In this episode, Ethan shares his insights about where information for the systematic literature review comes from, the types of tools used to make evaluations, and more.

Listen now (Coming Soon!)

CiteMed Podcast | Episode 9 | Systematic Literature Review for The EU MDR

Like this episode? Subscribe to our channel today on Youtube.

Links from this episode

Episode Transcript

This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.

(presenter): [00:00:00] Welcome to the Global Medical Device podcast, where today’s brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world’s leading medical device experts and companies.

Etienne Nichols: [00:00:16] Hey everyone, welcome back to the podcast. My name is Etienne Nichols, and I’m the host of today’s episode and today’s episode, Ethan Drower and I spoke on the topic of systematic literature review for clinical evaluation reporting. We covered a lot of ground and talked about things like what journals should you be pulling your information from, What tools are out there to help make these evaluations? And then also, what are some of the pitfalls companies get into when conducting this literature search and also during the reporting process as you compile that report from the literature search, we talked about a lot of other things, but Ethan is the co founder and operating partner of Cite Med, which is revolutionizing the EU MDR process for literature, search and review Literature. Search is the cornerstone of medical device companies clinical evaluation report, and Ethan is working to make this process more streamlined and more optimized than ever. He’s looking to fill the gaps right now in the medical device world, and his top goal is to help companies get their medical products to market as fast and efficiently as possible, all while maintaining state of the art compliance with European Commission guidelines and regulations. We hope you enjoy this episode with Ethan Drower on Systematic Literature Review. Hey everyone, Welcome back to the Global Medical Device podcast. Today I get to be speaking with Ethan Drower. Well, there’s several topics that we’d like to cover, but first of all, how are you doing Ethan?

Ethan Drower: [00:01:38] I am great. I’ve been escaping the weather in South America, so I really shouldn’t be complaining.

Etienne Nichols: [00:01:44] Fantastic. Guess it’s still Friday in South America. So appreciate you coming on to the podcast today.

Ethan Drower: [00:01:49] Absolutely. No, you guys are a great break from my week. So appreciate you having me.

Etienne Nichols: [00:01:53] That’s good. So let’s just go ahead and dive in. I’m curious, tell us a little bit about you and what you’re doing right now.

Ethan Drower: [00:01:59] So we have been in the regulatory affairs space for years now, and within that, we have been almost exclusively focused on EU MDR and the medical device regs there. The reason for this is there’s multiple reasons, but within that we’ve gotten even more focused on clinical evaluation and literature review. So we’ve taken a pretty small niche as it is and we’ve become even more specialized. We didn’t strategize to do it that way. It just kind of was what our clients have been asking for, and that’s just kind of where the market led us. So we went down the rabbit hole and we haven’t really looked back.

Etienne Nichols: [00:02:43] Yeah, and it’s interesting. So I know EU MDR, there’s some changes going on, but it’s really caused a huge need for what you guys are doing, the clinical evaluation reporting, and maybe we need to talk a little bit about what that even is. Yeah, why don’t we do that first?

Ethan Drower: [00:02:59] Yeah, the way we always explain it, when you’re submitting to Europe, you have to submit a lot of things, a lot of different documents to essentially prove that your device is safe and useful. The clinical evaluation part is focused on clinical data, so whether it’s you generating it yourself through studies, through testing, through your own internal results, or whether you’re going out in the world and you’re searching and seeing how other people are using your devices and the kind of results they’re getting. The clinical evaluation is about kind of compiling all of that data that exists on your product and being able to make a conclusion about how useful it is, how dangerous it is, and whether or not you think that it should be sold in the marketplace and it should be shared with as many people as possible. Obviously, we always want to say that, but that’s the decision point. You know, that kind of logic happens in the clinical evaluation.

Etienne Nichols: [00:03:55] So EU MDR has a real need for this because of some of the changes that they’ve made to require that additional clinical evaluation. When we look at the FDA, though, they have the 510 K program. So if you have a predicate device and you just show that you’re substantially equivalent and you can move through using those special controls, the testing that they went through, but nothing more rigorous than that. So I don’t know, I’m just kind of using that for my own way of comparison and contrasting. I wonder if you could add some color just to understand is different classifications are need this more than others? Is that correct? Or maybe you can educate me a little bit there.

Ethan Drower: [00:04:31] Yeah. So in comparison to the FDA, the big difference that’s happened with EU MDR is a kind of a renewed scrutiny and focus on your actual data, whereas previously it was very much the same in the sense of if you had a similar device that you could essentially prove we’ve made it the same way. It’s the same material, it’s got the same function. You could then share in that reputation has kind of changed that in the sense of you, most companies are really not able to do that anymore unless it’s comparison to a product that they also manufacture. So you can no longer use sites, your competition and say, we make the same thing as these guys. They’re approved, we should be approved. You have to now prove it. And justify it with more data. You have to do it a little bit more empirically. Guess so. That’s the big difference. And most companies with device classifications that are higher, even the lower ones, to be honest, they weren’t prepared. They weren’t ready to make those justifications with their data.

Etienne Nichols: [00:05:31] Yeah. You know, there’s not a whole lot of use in going down speculation when it just kind of mention EU MDR has pushed and caused or driven this need generated, this need, whatever you want to call it, for a clinical evaluation. The 510 program, maybe we don’t necessarily need it right now, but there’s been interesting, I don’t know, developments or thoughts about the 510 program that I almost wonder if once the EU MDR gets all their little kinks sorted out, if we might have some similar way of evaluating the moderate class of device. Don’t know. It’s just a interesting thing that I’ve been kind of noticing, but do you have something to add to that? Don’t want to put you on the spot or anything?

Ethan Drower: [00:06:06] No, I mean, it’s an interesting speculation because some people in the industry consider EU MDR kind of an overreach in terms of the level of compliance. So the big question mark is will FDA kind of increase to meet or will EU MDR be remediated to be more reasonable or neither? Or the gap stays forever? So I don’t know either way. But what I do know is that I haven’t seen much of a trend of remediation and repealing restrictions in Europe ever. So will the US follow suit? I wouldn’t bet on it in any immediate time frame, but think EU MDR is here to stay. They’re too far in. And so we need to just find better ways to innovate and make this a more reasonable process for manufacturers.

Etienne Nichols: [00:06:59] So let’s talk about the process of performing a CR. You know, there’s tools and I know you have a tool for this. What does it look like, though, to build out a CR and to go through that process?

Ethan Drower: [00:07:10] It’s a compilation game, which is why nobody likes doing it, because you have to bring in so many different pieces of data and different plans. And that’s why it’s a difficult document to write because there’s just lots of data to maintain it. And the process for us, we always begin with what we call the literature review. And as you mentioned, that’s what our software is for. The literature review is when you as the manufacturer, you go out into the world and you look at all possible relevant clinical literature and some that’s not. And you record exactly how you’ve analyzed this data. And then you take that data and you put it into your to help structure your argument. So as you can imagine, it’s a clerical nightmare because you have to not only go through hundreds and potentially thousands of articles, but you need to record exactly how you process them. You have to have an easy, replicable methodology of review. You have to pull out the right information in the right way so that it’s readable for somebody else. And then you’ve got yourself a 900 page document with tables that go on for 30 pages, and now you have to take that and do something useful with it and be able to write about it, right? So that’s the first piece is getting the data and doing your analysis. The second piece is the compilation where you pull in your other data. You start making your plans and then you start making your actual conclusions about your device. Yeah, it’s kind of a that’s the way that we do it. That’s the way we recommend doing it.

Etienne Nichols: [00:08:40] When I hear this process, I can’t help but wonder, Well, first of all, I guess you’re going to places like PubMed and what are the different places that people go to get that data?

Ethan Drower: [00:08:48] So for anybody doing these searches themselves, your searches are essentially being audited by your notified body, right? So they’re going to read your method. They’re going to determine if it’s thorough enough. That’s the big thing. So you can’t just search for your device name on Google and call it a day. You need to show a systematic process of how you’ve gone out to find the information. Pubmed is one of the biggest freely accessible databases out there. It’s got access to tons of journals. We almost always include it. That being said, we are seeing a lot of need for European specific journal searches. That’s when there are other databases, PubMed, Europe is okay, but what we really like to use is we really like Embase and they have access to a little bit more precise grouping of journals that focus on European trials, which results in a more comprehensive search, but mean we sometimes search up to 5 or 6 databases, depending on how complex the device is and how much literature there is out there. So Cochrane Library, those are great studies, in the US, PubMed central, which is a subset of PubMed. There’s a lot of places to look out there and it’s hard to keep everything organized.

Etienne Nichols: [00:10:00] So what I started to say before I kind of went down that little rabbit hole was How do you know when you’re done? How do you know when you’ve done a comprehensive enough search?

Ethan Drower: [00:10:09] That’s where you need to have a very algorithmic. You know, we say systematic. Is an algorithm. You need to have a process of refinement. So when you are determining what terms and where you’re going to search, you need to have a way to say, okay, we started here. It was way too broad, we got way too many results. Then we started here, we corrected and now we only got a few and that it wasn’t enough. So you need to have a process where you can take this big universe of literature about your device and you can start refining it and refining it and refining it until you get to somewhere where you can say this is a manageable amount that we can read. And because of we’ve done this process, we can be assured that the results were actually processing are as good as it’s going to get. And you demonstrate that with how well you’ve documented exactly how you refine those terms, kind of a funnel method.

Etienne Nichols: [00:11:03] And then once all of that literature is documented or compiled, you do have to have a PhD and go through it, don’t you? Or what’s the process there at the very end, Right.

Ethan Drower: [00:11:13] So once you’ve gone through the nightmare of pulling all of this information together, now someone has to read it, someone has to read it and critically assess everything. You don’t need a PhD. What you need is somebody that has significant, significant clinical experience that can come in many forms, but it’s usually justified by submitting the person’s CV. So, you know, we have some MDs and we also just have regulatory people that have been facilitating clinical trials for decades and, you know, have worked in clinical settings and that can be sufficient as long as their experience is sufficient. You cannot be however, you cannot just be a product engineer. You cannot just be the sales guy, the, you know, the marketing person. So you do need to be able to prove that whoever’s reading this stuff is qualified enough to be able to make assessments on it. Yeah, that’s a commonly misunderstood thing. You don’t need the degree. What you do need is you need the experience and knowledge that often comes with it.

Etienne Nichols: [00:12:11] Okay. Before we started recording, we started talking a little bit about the path companies go on and the different, I don’t know, opportunities I guess, for different tool makers and software engineers to go through. I’m curious how you founded the company that you’re currently with. How did that go?

Ethan Drower: [00:12:26] Sure. It’s always a pretty funny story because I’m not a trained regulatory person. This is my first venture in this space and I had always been in the software world. I’m an engineer by through university trade, through all my previous experience working in finance. Et cetera. The idea for the company actually came from my father, who is a trained regulatory person, and he was grappling with the looming EU MDR, and he was responsible for this massive portfolio of devices. He had to do all of these literature reviews, couldn’t find people to do them, couldn’t pay enough, couldn’t afford it for his company’s budget. And it was really in him venting to me about these problems literally at the kitchen table before the idea kind of clicked for us, that was like, Hey, if this is that big of a need and it’s coming up, how much of this process can we improve with a tool? And you know, you guys are in the same similar vein of an industry where a lot of the people that you’re helping, you know, they’ve done it on paper. You know, they have spreadsheets, right? So this industry to me is such an opportunity for not crazy pie in the sky innovation, but practical, easy to use tools, fundamentals. And that’s why it was so exciting to me because we didn’t want to just jump on the bandwagon of excitement. We wanted to build something that could be useful and lasting and have a serious impact. So that’s how we got started and things just kind of kept rolling from there and got sucked in to this world with all of these crazy and interesting people, and we’ve been loving it ever since.

Etienne Nichols: [00:14:05] Have you had to read some of the EU MDR? What do you think so far? I’m sure you’re being a finance a couple other things like that. You have to learn a little bit of legalese, I’m sure.

Ethan Drower: [00:14:12] Yeah, I found it fascinating. I mean, the first thing I did when my father told me about this, first thing I did was I didn’t believe him. So I went and read the whole regulation and kind of compared it to what people had done before under Med Dev and the stuff. It took me a whole weekend to go through the thing, but that’s when it kind of clicked and it was like, Oh my gosh, this is a significant challenge. And it’s even worse than war because at least law is granular and specific, right? A lot of these regulations, it’s kind of it says you should have a sufficient X.

Etienne Nichols: [00:14:47] Yeah. Too ambiguous.

Ethan Drower: [00:14:48] Okay. Yeah. Who decides that? How do you prove that? It’s that’s where kind of tickled that part of my brain that wants to make everything consistent and uniform because it doesn’t exist in these regulations. And it was clear right away when we started talking to people that companies were confused and they were worried about the risks that could potentially be mounting for their devices because who knew how tough it was going to be?

Etienne Nichols: [00:15:11] Yeah, it’s a great example of how. Heaters are great with tactics. The human brain, you can strategize and realize, like you mentioned, it’s a funnel. But then we as humans, we look at that, we’re like, okay, I’ve got to go through thousands of pieces of paper. That’s where we fail as humans. But then the computers can really grab on to that. It’s interesting to look at this regulation and how it’s changed. I hope I’m getting the number right. 1997 is when part 11 compliance became a requirement from the FDA and we were ahead of the time for software. The software was not ready to meet this Part 11 compliance. And I almost think, like you said, it’s generated this whole industry around just what they required. It’s almost like wishful thinking regulation. And so now you’re trying to get there to where we can make it happen. So it’s catch up game. Yeah. So I’m curious, you’ve worked with a lot of different people working on there or working through their needs and it’s already at home. You guys get to talk about it at dinner. So what are some of I don’t know if the best advice or pitfalls. I’m curious what you’ve seen people doing wrong that we can always learn from what people do wrong.

Ethan Drower: [00:16:11] I would say the common mistakes in the regulatory world, which aren’t even necessarily the fault of the regulatory people, generally apply here, which is starting way too late and grossly underestimating how much work is ahead of you. We’re one of the fastest providers in the space, so because of our systems, because of our team, this is what we focus on. We have exceptional timelines compared to many of the other providers. So a lot of times that means I’m on the phone with people that they waited until the last minute and now they have two weeks to get their literature search done or corrected because they’ve already been flagged on it. I’ve already gotten the cap. They’ve gotten the negative feedback. So timeline to me is such a big one because these documents just take a long time to prepare correctly. And whereas before under med dev, you could kind of nobody was really reading them at the same level and they weren’t auditing the lower classifications at all. So you could submit anything and just hope that they didn’t crack open the file. Now that’s not the case. Your documents are being read, so timeline is the big one for me.

Ethan Drower: [00:17:19] Within that, the literature search we talked about before, that’s a very time consuming process. If your search is not thorough and it’s not bulletproof and it cannot be replicated by a person that just happened to read it and doesn’t know anything about your device. If they can’t follow your steps and get the same result, you’re not going to pass and you’re going to have 25 days, 20 days, depending on who you’re notified body is to fix it, which is not a lot of time. So I would say don’t expect that what you searched and your process in the past, don’t expect it to just work and be glossed right over. It needs to be exceptionally thorough and it needs to be ironed tight. It needs to be completely incorruptible. So I would say those are kind of the biggest logistical ones for a team. Make sure you’re planning, make sure you have enough time. You start as early as you can and realize that it’s just not going to be comparable to what you did before. It’s going to be more work. There’s going to be more to do.

Etienne Nichols: [00:18:24] I’m not involved in the submission of a I’m not familiar with that process to be completely open with you. So is it a PDF or a document that they literally have to go through or is there a way to have links within that? I’m just curious how that works. Once it’s actually submitted.

Ethan Drower: [00:18:38] The deliverable ends up being a document or a word doc and what most people do, they don’t do links to live web documents or anything like that. But what they do is they reference other parts of their technical documentation. So everything has some kind of identifying number and you can reference other sections or other things within that. And that’s generally sufficient as long as when you submit your zip file of all of your things that your auditor can find things. So one of the big tips that we give people is treat your auditor how you would want to be treated if you had just started at the company and people were trying to onboard you about the devices. You don’t want to have to dig through 50 folders to find the one reference document. Things need to be organized. It needs to read through in a smooth way and it needs to make sense the first time you read it, not the 10th time. So organization is kind of paramount. Guess that’s another good tip.

Etienne Nichols: [00:19:33] Yeah. Okay. That’s really good. Any other suggestions or thoughts about, you know, just the literature review and actionable steps you can give companies?

Ethan Drower: [00:19:41] So another big one, this is a good one for you is in the CSR. You’re not just submitting your document, you’re committing to a plan and a process that you are responsible for carrying out year after year. This isn’t just a one time deal. Your device is good, it’s safe. Don’t worry. You have to continuously monitor and you have to continuously look out in the world and make sure that it’s actually helping people. It’s not hurting them. So you need to commit to processes about how you’re going to do this. How are you going to keep up with the data on. Your device. How are you going to keep track of adverse events, deaths, injuries, etcetera? And then how are you going to take all that information and then report it back to your notified body? So one tip that we give people when they pop the champagne and have gotten their device certified is we say, okay, but let’s not forget you have to do this work every year or every two years, depending on your classification forever. So don’t just bury the file and worry about it the next time you get audited. You need to be continuously updating your searches.

Ethan Drower: [00:20:46] You need to continuously be monitoring adverse event databases. Our practical way is use technology as much as you can, so whatever system you can find, if it’s ours, if it’s someone else’s, maybe they can even do some kind of reminder system within their. I’m sure they can make sure that you have some systematic thing that’s keeping you accountable for maintaining your care. So maintenance is a huge one for us. We see so many manufacturers after we’ve submitted, they kind of brush us off and say, okay, we’re certified, thanks for the help. And it pains me sometimes, but I know that we’ll see them in a year or two and they’ll be panicked and they’ll be saying, We got flagged for this this in our auditor. Can you guys catch up and make sure that our data for the last year or two is accounted for and processed properly and tracked? So that’s a big one is you’re not done. It’s not a one and done. You need to continuously keep this document updated in a way that doesn’t make you lose your mind. Yeah, that’s no small task sometimes.

Etienne Nichols: [00:21:48] Yeah. I’m just kind of walking through that in my own brain, just picturing you have your document and maybe other clinical trials are happening on with other similar devices or maybe, like you said, adverse events, injuries are occurring. It would make sense to roll that. So you continually compiling the next revision, I would assume, whether that’s through Google alerts or whatever, whatever the technology you’re using, rather than waiting till the end, that makes a lot of sense. Yeah.

Ethan Drower: [00:22:12] Whether you have somebody that has to sit down every quarter and replug in your searches and reprocess your data by hand, or whether you use some tool, right? You need to be continuously doing this and it needs to be consistent because that’s what you promised. That’s what you promised your auditor. So you need to do it.

Etienne Nichols: [00:22:31] I can see the new information having to be input. What about the old information having to be verified? Is that something that needs to be done.

Ethan Drower: [00:22:38] After your initial submission? You’re only concerned about the new okay. For your first submission, you’re concerned about all of the lifetime of your device, all of your previous data you need to account for. And that’s also partially why this is so complicated, because you’re not just pulling out a handful of useful articles. Your search needs to be verified, which means where’s the raw files? Where is the log that you ran on PubMed that specific day? How are these things linked and can you demonstrate that this was the day that you had available to you and you didn’t miss anything? So that’s kind of the verification game is just proving that you did what you said you did.

Etienne Nichols: [00:23:17] Do you have any idea how many of these have gone through since EU MDR has been submitted? I’m just curious what kind of.

Ethan Drower: [00:23:24] Pace they’re getting through, you mean?

Etienne Nichols: [00:23:25] Yeah, the pace. And I’m guessing that the European Commission at some point they’re going to look at this and we mentioned at the beginning whether they’ll reduce the workload or not. Who knows? Probably not, but I’m guessing they’ll check themselves at some point and say, okay, this we have to calibrate to what the industry is capable of. I’m just curious what you’ve seen go through so far.

Ethan Drower: [00:23:44] Well, I know that when we kind of got going, the average time for you submitted your documents before it to get looked at was a couple months. Now that timeline has tripled at best for most of the notified bodies. Now, of course, there’s different circumstances. It’s a hard thing to review thousands of these. I mean, there’s thousands of devices. There’s tons and tons of these things coming up every year. So I would say the average auditor, I don’t know how many they could possibly do. They can’t do 500 a year. Right? They can do, I don’t know, a hundred maybe. And how many notified bodies are there with how many auditors? Right. You have to kind of do that math. But the total capacity, it’s certainly not in the hundreds of thousands. I would wager that it’s in the tens of thousands. And that’s giving people a lot of credit for not taking vacation and working really hard. That would be my guess. So we submit at a very quick pace. But I’ve noticed that the timeline for when we get our feedback back to us, when it comes back to us, that’s getting longer and longer.

Etienne Nichols: [00:24:48] Yeah. So one of the actionable items in my mind is this is something that you would want to get done very quickly and get it in their queue as quickly as possible, I suppose.

Ethan Drower: [00:24:57] Yes, because even if you’re notified, body takes a very long time to do stuff. They’re not responsible for your previous deadline. Right. You can negotiate, you can ask for extensions. You can be hope that they’re reasonable. But when it comes down to it, technically, they’re not so submitting. Early is important because you’re going to have feedback. You’re going to need to fix stuff too. So don’t write it to the edge.

Etienne Nichols: [00:25:18] And one of the things I’ll just kind of add on that January 6th, I believe the proposal to extend the timeline, it really was primarily for those who have already been putting in the reps. So not somebody who just said, Oh yeah, I’ll do this as well. Yeah, those are the guys who are going to be benefited by that transition timeline. So not someone who’s waiting, right?

Ethan Drower: [00:25:38] Think that was a good decision. The only thing that I hate about extensions is that the people that need them never start working. When they see the extension, they just continue to wait a little bit longer. So I see it as kicking a lot of people’s problems down the road. I’m sure you guys see this all the time as well. When people wait and wait and wait and now they’re asking you to onboard them in three days, right? Yeah.

Etienne Nichols: [00:26:02] And I kind of feel bad. I mentioned the Part 11 compliance earlier. I didn’t mention actually what that was. That’s the electronic signatures. If you have document management systems that aren’t compliant to that, that’s a real struggle for people. So you’re absolutely right. When people get to the point where they need it, it’s usually, well, you probably needed it last week or last month or whatever. So yes. Yeah, exactly. Any other thoughts or advice we can give to companies as they’re going through this process?

Ethan Drower: [00:26:28] The other thing I would say is that I know it can be very painful to reach out for help, and sometimes it’s hard to find reliable practitioners that you can count on. But I would encourage regulatory affairs people, especially at smaller companies that might not have a big budget to at the very least get out there and network and try and speak with people that are submitting. A fair amount of these do calls with people all the time that just want to get a feel for their situation and just chat about it. And I think that’s a great thing to do when you can’t just hand over the responsibility to another firm. So I would say even if you can’t go out and hire for completing these documents, if you’re not confident in what you’ve done and you don’t have some kind of track record to be certain, run it. By some people. I mean, this is one of the friendliest industries probably ever when it comes to people’s openness and willingness to collaborate. I don’t know if you feel the same way, but I’ve been blown away by the collaboration within this industry.

Etienne Nichols: [00:27:26] I don’t exactly know what has caused it, but I agree. So in years past it seemed like to talk to a medical device professional about their company. They really keep it close to the vest. But I’ve really felt a big openness in the last few years, and I’m not exactly sure whether it’s an influx of new talent into the field so that we have sort of a different level of understanding. So everybody wants to learn together. I’m not sure exactly what it is, but it is an interesting phenomenon for sure.

Ethan Drower: [00:27:51] I’ve thought about this as well. I mean, it could be a very much technology related thing. I’m certain that the regulatory field was not as well connected in the past, and it’s pretty amazing how much time and effort people put into the content, you know, even on LinkedIn and the amount of responses that we get. I’m sure you guys have the same experience where there’s just thought and there’s effort put into connecting and sharing with other people. So maybe it’s the technology, maybe it’s, yeah, it’s the mindset. It’s kind of it’s all kind of gone towards a really nice environment.

Etienne Nichols: [00:28:25] And I guess the last thing that I should never take for granted is the fact that the people who are in the medical device industry, I think for the most part, they really want to improve those patient outcomes and they’re really working to improve the quality of life. So definitely can’t downplay that.

Ethan Drower: [00:28:39] It’s a pretty incredible mission when you really think about when we’re down in the weeds, to be honest, we all know it’s terrible, right? We know we’re in massive amounts of documents. We’re doing all of these things that we think are pretty much unnecessary for our device because our device is simple. That’s what everybody says, right? It’s easy. Yeah, exactly. So when we’re buried in the minutia, we don’t always see it. But when you look at the numbers of patients that are using a specific device and the tiny, tiny percentages of people that are having problems with that device, we have to step back and think like, wow, this is incredible. And if we had messed this up and we didn’t pitch it properly, it couldn’t go to market and it couldn’t actually help those people. So the impact is massive. And I think most people that work in this industry, they like it. We’re not doing it for the glamor. This is not that world where you’re getting the ego boost. This is a world of really thoughtful folks that quietly are ensuring that this industry advances and that technology advances and doesn’t hurt people in the process. I mean, it’s pretty unbelievable when you think about it from that perspective.

Etienne Nichols: [00:29:45] Yeah. Well, Ethan, I really appreciate all your insights and coming on the show. Where can people find you and see what you’re doing?

Ethan Drower: [00:29:51] Yeah, thanks so much for having me. This was a fun one. You can find us on LinkedIn. We’re very chatty on there. We post a lot of articles and white papers and give away our templates and things like that. So you can find me just Ethan Drower on LinkedIn, you can also look us up at If you don’t get enough reading in in your day job, you can do some more reading on our site

Etienne Nichols: [00:30:12] I’ll put botH Links in the show notes. My two year old may be about to come in. I’m not sure. Apologies for that.

Ethan Drower: [00:30:17] That’s good. That’s well end on a high note. It’s the weekend. They know it.

Etienne Nichols: [00:30:21] So good to have you and wish you the best in all of your endeavors. I’m excited to see where it goes and see how the industry is going to be impacted with this year.

Ethan Drower: [00:30:29] Likewise. Thank you so much.

Etienne Nichols: [00:30:30] Thank you all for listening. You’ve been listening to the Global Medical Device podcast and we will see you all next time. Thanks for listening. If you enjoyed this episode, reach out to Ethan on LinkedIn and let him know. Also, I’d personally love to hear from you on LinkedIn if you want to reach out to me or reach out to me via email. Etienne.nichols@greenlightguru. If you’re interested in learning about our software that’s built specifically for MedTech and how it can help you get to market faster, whether it’s through the document management system, Kappa management system design controls or risk management processes or electronic data capture for clinical investigations and how this software is integrated to work within itself. This is software built for medtech professionals by MedTech professionals, so you can check it out at W-w-w dot Greenlight Dot Guru. If that wasn’t enough, we also have an academy where you can go to learn or earn certifications in medtech specific categories such as project management, design controls or quality management. A lot of the courses are free, so check them out and share them with your colleagues. You can look and see the Finally, please consider leaving us a review on iTunes. It helps others find us and lets us know how we’re doing. Thanks again. Take care.