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Executive Series Episode #3 - James Gianoutsos
93 Plays8 months ago
Welcome to The Gens & Associates Podcast: Executive Series. This exciting series will feature 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 James Gianoutsos (Founder and CEO of Rimsys) to discuss Rimsys’ growth as a provider in the Medtech space and how it supports their costumers unique and complex regulatory requirements.
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Transcript
Introduction to Executive Podcast Series
00:00:00
Speaker
Welcome to the Gens & Associates executive podcast series where I have one-on-one conversations with leading executives that represent the regulatory software and services sector to learn more about how their organizations are supporting and more importantly innovating this space. So ah Steve Gens here, Managing Partner of Gens & Associates.
James Janutsis's Journey and RIMSES Founding
00:00:20
Speaker
Today, I'm happy to be speaking with James Janutas, founder and CEO of RIMSES. So welcome, James. I've been looking forward to this conversation. And, you know, as we have this executive series, it's kind of rare to have a founder, you know, founding Gens and Associates in 2005 seemed like a very risky proposition. And it's different when you're founding something versus just being a ah CEO of existing organization.
00:00:50
Speaker
So before we get started with RIMSYS being a fairly new company, I think you were founded in 2017. Could you give our listeners a brief history of RIMSYS and yourself and how you support the MedTech sector?
00:01:06
Speaker
Yeah, absolutely. And before I start off, just thanks for having myself on board and being a presenter here. And yeah, for everybody who does not under um understand the MedTech arena or know RIMSIS. So I myself, my name is James Janutsis. I'm founder and CEO of RIMSIS. And I've spent the last 17 plus years in regulatory regulatory and quality, specifically around the MedTech community.
00:01:34
Speaker
an industry And so I started of my career at ah Phillips and worked for several small and medium sized med tech manufacturers. um I've had the.
00:01:48
Speaker
um the experience of actually managing global regulatory operations, doing global submissions, moving $600 million dollar manufacturing locations under consent decrees in the midst of EU eu MDR and IVDR transitions.
RIMSES Focus on MedTech Post Layoff
00:02:06
Speaker
And so I've also had a really nice breadth of Medtech background as well, Medtech product background, I should say, all the way from CPAP devices to internal surgical adhesives, sealants, even on the consumer side, so ah such as the Suvi pacifiers, incubators, um you name it. I've really had a ah really diverse and broad experience level with Medtech itself.
00:02:32
Speaker
And so back in 2017, I was actually working for a small MedTech manufacturer and ah fortunately or unfortunately, I was i was laid off of that position. ah It was something that I know that there's a lot of MedTech manufacturers that are kind of doing the same thing.
00:02:51
Speaker
in in this year or last year, I should say. And um and it was, you know, that would happen on May 31st, 2017 at noon. And I started RIMSIS at 1 p.m. that same day. It was just something that I've always had in the back of my mind, something that I always wanted to pursue. ah And really looking at the landscape back then, there was only pharmaceutical RIM providers on the
Early Challenges and MedTech Solutions at RIMSES
00:03:17
Speaker
market. And so there was nothing really catered to the Megtech The MedTech world and MedTech and pharma are universes apart, not just worlds, but universes apart in terms of regulatory complexity, how you get products to market, how you maintain those products on the market, ah and just the the regulatory pathways and workflows around that. and so
00:03:39
Speaker
ah really started my my endeavor, hiring a couple developers offshore and and really started that way. And and to your point, it's definitely different to be a founder than just a CEO because you're so heavily invested and so heavily involved that over the last five to six years, ah ah seven years, I should say, ah it's been it's been a a really cool experience to be personally involved with this development and working with the largest MedTech manufacturers in the world to help develop our solution and improve their regulatory workflow so at the end of the day they can get the products to market faster and keep those products on the market.
Collaborations with Large MedTech Manufacturers
00:04:21
Speaker
Excellent. So thank you so much for that good introduction. And then again, from one founder to another, I still remember I had ah a fold up desk in a spare room with a laptop, my cell phone, you know, one customer, one contract, and you know, we're starting our 20th year.
00:04:38
Speaker
and have over a hundred ah global customers. Like I could have never imagined back then where it would be, but you you start someplace, you have a vision, you see a need, you go after it, you you just get the best team around you and you just do it. So so congratulations, you had a very successful liftoff. And that's where I'd like to start. I know when we first got introduced and started covering you about four years ago, and I think it's on your website too,
00:05:06
Speaker
is you know that context because again we support both the biopharmaceutical and med tech and they are very different although there's growing combinational products right so they're they're starting to be a little but blurring but there they are two different worlds or universes kind of in your case you know i know you say yeah we build this by regulatory affairs you know professionals there's a better way to do this And also like the other terminology that a lot of people will use big words like transformation and all that. But in regulatory, it's a major modernization and simplification. And I know on the med tech side organizationally, you know, they tend to be a lot more distributed design setter. So in some ways you have a different set of complexity.
00:05:49
Speaker
So we've been tracking you for about four
RIMSES's Competitive Edge in MedTech
00:05:51
Speaker
years now. We've watched your growth. We get those regular annual updates. But I think one thing our customers would really be interested in is, you know why why do your customers pick RIMSES? What differentiates you from the the competition? Yeah, there's a lot to unpack from that question. And I'm i'm happy happy to dive in a little bit more to it.
00:06:16
Speaker
you know One of the primary things that we do and understand ah is the MedTech industry period. um And so from day one, you know this is why our company exists to support MedTech, period. ah the you know there there's you you know the The whole thesis around RIMSIS, around our solution and our product in in the industry we serve is that MedTech is historically 10 to 15 years behind pharma from a digital transformation standpoint.
Digital Transformation and Innovative Solutions in MedTech
00:06:55
Speaker
Medtech has been undergoing this digital transformation initiative ah over the last several years. And since then, we've we've really taken off because, especially at the enterprise level standpoint, and the complexity around the workflows, the the understanding of how the interrelation between the data elements of not just you know regulatory information, but of how the products are associated ah to those registrations, to certificates, to really all of the entire regulatory product lifecycle really differentiates us ah because we we understand those those nuances better than anybody ah in the industry period. you know we've had We've had a lot of success because
00:07:45
Speaker
it feels like the the pharma industry is kind of waking up to medtech a bit and we've actually seen some pharma companies try to come into medtech and actually failed miserably ah because you know I would say with a hundred percent conviction that nobody wants a pharma rim with the medtech label stopped onto it period ah and what allows us to be successful in that is that we partner deeply with our enterprise customers ah to understand those nuances, and we're adaptable to those changing regulatory needs. we are are a We're a relatively young company, but we are broadly and vastly experienced in that Medtech space. um And so that's really been one of our competitive advantages is just understanding the space like nobody else does.
00:08:40
Speaker
um And you mentioned combination products and what's what's really unique about Medtech is that you know combination products at the end of the day are, if we're talking about you know a a drug-coded stent or some type of pre-filled syringe, those are a medical device.
00:09:01
Speaker
And based on the primary mode of action, some other items are typically more med tech forward ah devices. And so that creates an interesting opportunity for rim cysts because you know a drug's a drug at the end of the day. It might have different dosages. But the varying aspects of where that drug can be ah put into the system, or put into your system, I should say,
00:09:27
Speaker
um your body is is vast and a lot of those ah have or need a medical device to deliver that. And so the the variations and kind of complexity around that ah makes for RIMSYS to be at the forefront and leader of that combination product standpoint.
00:09:49
Speaker
And a lot of our customers have actually have adopted RIMSIS even more heavily because of that, not just on the med tech side, but on the accommodation side.
00:10:01
Speaker
and the other interesting ah item that we're seeing is that we are also, because MedTech is so vast and so ah complicated and complex from the workflows, um you know we're product-centric. And that has the adjacent categories as well, where you can go into veterinary, biocides, biologics, um consumer-side ah combination. Because at the end of the day, the framework and the structure is generally the same. However, the regulatory pathways might be different.
00:10:32
Speaker
um And so that that bodes well with our client base because a medical device manufacturer's product portfolio is is ever-changing, but also ah becoming more broad in nature as it expands and itself into its new markets.
00:10:50
Speaker
Yeah, thanks for that overview and I've been been taking some notes on that and I've seen kind of on the biopharmaceutical side some of the room providers, hey, we we should do med tech. And, you know, how I and maybe I'm looking at this naive is like in the biopharmaceutical, you know, generics.
00:11:08
Speaker
you you know It's more of a data paradigm where your your life is an engineering paradigm. And as opposed to like one to one with the health ministry or the health authority, you could have one to many in each country, right? Precisely. On your submission. So it's that extra kind of permutation, if you will, of complexity. And maybe another podcast maybe we'll do later on, too. I was just thinking about you brought up the stint. And earlier in my career, I think you know I was a Johnson and Johnson guy. And one day, you know one of the pharma scientists was, you know talking with one of the device scientists, and they came up with a stint that must be like 20 years ago, but maybe another conversation, just the emergence of ah software as a device, you know, that's that's a big, interesting topic.
00:11:51
Speaker
But that's venture on a little bit more. so And I know we talked about this kind of the the other day, you know about modernization of regulatory systems and processes. And they're such an intense focus. The big word this day is AI, right? But there's AI and automation. And sometimes people confuse you know the AI. The two. So there is a lot there. But like you know what's RIMSIS doing as far as helping your customers and maybe just in the very near term, so maybe tactical things we're doing you're doing either with AI or automation or the combination? And what does the longer term look like? Yeah, it's it's it's ah
AI's Role in MedTech Transformation
00:12:32
Speaker
it's a great question. And to your point,
00:12:35
Speaker
I think there's a couple items that I specifically want to address there because at the end of the day, you know, AI is this term that's being used from a marketing standpoint or just from a general industry standpoint in general, right? And it's this idea that these systems or software solutions can help do the work for you. It's not going to take anybody's job, um but there are ways that it can definitely help make you more efficient.
00:13:07
Speaker
you know what's What's particularly interesting in the MedTech digitalization transformation initiative that's going on right now is that MedTech industry in itself is 10 to 15 years behind the times period. And so, especially with these large enterprise level ah companies, so And so when you when when you're in a horse and buggy, which is what the med tech industry is today, and we're trying to get into ah a spacecraft, of course, I think the the logical ah and the initial item and in thinking is that, okay, we can just go straight to AI. and
00:13:47
Speaker
But really at the end of the day, AI is only as good as the data that it's trained on. And our phase one of the company has always been the information management period of MedTech and the organization in getting that right. We've invested so much time and money and collaboration with our partners of how product attributes, UDI attributes, attributes regulatory um ah attributes, and all of that plays well and interrelates with one another. Because if in the day, if you don't get that fundamental framework correct, ah you're going to have a hard time
00:14:28
Speaker
ah you You might do some really interesting things with AI, but you're going to have a hard time ah keeping that information organized in the manner that you will need to have it organized to do things later on. um And so what's really been interesting is that.
00:14:43
Speaker
ah We're about complete with our phase one of the company, meaning that um the information and organization and complex workflows ah have a majority of that has has been addressed, um meaning that we have now reached this pinnacle um where we're going to go into phase two of REMSYS.
Future Enhancements: Data and AI Focus
00:15:03
Speaker
Phase two has really been in all and is all about the intelligence. And so if you think about everything we've done in the phase one of the company where it's the information management, the data, we'll call it the the data layer. um Now we're entering the phase two where now we can overlay intelligence
00:15:24
Speaker
and market information directly over that data layer. So you can do some really fun and interesting and innovative things with that data. And so from an AI standpoint, um we actually have some things coming down the pipeline um at the end of this year, early next year. um That's really gonna help one with ah data ingestion in our system. you know we We have companies that have 300,000 products.
00:15:50
Speaker
in 249 countries globally. um And that's just one company, right? um And so there's some really interesting things we can do with data ingestion and data maintenance from that standpoint. ah But also, um there's some really interesting things we're going to do with ah market intelligence, ah notifications of you know regulatory um ah ah regulatory changes in the market, as well as um some things that are coming through with submissions as well. And and um we have a a really nice roadmap played out that ah in the next six to 12 months that it'll be really, it's gonna be really cool to see some of those those things come to fruition here.
00:16:36
Speaker
Yeah, there's there's a lot. I just took a lot of notes on that on this. And just just a few comments, I think, you know, for our listeners to just another layer of complexity between the the med tech and pharmaceutical is besides the things you've mentioned, I've mentioned, you know, you're dealing with a class one, two or three, you know, device. So like,
00:16:56
Speaker
the one client with, you know, all those products, it's almost kind of reminds me of the consumer side. And J and&J, it's like, Oh, you have Tylenol as a product, but you have so many variations than different names of it in so many different countries, that line explodes, just trying to manage the label, right?
00:17:14
Speaker
you know, on that. And I think the other thing on the, probably where you guys are more ahead on the MedTech side is there's this nirvana of embedded reg and tell, but yeah you know, where, you know, the reg and tell actually directs the workflow, you know, as opposed to the, the user based on whatever regulatory activity, you know, you're working on, if you're doing a renewal in Thailand, for example, it has the reg and tell and it knows what to do.
00:17:39
Speaker
So and yeah, in in the same thing to some people are scared of AI is going to replace, you know, my job, but I think, you know, more and more people realize it's it's a virtual assistant and or a writing assistant where the gen AI might do the first version one of a document, you know, the boring stuff, and then the expert medical writer would actually take it, you know, with their scientific knowledge.
00:18:02
Speaker
So yeah, and the last thing I wanted to comment too, because we just finished up our very large study. Now with AI, it's only as good as the data we've proved out and I don't know how much of an issue it is just like ah having the highest level level of data quality and regulatory.
00:18:17
Speaker
But you know a lot of folks on the biopharmaceutical side is like, well, you know should we enter it centrally, decentralize, harbor at that time, how the data is entered into data quality, where that is not linked. We proved it out as having those really good, and I think you alluded to this, these data quality practices, the data governance, the data have that in place, and that's a direct correlation.
00:18:42
Speaker
you know So we call those the data assets. you know and Then there's a shiny activity. If you have the right skills and the right right KPI, you put those four together and that's where the magic happens, right? Absolutely. We're sweat on.
00:18:55
Speaker
Yeah. So the the last question, and actually, you know from founder to founder, you know you had the sparkle in your eye when you thought about this and you actually pulled the trigger. So instead of you know kind of having the CEO voice, but from the founder's voice, what excites you most about RIMSIST in the coming years? um So where where are the companies going?
00:19:17
Speaker
Oh my God, it's such a loaded question because i just I feel like there's so much amazing things to do. i mean We're still at the the the beginning of this whole thing. and My mind has been going since 10 years ago when I first arrived this you know to 2017 when I first started putting a pen to paper. And you know having having all these ah tools and things that I wish I had when I was in industry would have been absolutely amazing, ah not just from ah my jobs perspective standpoint, but from the company's perspective standpoint, because
00:20:08
Speaker
The things that regulatory does has a direct impact on the revenue, as well as getting those products to market for the patients that need the most and maintain those products on the market for the patients that need the most. And so there's ah there's a high, high degree of ah you know in in in my opinion, great that um you have a vested interest to get those products and keep those products on the market as a regulatory person professional, honestly, just as a human being. And so the things that I'm excited for are, one, this new RIMSIS Intel that that we're going to be continuing to advance on here in the next six to nine months.
00:20:49
Speaker
ah And there's going to be some really, really exciting things come out of that. um I think there's some ah new adjacent um product regulatory lifecycle items that we can get into. So there's always the pre-market, on-market and post-market.
00:21:06
Speaker
um And we really haven't even touched post-market yet. We've really been concentrating on the on-market and pre-market aspects of things, and especially getting UDI right, because at the end of the day, that UDI and those UDI attributes ah are needed for a lot of the post-market activities that are, one, you know going to be a regulatory requirement or already a regulatory requirement, but then two, from a ah from a reporting standpoint, ah that you're going to need to maintain those products in the market. And so there's this continuum of of information management that we're going to be continuing to do and gather and in and address.
00:21:46
Speaker
And then and then the the layering on top of that RIMSYS Intel is absolutely going to be a game changer because nobody nobody really does rim like RIMSYS.
00:21:58
Speaker
um and ah you know you know we've We've had the luxury of building this from the ground up, specifically around dedicated to the MedTech industry. And those that has so many more advantages than ah trying to re reposition or retransform an existing system to MedTech because it just it doesn't it doesn't translate. And so I'm really excited for for for some of those aspects of the company.
00:22:26
Speaker
Yes, indeed, you know, a very exciting and and also just an amazing ah journey in just seven years. So and it seems like it's a very bright future, you know, for you so.
00:22:39
Speaker
So thanks again for your time, you know some very rich and insightful discussions.
Trend of Combination Products in MedTech
00:22:46
Speaker
um you know And it's great with our listeners, and some of them, or many of them, are biopharmaceutical, learning a little bit more about the MedTech side. But in the lens of why I thought this was so important, and we kind of touched on it, just the growing portfolio of combination products. It's just really merging.
00:23:05
Speaker
Our latest data had 60% of the other companies in with their product portfolios have combination products. So that's something that's growing. So certainly listeners, if you're on the biopharmaceutical side, you know maybe have combo products or a device division, definitely give RIMSES a look. So as we kind of you know close up,
00:23:27
Speaker
some of our listeners might want to get a hold of you. So what's the ah the best way ah to contact you? I don't know if it's through the website or LinkedIn or what what would you suggest?
RIMSES's Growth in the MedTech Industry
00:23:38
Speaker
Yeah, I would say definitely go to our website www.rimpsys.io.
00:23:46
Speaker
You can schedule a demo and you can actually just ah linkedin put a LinkedIn request to me directly. um I love Talking Shop. I love talking ah specifically around regulatory complexities and some of the issues that you're experiencing firsthand, because at the end of the day, those help continue to expand our system capabilities and serve the med tech market. One of the things that I'm really proud of with RIMSIS is we already have 40% of the top 10 medical device manufacturers globally, and we're expanding more.
00:24:24
Speaker
And this is a really exciting time for the industry, ah as well as as well as for RIMSYS as we enter into this new phase of of growth.
00:24:36
Speaker
oh Excellent. And, you know, indeed, and I think you you shared, you know, the other day, we'll need a like logo, another very impressive logo. Yes, ah that you're going to be starting to work with there. So before I say goodbye to the listeners, you know, we we do have we're both founders and comment in common, but I would be remiss.
00:24:55
Speaker
I hear maybe this is more for us listeners that you're based in Pittsburgh, Pennsylvania. I grew up in central Pennsylvania, so it's the black and gold. I know we talk about the Pittsburgh Steelers, the you know NFL football seasons about ready to kick off. So hopefully the black and gold the Pittsburgh Steelers are going to do well. I know we both thought another thing that we have in common.
00:25:17
Speaker
yeah oh Yeah. So with that said, with our listeners, if there's any questions you have for the GANS team, use our contact page off of our website or similarly just ah reach out. I'm on LinkedIn quite a bit. And please enjoy our other podcasts. We actually just reorganized our whole podcast web page to have a section for this executive series.
00:25:39
Speaker
our world-class room research and and then a third as we have different subject matter experts really talking in detail about some of the key issues that industry works on today. So again James thanks a lot for your time and maybe in another six or nine months we'll have you come back and see where yourself and RIMSIS are at. Sounds great. Thank you.