around using the AI on our platform. Yeah, absolutely. I mean, there's a few things that stood out there is is just it's fascinating to think about the societal effects of AI and like you were saying how much it's changed just in the last year um amongst you know the conversations we're having with uh friends, family and and those in the industry. I mean we obviously here on the source podcast we AI is like the center point. We always it's always it always comes up and it's always a main kind of pillar of a question of how companies are integrating it. Um, and a lot of the the trust really seems to be from the consumer level with some of the AI chat bots, but when you look at like the um the integrations companies are doing behind the scenes with some of the the services they offer in the SAS space, it's um there's some real utility and there's a lot less reason to be skeptical, let's say. Um, and then I think it's also important, you mentioned having that human in the loop to review everything. that is like always really good to reassure and and and you never want to ship something that's unchecked, let's say, by one of these automated tools because they make they do make mistakes. I mean, people make mistakes.

[00:35:16]These machines make mistakes. They're they're getting better day by day. And then I was going to ask you about like what advice you had for regulatory listeners if there was like one big takeaway, but it sounds like you mentioned you kind of have to start incorporating AI and if you don't, you're going to be left behind, right?

[00:35:31]Like is that kind of the biggest takeaway you would say? So let me actually give you an example of so Gartner uh they the the analyst there they every couple years they release their analysis on the rent space and they have been analyzing the rent space for quite a few years especially on the pharma side because pharma is always more tech that I guess smart and they are more opened and willing have willingness to adopt techn technology and they have so this whole grave concept came from pharma world and what Gartner analysts have summarized and sort of concluded from this is that they said that one technologies if if any organization wants scalability and ROI you have to have technology platform tools in place number one and then they show this graph that shows if you have these oneoff tools tools that perform only one function then you just don't have that scalability and your ROI is going to be small as well right but as you have an integrated tool which they call a holistic rim meaning what you mentioned earlier that a tool that has a lot of the functionalities that regulatory teams need and then it can integrate with their external systems their document management and QM and other systems that becomes the holistic solution and companies should strive for that because that's where you get the biggest ROI and and scalability.

[00:37:14]I would first suggest for companies that still are not able to get budgets and their leadership does not understand the importance of having technology you're already very very behind. Forget AI, just gag technology platform. It's the way they are performing their functions using homegrown tools. They're just not scalable. Number one. And my second would be if you are now today's day and age searching for technology, it would be your such a big disadvantage for you not to opt and select a technology that it's using AI. If Reges is also in the mind frame of not just you know whatever our legacy system is just continue maintaining it and build on top of it and not worry about AI we may not be in business in the next 2 years honestly.

[00:38:07]So it's the same application that you just if your competitors are working 10 times smarter than you and you're still chugging along using spreadsheet. There are many big businesses in other industries that have closed doors right overnight. So it's a massive business risk and I don't know how company could have an appetite for that level of risk.

[00:38:30]So yeah, I think that getting technology having a bigger picture when you're selecting technology understand for some they may need to start off small there's no problem with it but then have the bigger picture way that ultimately you want a holistic solution. So selecting the right platform that'll get you there and then also selecting a tool that a platform or a company that is focused on AI technology.

[00:38:58]>> Yeah, well said. Absolutely. Great takeaways. I think that's very true.

[00:39:01]It's it's I can on one hand I can see why maybe a company um they've been doing uh things for a certain way for for you know the last decade let's say.

[00:39:11]Um it's it's hard to kind of motivate yourself or or get the team to to switch gears entirely and adopt some of this new technology. But for the reasons you mentioned I mean you have to you have to now is the time to adopt. things are moving so fast competit uh the landscape's getting way more competitive um and you're just going to be left behind and I think also a lot of this information a lot of these tools are becoming more democratized too so um you know they become there's not only more solutions it's just easier to adopt in a way if you if you don't get so overwhelmed um and you maybe start small the point is you have to start in some way shape or form to start to start moving and um getting with the times Um but that's a great those are some great takeaways. I want to um kind of end on this note of of this forward-looking approach. Um obviously uh the regulatory teams are moving um you know they're they're switching gears to become almost like gatekeepers to being treated more like uh strategic partners within their organizations.

[00:40:16]There's all these AI tools coming down the pipeline. Just looking ahead, how do you how do you see the role of regulatory teams changing over the next few years? If we can even predict that far down in the timeline, >> it would be leveraging a gentic tool. It would be where language will no longer be a barrier.

[00:40:36]You would be able to speak and communicate with agentic AI tools in any language and they can perform function because AI is agnostic to languages. It can actually read and then give you an output in English or the language of your choice which is fantastic. So that in itself will bring global teeth together and it just makes it easier to work using one singular platform and yeah I think the it's going to be more and more the agentic capabilities as those become stronger which they are day by day week by week it's leveraging that and and the right tech company will know how to use that the latest technology and apply it to the applications that are necessary for regulatory teams. The future will be where regulatory teams can predict before even submitting their applications to the health agencies what the probability would be of them I guess getting sort of that grading bit you know what's the probability of it succeeding on the first round or predicting sort of what the health authorities might find as gaps or determining or ascertaining the gaps in the submissions before they even being submitted.

[00:41:59]the the predictions and understanding how are they doing a a comparison to other companies being able to and as health agencies are also adopting these AI tools they can also do revisions faster of submissions and this this whole timeline of several months before an application gets approved it could be shrunk the AI can do that quick initial review before it gets even handed to the to the to the auditor reviewer who's reviewing the submission.

[00:42:31]So there's a lot of capability here.

[00:42:33]It'll med slow to move but I think they need to just take that first step but the applications are there and actually they're coming up as I was mentioning earlier when as I'm speaking to leaders nowadays they have a plethora of applications that they want to leverage AI for which is excellent because it gives you ideas as well.

[00:42:56]>> I love that. I think that's I think it's it's just a good reminder too. It's really all about getting medical devices and diagnostics into the hands of the doctors and the patients who need them, right? And so every month a device is stuck in that regulatory limbo is just another month that let's say a patient doesn't have access to potential a device that would really help them out.

[00:43:17]So, um, you know, that's I think a great way to frame it and, um, I I think it's really exciting to see what technology you're incorporating and, um, your mindset, um, with with some of these these fundamental crazy new tools, um, that we have available to us. So, before I let you go, is there um, a link you'd like listeners to perhaps follow maybe to get in touch with you and your team or learn more about what you guys are doing over at Riges?

[00:43:44]>> Yes, absolutely. We send out monthly newsletters that are focused on alerts.

[00:43:50]We have blogs where we keep everyone alerted. We have a an excellent resource page as well if you're just needing to understand regulations in different countries. We try to provide a lot of free resources to our clients. You can go to our website. It is regest.comp.co and you can access everything there. And if you'd like to speak to somebody from our team, we'd be more than happy to speak to you and you can just contact us at desk dk ragdesk.com.

[00:44:21]>> Perfect. All right, that's Priya Bhutani, founder and CEO at regesk.

[00:44:25]Pria, thank you so much for everything you shared with us. I think this has really been a great conversation.

[00:44:31]>> Thank you, Bo. Thanks for the opportunity. Appreciate it.

[00:44:34]>> Absolutely. Thank you listeners for listening to the SourceForge podcast.

[00:44:38]I'm your host Bo Hamilton. Make sure to subscribe to stay up to date with all of our upcoming B2B software related podcasts. I will talk to you in the next one.