Transcript
Speaker: Welcome to the Regulatory Executive Podcast Series where we discuss innovation and digital transformation in the life sciences space. I'm your host, Steve Gens, founder and managing partner of Gens & Associates.
Speaker: ah Today, I am very excited to have James Danutis. founder and CEO of Rimsys as our guest. And James, this is the second go. We had you on around this time last year.
Speaker: So a warm welcome. A lot has changed. So in the last 12 months, it's really, really interesting times. But before we get into it, if you could just do a quick introduction of yourself and REMSIS, that would be great for our audience.
Speaker: Thanks, Steve, for having me on again. And yeah, absolutely. A lot has changed over the last 12 months. And for folks that don't No, myself or Remsis. My name is James Janutsis and I'm the founder and CEO of Remsis. And we are a regulatory information management platform.
Speaker: built by and for regulatory for the med tech industry. And we cover everything from. global registrations submissions standards essential principles UDI in one unified platform.
Speaker: And we are proud partners of six of the top 12 MedTech manufacturers globally. And over the last 12 months, we have been doing a lot of stuff behind the scenes that I am now excited to share with the world.
Speaker: That's great. And it is, in fact, a really interesting new era that we're in because A lot of the discussion about AI and automation, it was just early pilots, you know a little discovery. It's kind of like when any new wave comes in, there's that.
Speaker: initial learning experimentation. And now it's going a lot further than this, you know, some first implementations, you know, where do we take our first, second, third step? So we might as well just address the hot topic of AI and automation. I know there's been a lot going on behind the scenes in the last 12 months at Remsis. And as we go publish this podcast, I think you have some very exciting news too. so ah bring us up to date on the AI and automation. And then there's a lot of other stuff going on in ned techch
Speaker: you know that we'll talk about later on so uh Please, AI and automation, the big hot topic of the day, right? Yeah, absolutely. and You know, we've been we've been hard at work over the last...
Speaker: 12 months, even even longer. and developing a a brand new solution that is very unique to the market and not something that we've seen to date. And um I'm excited to announce that we are. introducing or have introduced Remsis Market Access. And so Remsis Market Access is a global market access platform for regulated products. And so it is.
Speaker: On the back end, it's powered by a regulatory corpus. And so what does that mean? That means that we have uh brought in and adjusted all the global laws, regulations, local jurisdictions of the local markets. in global markets such as fda eu health canada tga and brought that knowledge.
Speaker: Into. software. And so AI has accomplished something that's in any prior. point in history has never been able to accomplish before, but knowledge can now move out of people's heads and into software.
Speaker: And so. We looked hard at... a new way of looking at at the market. And we identified that. There is this. thing that medical device manufacturers and regulated product companies use a model from. And this is a market manager model.
Speaker: So a market manager model is typically you go hire somebody into a specific market Because they are. nuanced and specifically how the experience and knowledge of the local regulations of that market, how to get specific. products into that market itself.
Speaker: And so that is a very... low scale, high cost model. And when you look at a lot of the large medical device manufacturers. They have...
Speaker: dozens, if not hundreds. Of either. full -time employees or... Um, third -party distributors or local representatives. trying to figure out how to get their products in the market.
Speaker: And so for the very first time, We're turning that model on its head. and And we're introducing AI market agents. And so AI market agents are. trained on the local market regulatory corpus and have that specific knowledge Where now it is a high scale, lower cost with confidence to go into those markets.
Speaker: And one of the things that we found is that. regulatory is obviously is often nuanced right and meaning that there's a lot of tribal knowledge Typically, folks are dedicated to a specific product type.
Speaker: And working with a lot of the... you know, six of the top 12 MedTech manufacturers. A lot of these companies span hundreds of jurisdictions. and manage a diverse product portfolio.
Speaker: So it encompasses not only just medical device, but it also encompasses consumer products. combination products, IVD. veterinary, biocides, biologics, pharma, OTC, cosmetics.
Speaker: And so when we built these agents, it is not just specific to MedTech. It is actually product agnostic. Meaning that I can put in any single product into. Where's this market access?
Speaker: And instantly... The AI market agents know. Within each jurisdiction, what that market what that product is classified as. Yep. It is not just about classification. It's also...
Speaker: designating what that product is because if you look at Sunscreen for instance, right? you go into the us in the eu and health canada All three of those are different product designations, meaning that One's an OTC drug.
Speaker: One's under the cosmetic regulation and one's a natural health product. And so a lot of folks concentrate on, you know, what classification is or whatever. But our solution is really agnostic to that.
Speaker: Meaning that any product you put in there, it'll actually tell you the designation of that product. Is it and first and foremost a medical device? Or is it a consumer product? What regulations are associated with it?
Speaker: What adjacent? in Christ. domain regulations does it need to apply to So battery regulations, recycling regulations, RoHS. You name it.
Speaker: And so it's a multi -domain and multi - market matrix that we're really looking at to ensure that the product gets the right designation from day one, because without that, you can't really bring in any other design any other of the regulations. and so At the end of the day...
Speaker: you know, That is something we have looked really hard at. because all these top medtech native manufacturers just have such a diverse product portfolio that's There's just so many regulations and it's almost impossible for someone, a human.
Speaker: a single human to know all that information and so our ai market agents really Take that knowledge. digest that those laws and regulations and allow regulatory folks to actually do the strategic work they're allowed to do.
Speaker: and remove the mundane administrative activities that they've been prone to over the last decades. Yeah, and I would imagine this this has to be very, very significant for your client base because um it's interesting having this conversation because our summer, early fall pulse survey.
Speaker: is on regulatory intelligence. We do it every four years. And what was really interesting this round, and, you know, we tried to get between 35 and maybe 40, 45 companies. I think 42 is a record for our small pulse surveys. But it's well into the mid -50s, and people are saying, yeah, this is very timely.
Speaker: you know for a lot of the reasons that you have mentioned because The rag and tell has been such an unmet need, both on the biopharmaceutical side, you know, and in your world on the med tech.
Speaker: And kind of as I'm listening, taking notes to this big announcement, you know, I would characterize the workflow on this. It's just a series of start, stop, start, stop, start, stop, right? Because you're always, I have to talk to somebody in the local market. Are we sure that regulation is current?
Speaker: you know all that and people don't realize how many cycles that takes and one thing too in our survey because we we have different people from industry they participate in the survey of design both from biopharmaceutical medtech we had some consumer products in there but to them and there was about 30 people representing 20 organizations. Kind of the killer question, if you will, is how do we use AI for internal precedence? You know, so the whole precedence.
Speaker: And there's different techniques. So very excited for you guys, because like out of all the universe of software providers that fill this space, you know, you're probably now only the second one that has this capability. And it's a big game changer ah for regulatory professionals. So, you know, congratulations on that.
Speaker: The other thing that's striking too, and for our listeners that are more on the biopharmaceutical side, sometimes, you know, on the medtech side in your world, it in some ways, it's more complex because it's just not a one -to -one relationship with the health authority. So you have mentioned like the consumer products, the cosmetic act, it could be one -to -many. So you have a lot more. Complexity.
Speaker: when it comes to local regulatory intelligence and Kind of back in the day, and I'm sure most organizations, there's those spreadsheets, you know, that have all the kind of the local yeah regulatory intelligence and it's very, very manual. So I would imagine where you're going with your platform is.
Speaker: you know not only a series of automated workflows but that interface where you can talk about the guidance so maybe But your senior regulatory professional that might be in charge of like wave strategy, like given all this.
Speaker: you know What's the most effective way to roll this out in you know different markets? What's the sequencing? because we're seeing early days of simulation on that just like and i equate it to the example Where like ChatGPT and other things are getting so sophisticated, and like, hey, I want to go on a vacation for two or three weeks, right? I want to go to the six countries, you know, what are the hotels? And it comes back with a simulation for you.
Speaker: I think it's a fair analogy, but multiply it by complexity of 100. with what you're doing on the Reagan tell. So I don't know if you have any reaction to that, but it's very exciting news, James. Yeah, no, this is, in my opinion, ah the most complex.
Speaker: market industry, right? Because medical device encompasses So many nuances around it. and the Thing about what we're releasing is it compensates for that. And so if you look at the market today, right? So you have...
Speaker: Legal way I. where attorneys are using it for... their clients for case development, for legal writing, for... presenting issues and solutions to the client.
Speaker: And so the way that we've developed our solution. is really modeled directly after that. And so it's. cross jurisdiction, cross market. And it represents the specific regulatory outcomes that not only the regulatory needs, but the business needs on top of it.
Speaker: And. When we built this, it's really about... being context aware. And it's rag based on the back end. So that means that. It's really a vertical LLM.
Speaker: So it's not just a general chat GPT or Claude with some. you know documents uploaded to it The way that we built this is we have... literally taken and adjusted.
Speaker: Millions. of lines of information ah And when you have that conversation with Rimsys Market Access. It'll actually come back and cite the exact regulation.
Speaker: Exact content. and provide you with the level of evidence that you feel confidence. in the way that you are presented with that information so you can make the right decision. faster.
Speaker: And what we've heard in exactly to your point, Steve, is. One of the biggest things we've we've heard in market is is a global rollout plan. Right. And so typically. You have to go to these market managers. You have to.
Speaker: the business side, the product line manager has to figure out and go to regulatory, then regulatory has to go to each of these market managers to get the timeline, the resources, ah the regulatory requirements.
Speaker: and bring that back to the business. and what we Typically see is that that's a black box. Management doesn't have insight to the costs. The timelines, most of the information.
Speaker: they come back is. wrong. uh or or has a lot of nuances to it that gets lost in the translation of it. And.
Speaker: For the first time. Product line managers or product managers or commercial teams can actually use Remsis Market Access to get that information.
Speaker: within minutes rather than months quarters or years sometimes depending on the global rollout of their products They can get all of the information, a global launch strategy, the regulatory pathways,
Speaker: The budget analysis. the project plan the competitive landscape. All literally. within minutes at their fingertips. And this is a game changer because...
Speaker: That information lives in those AI market agents. And it's validated. to the point where you have the exact citation and context directly at your fingertips. And so it's been something that has been really unveiling. talking to six of the top 12 medtech manufacturers. And in fact, we even had pilots going on where Zeiss, Philips.
Speaker: Smith and Nephew, Gettinga, Boston Scientific, have all had a ah crack at that and showed us and we understand deeply what those specific workflows are. And that's just allowed us to make this solution even better.
Speaker: And so with that. parallel aspect of you know ai agents being used in the legal world with harvey and logora For attorneys. If it's good enough for it for them.
Speaker: we have modeled that same from a regulatory standpoint where at a product level and in the market level. you can get the same confidence and reliance that those companies have now. provided but we're drawing that parallel that this is a product -centric, regulated product platform.
Speaker: Yeah, again, congratulations on that. And the other thing as I'm listening to this, because we've always seen AI as like an assistant. So you have like a research assistant.
Speaker: an assistant to the the lead regulatory strategist. You have a workflow manager a kind of assistant all wrapped up you know in one. and too often we always focus on bringing new products to market the extensions and those things are so critically important but
Speaker: Now, a lot of the day -to -day work is lifecycle management, you know, of those registered products. So I would imagine this also, when you talk about just in these large organizations, like how many regulatory impact assessments do they do a year? It's probably hundreds or thousands. So I would imagine like on the from the lifecycle management.
Speaker: but Your AI market agent is like, wow, you know, there was a change in Thailand and it then it has a preliminary regulatory impact assessment summarized that the regulatory professional can take a look at.
Speaker: you know and decide how accurate it is, what is the impact, and whatever change, the whole change control process, get that going. So I would imagine from a lifecycle standpoint, it's it's just as impactful. now I would imagine. You nailed it.
Speaker: uh yeah yeah um and that's really the benefit of you know we we've over the last several years we built The world leading. regulatory information management platform. for MedTech, period.
Speaker: And all that information is now. contextualized in Rimsys, right? And so when you talk about impact assessments, we can already do impact assessments, but then you layer on top these.
Speaker: AI market agents that have the specific. knowledge for each of the jurisdictions and markets. You can now do AI impact assessments where. Essentially, it looks at the guidances, brings back the specific citations. looks at your products, look at what the impact assessment is. Is it design change, labeling change, manufacturing change?
Speaker: and not only it provides a Significant or non -significant. recommendation provides justification for that. and even completes a custom survey for you based on your own internal process.
Speaker: That is game changing. So if you think about. some of these large manufacturers they have two thousand to 5 ,000 impact assessments they do yearly That's a big, big deal. And so when we.
Speaker: Do our impact assessments. You can do that. for an entire product many products across 150 jurisdictions in minutes providing that recommendation and always having that human in a loop too review that.
Speaker: Because at the other day, it's still... that responsibility of that stakeholder to ensure that the information that is representative based on the information that was provided.
Speaker: Yeah, so that that that's actually a nice lead on to another area. And again, this is game changing an era, just like when. the personal computer came out we couldn't imagine and you know like what it would mean 10 years later, and the same with the internet, cloud computing, and all that.
Speaker: So it's really interesting. And I think what strikes me is as this gets rolling and fully embraced. Instead of ah a small change in the ways of working, it's a significant change because there' there's the trust factor, as you said. But if it's hey, if it's good for the lawyers of the world, but do you need that confidence factor to build up, you know, kind of over time and it will. Right.
Speaker: So I'm interested for REMSIS, because in some ways, will it start changing the nature of the relationship from a... traditional software provider because it's it's more than that. but You have content you're providing you know guidance you're actually providing some labor through these kind of market agents and all that So what's what's the impact more on on your side for Rimsys, you know, from a tech?
Speaker: an organizational process standpoint. And I think it's fair to say, if you want to blend in, what you would imagine for your clients. So it's kind of a forward -looking question because this this is very, very significant. so So what, as the founder and CEO of RIMSYS,
Speaker: Will this change your organization, kind of how it serves industry? and and what to what extent do you think industry is going to be changing. Great question. and lost It's a loaded question. and ah I'll give you... Two sides of the fence here. Um, So first and foremost. From our side, we know that this is going to change your relationship with. our customers in a positive way uh in a very accretive and sometimes even a stepwise change.
Speaker: what we're hearing from And what we've seen in the market as there is now CEO top -down directives to implement AI. within organizations.
Speaker: And... folks are planning 18 months to 24 months Uh, strategic plans to get AI embedded and change the way. that the organization runs today, period.
Speaker: We have continued to hear that. The organization needs to become more efficient. more effective. without increasing head count. And so the only way to do that. is to have something that is It delivers. something that is representative of the way they work today.
Speaker: does it in a much more effective way and is a workforce multiplier for the folks that they have today. And what we have seen even in our organization.
Speaker: So we have spent not only the last 12 months getting this ready for the market but we have been fundamentally changing the way that rimsis works We have created. our entire engineering team and developed it entire our entire engineering team And now.
Speaker: 70 % of the code that we write is AI generated. We have significant amounts of... Obviously our engineers use that. ai code and obviously vectat and still have a human in the loop But AI is... largely solved a lot of the coding problems that traditional software development used to have.
Speaker: And so we have fundamentally changed the way that we work. So we can deliver. the most confident, reliable, And. First to market. and quick to market solution for our organization because we know how fast these are coming down the pipeline.
Speaker: and ensuring that we have the proper guardrails in place to align with their vision. and to ensure that we keep up with them. And so it wasn't just a market thing was actually. a a large internal changing of the way that we were. to meet this demand.
Speaker: Yeah, and I would imagine, too, there's such a big conversation about rethinking. Maybe it's not rethinking. Maybe it's reframing. is the proper word about validation in this environment that we live in. And it's it's very, very different.
Speaker: It's just like, you know, i get more of a quote from the biopharmaceutical side when CFR Part 11 came out with electronic records. So this is back, you know, when, hey, we're going to go from paper submissions. yeah to digital submissions and you know that took like three or four years just to kind of figure out policies there's been things from here in the states with the fda with some warning letters about AI -generated content more on the biopharmaceutical side.
Speaker: Because there's such a strong relationship between the software provider and the sponsor as far as validation of, when we say traditional systems, but this is very, very different now. So any quick comments on the whole validation conversation that's going on out there?
Speaker: Yeah. I have some really deep thoughts on that because what we've seen in the market so far is that a lot of software companies say they have AI. But there was this black box in it that the customer doesn't know what the heck it's doing.
Speaker: It's just producing. Some result. That you hope is correct, right? you You hope is right. And you can rely on that information to make good strategic decisions on or tactical decisions for that matter.
Speaker: And so. I think validation is more than just... inactivity to show that Peace. The inputs are... are you know matching the outputs or expected outputs there's a whole trust factor on this And. It's opening up that black box.
Speaker: So the consumer. or the organizations actually know what you are doing. behind the scenes. And so. As part of our release, we're actually opening up the gates.
Speaker: to in opening up the curtain to take a look behind the scenes of what we're doing. We were making that public. to all organizations that use rimsis A lot of companies say they have a proprietary set of data.
Speaker: They use AI in the backend to present information to your user. We're actually going to. present our architecture. We're going to present the sources of information we use.
Speaker: and have that trust factor from day one in front of the organization. So not only does that provide a level of trust, it shows.
Speaker: it opens up that black box of how we're using it. to get them the right information so they can feel confident. And then you can validate the information. Based on. how we have collected it because i give it a day If you don't know how ai's being generat or generating the information for you.
Speaker: I think it is almost impossible to validate that information. um You need to have a peek behind the scenes of how it's actually working. to ensure that...
Speaker: The edge cases of validation are one verify, but then validated for that specific use. That's a really smart path that you're going on, because if you just take the core principle and it goes with anything in life is.
Speaker: transparency builds trust. Right. so you're open Like you said, it's you're opening up the curtain. There's no Wizard of Oz curtain there. transparency builds you know trust. And it also makes me wonder and think, because we've had some very recent client engagements.
Speaker: You know, where we've come in about, like, where is everything going in the next three or four years? There's changes in system and information architecture, and too often the focus is on the system architecture, but it's significant changes, like you've described already, on the information management.
Speaker: architecture and it really kind of occurred to us a couple of weeks ago is we're entering the fourth generation of systems so you have your like Basic systems way back when, when I started my career, from Johnson & Johnson. Then there was the client -server kind of time, cloud -based.
Speaker: And now we're not sure how to frame it or communicate it yet, but that we're definitely going into a fourth generation, not only from an architecture, but from a policy practices like you've just described.
Speaker: that it's very, very different. you know And as an industry, hey, we're a bunch of smart people and life sciences, we'll figure it out. So um although all the attention or most of the attention is on AI and automation, is there any other update outside of that with other things going on in MedTech that you'd like to share with our audience? Sheesh.
Speaker: Yeah, I think from just a general med tech standpoint, the things that we're seeing is. There's a lot of drive around submissions building. and around. regulatory reliance programs.
Speaker: And we have seen firsthand that. you know Submissions are becoming this. critical infrastructure still helping empower the current regulatory team.
Speaker: to be faster more confidence. and meet the specific regulatory requirements of the local authority. And so, you know, FDA is using AI.
Speaker: How can the manufacturer? use AI to in ensure. That's. The authorities AI. He does catch something that he didn't think was that one.
Speaker: And so we have really seen that. uptick in the last six months And one of the things that we've actually been working on is. How do you create a first time submission or a first time rate submission?
Speaker: Using AI as... Gap analysis. Checklists. writing contents. ensuring that the right Documents are linked to your submission.
Speaker: And that's. a part of the infrastructure that we've been building. so RIM in general has been... this previously described as you know a system of record, which it is. Yeah.
Speaker: But now we're seeing it transform into a system of execution. where all that information now lives and breathes in a rim, but you then encapsulate that with the context of AI. We can now generate all this information.
Speaker: that you previously couldn't. Because you have all those. AI market managers, you have all that AI embedded AI directly within the submission itself, directly within AI impact assessments.
Speaker: You have a REMSIS advisor directly within when you bring a product into a specific market. And that has just been. tremendous in seeing how the market has been shifting and adopting AI because I think over the last six months.
Speaker: it has shifted quite significantly. that yeah AI is now fundamentally a part of the organization and how it. transpires into that organization on a day -to -day basis is where these plans and activities are leading us over the next 18 months.
Speaker: Yeah, and the yeah analogy, and this is a dinosaur analogy, that back when it was paper submissions, so when I was in J and &J and Janssen, when I got rotated over to the Research Foundation, it was the first generation of electronic submissions. and There are three tractor trailers that they're, you know, taking different routes and putting those submissions in and, you know, getting heading down to.
Speaker: Washington, and then from an organizational standpoint, the shift was kind of regional hubs. We're digitizing everything. We have different skills that we need. so the whole workforce development. fundamentally shifted like in regulatory and also on the technology side of that.
Speaker: So, you know, and certainly this is the case here. I think the biggest takeaway I'm getting from this conversation is we have like the research assistant, the writing assistant for medical writers, people, you know, with all the kind of auto generation that's going on. But really what you've described as a subject matter expert assistant.
Speaker: Because the goals aren't different from a business standpoint. How can we reduce complexity? How can we increase speed and velocity in the organization, which is going to get us the the relationship with efficiency and productivity and assuming that it's effective, you know, right? So and hopefully I'm getting it right, James, that what you've developed is a regulatory affair subject matter expert system, too. So pretty cool.
Speaker: Yeah, we we we call it the... AI regulatory workforce at the end of the day. yeah and You exactly hit the... The nail in the head where it's like. You have.
Speaker: Folks are typically focused on one specific task, such as. Um, you know what's the classification of my device Right. You can't get that.
Speaker: Unless you have built. A solid. AI Foundation. in a solid regulatory corpus on top of that because There's so many nuances around that.
Speaker: And that AI workforce that you have. that we have built over the last 12 months becomes that workforce multiplier for you for your team. And it becomes that strategic partner.
Speaker: That. No longer you just have to be a dedicated person to the FDA. Now it's about. Well... If I have... this AI regulatory workforce working for me. Now I can be a strategic partner.
Speaker: For notches. the fda or us Now I can expand my knowledge as a regulatory person to. The U .S. the EU and Canada. So it's an opportunity for.
Speaker: In my belief, for regulatory folks to be cross -trained on different markets because you don't have to have, there's no there's no boundary or limitation to what's in your mind now.
Speaker: you have that regulatory corpus at your fingertips in those AI market agents. working on your behalf. Yeah, you know, and I really like the term you're using, the workforce multiplier. That's a really positive way because we track it in our surveys. People are concerned about, you know, losing jobs, things being or being automated out of the job. And then I forget. which famous person said, hopefully I'm getting this right.
Speaker: You're not going to lose your job because of AI. You're going to lose your job if you don't have those AI skills. Because to your point, it's a multiplier, like a dossier manager. Let's make up some numbers. Hey, I'm used to managing 20 submissions a year. Now I can you know manage 40 or 60 on that because I have these different assistants. But I really like your point. And I don't think people think about this enough.
Speaker: That like AI as a trainer, because I'm thinking just to your example, hey, I'm an expert on the FDA, but boy, at my fingertips. I can learn what are the most critical regulations and how you maneuver it in Asia PAC, you know? It's that kind of, you know, we get back to knowledge management, right?
Speaker: So it is the accelerator of knowledge management, which is really exciting. So, um yeah, my last question for you, boy, the time flies and all that. And as a founder, this has been your baby. And, you know, you have a flourishing organization that must be a lot of pride.
Speaker: And I think you've been you were incorporated, what, 10 years ago, was it, James? A little bit longer? It was just about, yeah. Yeah. So that's really, you know, it's a very, very impressive story. So like, as you look back, what are you most proud of? And looking in the future, what are you most excited about? And certainly this, you know, market agent, I'm sure is one thing. But what do you have as a founder? You you sit in a unique seat.
Speaker: Yeah, it's ah it's a hard job. so so fortunately or unfortunately we chose not only to build a very very large and global company But. To tackle.
Speaker: the med tech industry. and to tackle enterprise. And when you combine all those two together. It is a very difficult thing to do. And what I'm most proud of is. Partnering with our customers because I know.
Speaker: that we could not have done it without them. They have sat. And. We have talked for. hours and days and weeks about their issues and about the problems we're solving for them.
Speaker: and about Look. first and foremost, getting their regulatory ducks in a row. from an information manager standpoint. Data comes first. And the folks that have.
Speaker: and continue to to leverage. information management platforms are going to really reap the benefit. of AI moving forward. And what we have seen and the level of conviction. that we have seen in a level of adoption we have seen at the enterprise standpoint just signifies.
Speaker: How? close we have stayed to our cost and sought the journey And I think it's. easy to get away from that. As you grow. But I myself were still continue to be involved in these conversations because.
Speaker: I love regulatory. Like I literally dream of it. It's it's the most. bizarre thing. by For some reason, my mind... has developed a way to look at regulations and apply those to the business that other folks just haven't been able to see or have been able to see. And I've been able to partner with those folks to really deliver the most. value for the organization.
Speaker: And so providing that to our customers has been. remarkable and the conviction and dedication of the team. of my team has been uh incredible because They are now.
Speaker: pseudo regulatory folks, even our engineers are pseudo regulatory folks because of the way that they need to think about the workflows and development and how the user is going to think about certain things are doing it. and You know, I'll be the first to say we don't get it right every single time or the first time.
Speaker: Yeah. Nothing's perfect. Nothing's perfect. But it's it's about getting something into the market. and Getting that feedback quickly so we can. keep delivering, keep iterating and providing that value to the customers. and So that's that's what I've been most proud of.
Speaker: and And as far as the future, what are you most excited about? it We're in a new era here, and I know there's a lot of excitement around you know the market agent, but any anything else you're really excited about looking forward? Yeah, for for me.
Speaker: Yes, the market agent is there, but what this enables is it's not just enterprises that are going to be able to use this. So what we found with talking to a lot of different size companies is that.
Speaker: Rimsys Market Axis is really about... from first production introduction or first product introduction to worldwide market access. That applies to...
Speaker: A mom and pop shop? That applies to a small organization, a midsize organization, a large and enterprise because everybody has the same. issues. How do I scale?
Speaker: a regulated product No matter what it is, if it's a medical device, a consumer. Cosmetic I don't have the specific knowledge To get that. product into different markets.
Speaker: because one is costly. To do it today. with ah with the market manager model. And. Ripsys market access now allows. all sizes of organization.
Speaker: to have that knowledge at your fingertips. And if you have that, that is powerful. I always look at the sun balm example. If you're familiar with sun balm, it's the sunscreen. Okay. um and They grew that business. Very, very large in the U .S.
Speaker: And for folks that don't know Sunbomb, it's the one with the the yellow gorilla on it. um It's sunscreen. You go to any like Target or Walmart or anything else they have in. The only reason they sold That company.
Speaker: is because they didn't have the expertise. The knowledge. or the resources to go into a different market. because of all the regulations associated with it. Now if you think of the value.
Speaker: That was left on the table from that product. And I'm spelling it early? Significant. Boy, is that significant. And now we have an opportunity. where that knowledge. in that time, in that expertise is now at your fingertips.
Speaker: It can help launch your product, not in just one market. but globally. And that is something I'm i'm doing proud of. Well, excellent. You know, I love the conversation. And I think for our listeners, just quick recap on the last five minutes. And it's it's such a basic thing. and Sometimes people in small companies like ours, bigger companies, even if you're inside industry. um
Speaker: You never lose sight of your customer. If your customer is sponsored to a provider, your customer's inside in another department and all that. It's just that age old customer intimacy is critical. You know, um I've said because I was nodding when you were going through the question about your history is any critical decision here against an associates or major survey design. We just listen.
Speaker: and work with our clients and customers and you never go wrong. So it's just that basic, basic truth. So always a pleasure to chat, James. And if people out there want to get a hold of you, what's the ah the best way?
Speaker: Yeah, you can get a hold of me on LinkedIn. I love talking shop. So always feel free to connect with me or you can visit our website. and we have a contact form there that you can go and submit and we'll be in touch
Speaker: But really appreciate the opportunity, Steve. And you should be proud of yourself of of what you've accomplished. Every time I'm in the market and talking to customers. always hear about. the gens report and that really the the source of truth uh about the type of research and analysis you guys do on a quarterly, yearly basis. in Great work.
Speaker: Yeah, and appreciate that. We love doing the work. you know We love coming in and doing a good job and just kind of sharing sharing our knowledge. And I finally got the mission right. and We switched the mission about seven or eight years into it. I can't believe we're in year 22 here, James.
Speaker: But everybody gets better. It doesn't matter if it's you know industry, service providers, software providers, health authorities, and that's how we you know gear the research engine. So for our listeners to ditto with what James said, get a hold of us on LinkedIn. We're very active on it. Or also we have that contact form on our website too.
Speaker: So, James, always a pleasure. Best of luck, you know, significant announcement on the market, market AI. It's really brilliant. And like I said, my key takeaway is you've developed a regulatory subject matter expert with assistant. so Job well done to you and your team. It's always about the team, right? So well congratulations again. And thank you very much.
Speaker: Thanks, Steve.
