RegDesk is an intelligent Regulatory Information Management (RIM) platform purpose-built for medical device manufacturers to streamline global compliance, automate submissions, and stay ahead of evolving regulations. By combining live regulatory intelligence, AI-powered workflows, and end-to-end tracking in a single platform, RegDesk helps regulatory teams reduce risk, accelerate approvals, and operate with greater efficiency and confidence.
In this episode, we speak with Priya Bhutani, founder and CEO of RegDesk, an AI-powered regulatory information management platform for the medical device industry. We discuss the complexities of global regulatory compliance, the challenges faced by regulatory teams, and how RegDesk’s platform leverages AI to streamline the process. Priya shares insights into the importance of integrating technology in regulatory affairs and the future role of AI in transforming these processes. The conversation highlights the shift towards more strategic roles for regulatory teams and the necessity of adopting AI to stay competitive.
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Show Notes
Takeaways
- RegDesk was founded to modernize outdated regulatory workflows in MedTech.
- Medical device approvals require complex submissions across global markets.
- Regulatory teams still rely heavily on spreadsheets and manual processes.
- Missed renewals and compliance gaps can create major business risks.
- Regulatory intelligence is essential for staying ahead of changing laws.
- AI enables faster submission preparation and reduces redundant work.
- RegDesk combines regulatory intelligence with workflow automation.
- Agentic AI can auto-populate submissions for new global markets.
- Companies can save dozens of hours per application using AI workflows.
- Human review remains critical for trust and regulatory accuracy.
- AI adoption in regulatory affairs is accelerating rapidly.
- Integrated regulatory platforms provide stronger scalability and ROI.
- Regulatory teams are shifting from administrative to strategic work.
- Future AI tools may predict approval success and compliance gaps.
Chapters
00:01 – The hidden complexity of medical device regulation
01:35 – Priya’s background and the origin of RegDesk
04:55 – Recognition, growth, and the rise of regulatory tech
06:02 – What regulatory information management actually means
10:26 – Why spreadsheets and manual tracking create compliance risk
14:33 – The reactive nature of global regulatory work
15:57 – Regulatory intelligence and staying ahead of changing laws
20:07 – How RegDesk fits into the regulatory workflow
23:19 – Building an AI-native regulatory platform
24:30 – AI-powered submission preparation and automation
28:08 – How AI changes the role of regulatory teams
32:14 – Trust, accuracy, and keeping humans in the loop
38:23 – Why companies must adopt AI-driven regulatory tools
42:08 – Scaling regulatory operations with integrated platforms
43:52 – The future of agentic AI in regulatory affairs
Transcript
Beau Hamilton (00:01.358)
Hello, everyone, and welcome to the SourceForge Podcast. I’m your host, Beau Hamilton. And today I’m joined by Priya Bhutani, founder and CEO of RegDesk, an AI powered regulatory information management platform built specifically for the medical device industry. 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. 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. 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. 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 manual work and effort. And when regulations change, which they do all the time, 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.
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, Priya, welcome to the podcast. Glad you can join us.
Priya Bhutani (01:29.885)
Thank you, Beau. Thank you to SourceForge for this opportunity. Glad to be here.
Beau Hamilton (01:35.15)
Yeah, I’m excited to dig into this some more. So I think before we really get into RegDesk itself, I do want to start with your background because I think it really helps set the stage. You started your career as an engineer at Baxter. You moved into regulatory consulting and then you launched RegDesk back in 2014. And that’s really the spark notes version of it. What was the moment you realized this company and your solution needed to exist?
Priya Bhutani (02:06.163)
Yeah, well, A fun point about, a note about RegDesk, is that we actually started the company at a Google hackathon, those weekend hackathons, that’s where it was actually incepted. But I had this idea prior to participating in the hackathon.
We saw, the whole idea of hackathon as you build your minimal viable product, and you proof that there’s potential if anyone were to invest further into this idea. And we just over the weekend of sharing the thought and the idea behind RegDesk, 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, 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 struggle 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 RegDesk. Our mission from the very beginning has been to modernize regulatory affairs to introduce technology into the process and that’s how we got started.
Beau Hamilton (04:01.142)
Interesting. That’s interesting to hear that you’ve started from that hackathon, which we’ve covered a lot of the hackathon related kind of bug bounty programs over on our sister site Slashdot. So I’m pretty familiar with that. And it’s interesting to hear that your company was kind of born from that effort. That was back in 2014 era?
Priya Bhutani (04:30.323)
Yes. And this hackathon was specific to healthcare ideas. It wasn’t generic. So it was perfect. Philadelphia has a pretty solid healthcare scene and health tech and a of hospital systems. And this Google hackathon was specific to that, which was quite relevant. That’s why I participated in that.
Beau Hamilton (04:55.08)
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, and then RegDesk has been named Gardner representative vendor for both regulatory information management and regulatory intelligence. I also want to get that out there. So you guys are doing some really valuable, important work. So just want to tell the listeners kind of how much value you guys are offering in this space.
And I bring up the origin story to set this stage. a lot has changed since 2014. I mean, 12 years later, we’re looking at all these automations, which of course I want to ask you about AI and how that’s playing into what you guys are doing. But 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. How would you just describe, describe that term, describe what RegDesk does?
Priya Bhutani (06:02.161)
Yes, to laymen who has no familiarity with this space, we will for a moment shelf this term, frame or regulatory information management system to give some background. If you have a medical, 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, that’s, and any medical equipment that you see, everything is defined and 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 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 a goal, that the product is ineffective and you have to provide evidence for it.
So these applications are quite lengthy. 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. can take several months to sometimes even two, three years to get your one single product approved in a particular country. Whereas in medical device manufacturer, you’re typically thinking global you are usually selling more than one country. And it gets to be quite complicated because rules and regulations are constantly changing their new legislations. It’s an evolving landscape to say the least. And then your products expire. 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’s also very technical because you’re dealing with the rules and regulations in dealing with health agencies.
Most of the companies have been using spreadsheets to manage this process. As I mentioned earlier, consultants, lot of old traditional fragmented ways to manage and get these products approved, their products approved in global markets. And this concept of RIM 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 technology aspect, 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 of 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 know where each skew has been approved to then meet the maintenance bit, 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-to-end solution that essentially digitizes regulatory
Beau Hamilton (10:26.2)
So I imagine when you’re working with companies, the companies you’re working with weren’t necessarily using maybe purpose-built software before they found you and discovered what RegDesk offers. I mean, 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 spreadsheets, with email chains, maybe there’s like shared folders. And then the teams themselves can be relatively small. So that kind of adds to the, you know, the burden of everything. when you have a system that doesn’t work as efficiently as it should, where do, maybe you can elaborate on where those approaches start to really fall apart?
Priya Bhutani (11:11.987)
If you have a medical device company and you have let’s say 1000 product SKUs, you’re not typically selling every SKU in every country, you have certain SKUs that are specific to Japan and that certain ones to China and then Latin America. And you’re doing that all through a spreadsheet and Excel sheet that someone can go and change the formula on or somebody could be on vacation and forget to update. One of the big challenges and the risk, it’s not even a challenge, it’s actually a risk to an organization is that once your product is approved, you’re selling that product. If not that product is to be renewed in five 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 a huge risk to an organization because the product has to be revoked. It can slow everything down. It’s a P&L impact is what it is. That’s one.
Another is when, 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 changes in regulations? And if you’re not, that in itself is a noncompliance. That’s a stamp of noncompliance. No you have to address that issue and you have to have processes in place now. there are a lot of companies go through audits and there’s just a lot of compliance risk for doing it this haphazardly 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 people 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 and you’re constantly repeating the same amount of work rather than working in a smarter way leveraging AI. Now the technology is so smart that it can do a lot of this administrative work for you. So there there’s just a lot of risk the companies expose themselves to just way too much risk missing deadlines, missing renewals, not being compliant.
Beau Hamilton (14:33.216)
Yeah, that makes sense. I mean, it’s to your point about the reactivity. I think a lot of people outside of the regulatory industry might not appreciate maybe just how reactive the work is. I mean, you got the you got the FDA making changes on one side of the equation. You got the EU is rolling out their own requirements on the other. You have dozens of other countries have all their all their various compliances on top of that.
So it really creates this burden is back and forth and constant sort of stop and start. And you’re constantly having to like go back and, dot your I’s, cross your T’s, that sort of thing. And I think also just the scale and how much of a global challenge this is, you know, you’re not tracking regulations in five or 10 countries. Again, it’s 120 plus countries. 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 try and solve.
But, how do you actually stay on top of all that, from a solution standpoint? Is that more of like a tech problem? Is it a people problem? Does it lead into this, you know, kind of the AI solutions you’ve devised? Where’s kind of the, where does the problem lie?
Priya Bhutani (15:57.279)
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 is 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 have a Reg Intel team, but they also, many times lack tools. What they do is they’ll subscribe to newsletters and they attend conferences, etcetera. They’re hoping to gain 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 disseminated across different business units, especially for a large company. Then it’s the responsibility of each business unit to read that newsletter and determine what’s relevant to them.
On top of this, actual expectation of a health authority when an auditor comes in is not just, are you keeping up to date with changes? But what they’re asking is, great, you are keeping up to date with changes to 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 perform further assessment to determine what that impact is? Does that mean you have to now re-register? How does this change impact your products? First, if you are already delayed when 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 our RIM platform on top of it. That’s one of our big advantages. Most RIM 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 RegIntel. How do you make any regulatory decisions without having the 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 an agency comes they can show here the changes, these are the products that are being impacted in these markets, this is the impact and this is our action and 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 agentic 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, I don’t know, delivery devices so now you require different Intel and so you get curated reports leveraging technology in AI.
Beau Hamilton (20:07.278)
Okay. So let’s talk about that, that intelligence layer and then, and then get into some of those AI features. Cause you’ve got, you got this intelligence layer and you have this expert network of some 4,000 regulatory experts around the world, which, we can unpack some more too.
But, I want to talk about the platform. I know a lot of like the traditional, you know, regulatory information management platforms, they’ve become these tracking tools. So you upload your documents, you log into your, you log your submissions. And that’s really the main functionality, I would say, right? But then from what I understand, RegDesk goes much further and actually guides teams through that process, integrates with other systems, and kind of starts to really work and control all the different mechanisms at play to help a company get a finer understanding and really work through the problem and find a efficient solution.
Maybe you could talk about how RegDesk fits into that workflow that teams typically handle. And then what does RegDesk do differently than some of the other platforms out there? What’s your main value proposition?
Priya Bhutani (21:19.185)
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. 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 workflows on top of workflows. They have 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 third is the Reg Intel. That’s a unique point to us to have integrated Reg Intel because our system is built on top of Reg Intel.
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? That’s the first thing anyone would need to find out. What do I need to do? How do I do it? And our system gives them that formula of exactly what’s required, when it’s required. Here’s the legislation and here are the guidances that support this. We give you everything that you need. And then 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 system now is AI native platform where we’re using agentic AI 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. 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 technology really doesn’t matter to them, they just wanna go one little step above a spreadsheet, then yeah, there are lots of solutions out there. We can also support but the best alignment is companies and leaders saying, know, I need my teams leveraging AI. How do they work smarter? Can they build submissions faster? And they’re demanding these things. And that’s where we are a leader.
Beau Hamilton (24:30.574)
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 leading provider in that front. And it’s it’s interesting to hear about some of these AI features in this industry 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 a lot of privacy components, one security breach can really decimate a company. It’s just like, there’s more, it’s seems like it’s inherently a little bit further removed from some of these newest, from the newest technology, than other tech facing, tech industries.
So I want to unpack that some more. I know that RegDesk can actually take data from a previous submission, let’s say, and use it to sort of auto populate forms for new markets. And that’s like one use case. So you don’t have to like go in there manually and, and, every time a team files in a new country. And then just like those little, little automations can really, accumulate and start saving some real time, right? Like the, what’s the typical like process timeline for, a submission? Is it like a matter of months, in some cases it weeks?
Priya Bhutani (25:59.707)
So a submission preparation. So there’s, we call them four pillars the plan, build, track and maintain. If we just focus on the building part, you’re building submission. Submission preparation is also an arduous process. One you need to understand what the requirements are for that market. Then you need to put together this application right you need to and have your sterilization report, your validation report. There’s a lot of evidence that you have to provide 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 they 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 we have the base application and 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 auto-populate your submissions for you.
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 auto-populate as much of the application as it can for India. So within seconds you can have 60 to 80% of your application auto-populated. 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 savings.
Beau Hamilton (28:08.428)
So do you find that when you have, when you work with the team to integrate some of these, tools, these AI tools, do they, does the role of the team shift into kind of becoming a more judgment based and like, their goal is less like punching in numbers, and doing some of the redundant tasks to kind of reviewing what some of the agentic AI has, has delivered for them. They can become like the, they have to kind of review and check and then if they have any time savings, which sounds like they’re able to save on average 35 hours per submission, are they able to reinvest that time into other areas that are more, you know, productive or rewarding, let’s say? How is, how is that causing a shift?
Priya Bhutani (29:00.789)
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 submission, and I’ll give Saudi Arabia for example, or another. And without the tool, you would have to reach out to the agent in Saudi and say hey what do need from me and then you wait because now you have to wait for them to tell you what they require what docuemnts they need. Once they send you the documents, you don’t know where to verify, right? You have go first find the law on the Saudi health website. Then if it’s in Arabic, you have to now translate that law, read it to decide whether the requirements provided by your local regional partner is exactly what they require if 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, you just, so much time gets wasted. Whereas with our platform, it’s within seconds you create workflows and you’re communicating. So, because they also have the right intel, they no longer ask the distributor what is required. They are proactive. They practically tell the distributor this is what we think you need. Tell us just add on to this list if you need anything additional. They’re just so much more efficient and getting work done versus being flunked by, and delays in the latency involved with all the bureaucracy and the holidays and 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 three weeks. Or when the distributor comes back two months later complaining that so and so is missing from the documents and now they have to search. It’s all this busy work. Instead of this administrative work, they are having strategic conversations and they’re doing the reviews and getting these submissions.
Regulatory is 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. 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, you can enable 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 well worth the investment for any organization to have such a tool.
Beau Hamilton (32:14.574)
Maybe you could also talk, to speak to the what you’re doing to ensure accuracy and the trust in the technology, right? Because I mean, 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, you know, get their medical devices approved, and be regulatory compliance. And so, and then you know, it’s an important decision. You want to make sure all the right facts and information are being, you know, translated over and communicated.
So how do you solve that trust issue? Like, do you notice teams, like, apprehensive at all about incorporating any of the tools? Do you have a good kind of robust system to make sure everything is on track and accurate?
Priya Bhutani (33:07.285)
It’s a good question because I’ll answer it in two separate parts. 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, 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 of having conversations with some prospective clients, when you ask them what do 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 X, Y, Z, 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 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 most companies are using AI in their day to day. They have approved AI platforms that they are allowed to use. I mean, grandparents using AI now. So it’s becoming a very common theme. It’s helping. their trust factor, it’s increased a bit more just because of the 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. Well, one, we don’t believe in the entire platform being just AI driven. It’s heavily AI driven. However, with every step, there’s 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. 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’s very important to us and that’s there. Second, the way our AI works is it’s not a large loop 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 the submission for company X, you need to learn the information about company X’s products, company wise 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 Intel based on their products, their documentation. That in combination with the human in the loop and also our Reg Intel, though we leverage AI, there is a human factor, it’s human curated. So that eases a lot of the stress and anxiety around using the AI on our platform.
Beau Hamilton (36:41.944)
Yeah, absolutely. I mean, there’s a few things that stood out there 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 amongst, you know, the conversations we’re having with friends, family, and those in the industry. I mean, we obviously here in the SourceForge Podcast, AI is like the center point. It always comes up and it’s always a main kind of pillar of a question of how companies are integrating it. And a lot of the trust really seems to be from the consumer level with some of the AI chatbots. But when you look at the integrations companies are doing behind the scenes with some of the services they offer in the SaaS space, there’s some real utility and real, there’s a lot less reason to be skeptical, let’s say.
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 you never want to ship something that’s unchecked, let’s say, by one of these automated tools. Because they do make mistakes. I mean, just as people make mistakes, these machines make mistakes, they’re getting better day by day.
And then I was going to ask you about what advice you had for regulatory listeners reading if there was like one big takeaway, but it sounds like, if you mentioned you kind of have to start incorporating AI and if you don’t, you’re going to be left behind, right? Like, is that kind of the biggest takeaway you would say?
Priya Bhutani (38:23.03)
So let me actually give you an example of, so Gardner, the analysts there, they actually write every couple years they release their analysis on the RIM space and they have been analyzing the RIM space for quite a few years, especially on the pharma side because pharma is always more tech, I guess smart and they are more open and willing, have willingness to adopt technology and they have. So this whole great concept came from pharma world. And Gardner analysts have summarized and sort of concluded from this is that they said that one technologies, 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 one-off tools that perform only one function, then you just don’t have that scalability, the ROI gonna 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 QMS and other systems, that becomes a holistic solution and companies should strive for that because that’s where you get the biggest ROI and scalability.
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 are already very very behind. Forget AI, just get a technology platform. It’s the way they’re performing their functions using homegrown tools. It’s 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 such a big disadvantage for you not to opt and select a technology that is using AI.
If RegDesk is also in the mind frame of not just, 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 two years, honestly. 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 spreadsheets, 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 a company could have an appetite for that level of risk. So yeah, I think that getting technology, having a bigger picture of 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 of 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.
Beau Hamilton (42:08.162)
Yeah, well said. Absolutely great takeaways. I think that’s very true. It’s, I could, on one hand, I can see why maybe a company, they’ve been doing, things for a certain way for, you know, the last decade, let’s say, it’s hard to kind of motivate yourself or get the team to switch gears entirely and adopt some of 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, the landscape’s getting way more competitive and you’re just gonna be left behind. And I think also a lot of this information, a lot of these tools are becoming more democratized too. So, you know, they become, there’s not only more solutions, it’s just easier to adopt in a way. If you don’t get so overwhelmed and you just maybe start small, the point is you have to start in some way, shape or form to start moving, getting with the times.
But that’s great. Those are some great takeaways. I want to kind of end on this note of this forward looking approach. Obviously, the regulatory teams are moving, you know, they’re switching gears to become almost like gatekeepers to being treated more like strategic partners within their organizations. There’s all these AI tools coming down the pipeline. Just looking ahead, 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?
Priya Bhutani (43:52.308)
It would be leveraging agentic AI tools. It would be where the future would be where language will no longer be a barrier. 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 teams together and it just makes it easier to work using one singular platform.
And yeah, I think it’s going to be more and more the agenda capabilities as those become stronger, which they are day by day, week by week. Then it’s leveraging that 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’ve been being submitted. The predictions and understanding how are they doing in 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 whole timeline of several months before an application gets approved. It could be strong. The AI can do that quick initial review before it gets even handed to the auditor reviewer who’s reviewing your submission.
So there’s a lot of capability here. MedTech is slow to move, I think as they need to just take that first step, but the applications are there and actually they’re coming up as a, it was mentioned 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.
Beau Hamilton (46:38.67)
I love that. think that’s I think it’s it’s just a good reminder to 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 the 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 will really help them out. So, you know, that’s I think a great way to frame it. And I think it’s really exciting to see what technology you’re incorporating and your mindset with some of these fundamental crazy new tools that we have available to us.
So before I let you go, is there 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 RegDesk?
Priya Bhutani (47:24.907)
Yes, absolutely. We send out monthly newsletters that are focused on alerts. We have blogs where we keep everyone alerted. We have an excellent resource page as well if you are 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 regdesk.co, not “com”, dot 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, d-e-s-k, desk@reddesk.co.
Beau Hamilton (47:27.51)
Perfect. All right. That’s Priya Bhutani, founder and CEO at RegDesk. Priya, thank you so much for everything you shared with us. I think this has really been a great conversation.
Priya Bhutani (47:39.029)
Thank you Beau, thanks for the opportunity. Appreciate it.
Beau Hamilton (48:16.142)
Absolutely. Thank you listeners for listening to the SourceForge Podcast. I’m your host, Beau 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.