Modernizing the EUMDR Clinical Evaluation Report Process with Ethan Drower Co-founder of CiteMed

 

 

Kelly Stanton: 0:17

Hi everyone. Thanks for turning into from lab to launch today. We're glad you're here. I'm Kelly from Qualio and I'm your host. 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 it helps get the message out there. 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. Today we have Ethan Drower who's joining us from Argentina. Uh, He is the co-founder and operating partner of CiteMed which is revolutionizing the European Union Medical device Regulation process or EU MDR. With some major updates to the EUMDR in the past couple of years, the need for innovation and efficiency, there has never been greater Ethan and the team at CiteMed are making a streamlined process for med device companies, clinical evaluation report documentation, which some medical writers spend hours and hours well spend entire careers on, frankly, he'll explain more about their literature search and the review process later. CiteMed's top goal is to help companies get their medical products to market as quickly as possible all while maintaining state of the art compliance with the European Commission Regulations, which is actually very aligned with what we do here at Qualio as well. So we're going to have fun nerding out on all this stuff today, they have several EU MDR templates and content on their website, which we'll link to in the show notes. If EU MDR is on your mind, you'll get a lot from what Ethan and the team at CiteMed. All right, let's get to it. Welcome Ethan. Thanks for joining me today.

Ethan Drower: 1:48

Yeah. Thanks so much for having me Kelly I'm really excited for this one.

Kelly Stanton: 1:52

Awesome. We love hearing how companies launched. Tell us the story behind launching CiteMed.

Ethan Drower: 1:57

Well, we saw an opportunity years ago When EMDR, the draft was first launched. And my, my background has always been in software. I have not been in the medical device space for very long, and my co-founder has been in the space for a very, very long time, probably 30, 40 years. And when he saw the regulation one of the companies, he was. Consulting for and working with and helping. He realized that there was just no way that they weren't going to, they had hundreds of products. They had a quality team, regulatory team of two or three people. And he, he knew that there was no way they were going to get this work done because the clinical evaluation standards specifically just ballooned. It was it's exponentially harder to. To, to get this work done for MDR. So he saw the opportunity. He came to me and he said, I don't know much about software, but is there something we can do? Is there a tool we can build to make this process more efficient for us? Because we're dying here and w we're not going to be able to get the work done. So that was kind of the light bulb moment for me, you know, the intersection. This is coming. This is a big market change, and here's an opportunity to use technology to solve to solve a problem. That's going to impact, you know, millions of people and thousands of companies. So, we, we kind of got into it and you know, signed a first client scrambled to build some products and get some stuff done. And you know, the rest is history. We've been, we've been humming along ever since.

Kelly Stanton: 3:37

Yeah, I definitely a pretty scary you know, having been in industry a long time myself here in the us that the biggest change, of course, the companies that had been doing, you know, CRS already had the infrastructure in place, but when they expanded the D the definitions of devices and said, no, all these other things are now a device and you must do clinical evaluation reports. Yeah. There's a whole lot of little bitty, you know, One and two person companies with one device in the market going, oh my God, how am I going to do this? So that's a, that's an amazing opportunity story that you that you share there. And definitely one week we feel here across the entire device market, for sure. So walk us through the literature driven regulatory process that your team has architect.

Ethan Drower: 4:22

So what we do, we do two different things. We do it for you, or we give you the tools to do it yourself. Right? So the, the process that we've built It is essentially just a software tool that helps you compile all of these massive amounts of clinical literature that you have that are relevant to your devices, and then go through them in a systematic way and apply. You know, your whatever type of rankings or criteria you want to them. Right? We need to evaluate all of the literature in, in a documentable and recordable way, in a way that can be reproduced most importantly. And then we need to click a button and we need to spit out a report that actually makes sense to an auditor and, and gets them the information. Patient that they want to see in a way that's digestible. You know, these reports can, can get into the hundreds of pages, right? I'm I'm sure you guys have seen, seen these documents really balloon and it's critical that you have an organized approach and every time you do it, you do it the same way. Because if you have an auditor, that's going to read through multiple of these submissions of multiple products. You don't want to be surprising them and confusing them every time because you had a contractor do it. And the formatting is different. The tables are all in a different order with different columns. None of that. So what we do is we've, we've built a process. We use software to assist the writer in the process and, and handle all of the monotonous, heavy lifting. Of formatting tables, blah, blah, blah. And then what we did after we built this tool for our writers and our team is we turned around and we made it available to some of our clients. And they can, they can use it themselves or they can have us drive the whole process for them. So it really depends on where you're at with your team. How many, how many people you have, how. How far behind you are you know,

Kelly Stanton: 6:25

how far behind are we?

Ethan Drower: 6:29

That's almost always my first question, right?

Kelly Stanton: 6:31

Yeah, yeah, exactly. I was going to say, I think that's part of the standard response and the timelines is, yeah. How far behind are you on keeping up with it? All?

Ethan Drower: 6:44

Well, and so that's

Kelly Stanton: 6:46

how bad is it effectively? Exactly. Well, and that's the nice segue to the next question, you know so why is having a systematic literature review process important for a medical device company's CERs?

Ethan Drower: 6:59

Sure. Well we find that for most products. a lot of these companies are not, they're not doing their own studies, they're not doing their own post-market clinical. Follow-up a lot of the devices are of a simpler nature and they just don't have a lot of data. They don't have their own clinical data. It's it's expensive. You're not going to do studies for, you know, your. Right. Your surgical gloves or something like that, you're just, nobody's paying for that. So it's, we found that especially, you know, with our experience with, with the notified bodies and with MDR that the, if you can present an incredibly comprehensive approach to how you've searched for and sought out clinical literature that's related to your device if you can do that, then. It makes the, it makes your whole cer submission, just go a little bit smoother because you've, you've, you've established a foundation of, you know, of clinical knowledge. And if your NBC auditor buys that and says, okay, these guys have done their research, they've done their homework and this is what they find. Almost almost always they are okay with, with that approach. So we try to use this literature review to kind of drive the document and, and we, we use it as, as a core, a core pillar of of what we referenced in a CR furthermore, we take that and we take that same process and we apply it to a proposed part of our proposed post-market clinical follow-up. Plan and process, and obviously the periodic safety update report if required. So we take this, this core literature review process. We say, this is what we do. And we do this all the time. We do it every year or every two years depending. And we use that as the pillar to drive, to flow into these other documents as needed. It doesn't cover everything of course, but we find that the solid process really. Th the notified bodies seem to understand it. And they, they, it seemed to be what they're looking for. They're looking for reproduce the bowl well-documented methodology that you can actually stick to and maintain.

Kelly Stanton: 9:16

Yeah, the maintenance of it too. And, you know, to that end, you know, there, there, there are living, living documents, you know, you don't, it's not a one and done kind of situation. So I assume your software tool you know, once you've sort of built a search criteria, then you know, it becomes a lot easier to just reroute. And keep adding information, is it as it comes to mind, right,

Ethan Drower: 9:39

exactly. I mean, probably much like how your system works, right? You want an audit trail, you want a, a storable list of the work that you've done previously. And then when you want to add new stuff, you want that to be, you know, at least some at least accounted for. So, that's, that's part of, part of the big reason for trying to use software for this. You want to keep track of your exact search protocol that you ran before so that you can show your periodic updates, quarterly, annually, whatever interval you want, and you don't have to think about it each time and read, dig up the document and do the searches by hand. And it just because it was a nightmare, how could you do that on 50 products every year? There's no time.

Kelly Stanton: 10:27

Yeah, definitely. That's I, in a wide variety, you know, especially, I mean, if you've got 50 products, you're probably in a similar space, but yeah, the, the, the, the, the, the, the tiny details of the differences there can certainly make or break your whole approach to that process. You're in the med device, regulatory space for the longest. You know, how do you, how do you see things changing over the next decade

Ethan Drower: 10:52

we are? And we couldn't be more excited about it. I think especially in the regulatory space, there is, there is a lot of work to be done when it comes to improving quality systems and regulatory processes obviously. You guys know that too, because you're, you're at the forefront of getting these companies off of paper, paper, QMS, and, and complaint management and all of those things. So, you can, you know, as well as anybody else, how hard it can be to be a technological innovator in this space right now, because there were old there's, there's the old guard. And now the regulations are forcing. Forcing companies to be more efficient or, or, or they're going to struggle. Right. So we're excited to see more use and more acceptance of technology. I'm, I'm hoping for a grander vision where clinical literature and especially things like adverse events and complaints can be, can be stored in a much more centralized and accessible network for everyone. I think that there are, especially for big manufacturers that get a lot of complaint data. I think that there are endless opportunities to use different kinds of machine learning technologies to help. risk profiles in devices. You know, we're, we're a very reactive industry right now, and there are ways technology is not going to do it all for us. There's still judgment calls to be made. There's still, you know, there's still a lot that needs to be done, but I think that. Especially machine learning can help us help at least raise red flags when they're needed and can help quality, quality assurance and regulatory affairs professionals kind of navigate the waters a little bit more effectively and feel a little bit more in control, as opposed to at the end of every two years we get the report and we say, oh, that could be a problem. Right. So, I'm hoping to see it. I'm hoping to see the trend of using leverage of technology and software we're really, really start to, to get adopted. And I'm sure you share that. I'm sure you

Kelly Stanton: 13:07

share that. Absolutely. No, we used to, yeah. Once upon a time I ran a complaint team and trolling the mod database for that. You know, you never want the FDA to come to you and say, oh, we see this trend in your reporting data. Right. You know? Cause if they see it and you haven't already fixed it, you know, then yeah. Obviously that's a huge you're behind the curve. Definitely. And, and it's interesting that you bring up the whole machine learning and that sort of thing. Cause it's, it's a topic we talk about internally here all the time, where are places that we can leverage machine learning or. Predictive, you know, sorts of data analysis within the quality space and you know, it, and just, I, I remember when we used to record data on carbon copy lab papers that were numbered. So it's, that tells you how long I've been around in the industry. Now that we're doing all of this electronically, it's like, wow, what, what sorts of things could I learn from that data? And The post-market surveillance space and the clinical evaluation reporting. That's definitely, I think that that's probably the most powerful place I think, to apply the kinds of technology that you guys are doing. Because even if you had clinical data, I mean, did you have 250 people in your trial? Did you have a thousand people in your trial? You know, now that you're on the market, that's, that's, you know, Anybody might not like to think about we're all just part of a big clinical trial, right? Once a month, even if it's approved, there's still so much more to learn about the product in the field. And, and and yeah, now that we also don't have to do it through you know, GAAP magazines and all that, that old school sort of stuff, you know, the, the, the group and the team and the clinical group whose job was to write. Magazines all the time for exactly the kinds of things that your softwares is doing. So that's that's really powerful. That's really exciting. If you could go back and tell yourself something at the start of your career, what would that be?

Ethan Drower: 15:18

I would say the biggest challenge that I've faced in my earlier years was getting too excited about too many new ideas and spaces every year. There's. Shiny thing that you can build and try and fix and go after and change the world. But what I've learned in my older years is that if you really want to make a big impact and create lasting change, Thing you do choose wisely. The choose wisely, the vehicle choose wisely, the industry and the product that you're trying to build, and you need to stick with it. It's going to take years to build a good brand. It's going to take years to build a product that actually is useful. It's going to take years. Build these relationships with, with customers and other companies in your space that can yield those big lucky moments. And if I could tell myself anything, you know, 15 years ago, 10 years ago, I would say, pick something, stick with a kid, pick something you love doing and, and, and stick with it. Don't chase a new thing, a new project every six months. You'll you'll never get there.

Kelly Stanton: 16:29

Well, and that's, I think that's powerful too, is, as you said, when you started off, you know, you're you're not from life sciences, you're, you're a software guy. And I don't think people necessarily understand or recognize, you know, life sciences, obviously as an industry that there's so much to it. There's so much opportunity. In lots of different ways, you know, you've, you've taken your software expertise, partnered with an industry expert to solve a pro you know, a very large problem we have in this industry. And, and I'm sure you probably didn't get your computer science degree thinking you were going into medical devices, right? Like that's, so that's an interesting sort of progression, but I feel like that's really. That's a, that's a powerful story. That's really encouraging to share with people. Because you know, like here at quality we, we really believe in, you know, helping companies launch lifesaving products and, and we're, we're all here for that. But I was talking with somebody who's people, communications manager. And he was going to go work in the pharmaceutical area. Right. But here he is supporting an industry that really touches lives. And yeah. So that's, I love that. That's a great story. And, and certainly something to think about for folks doing computer stuff. You know, you, you can come change the world too in ways that maybe you didn't think of when you were studying in college,

Ethan Drower: 17:52

there are a lot of paths that are not. the flavor of the day technologies, and I think that's as engineers, it, it's kind of, it's kind of our responsibility to. Find the, find our home, find the way that we can put these skills to use, to have the biggest impact. And, and for me, it just, everything lined up and, you know, the life sciences world just became a no-brainer for me. And it just, it felt right. You know, it aligned with my values and the values of the type of company I wanted to be. And, you know, a year in, we, we all kind of looked at each other and said, this we're doing this. This is it. This is, this is the, this is the venture. This is going to take us, you know, 15, 20 years to really, to really get to where we want it to go to have the biggest impact. And yeah, so couldn't be more excited to be here.

Kelly Stanton: 18:45

Awesome. To wrap it up, people to learn more, follow along and connect with you.

Ethan Drower: 18:51

They can, they can always find me on LinkedIn. I'm very chatty on there, so you can, you can search me Ethan drawer on LinkedIn. I'm the only one which is nice. Or you guys, yeah, there are no other Ethan drivers out there. You can check out our website, which is site C I T E like citation citemedical.com. But that's that you can, you can find us pretty easily.

Kelly Stanton: 19:12

Awesome. Well, thank you. Thank you so much for your time today, Ethan, it's been great chatting with you and I've definitely bookmark your bookmarked, your website. I have several friends in industry. I'll be sending that information along to cause that is definitely a service we need in this industry big time. So thank you very much for your time.

Ethan Drower: 19:29

Thank you so much for having me, Kelly. I appreciate it.