Regulatory landscape is growing increasingly complex with new European Union Medical Device Regulations and In Vitro Diagnostic Regulations. In fact, research from MedTech Europe predicts that as many as 76% of products will be withdrawn from the market as a result and the complexity isn’t limited to just our friends in Europe. The US, Australia, Canada, China, and many more countries are adapting their regulatory approach. The only thing that doesn’t change is change itself - applies both in life and regulatory.
Today we’re going deeper into how to modernize regulatory affairs, specifically for medtech. James Gianoutsos is the Founder & President of RimSys - a regulatory information management platform that centralizes regulatory activities in the cloud. From product documentation to streamlined submissions to monitoring market status, RimSys can save RA teams hours and hours. Any life sciences founder listening in can learn from James's experience jumping into entrepreneurship from his career in Quality/Regulatory and how to get to market faster utilizing digital technologies.
About James Giantoutsos
James Gianoutsos is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James’ professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants. James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.
Rimsys was founded in 2017 by regulatory affairs professionals who asked the simple question: “Isn’t there a better way to do this?” Like all RA teams, they spent hours looking for information, manually managed global product registrations, and struggled to keep up with changing regulations and standards. The Rimsys Platform is designed specifically to help medtech companies address these challenges, and confidently establish global regulatory compliance.
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Hey everyone. Thanks for joining the show today. I'm Kelly from Qualio and I'm your host here From Lab to Launch. We hope you enjoy the conversations on the show as much as we do. We'd love a quick review of the show on Apple or Spotify takes just a minute and helps get the message out. And if you want to be on the show, fill out the application linked in the show notes. We've had a lot of people reach out and it's been a pleasure connecting with you all. The regulatory landscape is growing increasingly complex. We've got new European union medical device regulations in vitro diagnostic regulations in play. In fact research from MedTech Europe predicts that as many as 70%- 76% of products will be withdrawn from the market as a result. And the complexity isn't limited to just our friends in Europe, the U S Australia, Canada, China, and many more countries are adapting their regulatory approach. The only thing that doesn't change is change itself, true of life and regulatory. Today, we're going deeper into how to monetize regulatory affairs specifically for MedTech. James Gianoutsos is the founder and president of RimSys, a regulatory information management platform that centralizes regulatory activities in the cloud. From product documentation to streamline submissions, to monitoring market status rim, SIS can save regulatory affairs teams, hours and hours. Any life scientist, founder listening in can learn from James's experience, jumping into entrepreneurship from his career and quality and regulatory, and how to get to market faster utilizing digital technologies. We'll get more about James' story and Rimsys rights now. Let's bring him in. Hi James. Welcome to the show. To get us started. Tell us a little bit about how rooms started and what you do today.James Gianoutsos:
Well, it really started with, with myself and spanned a MedTech regulatory and quality career of about 16 years. So I started my career really with Phillips health care large multinational MiTek corporation, and then went on to many small, medium sized medical device companies throughout the. Area. And so I've really had the full gamut of risk device classifications under my belt all the way from Susie pacifiers all the way to to internal surgical sealants and adhesives. And so which are class three, by the way. And so really the full gamut in terms of electromechanical devices to implantables to even bone, plenty that's made from plasma. So it was a combination product that was here in the U S a medical device, but in the EU, it was a combination product. And so, throughout that career, there was really a lot of unknown around where products were registered globally for each of those companies. And when I say unknown, it was I mean that literally because a lot of these companies manage their regulatory products on a color-coded Excel spreadsheet with you know, all the skews down to down down one column and then all the countries across the columns. Right. And everything in between for expert, expert dates and making sure that they have proper linkages to tech files and things of that nature. Right. And it really came to light when we acquired products from Phillips and about 50% of those products were wrong of where they were marketed globally. And so from a due diligence standpoint, it seemed like that was an overlooked type of due diligence factor. Whenever we were bringing up that business partnership and from there, it was really, I was really looking for a solution that exists. In in the marketplace. And really there wasn't a solution that, that exists is specific for med tech. And so a lot of the pharmaceutical, the pharmaceutical industry, a lot of the pharmaceutical companies have had their day with rim. And now it's really, the spotlight is on med tech to help manage from a regulatory compliance standpoint and market standpoint all of their products globally. And that's where room.Kelly Stanton:
Nice. Nice. Yeah, I can I can remember trying to keep track on those spreadsheets myself as a quality engineer, trying to approve changes, and then you find the spreadsheet. Is it the right version? Oh my gosh. Wow. Alright, well, so, tell us a little bit about your observations so far in industry with the EU MDR and IVD our update. Yeah, I think it's a whole new level of complexity, right?James Gianoutsos:
It is. It is. It's, it's, it's a complete nightmare scenario for, for industry it's it's and what I mean by that is certainly there's a lot of benefit from a, from a regulatory requirements standpoint, patient safety you know, risk mitigation standpoint that these regulations have in order to enter into the EU from from regulation standpoint, but what we're seeing from an industry standpoint is there's so a lot of confusion around how to interpret these regulations what is actually out of compliance or noncompliance issue. And it seems that industry, and, you know, notified bodies and the regulators themselves are learning along the way. And we're kind of leaning on each other to say, Hey, does this sound right? Is this the way that we properly interpret this? And. It's an interesting scenario because we're all in the same ship, sailing in the same direction. But we all have different opinions of how these are supposed to be interpreted. And so really, I think the day, you know, these regulations are for, from the EU perspective are really the benchmark and the baseline of getting into other countries as well. And so what we're finding is that as these regulations come into play. All of the medical device manufacturers you know, medical device software in vitro diagnostic are lagging behind where they should actually be in complying with these regulations. And a big part of that is, you know, making sure all the technical fouls are updated to the latest MDR and IVD are based on the MDD or the. Making sure that from an MD SAP standpoint you have proper even though the, you is not part technique, not part of the MTSS program you still have to comply globally with those. Right. And there's just a lot of nuances with UDI and some of the. Items that are coming down. The pipeline here shortly, that industry is still preparing for and quite literally regulators in the EU are still changing and in trying to find the right path forward. So it's, it's an, it's an interesting time for everybody, I think in the industry and we're all trying to do the best we can, but it's certainly a challenge. When things are changing on the fly.Kelly Stanton:
Lately. I know. And, and you know, I think personal experience, we were helping a customer get ready to do their tech. Under MDR, assuming everything was going to go into effect. And then they delayed it going into effect, but they still needed to get to market. So we had to rework everything to get them under MDD. And we slid in under that extended deadline. But now that I have to go back and do it all over again, up to MDR. Are we sure they're going to implement or not the moving target there certainly doesn't facilitate any sort of ease of implementation. Well, let's talk a little bit more on the rim SIS side. Nice job securing fundraising with your series a recently. What advice would you have for other founders on fundraising from your experience? Sure.James Gianoutsos:
Yeah, the fundraising aspect of things was definitely a skillset that I don't think anybody is prepared for whenever they go into fundraising. It is something that you get a lot of black eyes. You get a lot of you take a lot of swings and you miss a lot. And you're kind of hoping to Atlanta, Atlanta a couple here and there. Right. And so from a fundraising standpoint, it's certainly interesting because we really went out earlier in the, earlier in the fundraising series you know, seed series where we went out to 75 different investors and, you know, there's a lot of people that say no. And there's various reasons for saying no. And what we primary. Understood was that these investors just didn't understand med tech. And it was, it was interesting because a lot of the VCs investors do not understand the industry. Even though they claim that they do, they understand it from, you know, investing in medical devices themselves. From that standpoint and potential market benefit and patient benefit from that matter. But as an industry, as a whole, it's kind of a, a gray area. It's hard to get some data, some real concrete data on it. And from that matter, it's, it's hard to have that compelling outlook from the type of solution that we're, or problem we're trying to solve with with SIS. And so. As we went out and, you know, got our seed round, we then limited our search quite significantly of who would we really want to partner with as an investor, as a, as a partner to help us leverage you know, their network and help understand how they can help us really. Gain traction in the market and based on their knowledge and maybe some of their existing exist, their existing company portfolios, that that might be a benefit to with us. And so really it came down to, to Bessemer as, as being the fundamental strategic partner that we were looking for from day one and everything just aligned from that point forward, it was something that we. We specifically sought them out. They kind of sought us out a little bit and it was it was certainly a, a marriage meant to be, which is fantastic. And in terms of just some of the things that. No lessons learned. I would say that you know, I would very much looking back on, on, on things. I would very much kind of take the time, the box in who I, one is a strategic partner, rather than just kind of a spray you know, it was kind of spraying everywhere, just kind of seeing who's gonna, who's gonna you know, take, take the bait if you will. Really understanding the VC culture and knowing that there's there's, they have a very specific box that they invest in. And if you don't match that specific criteria they're not going to invest no matter how hard you try. It's they have certain thesises and, and information that they, they need to take back to their board to their, to their committee and make sure. Fits their portfolio and their strategic vision. And many of the times they'll take these meetings because they want to learn about the industry. And maybe it's a better fit for them at a later stage, which is always you know, an opportunity down the road. But certainly if you're looking for very specific type of investors, I would say definitely take the time to do that research.Kelly Stanton:
Lately. Yeah, I think, you know, it's, it's interesting. There's some big parallels here to our story. I think the general public, they don't understand what it takes to get a product to market. You know, they just see, you know, it's, you know, this much money or this many people in the clinical trial, blah, blah, blah. I think, I think some of those high level bullet points are very visible and quantifiable, but the underlying things like. Regulatory affairs, like quality systems management, right? It's very parallel to our story. I think they aren't direct measures right there. We don't make the product. We make the product you make better. Right. That old VASF comer full that's one of my favorite ways to characterize what quality assurances. And we all certainly know when it. Right. I would say the same thing is true of regulatory affairs. One of the biggest challenges I saw in my time in consulting to the startup space was poor regulatory strategy, you know? Oh yeah. We'll just, you know, they make this series of assumptions that the regulators are going to be okay with X, Y, and Z. And now we don't need to worry about that right now. They throw their application at the wall. They have investment money tied to milestones, and then everything gets shut down because the agency's like, wait a minute, we didn't do this. Or you said, you said this, but you didn't characterize the interface or whatever. Right. So it sounds like your platform kind of. Maybe better inform those regulatory strategiesJames Gianoutsos:
for sure. And I, I would echo that, you know, what you said is, is poor regulatory strategy is, is the deal-breaker in a lot of things, right. Without it. I think there's a lot of assumptions that are made because quite candidly. I think from a regulatory standpoint, you just don't know half the time because the regulations are so disparate. Each market has its own flavor of regulations and how to apply them and how to interpret them. And that's, that's the real challenge right now with regulatory affairs is, you know, it's, it's, it's always been a critical department and business process for specifically for a medical device manufacturer. But what we're seeing with all these regulation changes, especially with the EU MDR and IVs. Is that regulatory affairs now has a seat at the table. It is front and center that you can not any more ignore regulatory affairs. It has to be a strategic and systemic process throughout the medical device manufacturers, you know, mission and, and getting products to market and keeping those products on market. Without. Those products are coming off the market guaranteed you know, with EMDR and IVR, right? I mean, if a medical device manufacturer has a hundred thousand skews, they're literally going in and drawing a line through that a hundred thousand skews and saying, you know, we're getting rid of these 50,000 because we can no longer support it. And it's not just a, you know, it doesn't make sense from a, from a revenue investment standpoint anymore. And we're keeping these ones, right? So we talk about all these products coming off. Because of that. The other issue is that, you know, these registrations globally expire, or there might be a renewal period. And if you do not renew at the right time before it expires, your markets are coming off or your products are coming off the market period. You know, we have, we have one customer that's they were using a color code, Excel spreadsheet, and they had an intern managing it. Unfortunately that intern. I didn't see the expiry date on one of those registrations. And that company was out $4 million in revenue just from that one registration expiring. And so the ramifications from a revenue impact standpoint from a company is huge. But then also, you know, from a patient standpoint, those products are no longer available on the market. And it's certainly a very challenging time because of all the. More administrative regulatory activities that are coming into play. It makes it challenging for, for the patients as well as for the medical device companies that, you know, make a rural business case to keep products on.Kelly Stanton:
Natalie. Yeah. And that's, I don't think people in, well, the funding considerations that the cashflow, all of those kinds of things, you know, these little mom and pop shops that have one or two products. I mean, that's, that's the end of your organization, if you suddenly are missing $4 million in revenue.James Gianoutsos:
Well, what benefits are you seeing with companies that take a more modern approach to these types of activities and monitoring?James Gianoutsos:
Yeah. So that's, it's what we're seeing is astronomical. It's, it's been such a great ride so far, and really it's been a great ride for regulatory affairs because we have now a dedicated you know, vertically built SAS solution. That's servicing specifically regulatory affairs for med tech, and it doesn't sound really. Beautiful and compelling. But when you, when you think about the underlying processes that were, that were making more efficient and consolidating from a, from a cost reduction standpoint, from an efficiency standpoint of a medical device manufacturer, the implications are huge. And when I say that, You know, we are bringing in documentation records from quality management systems, right? So we are actually integrating with eco EMS providers, such as, you know, Kaleo or others to help manage the technical files and regulatory documentation that needs to be submitted to different regulatory agencies in different markets. And so our system, actually, it also integrates with PLM systems where we bring in the regulated products at the finished good level. Right. We bring into EAMS documentation and then we met. All those products say a hundred thousand products or 10,000 or even 10 products into each and every single specific market and manage all of those expiry dates types of registered registrations versions of registrations amendments things of that nature that really was handled by you know, Google drive or one drive or outlook reminders and things of that nature. And then we also. Back into the other systems, such as the RPS for sales flags, for commercial distribution, for sales ordering processes, that if a product is not registered in the market, they can't sell it, period, because of the way that we have our integration. And so it's a really nice consolidated solution that provides huge benefits huge efficiencies, just in terms of visibility and maintenance and management of, of these regulatory, technical files and documentation and information moving forward.Kelly Stanton:
Wow. That's I was just thinking about the, the you know, the flag back to the ERP because. That color-coded spreadsheet that lives in, you know, SharePoint, right. That the guys in the warehouse they're shipping the product, don't check that spreadsheet. How do they write? Like, you know, so, yeah. Wow. This is, this is amazing. I love it. Well, so you've been in the med tech tech space for a while. What changes do you foresee in the coming years?James Gianoutsos:
A lot more. A lot more digitalization for sure. I think is. You solves, Qualia's seeing that quite significantly, right? Yep. It's, it's just, it's always been a lagger in technology. For some reason, it feels like we're always like 10 years behind everybody else. From an industry standpoint and we're always playing catch up. And I think a big part of that obviously is the quality side of things, right? Risk mitigation, and things of that nature. There's just a reluctance reluctance to change. What's what's working. That's not always the best for business or for patients. And the fact that these regulations are now changing and you know, really the workforce is changing to more remote. For that matter. It's just, it's a must have at this point, right? It is something that from a digital transformation standpoint needs to happen within companies. And what we're seeing more and more now is that these companies are coming to us to help. Digitally transform their internal processes to help them move forward and get ready for the next next phase or, or, you know, the next 10 years. You know, also what I see is that regulatory affairs is also becoming a competitive advantage for companies. If you can get products to market faster and you can keep your products in market, that's a huge competitive advantage for your specific company. Phillips for instance, right. They just had a huge recall for their ventilators and now they have lost a significant market share one of the biggest competitors. And there's just, you know, that was a quality related issue, but certainly anything registration or regulatory related would have the same impact. Barnard. And so it's, it's, it's a matter of making sure that you have those processes in place today that those are preventable in the future.Kelly Stanton:
Yeah, it's definitely, definitely on a more personal note, if you could go back and tell yourself something at the start of your career, what would that be?James Gianoutsos:
That's an interesting one because I think what I would do is just. Hone in a little bit more on really what I wanted to do. And, and that's always easy to say in hindsight, but, you know, I started my career in quality and you know, been a quality analysts, quality engineer quality manager, and then made the jump into regulatory and that it was quality and regulatory. And I really found that I was really good at quality. And I wish I would have dedicated even more time to it and really focused and hone that skill. Because now I feel like I, I, I really do have that honed in skill, but I feel like I could have even went back and, and just said, Hey, look, you know, I don't think anybody really goes to school for quality and regulatory. You know, I feel like we're like the lost children that you know, we kind of just find our way into it because we find that we're really good at it. Right. Or and then we get really passionate about it too. And there's certainly, I guess I would I, out of that myself be com you know, that myself be that passionate about it back then, because I wasn't really quite sure I wanted to do it. And then, you know what? I was like, you know what, I'm really good at this. And I really enjoy it. And I'm making an impact and I'm working for medical device companies, and I ha have this, you know, I'm ultimately helping patients back in the day an amazing experience. And so I think just from that standpoint, just kind of letting it ride if you will, I guess.Kelly Stanton:
Yeah. Yeah. It's definitely one of those. Career path that you may under your way into that's for sure. Yes. I haveJames Gianoutsos:
a cigarette story. Then you findKelly Stanton:
out exactly. Exactly. I want to go work in the R and D for a while you get over there. Oh my gosh. They have no rules here. I don't think I can do this. And then you go back to QA, right? Like, yep, absolutely. Awesome. Well, thanks a bunch, James. Where can people go to learn more follow along and connect with you?James Gianoutsos:
Yeah, absolutely. So you can certainly visit our website, www.rimsys.io or, you know, I'm always available with talk shop, so feel free to connect me on LinkedIn. I'm available all the time. I love talking shop quality and regulatory.Kelly Stanton:
Awesome. Thank you so much for your time today.James Gianoutsos:
All right. Thanks, Kelly. Appreciate it.