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Executive Series Episode #4 - Priya Bhutani
76 Plays8 months ago
Welcome to The Gens & Associates Podcast: Executive Series. This exciting series features Steve Gens, G&A Managing Partner, conversing with key senior executives that represent the software and services sectors. These informative one on one conversations will explore how they are guiding their organizations to effectively support key industry initiatives and technology advances.
In this episode, Steve Gens is joined by Priya Bhutani (Founder and CEO of Regdesk) to discuss how Regulatory Intelligence and AI has helped costumers and the exciting future for Regdesk!
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Transcript
Introduction to the Podcast Series
00:00:00
Speaker
Welcome to the Gens and Associates executive podcast series where I have one-on-one conversations with leading executives that represent the regulatory software and service sector to learn more about their organizations or how their organizations are supporting and more importantly, innovating the space. For those that don't know me, I'm Steve Gens, founder of Gens and Associates. I've been around life sciences for some 35 years.
Innovations in Med Tech with Priya Bhutani
00:00:27
Speaker
ah Today I'm very happy to be speaking with not only the CEO but the the founder Priya Bhutani from Regdesk and welcome ah ah Priya.
00:00:39
Speaker
I've been looking forward to this conversation. There's so much going on in the med tech and as a small emerging company and growing quickly, really excited about the a chance to explore a few things with you for the benefit of our listeners. So before we get started, can you introduce yourself in the company to our listeners?
00:01:00
Speaker
Absolutely. Thank you, Steve, and Gens and Associates for inviting me to this podcast. Delighted to be speaking with you. we I'm Priya, Paul Butani. I'm the founder and CEO of Ragdusk, and it's been an exciting journey, survey specifically medical device industry, and providing them with innovative solutions, which we'll talk about more today.
00:01:26
Speaker
Great, you know, and thanks
Regdesk's AI Advantage in Compliance
00:01:28
Speaker
for that. And the one thing when we started to get to know you, and really, you know, how are you different from some of your competitors? We've always been impressed. I know you talk about an AI, you know, kind of the driven software and processes, but it's it's that combination of AI and the reg and tell. You know, clearly we see that as a separator, you know, and we've talked to you about that. That combination is so,
00:01:53
Speaker
So powerful. So where I'd like to start is you know kind of finding founding a fairly new company.
Vision and Industry Standards at Regdesk
00:02:01
Speaker
And I think it was around 2015 supporting the med tech space. And even though a lot of our listeners are biopharmaceutical, some are med tech, there's this growing combinational product space. Can you provide our listeners with some of the near and longer term vision of the organization? So again,
00:02:21
Speaker
you know being about eight or nine years ah young, if you will, in such a big space. It'll be great to to understand or our listeners could understand your short-term and longer-term vision for the company.
00:02:35
Speaker
Absolutely. In fact, this year will actually be our 10th year. And I've been told not to call ourselves a startup anymore. ah But nonetheless, yes, we are a consider we are a small kind of company considering you know we deal with very large organizations, but have a pretty powerful tool.
00:02:55
Speaker
To address your question about about our near term and long term vision, well, I would say I'd like to focus on four areas that we are focused on. So number one is innovating regulatory compliance with integrating the regulatory intelligence within our RIM platform that's that' important to us. And our near term vision for for this is to develop advanced compliance tools that simplify and they automate regulatory compliance processes for medical device companies. and This includes robust tools for managing submissions, tracks tracking changes and regulations,
00:03:38
Speaker
and ensuring that ongoing compliance with goal with global standards is being met, and also ensuring quality of and and efficiency while doing that. And our long-term vision with this specifically is to expand our global reach. That's really big thing for us and become an industry standard. i Those are the two long-term vision that we have ah when we consider our RIM platform and We want to be known is as an industry standard and in the long term, we want to aspire we we aspire to set the industry standard for regulatory compliance
Data Integration and Automation Enhancements
00:04:17
Speaker
software. We want to be recognized for our cutting edge technology and our comprehensive solutions.
00:04:24
Speaker
And also with the expansion of at a worldwide level, we want to continue to expand our services globally and so that we can ensure and serve our rapidly growing customer base who have diverse regulatory requirements in different regions. So one was the innovation and within our RIM, the second area of focus is enhancing our data integration and interoperability. We find that's highly important. So with that, we are focused on seamless data integration.
00:04:56
Speaker
Our focus is on developing solutions that enable the integration with existing systems such as yeah ERP, CRM, yeah QMS systems. And through this integration, then we can ensure that the data flows smoothly across different platforms. And it truly enhances the overall operational efficiency that companies have and they get this holistic solution.
00:05:19
Speaker
and while making sure that there's data accuracy with it. And we want to continue to yeah create and integrate more ecosystems within it so that at some point in the in the future, our platform is so And interoperable that it's not only connecting to the yeah ERP QMS, but it expands to the R and&D function and the post market surveillance. And then you have a truly a turnkey approach there to this. The third factor that we're focused on is
00:05:54
Speaker
driving innovation through AI and machine learning that's highly important to us and with that we are already focused on incorporating AI and machine learning into our software as we speak today which is available to our clients and we do so by automating some routine tasks such as building forms or or document compilation And we also aim to do more predictive analysis and build those tools to help companies start you know anticipating what the regulatory changes will be, what the market trends and what the potential compliance issues would be. And within the scope of the AI and machine learning,
00:06:35
Speaker
Our long-term vision is we intend to lead the industry, especially the RIMF industry in AI innovation, by offering solutions that not only automate, but also intelligently start optimizing regulatory and quality processes.
Commitment to Customer Success
00:06:54
Speaker
So one of the examples would be developing a smart assistant or multiple smart assistants and these would be virtual assistants that can guide users through complex regulatory landscapes and ideas as such so that that's what and is in the vision and and not to forget our commitment to customer success and they are at the forefront of our mind. And in fact, with Ragdusk, what sets us apart, and yes, it's the features of the Rag Intel, et cetera. But I think what truly sets us apart is because from the onset, we have always been committed to being a very customer-centric driven company. That's been our approach. And our entire system has been
00:07:38
Speaker
built by us, designed by us, but a lot of the brain work has come from our clients and we're grateful to them for that. So we continue, we want to continue offering personalized support and ensuring that our solutions are tailored to meet their unique needs And then also continuing to be agile, we find that that's highly important for large organizations is the the agility, so developing methodologies that that can quickly adapt to their changing needs. And regulatory land framework is constantly changing anyway, so with clients increasingly changing needs and then the regulatory framework changing,
00:08:22
Speaker
ah We have to make sure that short-term and long-term that we, as we develop and enhance our RIM platform, that we also keep that agility in mind.
00:08:33
Speaker
Well, certainly a very ambitious schedule. I was taking tons of notes on this. And certainly I know, you know, with all the connectivity you have, the interoperability, people really get hung up on system connectivity, but we're in the age of data connectivity, you know, irregardless where it's housed. And we're really big on metrics program and continuous improvement. We kind of preach that to, you know, the regulatory folks we worked with. but kind of where you're going with a predictive analytics is really that that's the future, you know, the future value. The other thing I really liked about your comment because sometimes people get overwhelmed with AI or they get AI confused with automation. There is, you know, and it's very not only in our industry, but other industries, some
00:09:21
Speaker
A lot of people are scared that AI is going to replace you know my job versus, you know I think you used the term you know smart assistant. We use the virtual assistant here that it's a helper, not a replacer. And you know another company I was talking with about AI, they said, yeah, it's a co-pilot. So all those metaphors, I think, really yeah you know really work well.
00:09:43
Speaker
So, um, the one thing when, you know, myself and the team and we had, you know, the first briefing or two and we're like, you know, did we get this right? Are we understanding it? Cause we've been preaching to the software providers and really on the biopharmaceutical side, the Nirvana.
00:10:00
Speaker
is the binding of Regentele with the software. In your case, it's the triangle of AI, Regentele, to interrogate that. And actually, you know if you're in Thailand, it'll start a you know workflow from that. And I believe you also, if i memory serves me correct, have staff that just you know focuses and researches the regulation, so the power of that combination. we We see that as a separator for you. So could you ah talk with some of your clients, like how has your approach, you know, helped some of your customers, you know, and do you see this approach as a competitive advantage? Well, first of all, thank you for the kind words. We do have a staff that's focused on reg. Intel and that alone, but
00:10:49
Speaker
Our objective and our belief is that integrating RegIntel and AI into our RIM platform. And in the data has shown that it has profoundly benefited our customers and has indeed become a significant competitive advantage for us. Then I can elaborate on how this combo has helped our clients and why it stands out in the industry.
Streamlining Operations through Automation
00:11:15
Speaker
So first of all, it has definitely enhanced the compliance efficiency.
00:11:20
Speaker
By automating processes, by incorporating AI to automate, we have been able to eliminate that rework and that redundancy that leaders have been complaining about and even regulatory associates have been complaining about. And through the use of AI by automating document compilation, regulatory checks, reporting, e etc. This has drastically reduced the time and effort required by our clients to stay compliant with the changes, all the changes that are happening globally, but also just saving them time as well and
00:12:03
Speaker
ah reducing their compliance with and the The real-time updates that we provide, they can the the continuous monitoring of global regulatory changes and then updating our clients in real-time, this proactive approach has ensured that they're always ahead of the curve. They're avoiding any potential non-compliance issues and they're not reacting. They're much more proactive and that it's an empowering state to be in.
00:12:32
Speaker
and Also the streamlined workflow, so we are more than just AI and and break Intel. One of our other strengths and unique differentiators is the fact that we're using the latest technology and through that we're able to build a lot of workflows because regulatory operations functions that way. One action leads to another action that leads to another action and clients we find especially mid to large enterprise companies need the workflows to support that functionality. So we have these streamlined workflows and and not only that but
00:13:13
Speaker
the workflows help them manage their entire regulatory operations, but also the the fact of the integration, then it pulls it all in all in together, which in itself provides them efficiency. And I would say in terms of covering you know how it has helped clients, it's also helped them with cost savings because the automation in itself ah reduces time, significant time. I mean, applications that take months to complete utilizing multiple resources, now you can complete within hours, and which is significant. So the cost of that that administrative cost that companies sometimes don't even account for, there's a lot of savings there.
00:13:58
Speaker
and the routine handling of the task through automation that just, just overarching lead. I mean, that it's the It's a compilation of resources, time, cost savings. you know It all just happens together. It's not one or the other. And clients do find they get the competitive advantage. In fact, thanks to organizations like yours and you preaching to the clients to leverage technology and and organizations like Gartner,
00:14:28
Speaker
it It's helping our cause and and conferences talking about AI and pushing teams to at least consider being more innovative and and digitizing what they've been doing manually. And so what our competitive advantage has been, the the what you mentioned, the reg intel and the AI and the workflows.
00:14:48
Speaker
it these advanced capabilities do set us apart from our competitors who may still in fact many of them still rely on more traditional manual processes even as they offer the RIM platform. And then see we have been able to build a lot of customer trust and loyalty through proven crack record. They can see and the teams can appreciate, one, the comprehensiveness of the solution, and the fact that you don't need desperate systems, so one to just do tracking, and then standards management is another system, reg-intels another system. Submission generation, that's not even a tool for most REM solutions, so bringing it all together as one comprehensive solution is,
00:15:37
Speaker
then becomes a more powerful tool for for companies. and And the fact that within our system, there there are tools for distributors to collaborate. I mean, we're trying to hit it from every angle that, OK, if you're not doing your own submissions, you're doing it with a distributor, no problem. We have a solution for that. Oh, by the way, you do submissions this way, no problem. We can handle that. Oh, now you have to manage change assessment? No worries. Our system can also allow you to do that. So it's that.
00:16:08
Speaker
It truly is a powerful platform and once companies understand that all the capabilities one platform offers, it in itself is a massive competitive advantage because most clients either don't have a solution and if they do, they have one-off systems that are not talking to each other or they're utilizing a RIM technology that's already outdated.
00:16:35
Speaker
Yeah, that's a ah very impressive list. and And, you know, as I was kind of listening to your comments, you know, it kind of reminded me when I was in industry with, I think I had mentioned, you know, with Johnson & Johnson, but in their pharmaceutical sector.
Balancing Compliance Costs and Risks
00:16:49
Speaker
But we collaborated, you know, with the consumer division and the and the med tech. and We reported up through finance, actually the CFO was my boss for a couple of years. And, you know, it isn't, you know, do you have to be compliant? It's not a yes or no, you have to be compliant, but there's a cost to that compliance without impacting any risk, right? So that's kind of the sweet spot. And really what that meant for us, if we really got good at the compliance, where can we automate, you know, aspects of it?
00:17:22
Speaker
and there's no undue risk, you know we can reallocate those valuable resources to do more value-added things. And it seems like you've really solved that on the MedTech side. and And certainly on the biopharmaceutical side, we see it picking up on the MedTech is one of the biggest elements or dimensions in the business case for change is how can we reduce complexity.
00:17:47
Speaker
which is really a statement of how can we simplify, you know, with all these various systems, you know, going with broader platforms, you know, like yourselves, you know, more standard ways of working on the the process levels. So, yeah, my hat's off to you, you know, a lot to accomplish in a very ah short period of time.
00:18:06
Speaker
um So our our final question for our listeners, and you know, as we have this executive series, it's, you know, ah different CEOs and only a few of the companies, you know, like yourselves, it's the founder and the CEO just like you know And there's that saying, it's your baby, right? So certainly with the Gens and Associates back in 2005 kind of you know took that, ah it's not the low dive, but the high dive in the pool and took that leap, you know but had a vision, saw a need. So maybe I'm going to appeal to your founder side and not CEO side is what should industry expect from Regdesk in the coming years? I know you already hit on some of the points, but what are you most excited about?
00:18:52
Speaker
For me personally, as the as a CEO and founder, it's evolving our technology. I think that's where we add tremendous value to our clients is we consider ourselves to be a tech company and I take onus of that in true sense that tech is evolving in other areas, vectors. There is very unique and innovative technology solutions being leveraged to solve problems. And we've just been very behind on the for in terms of regulatory compliance of adopting technology.
00:19:29
Speaker
And so our driving factor really is data. There's a lot of data. And I'm not talking about product attributes, just within learning from from the deficiency letters, et cetera. So for us and for me personally, the goal is to keep advancing our AI and machine learning capabilities Enhancing predictive analysis, that's an area that excites me the most. ah Performing, doing smart smart ah automation. So how do we automate more and more of those routine compliance tasks? And that that's how we can add value. The other is also it continuously expanding our global regulatory coverage. So can we address more topics with Reg Intel and and more verticals? as well as we get requests from clients all the time. The other is the user experience and integration. So it's one thing having innovative technology, but if it's too complex for a user to use, no one's going to use it. And organizations already struggle with change management. So for us, it's
00:20:41
Speaker
Okay, we even if we use leverage AI and machine learning, but is the user interface friendly? Is it user centric design? Do we have intuitive interfaces? And can we help ease that the struggle with change management? I know that's a huge task of its own, but that's another area of of interest. and then the ah Also, just you know ah a responsibility as as a founder is data security and compliance, making sure that clients are trusting us with data.
Data Security and Lifecycle Management
00:21:17
Speaker
That's one of our biggest areas of of something we don't take lightly, let's put it that way. ah so It's a high priority, areas of high priority for us where
00:21:28
Speaker
we are always working to enhance our security and our own internal compliance and our QA to make sure that all the processes, procedures, and on the tech end, everything is quite robust in terms of data security. so that Those are the the main areas ah that I'm focused on. so Again, enhancing the technology and And then continuing to be client-centric, I think that's helped us the most. And I'm grateful for that approach. We were never trying to be a better version of a rim. We organically actually fell into this category of rim. And it's because we weren't trying to copy someone else. we we Even now, we stay in our own lane. ah We are not too concerned about our competition and and what's happening for us. We sort of know our vision for where we want to go. And we're just focused on that.
00:22:26
Speaker
Yeah, that's very, very exciting, and and certainly you can never go you know wrong if you're your focus for the entire organization is to be client-centric. Only good things come from that, you know the feedback, and certainly your point about, you know, kind of the goal becoming the industry standard, but that still, you know, that starts with building trust, you know, one customer at a time on that. So it seems you and your team are doing a really nice job on that. And and certainly some of the like the automation goals, what I wrote down here is just one of the biggest burdens in regulatory is reducing the burden of life cycle management, you know, people that
00:23:05
Speaker
don't work or in life sciences, maybe they're in manufacturing or clinical or, you know, on the design centers, kind of in your case, is just the the complexity and all the work, you know, just to be compliant and keep those products on the market. It's it's a really big deal. And it sounds like you're making a great impact on that with your customer base.
00:23:27
Speaker
So, before um we wrap it up, Priya, first of all, thank you so much ah for a delightful, really insightful discussions. I'm sure our listeners have learned a great deal. And, you know, we have different types of listeners, some on the biopharmaceutical side, on the med tech. And I think the med tech might know RegDesk, you know, pretty well, or they should should know it.
00:23:50
Speaker
But certainly on the the biopharmaceutical side, if you have a division of me med tech or maybe you know growing combinational products, you need to you know give Priya's team a
Connecting with Priya and Regdesk
00:24:02
Speaker
look. So if people wanted to reach out Priya, what's the best way that they can contact you? Is it through the website, through LinkedIn? What what would you suggest?
00:24:11
Speaker
Yes, either way, the website's a great way. yeah Also, it's regdesk.co. And just you can contact us through that. You can contact me directly through LinkedIn as well. We're always here, available to address questions. and And we're also one of those companies, if we find that our solution does not meet the needs that you have, we're the first ones to tell you it's not about pushing a solution.
00:24:35
Speaker
To you, it's about understanding what are your real requirements. And sometimes, it we may not be the right fit, and it's OK. But many times, we are that ideal solution. But yes, and we, again, thank you, Steve, for the opportunity to be here to talk about Regg Desk. And thank you for the kind words and and helping us promote our our name.
00:25:01
Speaker
Yeah, no, I'm glad to do it. We always like, and been doing this for over 20 years, it's it's great, you know the the young, innovating you know companies that maybe have a different ah ah way to look at you know you know serving industry, and you you guys certainly fit that. um ah That bill so it's, so you know, our pleasure. So, um just to wrap it up folks, you know, certainly reach out ah to a previous team, you might have some questions for us, you know, just go on our contact page off the website, you know, or or on LinkedIn to.
00:25:34
Speaker
And please enjoy our other podcast. We just reorganized our podcast landing page. So we have the executive series here. We just finished up on our world-class room research so that different members of the core research team talk about what they learn most and most excited with each one of the sections of the world-class room research. And then different subject matter experts that talk on some of the complex challenges of the the day.
00:26:01
Speaker
So again, Priya, thank you very much. Maybe later in the year, next year we have you back and see how things are progressing. Absolutely. We'd we'd love to do that.