What’s involved in a systematic literature review for the EU MDR, and how should companies handle those steps? In today’s episode, you’ll hear from Co-Founder and Operating Partner of CiteMed, Ethan Drower, on the topic of Systematic Literature Reviews for EU MDR Clinical Evaluation Reporting.
In today’s conversation, we covered topics like where information for the literature review comes from, the types of tools used to make evaluations, and more. Listen to the episode to hear what Ethan has to say about the process of performing a CER, the mistakes and pitfalls he sees people make in the process, and what kinds of actionable steps companies can take.
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Some of the highlights of this episode include:
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What clinical evaluation reporting is
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The big change in EUMDR
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The process of performing a CER
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Where people go to get the data for a CER
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How to tell if a search is comprehensive enough
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What mistakes Ethan has seen people making
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The process once the deliverable is submitted
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How much time it takes for evaluations to go through
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Advice for companies going through the process
Links:
Memorable quotes from Ethan Drower:
“In comparison to the FDA, the big change, the big difference that’s happened with EUMDR is kind of a renewed scrutiny and focus on your actual data.”
“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.”
“Once you’ve gone through the nightmare of pulling all this information together, now somebody has to read it.”
“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 iron tight.”
Transcript:
Etienne Nichols: Hey everyone. Welcome back to the podcast. My name is Etienne Nichols and I'm the host of today's episode.
In today's episode, Ethan Drower, and I spoke on the topic of systematic literature review EU MDR 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 some. 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 with which is revolutionizing the EU MDR process for literature search and review.
Literature search is the cornerstone in medical device company's 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: I am great. I've been escaping the weather in South America, so I really shouldn't be complaining.
Etienne Nichols: Fantastic. And I guess it's still Friday in South America, so I appreciate you coming onto the podcast today.
Ethan Drower: Absolutely. No, you guys are a great, great break from my week, so appreciate you having me.
Etienne Nichols: That's good. Well, 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: 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, you know, 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.
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, you know, we haven't really looked back.
Etienne Nichols: 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 CER, clinical evaluation reporting. And maybe we need to talk a little bit about what that even is.
Why don't we do that first?
Ethan Drower: Yeah, I mean, 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: 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, 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 anymore.
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, if you could add some color just to understand is different classifications are need this more than others.
Is that correct? Or if maybe you can educate me a little bit there.
Ethan Drower: Yeah. So, I mean, in comparison to the FDA, the big change, the big difference that's happened with 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, you know, essentially prove, we've made it the same way, it's the same material, it's got the same function, you could then share that, you know, share in that reputation. MDR 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, cite 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.
I guess that's the big difference, you know, and most companies with class of 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: Yeah, and you know, there's not a whole lot of use in going down speculation. I just want to just kind of mention, you know, 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(k) program. Maybe, maybe we don't necessarily need it right now, but there's been interesting,
I don't know, developments or thoughts about the 510(k) 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, you know, the moderate class of device.
I don't know, it's just interesting thing that I've been kind of noticing. But if we get back to the.
Do you have something to add to that? I don't want to put you on the spot or anything.
Ethan Drower: 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 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'm, I wouldn't bet on it in any immediate time frame.
So. But I think MDR is, you know, it's here to stay.
They're, 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: So, let's talk about the process of performing a CER. I mean there's tools and I know you have a tool for this. What does it look like though to, to build out a CER and to go through that process.
Ethan Drower: 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.
And you know, 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 CER to help structure your argument.
So, it's as you can imagine, it's, it's a clerical nightmare because you have to not only go through hundreds, 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, you know, 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 making your, 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.
That's the way that we do it, that's the way we recommend doing it.
Etienne Nichols: When I hear this process, I can't help but wonder, you know, 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: So, if for anybody doing these searches themselves, every 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 systematic process of how you've gone out to find the information.
PubMed is, you know, 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 I mean, we sometimes search up to five or six databases depending on how complex the device is and how much literature there is out there. So, Cochrane Library, those are great studies.
ClinicalTrials.gov in the US PubMed Central, which is a subset of PubMed, you know, there's a lot of places to look out there and it's hard to keep everything organized.
Etienne Nichols: 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: That's where, that's where you need to have a very algorithmic. You know, we say systematic, but it 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 we've done this process, we can be assured that the results we're 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.
So, it's kind of a funnel, kind of a funnel method.
Etienne Nichols: And then once all of that literature is, is documented or compiled, you do have to have a PhD on go through it, don't you or what's the process there at the very end.
Ethan Drower: 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 an MD; you don't need a PhD. What you need is somebody that has 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, you know, 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 know, you cannot just be a product engineer. You cannot just be the sales guy, 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. But.
Okay, yeah, so that's a commonly. That's a commonly misunderstood thing. You don't need the degree, but what you do need is you need the experience and knowledge that often comes with it.
Okay.
Etienne Nichols: Before we started recording, we started talking a little bit about the. 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, this is my own curiosity. I'm curious how you founded the company that you're currently with.
How did that go?
Ethan Drower: Sure, yeah. 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, you know, 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, you know, couldn't afford it for his company's budget.
And it was really in him, you know, venting to me about these problems literally at the kitchen table before, you know, 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, is such an opportunity for, you know, not crazy pie in the sky innovation, but practical, you know, easy to use tools, fundamentals.
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, you know, that's, that's how we got started. And you know, things just kind of kept rolling from there and I got sucked in to this world with all of these, you know, crazy and interesting people and, you know, been loving it ever since.
Etienne Nichols: What do you think? Have you had to read some of the EU MDR? What do you think so far? I mean, I'm sure being in finance, a couple other things like that, you have to learn a little bit of legalese, I'm sure.
Ethan Drower: But yeah, I found it fascinating. I mean, the first thing I did when, you know, 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 you know, kind of compared it to what people had done before under med dev and you know, the FDA stuff.
And once I, you know, it took me, it took me a whole weekend to go through the thing. But that's when, that's when it kind of clicked and it was like, oh my gosh, this is a significant challenge. And you know, it's, it's even worse than law because at least law is granular and.
Right. You know, this, a lot of these regulations, it's kind of, you know, it says you should have a sufficient X. Yeah.
Etienne Nichols: Too ambiguous.
Ethan Drower: Yeah. Who decides that? How do you prove that? It's, you know, that'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, they were confused and they were, you know, they were worried about the risks that could potentially be mounting for their, their devices because who knew, who knew how tough it was going to be?
Etienne Nichols: Yeah, it's a great example of how your computers are great with tactics.
Once you see the human brain, you can strategize and realize that like you mentioned, it's a funnel.
But then we as humans, we look at that like, okay, I've got to go through thousands of pieces of paper that that's, that's where we fail you know, as humans, but then the computers can really grab onto that.
It's interesting to look at this, this regulation and how it's changed.
So, in 1997, if I get this number right, 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.
We weren't really the, the software was not ready to meet this part 11 compliance. And I almost think, you know, EU MDR, it, it's generated this whole industry around just, you know, what they, what they required. It's almost like wishful thinking regulation.
And so now you're trying to get there so to where we can make it happen.
Ethan Drower: So, it's a catch-up game.
Etienne Nichols: Yeah, yeah, yeah.
So, I'm curious, you, so you've talked, you've worked with a lot of different people working on their CER or working through their needs and you know, it's already at home.
You guys get to talk about it at dinner. What are some of, I don't know if the best advice or pitfalls? I'm curious what you, what you've seen people doing wrong that we can always learn from what people do wrong.
Ethan Drower: 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, you know, starting way too late and grossly underestimating how much work is ahead of you.
So, the majority of, you know, we're one of the, we're one of the fastest providers in the space.
So, because of our systems, because of our team, this is all we, you know, this is what we focus on. We have exceptional timelines compared to many of the, the other providers.
So, a lot of times that means I'm on the phone with people that, you know, they waited until the last minute and now they have two weeks to get their, their literature search done or correct it because they've already been flagged on it, they've already received it.
You know, they've already gotten the CAPA, they've had the, they've gotten the negative feedback.
So, the 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 five.
You know, now that's not the case. Your, you know, your documents are being read.
So, timeline is the big one for me.
Within that, you know, the literature search we talked about before, that's a very time-consuming process.
If your search is not thorough and it's not bulletproofed and it cannot be replicated by, you know, 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, you know, 25 days, 20 days depending on who your notified body is to fix it, which is not a lot of time.
So, I would say don't expect that what you searched in your process in the past, don't expect it to just work and be, you know, glossed right over you. It needs to be exceptionally thorough, and it needs to be, you know, iron type needs to be completely incorruptible.
So those are, yeah, I would say all 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, there's going to be more to do.
Etienne Nichols: Have they made it to where I'm not involved in the submission of a CER. I don't know. 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?
Or I'm, I'm just curious how that, how that works once it's actually submitted.
Ethan Drower: Yeah, it's, I mean it, 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's got, everything has some kind of identifying number and you can reference other sections or other things within that and that's, that's generally sufficient as long as when you submit your, you know, your zip file of, of all of your things that your auditor can find things.
So, you know, one of the big tips that we give people is, you know, treat your auditor how, 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, in a smooth way and it needs to make sense the first time you read it, not the tenth time.
So, organization is kind of paramount, I guess. That's another good tip.
Etienne Nichols: Yeah. Okay.
That's really good. I'm trying to think other things that. What other things?
I don't know.
Any other suggestions or thoughts about, you know, just the literature review and, or actionable steps you can give companies.
Ethan Drower: So. Oh, another big one, this is a good one for you is in, in the CER, you are, you're committing, you're not just submitting your documents, you're committing to a plan and a process that you are responsible for carrying out year after year.
Right.
Etienne Nichols: Okay, interesting.
Ethan Drower: So, so you have to, this isn't just a onetime deal. Your dot, 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, 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, you know, deaths, injuries, etc.
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, you know, 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, you know, depending on your classification forever.
So let you know, don't just, don't just bury the file and worry about it the next time you get audited. You need to be continuously updating your searches. You need to continuously be monitoring adverse event databases.
You know, our practical way is, you know, use technology as much as you can.
So whatever system you can find, if it's ours, if it's someone else's, if it's, you know, maybe they can even do some kind of reminder system within their QMS. I'm sure they can make sure that you have some systematic thing that's keeping you accountable for maintaining your CER.
So, maintenance is a huge one for us.
We see so many, so many manufacturers after we've submitted, you know, they kind of brush us off and say, okay, we're certified, thanks for the help.
And you know, I, it, 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, you know, can you guys catch up and, and make sure that our data for the last year or two, you know, is, Is accounted for and processed properly and tracked.
So that's a big one. Is you're not done.
It's not, 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: 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 are compiling the next revision, I would assume, whether that's through, I don't know, Google Alerts or whatever, whatever the technology you're using. I don't. And then rather than waiting till the end, that makes a lot of sense.
Ethan Drower: Yeah.
You need to, you need to, if you, whether you have somebody that has to sit down every quarter and re. Plug in your searches and reprocess your data by hand, or, 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, your auditor.
So, you know, you need to do it.
Etienne Nichols: 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.
Ethan Drower: Done after your initial, after your initial submission, you're only concerned about the new.
Etienne Nichols: Okay.
Ethan Drower: For your first submission, you're concerned about all of your, the lifetime of your device, all of your previous data you need to account for.
And that's part of, that's also partially why this is so complicated, because you're not just pulling out a handful of useful articles. You need to be able to prove your search needs to be verified, which means where's the raw files?
Where's. Where is the log that you ran on PubMed that specific day?
How are these things linked? And can you demonstrate that these are. This was the data you had available to you, and you didn't miss anything.
So that's, that's kind of the verification game is, Is just proving that you did what you said you did.
Etienne Nichols: 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. And the reason I asked that, I'm just curious, what do you say again?
Ethan Drower: What kind of pace they're, they're getting through, you mean?
Etienne Nichols: Yeah, the pace. And, and I'm, 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, the workload or not.
Who knows? Probably not. But I'm guessing they'll check themselves at some point and say, okay, this, you know, we, we have to recalibrate to what the industry is capable. I'm just curious what you've seen go through so far.
Ethan Drower: Well, I know that when we kind of got going, the average time for you submitted your documents before to get looked at, you know, was, was a couple months.
Now that timeline has tripled at best for most of the notified bodies.
Now, of course, there's different circumstances. I don't, I don't mean to, you know, it's a hard, it's a hard thing to review. Thousands of these, these, I mean, there's thousands of devices. There's tons and tons of these things coming up every year.
So, I would say, I mean, 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.
So, in 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, 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's right. 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: Yeah.
So, one of the actionable items in my mind is, you know, 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: Yes. Because even if, even if your notified body takes a very long time to do stuff, they're not responsible for your previous deadline.
Right. You can, you can negotiate, you can ask for extensions, you can be, you know, 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, don't ride it to the edge.
Etienne Nichols: And one of the things, I'll just kind of add on that January 6th, I believe the proposal to extend the EU MDR 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, it's the one who, those are the guys who are going to be benefited by that transition timeline.
So not someone who's waiting.
Ethan Drower: Right, that's. And I think it's. I think that was a nice, that was a good decision.
The only, 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?
Etienne Nichols: Yeah.
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, that's a real struggle for people.
So, you're absolutely right.
When people get to the point where they need it, it's, it's usually, well, you probably needed it last week or last month or whatever. So.
Ethan Drower: Yes. Yeah, exactly.
Etienne Nichols: Any other thoughts that. Or advice we can give to companies as they're going through this process?
Ethan Drower: I would say. The other thing I would say is that I know it can be very painful to, to reach out for help and sometimes it's hard to find reliable practitioners that you can count on.
But I would encourage, 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.
You know, we do, I do calls with, with people all the time that just want to get a feel for their situation and just chat about it. And I think that that's, I think that's a great thing to do when you can't just hand over the responsibility to, 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, Run it by some people. I mean, this is one of the friendliest industries probably ever when it comes to people's openness and, and Willingness to collaborate. I don't know if you feel the same way, but I've been, I've been blown away by the collaboration within this industry.
Etienne Nichols: 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 VE.
But I've really felt a big openness in the last few years and I'm not exactly sure what that, whether it's an influx of new, new talent into the field so that we have sort of a, 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: I could also be, I've thought about this as well, but I mean it could be, could be a very much technology related thing.
I'm certain that the regulatory field was not as well connected in the past and I mean it's, it's pretty amazing how much time and effort people put into the content, you know, even on LinkedIn and, 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, with other people. So maybe it's the technology, maybe it's.
Yeah, the mindset kind of, it's all kind of gone towards, towards, towards a really, yeah, really nice, a really nice, really nice environment.
Etienne Nichols: And I guess the last thing that I should never, you know, 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: Yeah, it's, it's a pretty incredible mission. When you really think about, you know, when we're down in the weeds to be on it, 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?
Etienne Nichols: The tedium.
Ethan Drower: Yeah, exactly. So, when we're buried in the minutiae, we don't always see it, but when you look at the numbers, you know, 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, you know, you have to step back and think like, wow, this is incredible. And if we, 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, is massive. And I think, I think most people that work in this industry, they like it. You know, we're not, we're not doing it for the glamour. This is not that, this is not that world where you're, you know, you're getting the ego boost.
This is a world of really thoughtful folks that, that quietly are ensuring, you know, that, that this industry advances and that technology advances and, and doesn't hurt people in the process. I mean, it's pretty, it's pretty unbelievable when you think about it from that perspective.
Etienne Nichols: 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: Yeah, thanks so much for having me. This was a fun one.
You can, you can find us on LinkedIn. We're, 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 citemedical.com if you, if you don't get enough reading in, in your day job, you can do some more reading on our.
Etienne Nichols: Site and I'll put both, both links in the show. Notes My 2-year-old maybe about to come in. I'm not sure. Apologies for that.
Ethan Drower: That's good, that's. We'll end on a high note. It's the weekend, they know it.
Etienne Nichols: What's good? So good to have you and I hope to 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 the CERs.
Ethan Drower: Yeah, likewise. Thank you so much.
Etienne Nichols: Thank you all for listening. You've been listening to the Global Medical Device Podcast, and we'll 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@greenlight.guru.
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Improving the quality of life, I know we say it a lot here at Greenlight Guru, and I'll bet it's something you probably said at your company too.
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Those are some of the things the medical device industry and our customers are able to say because that's what they're doing.
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