The regulatory world is being stretched to breaking point these years with new regulations, increased post-market surveillance demands, and stricter reviews from notified bodies and competent authorities.
However, hardship can be a driver for innovation and that is exactly how CiteMed came
into the world.
Listen to Ethan tell the story himself in this podcast!
In this episode, Ethan shares how to listen for new ideas, R&D differences and similarities in industries, build early prototypes and capture customer feedback, scope a Podcast post 2 project, pricing for value, and how CiteMed has positioned itself.
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Links from this episode
Some of the highlights of this episode include:
- How a Regulatory Change Created a Product Opportunity
Memorable quotes
“I realized that the juicy problems, the real opportunities, they are the ones that are so great that you can’t ignore them. You don’t have to. You don’t have to dig them out. It’s not like looking for gold”.
“…the younger version of Ethan definitely struggled with trying to build too much too quickly. But it’s a real thing that the younger entrepreneurs face”…
…”with software, you can you can create a product in two days, in the medical device industry, it’s very well understood that building something truly great, it takes time, and it takes Research and Engineering and then you have to test in the software world is more like more geared towards what is the absolute, craziest, quickest thing we can put in front of people and have them use it”.
…”we want safer devices for the people of the European Union, we want better oversight of what’s being sold, we want to be certain that things that are being sold in high volumes are being monitored appropriately and pulled if if they’re hurting people”…
“We chose to focus on the increased to put it lightly increased clinical evaluation standards and clinical literature standards that many devices and many companies were really not prepared to go after. Specifically in the light of conducting global systematic literature searches and sharing your findings”
“So my father came to me and he said, I know you build tools that automate processes and process data – I was doing a lot of financial transaction processing at the time – and he said: — Well, could you do clinical data? Could you build me a tool that lets me run all these searches, go through the results, and then generate an output that I can present to my notified body?
— And I said, Well, I’ll build one, but I’ll build it for the world”.
…”our approach is: a medical writer can now do 50 of these instead of doing one, and they can do it at the highest level of attention and quality. We’re trying to enhance the medical writer, we’re not trying to replace their experience and their expertise”…
Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome! We’ve all heard the saying nothing is consistent but change. The thing about change is change usually results in opportunities – if you’re paying attention. Today
we’re going to discuss one of the big changes that occurred recently in the medical device industry, the European Union medical device regulation or EU MDR. This change is really caused some big pain for companies. If you were listening at the time, what that meant was a big opportunity. Our guest today is Ethan Drower, founder and operating partner at CiteMed solutions, who provide full clinical evaluation reports services for EU MDR. Ethan’s a software engineer and entrepreneur trained to identify problems and
implement solutions. In our conversation, we discuss how to listen for new ideas, R&D differences and similarities in different industries, build early prototypes and capture customer feedback, scope a project pricing for value, and how CiteMed has positioned itself. Here’s our conversation. Ethan, before founding CiteMed, you were working on financial and consumer products. Can you provide a little bit of an overview of your career before CiteMed?
Ethan Drower 02:06
Yeah, absolutely, Patrick, I’ve been in I’ve kind of been in the software industry for about 12-13 years now. And I started off in electronic trading. And then I kind of transitioned off of that into a whole host of different industries; we built some consumer apps, we kind of went the startup route, some financial, you know, kind of banking in there as
well, I pretty much just tried to key on finding a unique and challenging problem and you know, build a team and build a piece of software to, to attack it. And as you can imagine, that can lead you down some pretty funny roads. If, if that’s your main criteria.
Patrick Kothe 02:54
So if you’re in an industry, you start looking for problems within that industry, you’re looking for problems across many industries, how did that come about?
Ethan Drower 03:05
It’s kind of challenging, right? Because most people spend their whole career in industry and they really get to know it intimately. And the beautiful thing about the software world is that if you are a capable problem solver and if you have a bit of an entrepreneurial streak, there’s really no limit as to what you can get involved with. So most of the work and the projects that I started either myself or that I’ve been involved in. I mean, they were kind of happenstance, how I would stumble across that industries problem. They certainly weren’t always long-term passions of mine or something like that was more, you make a connection with somebody, you do a little bit of contract work. And then you start to catch on to a thread of a problem, which turns into an idea that can turn into a business. And that’s kind of how I’ve always found the next, you know, found the next industry, the next challenge, the next project.
Patrick Kothe 04:09
So would it be correct to say that the problems came looking for you and you are open to the problems? Are you actively looking for problems?
Ethan Drower 04:18
I would certainly say in the case of my most recent venture and the reason we’re here, the problem came to me. When I was a bit younger, I think I definitely was guilty of trying to force the problem force the idea. And as I kind of progressed in my career, I realized that the juicy problems, the real opportunities, are the ones that are so great that you can’t ignore them. You don’t have to. You don’t have to dig them out. It’s not like looking for gold. It’s more about sitting back and being observant and listening to people about their challenges and what they’re going through and being more empathetic than then kind of being a driving idea, searching machine if that makes sense?
Patrick Kothe 05:10
Well, it does. And I’m curious as to why that happened. So what was it about your younger self that you were forcing it? Did you have this mental picture of being an entrepreneur or what was for you, forcing you to force
Ethan Drower 05:26
it? I think I think it’s a combination of things. When when you’re younger, especially, and you have an entrepreneurial streak, you want to prove to the world and prove to yourself also, most importantly, that you are a person that can create value and you’re a person that can build something useful. That’s, for most engineers, most software base people, our pride comes in the ability to create tools that do something right, something authentically useful in the marketplace, when you’re younger, and you don’t really have years of experience of proving that you can actually you can help, you know, build something in the marketplace, I think there is there’s a little bit too much, too much ego, and that can lead to urgency. And I would say that, yeah, the younger version of Ethan definitely, definitely struggled with trying to build too much too quickly. But it’s a real thing that younger entrepreneurs face, I think especially everybody does, but
Patrick Kothe 06:29
I think it’s also interesting, it may, it may be the younger software engineers, as opposed to medical device engineers, too. Because the traditional medical device people it’s come in, get your feet wet, it’s it within an established company, it’s not as much of a drive to be the entrepreneur, because it’s a pretty complex regulatory environment and a lot of investment needed and things like that. And you don’t have the same opportunity to rapidly make it make a product and to get that out in the marketplace as you do within the software. So when I’m talking with different early-stage careers, people in the medical device field, they want to be part of a startup, but they don’t necessarily want to start it themselves. Because it’s it’s a much more complex thing. It’s so I’m curious about this on the software side of things; if you’re developing software, is it because you see all these people that are doing big things at a young age? Is it the school they push entrepreneurship? What is it about software people that they want to go out and do it themselves?
Ethan Drower 07:47
I think there is, you touched on that, right? Because with software, you can create a product in two days, in the medical device industry, it’s very well understood that building something truly great takes time and takes Research and Engineering and then you have to test in the software world is more like more geared towards what is the absolute, craziest, quickest thing we can put in front of people and have them use it. And obviously, in medical devices, that is not a feasible way to do business. In the software entrepreneur world, there is pressure because so many people, it appears, are seeing such quick results. And that can create an environment of especially when you add big venture capital dollars and valuations to ideas that add creates kind of a crucible of bigger and faster to market, trying new ideas. If it doesn’t work, get rid of it, there’s less slow deliberation. And at least that’s the appearance. If you’ve been around for a while, you realize that the real players do test things, and they take the time before they really commit to an idea or product. A surface level is how quickly can we do this. Right. So yeah, it’s a very interesting world.
Patrick Kothe 09:17
Yeah, the concept of a minimal viable product is very fluid when it comes to different industries, a viable, viable product. There’s no downside to putting something on and pulling off in the software world, or there’s much less of a downside than it is an implantable medical device. You’re at different thresholds, thresholds of what a minimal viable product really means.
Ethan Drower 09:46
There are no minimum viable implants. That’s for sure.
Patrick Kothe 09:50
Yeah, but at the same time, there there are because you can say, you know, imagine this, and instead of building it and planting it. Let’s talk through the use case scenario of it. And this is what it does is what it’s intended to do. So maybe that is part of the
minimal viable product when you and you’re talking medical devices as opposed to software for different ways of looking at it.
Ethan Drower 10:16
That’s a fair point right ideas in the medical space. They’re not necessarily tested in the market, the patient marketplace, but they can be tested in the engineering process, first and foremost, but then also the clinical data and research process; what are the comparable things that are made up of similar things and designed in a similar way?
And how did those do that data is incredibly valuable to manufacturers that are considering investing in new product lines, and they need it to be able to make a reasonable decision and go down a multi-year path,
Patrick Kothe 10:55
or clinical data, as you mentioned, is the bedrock of what the medical device field is built off of; it’s one of the most important things that we do, it’s one of the most important things that we’ve got from a regulatory and from a product adoption standpoint. And it’s the reason one of the reasons why we’re here today is to talk of talk about clinical data and regulation and some major changes that happened in the EU. So let’s talk a little bit about the EU MDR. And what it means, why it occurred, and what problems surfaced as a result of this MDR process.
Ethan Drower 11:39
Yeah, I can kind of just give a quick overview of the status quo and kind of what the drivers were behind it. MDR is, is the bigger, badder version of the medical device regulation in Europe. Like most regulations, it was incredibly well-intentioned; the guiding principle behind it was that we want safer devices for the people of the European Union, we want better oversight of what’s being sold, we want to be certain that things that are being sold in high volumes are being monitored appropriately and pulled if they’re hurting people, that’s really what it comes down to, of course, the devils in the details and a whole host of I consider them challenges. They’re not always problems that imply that things are broken. And I think it’s far too early to say, with any kind of conclusive tone that this regulation isn’t going to do what it was intended to do. I think it might, but it does pose significant challenges for manufacturers on the regulatory side.
Patrick Kothe 12:53
it was extremely painful and continues to be extremely painful for companies as well. Unlike the United States, where you have a government agency, the FDA is the regulatory body, and regulatory bodies in Europe are a little bit different. They don’t; they’re independent companies. And there are a few of them. And they’re accredited, so to speak, that they can be used as notified bodies. And they can work with companies to make sure that the companies are following the regular regulations. And they can put a CE mark on their product. At this time to work. There was Brexit going on. There were some companies in the UK that were notified bodies; they were no longer going to be notified bodies within Europe, and the number of notified bodies went down. And you’ve got this new regulation that was coming on. That was more onerous for companies. And they were going to need to use these, these notified bodies as well. So you’ve got more regulation, different regulation, you got fewer notified bodies, that were doing it, you had a deadline. And that deadline kept moving out and out and out and out because of all the challenges that people had with it. But it’s now the law of the land. And there’s regulation for new devices. And there are regulations for devices that are on the market. And because all of this was going on, some of those devices were pulled off the market because companies didn’t want to go through a lot of the steps to keep them on the market. Yeah, or they couldn’t afford it, or it wasn’t worth it. You know that their sales didn’t support the investment that it was going to take to continue to have their product on the market. So let’s talk specifically about the problem that you guys uncovered.
Specific to this change in regulation.
Ethan Drower 14:58
Right, Because we could, we could be here all day talking about the challenges brought on by all EU MDR. We chose to focus on the increased, to put it lightly, increased clinical evaluation standards and clinical literature standards that many devices and many companies were really not prepared to go after. Specifically, in the light of conducting global systematic literature searches and sharing your findings, sharing the findings related to your products, your product safety, and performance, within a clinical evaluation report document, it existed under the previous directive; it was just never enforced.
Patrick Kothe 15:46
Let’s take a stop here for a second. So this is for a product that’s already on the market.
It’s your product; you’ve been selling that product. And now the new medical device regulation says we want to see the performance data of your product.
Ethan Drower 16:05
Correct. If your product has been on the market, the notified body might come and say to you, what claims are you making about this device? Are you making a performance claim? Are you making a safety claim? They want to know what they are; when you
make those claims, you need data to back them up. And the reality is Patrick, for most devices and for most smaller manufacturers, they don’t have a whole host of their own clinical data to support it. This means you have to get it from somewhere, you have to use other people’s data, and you have to be able to interpret it and present it to your notified body to say, these are our claims. Here’s the search that we did. And here’s the data we found that supports the claims we’re making. Thus, our claims are valid.
Patrick Kothe 17:01
Companies do this prior to putting a product on the market; they may perform a clinical trial of their product. And that will be used in the submission to get your product on the market. So that is that’s one piece of that. The other piece is once you do that, and now you’re on the market, then you also have to continue to monitor the performance of that product.
Ethan Drower 17:26
You have to prove it. You have to and for some products, you need to prove it year over year, those kinds of ongoing requirements, the updates, that’s also a fairly new MDR rule. It’s been well; I shouldn’t say it’s just being enforced. Now. It always existed. But yes, you’ve been approved for your products on the market. Congratulations. Now, what are you going to do to continuously monitor not only safety data but also clinical literature that gets published on your devices? What are you going to do year after year to monitor and make sure that your device is still safe and is still performing the way that you’ve set it? That’s a lot of work, especially if you have a multidevice portfolio and a small regulatory
Patrick Kothe 18:19
And it’s a small clinical team because sometimes, you know, other people are publishing on your product. But does this mean that you have to publish your own product? Do you need to sponsor clinical trials on each one of your products to keep them on the market? So there are different ways of doing these performance reports? So we’ll talk about that in a second. But this is different than what it is in other parts of the world from a regulatory standpoint. There are post-market surveillance types of things with the FDA, but not to the level that we’re talking about here. Can you speak a little bit about that?
Ethan Drower 18:58
It’s my understanding. And we’ve only we don’t operate very much in the FDA world, partially for this very reason. reporting requirements, the post-market reporting requirements are far more or far more challenging and far more robust in Europe. I mean, I think I think by comparison, it comes down to the interval of which you have to submit reports to your governing agency, FDA, versus your European notified body. It’s also the content and the scrutiny of what you’re submitting. It’s only been a few years, so we don’t have tons of personal data in terms of how these update reports and how this post-market surveillance is being scrutinized. But I can tell you from the last year or so that the notified bodies are working, and they are responding; they are commenting on the approaches of customers. I’m pretty young in life year and industry years, but I can tell you from our senior, our Senior Consulting, and our senior medical writing team they’ve never quite seen anything like the amount of feedback that they’re now having to respond to for our clients. Cutting the corners, I guess you can say, when it comes to how you’re submitting your reporting, is not something that’s really working at this current point. And it used to, to be honest, it really used to.
Patrick Kothe 20:29
So I’ve been through, you know, many different different types of audits from notified bodies FDA, and a lot of times what happens is, is the entity focuses in on something they’ve got, they’ve got an emphasis on a certain thing in that time period. So it could be on complaints, it could be on your career, your CAPA system, it could be on things from a marketing standpoint, there’s kind of focal areas that they’ve got, it appears that from the notified body standpoint, this is one of those focal areas right now.
Ethan Drower 21:08
It really has been an especially as it comes to proving that you have put repeatable processes in place to perform your surveillance and Perform your search of global literature; I would say the vast majority of our clients that have come to us they’ve already been, they’ve already been flagged with nonconformities when it comes to their clinical evaluation strategy. And we’re not just talking about their own studies; we’re talking about how they plan to do their vigilance reporting, how they plan to do their periodic safety update reports; it’s clear that the notified bodies are this is one of their bigger checkboxes. So it just needs to be a focus. Now, it needs to be can’t be an afterthought.
Patrick Kothe 21:57
So you said that it starts with claims that whatever claim that you’re making has to be supported not only by safety claims but efficacy claims, as well as to be supported with the literature or with the clinical information coming forward. Is that is that the process starts with the claims and then starts looking for the pieces that support that?
Ethan Drower 22:23
Generally, yes, it’s kind of, it’s kind of a reciprocal relationship. One of the challenges that a lot of our clients face is that they tend to conflate their marketing versus their competitor claims with the claims that they’re trying to make in their clinical evaluation report; we often see that manufacturers are, they’re making too strong of a performance claim. Because their device is the best, of course, it’s the best in the marketplace, right?
When that’s really, that’s a marketing claim. And it doesn’t have anything to do with looking through clinical literature and supporting, you know, supporting your actual device and how it affects the patient. For most devices, the average study is not going to be testing a lot of the marketing claims that the company is making about their device. If we’re testing a surgical clamp, okay, your claim, it’s going to be hard for you to find clinical literature that supports just how great your clamp is.
Patrick Kothe 23:33
Ease of use is a classic one, right? Is abuse better than competition?
Ethan Drower 23:40
Right? And how do you measure that the notified body would say if that’s your claim, I need to see some studies, I need to see some literature that we’re that’s measured and supports it. Whereas you should really be more considering your claim of your clamp to be. Well, it works. Right? It closes the artery; it does what it intended to do. And it hasn’t killed anybody in X amount of surgeries. So we often find that that that can be kind of a tricky point to understand. Be certain that whatever it is you’re claiming, you can support it with either your own data or data that you go out and find in the world. And don’t overshoot your claim. You don’t need to for the average, you know, fairly straightforward device; you don’t need to be the best in the world. They don’t care. They just want it to be safe and work.
Patrick Kothe 24:34
What is the problem? So you’ve got a multinational company that has 1000s of products, and they want to stay? What want to continue to sell those products in Europe? So they’ve got all of these. They’ve got regulatory and clinical departments that are responsible for this. What is the problem that you heard that these companies had
Ethan Drower 24:59
that challenge that we set out to tackle is that, especially if you’re a big portfolio manufacturer, there aren’t enough hours, there’s not enough time to comply. If you have hundreds of these products, most of which are simple. And we’re talking double-digit hours to, you know, 60 100 hours per device, sometimes per year, it’s impossible to bring on that much staff. And it’s impossible to coordinate an army of contractors to consistently update these documents and consistently monitor the literature in any honest way. You could say you’re doing it. But if you actually intend to comply with the systematic literature, review requirements, and keep your clinical evaluation reports updated, there are just not enough hours in the day; it’s often hard and labor-intensive work that your engineers, your regulatory affairs, top potshots, they it’s a waste of their time in most cases because it’s really just legwork. They’re not making the high-level decisions where they’re processing the data. They’re reading the studies; they’re organizing the outputs. That’s really what we set out to challenge. It’s the capacity and timeline issue.
Patrick Kothe 26:20
What’s the capacity timeline, there’s also content. And while there may not, we may or may not touch on this, if you’ve got heartfelt and there are studies out there on heart valves performance and things like that, that’s one thing because you’re probably going to find some things in literature and the literature there. But if you’re selling a scalpel, there’s probably not going to be a clinical study on the performance of your scalpel. It’s really hard to get, so that’s why I say there’s a capacity issue. And then there’s the content issue. And it’s how you develop this because if you’re just combing the literature for things, heartfelt studies, that’s a doable project. But if you’ve got to create something that’s a little bit different. So tell me a little bit about that.
Ethan Drower 27:11
Right? When and we often do quite a few lower classification devices where you’re right; there’s not going to be a safety study done on your particular brand of surgical gloves, still need to see if you’re still submitting your documentation. So you got to do something; we’ve generally found that the approach that it’s kind of it can be twofold. But we’ve also found the notified bodies to be understanding when the device is, is simple. And it’s clear that there aren’t going to be necessarily trials done on that specific device. So you can kind of restructure your argument in the aggregate, you can say, our device was used on this in these amount of studies in these amount of procedures.
There was never a single thing reported about the scalpel breaking, there was never an issue reported, and anything that we came up with, here was our process. We’ve looked at every single, every single reported piece of literature that even mentions our device, and they got nothing there for weakens the claim that it’s continuing to work. And it’s continuing to do as an intendant, it’s a scalp, and its job is to cut and not break. Right not not not breaking the patient. Oftentimes finding nothing and proving that you’ve searched everything is the strategy.
Patrick Kothe 28:38
So MDR hits, you’ve got regulatory and clinical people throughout the world saying, I don’t have the capacity to do something like this. I need help is that the big issue that you ran into?
Ethan Drower 28:53
It really is. And I mean, most I think most regulatory people will tell you even before MDR, the regulatory department is often the last one to get budget and staff. And we have so many clients where it’s a team of one to two people, and they’re superheroes, right? And they’re regulatory, quality, and clinical. And they’re responsible for all of these things on multiple devices. They were getting it done barely before. And now, with even a further increased workload. That’s what we found; we just found that there has to be a better way. These regulatory affairs professionals can’t just do all of this by hand, do it all in Excel, and be expected to complete all their documents on time.
Patrick Kothe 29:40
So how were they doing it? In the early days without you, how do they do it?
Ethan Drower 29:46
Well, you either don’t do it. Number one, and you punt, and you say, Oh, we typed some search terms into Google Scholar, and this is what we found. Or, you know, if you wanted to do a fully compliant MDR, is a systematic literature review today. And you’re not using any tools; you’re doing it in Excel, you’re basically searching multiple databases, you’re pulling all the results in, you’re trying to find and remove all of the duplicate results, you’re counting up all of your search results per search term, then you’ve got to review each one, pull out the relevant data, determine whether or not that study is relevant or not, record your feedback, and then submit a report that’s actually readable and understandable to the notified body, showing not only your results but an exact repeatable process as to how you got there. And that’s what trips most people up most people find good studies and submit them and have read them. The problem is the notified body says, Okay, well, how did you get there? And if you can’t give them a protocol that they can repeat on their own, then you’re not conforming? You got a problem?
Patrick Kothe 31:02
Okay, so let’s go back to the business for a second. You said that problems kind of find you. So you’re often software world, and all of a sudden, how did this one come and find you?
Ethan Drower 31:13
this was, believe it or not, it was my father. He has been a regulatory affairs veteran pretty much his entire career. And he was in pharma for decades to 20 years plus in devices. When MDR hit the company he was with, he was tasked with doing literature reviews on hundreds of devices and hiring out firms and things like that, you know, after he read the regs and deliberated. He put together the hours, and he was like this is impossible. I can’t do this. And there’s not enough money to hire just an army of consultants to push it out the door; it just wasn’t economically viable. Right? I mean, how much can you spend for a literature review on a scalpel? You can’t spend 70 $80,000; it just doesn’t make sense. So he came to me and said, I know you build tools that automate processes and process data, I was doing a lot of financial transaction processing at the time. And he said, Well, could you do clinical data? Could you build me a tool that lets me run all these searches, go through the results, and then generate an output that I can present to my notified body? And I said, Well, I’ll build one, but I’ll build it for the world, not just you. That’s kind of how the idea was born. And yeah, the challenge presented itself to me, you know, over at the dinner table, more or less?
Thank you, dad.
Patrick Kothe 32:53
Yeah. Sometimes it comes through taking it from that conversation. What was the next step for you? Was it just jumping into it? Was it validating with other customers? What was the next step for you?
Ethan Drower 33:11
The next step is always for me. It’s always validation. So it’s, do other people have this problem? And how many of them are there? And how painful is it? And right, how badly Is this hurting companies? And so so we did; I did some research. That’s the other thing about this industry that I’ve never really; I’ve never found anywhere else. And why I kind of call it, my home now is in the regulatory affairs industry. I’ve never seen such a collaborative environment when it comes to being able to reach out to people and ask for their advice and their opinions. It was one of the easiest things in the world to get on the phone with some incredibly talented and experienced people and say; this is kind of what we think the problem is; what are your issues? And what do you think we were able to find that this is pretty much an issue for everybody that has to do these things? And the device market is obviously a huge and growing, growing market, especially in Europe; it was pretty simple to realize and say, Hey, this is something that’s worth committing to because this is a problem that’s not going away. This is something that people really need. And it would really make an impact if we built it. This isn’t just a, you know, a funny app that changes the filters on your face, right? This is something that has a real impact in real impact globally,
Patrick Kothe 34:35
taking it from the idea. And once you validate that there’s a problem now, you start thinking about potential solutions for it. I’m sure this is a software solution. So, tell me a little bit about the development of that product. And what are you providing at this point?
Ethan Drower 34:55
The solution that that we ended up with, you know, we tried to look and say if We were going to do the most thorough, absolute best literature review in the world, right? We have unlimited time and unlimited resources; we are going to search everything and review everything; how would we do it? And then we just kind of worked backward from there saying, how much of this is achievable with a software tool with an effectively built piece of code, basically. And we kind of tried to, we kind of tried to arrive at the intersection of that of this is the absolute best process that can be done. And what’s actually viable in terms of how we can build software, how expensive is it going to be to make, How easy is it going to be for a regulatory a medical writer to use, and that’s kind of where we ended up with, with a tool that it’s not going to, it’s not going to do the research for you, you still need to be a regulatory affairs professional, you still need to be qualified, you need to pick your search terms, you need to pick your strategy. But what the tool does is it facilitates all of the work. That is a nightmare. When it comes to processing all of this data and generating your outputs, we ended up with essentially the most effective tool out there for wrangling massive amounts of abstracts, clinical studies, and clinical data and building it into a single portal that a medical writer can use to just focus on their expertise, which is reviewing studies and determining the relevancy to their device. That’s all we want the writer to do. We don’t want the writer to build summary reports and build giant tables and 1000-page Word documents; that’s for us; what we wanted was a tool where all the writer did was focused on the research, and everything else kind of melts away for them. So that’s always been the goal. And that’s really kind of where we’re at now.
Patrick Kothe 37:01
So if I understand this correctly, you looked at you starting with the end product in mind, saying this is what we need to do, then this is what we can do. And we’re going to build the best piece of what we can do. And notice that there’s a gap now between what we can do and what is necessary for the final product. So you say this is the software solution that we can provide, but there still needs to be a human involved in putting the terms in and writing the report. So we can tee it up for them to a certain amount. And then they’ve got to take it the final mile. But they’re not running 25 miles; they’re just running 26 miles.
Ethan Drower 37:44
Correct. And they’re doing what they do best we’re optimizing the regulatory professional, we’re optimizing the medical writer, instead of trying to replace them. One of the problems I’ve seen kind of crop up; it’s gotten trendy in this industry over the last few years is everybody’s trying to push and build an AI and artificial intelligence solution. Artificial intelligence can be great as a broad topic. However, in the context of today, what’s useful for regulatory professionals, it’s not they don’t need a machine to make decisions for them. They’re the best, they know their device, the best, they are top-tier professionals in their industry, and they need to be making the decisions, but what they don’t need to be doing is all of the other stuff. So our approach is not okay; you don’t need a medical writer. Now, our approaches, a medical writer can now do 50 of these instead of doing one, and they can do it at the highest level of attention and quality. We’re trying to enhance the medical writer; we’re not trying to replace their experience and their expertise. In my opinion, it’s a waste of time to try to do that. These people are incredible; we cannot, we cannot just optimize them with a machine-learning algorithm. It’s not the time,
Patrick Kothe 39:04
the functions that you’re taking over as you’re helping them to make it easy to input the search terms. You are systematically doing the searches; you are formatting the data as it comes back and presenting interim reports. And then they take it from there. Is that kind of the main function?
Ethan Drower 39:28
Pretty much, I mean, with our solution, either we’re doing it for you, or you’re using the software yourself to run your own reports. You pick the databases that you want, you put in your terms, you’re going we go out into the world and we get all of that research. We mark, we remove all of the duplicate articles, we count everything we keep track of everything. And then all you’re presented with is a list of articles to review. Mark them with their relevancy, the relevant ones will get you the full-text articles or whatever you need. And then, you will actually perform your analysis of the studies you want to be analyzing. And then, when you’re done, you click Done. And you’re going to get back from us; you’re going to get a full output of exactly what you needed, the full summary of how the search was performed, the results of the search, and all of the classifications that you’ve you’ve chosen, and all of the data extractions that you’ve opted to do, somebody has to read the studies and make the decisions. Right, we either will do it with our experts, or you can do it if you prefer, but the labor is in the formatting of this report. What do we do with all this data? How do we get it into a CDR so that it makes sense to a notified body auditor? That’s no small task; that’s a lot of Excel and Microsoft Word table work. It’s hours and hours and hours of manual formatting. So that’s all of the stuff that we try to take off the table, we try to say, you just review literature, or pay us to do it, whatever. But that’s all that’s the only focus.
Patrick Kothe 41:12
So you do have people that are going to be doing the reviews and doing the writing as well. So somebody could go for a turnkey solution with you, or they may use your tool and take it in-house. What’s been the breakdown of your customers? Is it 50-50? Is it a lot of people doing it themselves? What’s the approximate breakdown?
Ethan Drower 41:31
It’s mostly people soliciting our expertise on the reviews. So I would say it depends on the size of the company; generally, the bigger the company and the bigger the regulatory department, the more apt they are to want to take control of the process and make their own calls. But for a small manufacturer, where it’s one Regulatory Affairs Director and one QA person, they want to lean on our expertise and say, We’ve never done a systematic literature review. Can you guys have a notified body-qualified person talk with us to understand our devices, pick our terms, and conduct the review for us?
And so we’ll do that. But I have a feeling Patrick that it’s going to lean much more towards people who will want to do it themselves at a lower cost point as they start to get comfortable with the regs and get some more experience doing these reviews. But right now, it’s more heavily towards people who would like our expertise on the review as well, not just the processing.
Patrick Kothe 42:34
So if the customers that you have supplied this and solution for them. What do they say when they get these reports? This terms of speed in terms of quality? What are the comments that are you that you’re getting back from them?
Ethan Drower 42:50
I’m pleased to say, generally, they’re quite good. It’s always interesting to see what a client’s expectation is when it comes to these kinds of reports. A lot of clients don’t; they don’t really know what these reports should look like in their ideal state. Remember how we were talking about the perfect literature review? A lot of people we work with couldn’t tell you what that is; they’re just happy as long as it makes it through their car audit and looks good, and seems comprehensive. Some of the more experienced clients know exactly what they’re looking for. And they’re generally impressed with number one, the timeline; there’s nobody in the industry that can do these things. And in under two weeks, we can do them well without missing things. And then number two, they’re impressed with how standardized the output is.
Patrick Kothe 43:43
That’s kind of the next question what are the companies saying about it? But more importantly, what are the regulatory agencies doing? What is What are the notified bodies saying about it? Because I gotta imagine that a common format would be something that would be attractive to the notified bodies as well.
Ethan Drower 44:04
We’re hoping to kind of build that, you know, that kind of expectation over time as to this is the best way to present this data. The feedback that we’ve received from notified bodies with this format, it’s pretty exceptional in the sense that our process has been so thorough that we’ve only ever gotten a few clarifying questions as to where your verification data is. That’s a big one is, okay, you’ve done this, you submitted this massive document, here are all the results. But now, how do I know that? If I plug these terms in the same way into a database, my results are going to match what you’ve listed here. So all of the feedback and a lot of our work is done to answer that question to notify the body, and we can say, here are the terms here’s when they were run. And here’s an exact matching database file that you can review if you Want to? And then when you kind of have that whole process built, and you have the entire verification in place? We’ve never had more than a clarifying question of where I can find this from a notified body. So it’s been surprising, to be honest; I was expecting when we started this that we would, you know, you always mistakes are made, there are always problems. But on the literature review side of things, if you follow the rules, we’ve generally found consistent responses from the notified body, and everything goes through. So I couldn’t be happier with the results.
Patrick Kothe 45:35
So what was the amount of time from that conversation with your dad over the dinner table to the first customer to repeat customers,
Ethan Drower 45:46
it was about six to nine months to get the first customer; most of that was due to having to do quite a lot of legwork on my end, not just build a minimum viable product of the software but also to really understand the industry and understand the problems that the average RA professionals are facing. From there, the growth kind of started to come in more of a snowballing fashion. And we’ve probably done in the last 12 months 20 times what we did in the first two years; it’s kind of started to hit that more exponential growth curve. And bring all the fun challenges that come along with growing quickly.
Patrick Kothe 46:28
So let’s talk about the business model for a second. So you said one product is an end- to-end solution; you do the search, you do the writing. And they said customer submit. And the other is, is it a licensing model?
Ethan Drower 46:41
Yes, the other would depend on your needs. If you’re a single writer or if you’re a larger company. The other model is you can use our software per project or per device, as it were. And you can store all of your data and perform your updates very easily and keep track of keep track of the progression of reviews over time. And that’s kind of the bigger; the bigger value proposition to a larger company is to imagine having all of your devices tracked and easily repeatable search processes all in one place. It’s unheard of. It’s unheard of until now. So that’s kind of our big, our big push,
Patrick Kothe 47:25
scope me a little bit on pricing. I know pricing has got to be kind of across the board based on volumes and all kinds of different things. But scope me a little bit about if you’re doing the work; approximately how much are we talking about if somebody else is licensing this on for an individual product, approximately? Where are we talking about?
Ethan Drower 47:47
To be honest, Patrick, this is one of our biggest, biggest challenges because, you know, we feel that the value of our tool is not truly realized yet in the marketplace. On the software licensing side, Patrick, we’re still working to really refine and dial in how it’s going to best serve larger companies. On the managed service side, when it comes to us conducting literature reviews, we generally find that we’re coming in 50% lower than the industry standard kind of consulting rate. So you’re looking at low ends in the upper single-digit 1000s. You’re looking at for the average project; you’re looking at much closer to, you know, the 20,000 mark. And it also depends on how many devices you have and how fast you’re trying to get these done. Many people are on very urgent, shall we say, timelines where they’re late, or, you know, facing a next round of audit submissions. You know, that’s something that’s very possible for us to do. And obviously, that affects the pricing as well. We try to be as flexible as possible with the customers. This is not a commodity product. It’s not about cheaper. And it’s not just about faster. It’s about what’s going to work and what’s going to fit your business needs. So we try to be as flexible as possible and make sure that the client is getting a fair deal.
Patrick Kothe 49:27
Are these reports done annually?
Ethan Drower 49:30
Depending on the classification of the device, if it is 2b or 3, you’re going to need to be updating your literature review at least every year. The two A’s depends on the device, and it depends on who you get for your notified body. But most of our customers in the range stick to every two years. They do a literature review, update, and kind of update their car as well.
Patrick Kothe 49:57
Is it more difficult to do that do it the first time And then become easier with each subsequent one? Yes,
Ethan Drower 50:03
mostly just from a standard of it’s a function of how many results you’re going to be processing. And your first one, you’re going to want to look much further back; when you’re doing the updates, you’re only looking back until your last search. So an annual update covers 12 months of the first literature review, often can cover, you know, between 10 and 20 years, depending on the device. So that’s a whole lot more literature to review.
Patrick Kothe 50:29
And the pricing would be reflected on an update versus the first time.
Ethan Drower 50:35
Correct. Generally, for the updates, it’s, the pricing is around 25% of what the original project was. You also have to remember if you’re using our platform to do it or we’re using our platform to do it; we saved all of your previous results. We know your search terms; we know your devices. So the efficiency that we gained from being able to just spin up the new searches and generate a new protocol, we try to pass all of that on directly to the customer, because that’s, that’s really where it kicks in the value of the software is you can easily update them.
Patrick Kothe 51:13
And going back to the point that you made earlier, what is the process that you followed? And if you continue to follow the exact same process year after year after year? That’s what the agencies are gonna want to see. Correct?
Ethan Drower 51:29
Can it be consistent? And do you? Do you have a hope of maintaining it? We strive to make that as clear to the notified body as possible because that’s, that’s really what they want.
Patrick Kothe 51:41
Well, this has really been an interesting conversation. It’s kind of a specialized area, Ethan, but it was interesting to look at a startup company solving a problem within our industry and the pain points that we’ve got with it within our industry. So my question for you is, you know, you’ve been involved in a lot of different things and a lot of different industries. What’s next for you? Is it to expand out into medical devices? Is it going to expand out to other things within regulation? Or if another problem outside of our industry comes calling? Is that the next step for you?
Ethan Drower 52:18
I think we have a long way to go in the medical device world and specifically within the regulatory affairs world. I think I think we found our home in this industry. And I’m looking to try and build the most valuable and useful suite of tools around clinical literature, vigilance, essentially, just data, essentially clinical data. Our main vision is to stick with this and really try to turn it into the industry standard of systematic literature review. That’s where we’re headed. And I don’t see us diverging from that path. No matter how many dinner table conversations I have with my dad, I think I think we’re onto it. We’re on to the big one here.
Patrick Kothe 53:05
The medical device ecosystem provides a lot of opportunities. We often focus on the products clinicians use on their patients. But there’s actually an opportunity to help people and medical device companies become more efficient and allow those companies to continue to provide those products; a few of my takeaways are to pay attention to your surroundings. Ethan really did a good job in different industries and paying attention and looking for problems. And when your antennae are up for listening for these things, they tend to find you. And certainly, it was nice that Ethan’s dad provided him with that opportunity. But there are a lot of ideas out there if you’re paying attention. The second is when you enter a new area, you’ve got to immerse yourself in it. As Ethan described, he had the product idea, but he wanted to go and learn about the industry. So spending time embedded within the industry, finding out about the customers and their processes, in addition to the pain and the solution that he was going to come out with. The last thing was to know what your product does and what it doesn’t do. He started off by trying to thoroughly understand the whole process. And what he discovered was that he could provide an answer to a portion of it, but the regulatory professionals are the heroes. So he designed his product to make sure it fit in the workflow and the capabilities of the professionals that we’re going to be implementing. Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical device podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the mastering medical device podcast, as interviews like today’s can help you become a more effective medical device leader. Work hard, and be kind!
