Clinical Study, Case Series, Registry, Survey - What They Should All Have in Common
Jon Bergsteinsson is the Founder and Chief Commercial Officer at Smart-Trial, a company dedicated to providing a simple, yet robust platform for electronic data capture. In this episode Jon shares the differences between pharma and device trials, pre-approval and post-approval studies and scoping them appropriately, why electronic data capture is preferable to paper based systems, his advice to start-up companies contemplating a clinical trial, how changes to the EU MDR have impacted companies and how they are managing the requirements, and the future direction of data collection.
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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 all know that clinical trials are crucial within the medical device industry. We also know that there are many components to consider when you're designing, conducting and analyzing a valid clinical study. And your method for collecting data is one of them. Our guest today is Jon Bergsteinsson, the Founder and Chief Commercial Officer at Smart-Trial. Jon has been involved in medical device and pharma trials for years based out of Copenhagen, and discovered a market need that could better serve the medical device industry by providing an easy to use, yet affordable electronic data capture platform. In this episode, we discuss the differences between pharma and device trials, pre approval and post approval studies and scoping them appropriately. Why electronic data capture is preferable to paper based systems. His advice to startup companies contemplating a clinical trial, how changes to the EU MDR have impacted companies, and how these companies are now managing the requirements and the future direction of data collection. Here's our conversation. Jon, welcome. So glad that you're here joining us today.
Jon Bergsteinsson 02:02
Thanks, Patrick. Happy to be here as well.
Patrick Kothe 02:06
So clinical trials have always been critical when you're dealing with medical devices, both from a regulation and an adoption standpoint. But there's been a lot that's that's changed recently. I'd like to kind of kick this off and go back to 2012. When you were starting to think about clinical data capture and clinical trials, kind of what were you thinking at that point in time?
Jon Bergsteinsson 02:33
Well, that's a good question. A lot of things were going through my mind at that time, I come from a fairly tech minded family. You know, my father was a hands on electrician did, you know partial engineering as well. And I've always been fascinated by technology that's been surrounding what I'm doing. And back in 2012, I have been working for a couple years as a technical assistant and steady coordinator assistance in pharmaceutical based clinical trials here in Denmark, where I was assisting with the day to day tasks at the clinical trial site. So it says welcoming patients, and noting down questionnaires, taking interviews, transcribing data into a web based system where all the data was gathered from all sorts of sources. Well, one of the first things that that it started to irritate me quite a lot was the fact that I needed to use Internet Explorer, that was the only browser that was afforded for the tool that we were working on. And that back in the day, I was using, you know, some of the, you know, browsers that we are very well used to today, like Apera, Chrome, you know, Firefox, and you know, that just the fact that I had to install a separate browser to use, like, a very highly sophisticated software for clinical trial irritated me. And the fact that I also disliked the user interface, it wasn't as sleek as Facebook, it wasn't as nice and as intuitive as some of the other websites I was visiting on a daily basis. And I just felt like there was something missing. So that was kind of the energy and the feeling that I you know, was experienced at the time. I guess that was the spark to, you know, what I'm doing today.
Patrick Kothe 04:27
You're managing clinical trials are you're dealing with a data capture, and you're using a tool that is not an optimal tool. Somewhere in your mind. You said, Hey, there's got to be a better way.
Jon Bergsteinsson 04:39
There's got to be a better way to do this and actually come to think about it. I think that was exactly what I told my now co founder at the time, Paul, I met him at the cafeteria at the university so we were still at the University at the time, almost finished with our master's degree. I told him there must be a better way to do this because you You know, we're using smartphones every day. And at that time, you know, we were still getting used to downloading apps for everything that we do. But everything was becoming so sleek and easy to use, you know, on a modern device. So, you know, come to think about it. Why would that amount of money that is put into clinical trials in the life science industry? Why has this to have to be a showstopper? And I remember there was a talk about it at that time. I can't remember who or what was the hat, there's talk at one of the TED talks, and at the time, but that was a person that was referring to the fact that the life science industry or the hospital industry was one of the few industries that missed out on the internet, there is a gap in what has been happening in the rest of the IT or other service industries. When it comes to the internet in the user, internet and application of internet in healthcare.
Patrick Kothe 05:57
I'm sure it was had a lot to do with the regulations and and how much time it was going to take for someone to change a system and still stay compliant with regulations.
Jon Bergsteinsson 06:07
Yeah, I guess your that had that had a huge influence. At some point. Yeah. The regulations around that is is a little bit tricky.
Patrick Kothe 06:18
I think that's probably why you still see people with quality systems in their companies that are paper based, as opposed to electronic, just because it's a legacy system, you know, that you can you can utilize that paper based system and switching over to electronic is time, and dollar and investment. And maybe it's just better to stay with paper.
Jon Bergsteinsson 06:40
And I think even just a year before that, too, I was working like a part time assistant at one of these departments where they were using a DOS based software to calculate results from a specific test that was being performed at the clinic at the department. And I was watching this guide, hitting some numbers into this Das program and pressing enter and waiting five minutes. And I just thought to myself, really, really? Is that how we're still doing it? Wow. And at that time, I just, you know, my my brain started flossing. There must be a better way to do this in general and healthcare. And since then, we've, I mean, it's only a couple of years, since that time, eight or nine years, but we've gotten a little bit further, I'd say.
Patrick Kothe 07:27
So yeah, you started off with pharma studies, and pharma study sometimes are different than medical device studies. So let's kind of start there and talk a little bit about the the differences between pharma and med dev studies. Yeah,
Jon Bergsteinsson 07:43
so I guess if we're going to address that topic, we might need to go a little bit further back because I'm a biomedical engineer. And one of the things that you learn studying biomedical, biomedical engineering is the difference between medical devices and pharmaceuticals. And often when you think about pharmaceuticals, or medical solutions, people just think about pills. They think about medicine. But when you specifically say medical devices to people, they start thinking like, Okay, wait, wait a minute, what, what is medical device specifically. And then you start mentioning these examples of, you know, everything from, you know, a theater to a band aid to, you know, a more high tech implantable device of some sort. And people start realizing that there is something called a medical device. And it might be different from what you otherwise might be used to when it comes to pharmaceuticals. Because most of the times when you say pharmaceuticals, people just put everything under the same umbrella. When I was studying biomedical engineer back in the days, I came to realize that there was a whole set of regulations and standards around medical devices that I've never, ever heard about before. I just thought, I thought, as dumb as many others, you know, in that age, and many others that have also embarked on the same journey as I have within the medical device industry, finding a company launching a product, getting it to market, you only realize when you get actually into the medical device industry, how regulated it actually is, and you can then debate whether it's regulated enough.
Patrick Kothe 09:17
And we'll get into that conversation a little bit with all the changes going on in Europe.
Jon Bergsteinsson 09:21
And but there is a difference between the pharmaceutical products, some medical products, such as you know, medicine, and medical devices, and in the essence, it's the way we apply them. And in practice, medical devices are all sorts of types of sizes and, you know, they're used within outside of the body in relation to, you know, a treatment with a physician of some sort. And the way that you apply them in practice is so vastly different from how you use pharmaceuticals which are usually just injected or can get it somehow into your body and that The effects of, of measurement of how the device is, you know, used in practice is, well, the way that you measure them it just completely different. Usually you measure, you know, blood level, you know, some different blood levels or other, you know, laboratory samples from the human body, when you're evaluating how the medicine is effect impacting the body. But for many devices, that's not relevant, it's irrelevant to measure laboratory results when you're looking at, for example, a low grade bandage or a wound healing device. You know, they might be relevant, at least when it comes to the human testing stages. Coming back to your question, or what is the difference between these kinds of studies and what you know, and devices and pharmaceuticals in general for when it comes to clinical operations. It all comes down to the fact that we're using and applying devices differently, clinical practice versus how we're using and applying pharmaceuticals.
Patrick Kothe 11:00
So let's switch gears a little bit and talk about clinical data. So capturing the data and why that's why that's so important. And what are the different methods that people are using for capturing data right now,
Jon Bergsteinsson 11:16
clinical data collection within clinical trials, clinical investigations, clinical operations, in general, whether it's pharmaceutical or medical devices, or something else, has, in general been conducted on paper in, you know, assisted with computer technology for decades. And within pharmaceuticals, most companies have been doing so primarily in a digitalized matter, with the use of electronic data capture solutions since the late 70s. The reason why that has become popular is mainly due to the fact that it really it's a lot of pain related to erroneous data entry, missing data, lack of overview, lack of data structure, validation, error checking, and so forth. So, for years and years, the pharmaceutical clinical trial industry has been using these electronic data capture solutions, along with a lot of other additional solutions to keep control of the data while they're running the clinical trial. So you have people logging in from different sites, and doing data about every single case they have at the site. And thus, there's a centralized system to keep track of all that. Device studies have been kind of left out in the cold. For the past, I'd say more than than a decade or so because the regulatory requirements in the US or Americas and Europe are super similar in that regard that you can actually, or at least you could in Europe, put a medical device product to the market with out having to necessarily conduct a large clinical trial. But there is a loophole in the regulation that, for example, a lot of companies have used to get the device to market in Americas and European Union without having to conduct a clinical trial. So what that has resulted in is a lot of companies have not had to collect a lot of device data in relation to the devices getting to market. Most of the time, it's the higher class devices, the high risk devices that have had to do that, because of the risks that involved in using those devices. Those devices have either than use paper as their primary source of data capture. So you have sites still entering data, or registering data on every single patient that is using the device by completing a set of paper based questionnaires in a folder, the site which then the sponsor, the device manufacturer has to fly out to and get transcribed and an analyze to get the results in some of the companies that have had the funds, which are very few and we're talking, you know, two 3% of the medical device companies have had the funds to finance all the clinical braces with the pharmaceutical versions of data capture tools. What that has resulted in is an imbalance in the device industry for small medium enterprises to use this technology to their benefit as well when they have devices that need to go to trials. So what what we have seen being in this industry for now, almost 11 years in total, is that there's a there's a certain change happening right now in the life science industry. There's a lot more companies similar to ours that are seeing the potential to provide a high quality solution in terms of data capture, and offering it to the segments of the life science industry that haven't had the funds or haven't had the chance to acquire the more expensive pharmaceutical solutions. When it comes to data capture, in general, we have medical device companies that are using pharma based data capture systems purely because of historical reasons. Or some of them have started to use solutions, like, for example, our smart trial to gather data, or we have still, and I'd say it's probably still roughly half of the time when I talk to companies, companies that are using Excel or paper based methods to gather the data. And this is significant. Well, this is a more significant or significant higher number that I expected. Getting into this industry that there were so many companies still using XML as primary data collection source, where I been, you know, involved in a trial, which was using a web based system, and I was just automatically thinking everybody's probably using something like that. But there's still a significant number of medical device companies that hasn't had the chance. And that's purely because of the fact that it's a too expensive, the not very well designed to be adjusted to device studies. And the third thing, horrible, time consuming, complex to implement. And for device studies, which are usually like we said before, small, often done multiple times over, you know, two or three types of protocols. Implementing such a system for just one study is, you know, out of the picture for many companies,
Patrick Kothe 16:27
not all clinical studies are created equal, not all of them have the same objectives with it. So when we're talking about clinical trials, who can I kind of separated them into pre market studies and post market studies, and pre market studies are generally done to gather the data on the safety and efficacy of your product, in order to submit them to a regulatory body to obtain clearance or approval to sell it, sell your product. And that's one section of products. And then there's the post approval, and we'll talk about Europe in a second. But the post approval is some type of surveillance of your product, as well as expanding out marketing claims, and doing things from a marketing and sales standpoint, to get your product further validated with key opinion leaders, and to have people speak from the podium at that meeting. So those are kind of the post approval studies that are going to go into any they're different sizes, different level of levels of complexity, different levels of scrutiny that go into, and also different endpoints that you're that you're looking at. So as we kind of divide these these things up, it's different when you're large company, small company, depending on where you are on that continuum of different different trials. Is that Is that right? Yes.
Jon Bergsteinsson 18:00
Yes, and I think a lot of it has to do with, with the regulatory pathway that you choose for your devices, some of the logic companies, they might have the funds to choose the more expensive pathway. But you know, why go that route, if you have a chance to not do that, most of the companies that don't have the funds, they'll take the cheapest route possible to get to market. But the type of endpoints you choose is critical, especially when we're talking pre market because that data is of course supposed to mirror the minimal requirements that you have to illustrate to get to market. So that might be different, depending on the product. When that is accomplished, you can then start thinking about other end possible endpoints that could help you assist, for example, with sales and marketing. You can probably speak more of that than I have, because you've been working on a lot more medical devices, right? So from your own experience, I mean, how many of the studies that you've seen or have been initiated from the companies that you work that have actually been focused on sales and marketing versus regulatory? Is it about the equal or it
Patrick Kothe 19:16
really depends on the product? It depends on what the market is asking for. It depends on whether it's a 510 K product or whether it's a it's a PMA device. There's a lot of different different reasons why you go in there. It also depends if you're the first one end if there's one of many, what competitive landscape looks like. So there's a whole host of reasons, but it's typically everyone who who needs to does that. Does that regulate a trial and then they also do trials post and we'll talk about you know, what's going on in Europe right now, but they'll typically will do post approval studies for the for those sales reasons and expanding out indications and keeping the product in In top of mind awareness with clinicians, so I think it's kind of both.
Jon Bergsteinsson 20:05
But you know what, one of the things that I often see companies embarking on this journey for the first time do is to try to do everything. At the same time. Try to do one trial that encapsulates everything. But like you're saying, it's important to keep the focus on what you're trying to do in terms of your end goal for that particular trial. And complicated with too many additional things like for example, parameters that you need for sales and marketing. Because regulatory, and operate at trial versus sales and marketing trial is two completely different things. And the endpoints that you collect in your sales and marketing trials, might not be necessary for regulatory approval, but implementing them in the regulatory trial might complicate things a lot, and could result you in failing reaching your endpoint or your goal. Because your sites and your user sponsor, your series might be too focused on, you know, ad endpoints that are relevant. And then the 20, you know, get left out.
Patrick Kothe 21:13
That's a, that's a great point you're on. And we really have to be careful in designing the studies to enable you to get to your primary endpoint, but at certain times, you're going to bring some other things in, because those things immediately happen. And one of the things you may or may not be, I won't file it under sales and marketing, but really is its reimbursement. So as you're designing your initial clinical trial for regulatory purposes, certainly having an eye on reimbursement is also critical. Because that is is also a long lead time items, something that you can capture data relative to reimbursement and value created with use of your product. That that's, that's critical for for product adoption as you get to next one. But if it's more of a sales and marketing type of study, then those are the types of things that you wouldn't want to cram into your initial study to slow it down.
Jon Bergsteinsson 22:07
And I think there's actually a reason to why companies fall into this pit because people don't realize how difficult it might be to get a device to market when it falls on to the medical device regulations. And this might be something that angels that are embarking on their first investment in the medical device industry might not realize. So you have young companies, young founders, young investors, new medical device investors, that are pressing on this new technology to be put to market. And failing to realize before that, there's a lot more work that needs to be done. So they try to produce everything into this one trial that they can do just to get that device to market so that you start selling and so on, and so on, so on, which is not really what you should be doing because as soon as you get the device to market, that is one thing. So it probably has a lot to do with the way that investment is done in the medtech industry as well.
Patrick Kothe 23:09
It's really an interesting point and dividing that out and making sure that you have the appropriate level of data capture is really an art, you know what you're going to do regulatory wise, but what is going to be reasonable to take that take that next step in. But let's let's go here for a second because on a regulated study for you to obtain regulatory clearance or approval on companies, it could be a startup company could be a small company could be a large company. And those trials can be managed a couple different ways. First of all, it's a regulated study, you're gonna need to go through an IRB somewhere and have a have a set protocol, and then that data capture is going to come in come in somewhere. Now larger companies, they probably will have internal resources to manage a clinical trial. Smaller companies may or may not typically may not because it's bringing somebody somebody into a company with that expertise, maybe somebody that you need for a period of time and then wouldn't need them going forward. So many startup companies or smaller companies will use CROs to Matt to manage that that processes as well. So let's let's talk about that process. And and this tool, this, this, this web based tool and why it's important for that startup company to start implementing that type of tool right from day one.
Jon Bergsteinsson 24:39
Imagine that you're a founder of a new medical device company and you're ready to initiate your first trial. And you have the budget to finalize one trial over two years, you know, 200 subjects, and it's supposed to run over you know, six or 12 months. The steady basis of success you learn to product to market. Two years down the road, you get approached by the FDA or an investor and have a body, some kind of governing body or an actor that is interested to look at your data, most companies would probably makes sure that the data coming from the clinic trial is stored according to industry level requirements for data data storage, backup, etc, etc. However, if you conduct your study on a piece of paper, or Excel and so forth, explaining and illustrating how you comply with traceability, permission management during the study, audit logging, who did what at what time? Was it any data changed? How are you going to prove that, who got access to the data at some point to didn't? When was it exported? Was it validated quality assurance, etc, etc. All of these things that relate to good clinical practice, which is, you know, one of the things that you need to comply with if conducting a clinical investigation on medical device is very, very difficult to do if you're just running a clinical trial on a piece of paper XL. So the first thing that that adductor and data capture systems do very well and support you with is take care of all that. So a lot of this is automated already. So as soon as somebody logs into the system enters data, its audit log, this track is verified and quality assured, you can enter a number into a text field or text field into a number field, and so forth. These are the kinds of rules that you can check and do in real time with a digital system, which you can't on a piece of paper. And then there's the the challenge of oversight or overview and access to data. If you have data collected on a piece of paper, which is then transcript to a computer, you can still store it somewhere and have access to it and whatever. But during the course of the trial, a lot of the times you're you have to be aware of how things are going, you might have to report to authorities, you might have to report to investors, you might have to report to potential new investors, you're bored, you're the rest of the team. And having that oversight is almost impossible if you're conducting a clinical investigation, multiple sites or even one site, especially during the kind of times of COVID where you have to visit the site physically to check a double check all the data, bring it back and then transcribing so the oversight and control and being able to manage and all of your all your data at the same time while it's being put into two, this centralized system is also highly valuable. And then you have the additional values such as being able to store your data for a long term purpose in one centralized system. And at a later point, when FDA normal buddy or somebody knocks on your door to look at the data, you can open up the platform, say hey, here's my data. Everything's tracked, audit locked. And by the way, we have three other studies running and they're also here as well structured, well defined, and so forth. So these are some of the values that you get out of having a centralized systems like that. But then there's a bunch of these nitty gritty things such as you know, uploading raw data or images, which is, you know, impossible if you have a piece of paper, having the possibility to hire a physician in another country to review and provide their own opinions on a picture that is taken off a new implantable device that you're testing in a new clinical investigation. There are these options that for web based systems, cloud based systems now that open up for possibilities that might not have been possible before, which could you know, reduce expenses, improve efficacy or efficiency of the trial, so forth.
Patrick Kothe 29:05
So I'd like to open this a little bit further now and talk about the post approval studies and to frame it. Let's talk a little bit about what's going on in Europe. So the MDR ivdr. That's that's been going on for several years finally implemented in May of 2021. Give us a kind of an overview of MDR and what it means from a clinical data capture standpoint and a clinical data standpoint. What's What's the main main change
Jon Bergsteinsson 29:42
the MDR is is actually an old regulation. It was first drafted back in 2012 13. But it was only applicable from this year. All products that are going to be placed to market have to start undergoing MD We are compliant to quality management processes to be able to be marketed in within the European Union. Now, we also have other countries looking at the regulations in Europe that are outside of the European Union thinking about implementing similar requirements. Here, I mentioned the UK, for example. But that's a completely different story. But when it comes to the medical device regulation and the in vitro device regulation, there's a great change of focus in the regulation compared to what it was before. So if you, if you look at the standard that FDA has today, and the old regulation in Europe, they're very similar when it comes to how you can place products to the market, there is the possibility of getting a product to market in the US through the 510 K, which requires that you illustrate how a predicate device or devices already in the market serve similar efficacy or performance as the device that you want to put to the market. And the same way, you could do that in Europe as well with equivalents device, as it's called there. So you would produce documentation through clinical emulation that illustrates how that device is similar to yours and why the safety performance is similar, and so on, and so on. Now, you need to have access to the data that you are referring to in your clinical emulation. What that means is that if you have a quality device, let's say a computer, it's been in the market for years, you want to put a new computer to the market. And it's almost exactly the same, you want to be able to illustrate that cuffy to a is safe because of XYZ, that you have to then use the same data that was used to illustrate XY set for configure a, for your own configure B, to be able to be compliant with the new MDR. What that basically means that you need to gather the data either by yourself, or you need to get access to the actual data that refers to these results. And this is where it becomes tricky, because getting access to data to you know, from competitors that have been in the market for decades, might be impossible, I'm not going to say that it's impossible. But for a lot of companies, especially small companies, that that might be almost impossible.
Patrick Kothe 32:27
Because because they didn't publish that data, if it's published its public data, if it's not published data, and somebody is chest to chest to drain is is on the market, but they didn't publish any data on it, they've got internal things that they could stay on the market, you would not have access to that true.
Jon Bergsteinsson 32:45
And even though you publish like an article or a bunch of you know, scientific journal articles, that might have some results, data and you know, statistical results and everything that you might need to produce the same type of record in your own system. It's still not raw data. You don't know how they got to that point, how their study was conducted, and so forth. And this, this is the data that the notified spot notified bodies in Europe, which are the governing bodies that review your applications, basically, especially for for the higher risk devices. This is the kind of data that they can request access to it doesn't say that it has to but they can. And because of that can, you don't want to take that risk. So what's changing is that there's a lot of companies now that have to a either conduct their own studies are be made contracts with their competitors to get access to data. That's how you know new devices or new technologies will have to do things from now on. When it comes to postmarket. devices that are already in the market have been there in the market for decades, maybe the subject of data is a little bit different. There's this thing in under the MDR, or medical device regulation called post market surveillance, similar to how you do post market surveillance in the US. within that area. Or within that topic of the regulation, you have another concept called post market clinical follow up, which is basically a description of a set of activities that a medical device manufacturer has to initiate to still illustrate or document that the device is performing well safe and is effective. Or at least not, you know killing anybody. There was a huge scandal with a couple of different device manufacturers, you know, 10 years ago, which showed that there was not enough surveillance conducted on the real efficacy or clinical performance or safety of some of the devices that have been placed in market. This is what I think the FDA does a little bit better when it comes to postman market surveillance, they're a little bit tougher in that regard, because you can actually get handcuffed by the FDA, if you if they realize that you've made a huge mistake. In the in the European Union, you can't really you can get fined. But nobody can handcuff you, unless they can, you know, illustrate the defects, lean meats, you know, deliberately made a mistake with how the product was designed, and so forth. So there's a certain scale scarcity around the FDA process, the purpose bar post market surveillance, which I think has somewhat of a positive impact on device manufacturers, which wasn't existing in Europe, which is also why most of the products that have been put to market would first put to market a Europe before they went to the US because it was easier. And you know, if it gets slapped on the wrist, the only slap on the wrist, the medical device regulation is not changing that
Patrick Kothe 35:54
it's changing. And companies are being forced to evaluate whether they want to invest in the clinical studies in order to keep a product on the marketplace. Because that there's going to be costs associated with doing those clinical trials. And sometimes it's not worth it from a financial standpoint, to make that investment and people are pulling products off the marketplace,
Jon Bergsteinsson 36:18
then you might ask the question, was it relevant? Or is the product needed to be in the market? If that's the case?
Patrick Kothe 36:27
It's an interesting question. Because whether it's needed and whether there's financial justification, those are two separate issues needed in the marketplace. I mean, there's a lot of devices that are needed in the marketplace that don't have the financial benefit to companies to continue to market them. So that that's that's a really interesting question. If you think about all of the pediatric devices, there's a lot of blood of devices that are needed by pediatric physicians, but companies aren't investing in them because of whatever financial financial justification they've got. But so let's let's leave that part of the discussion for a second and talk about these post market studies in general, because sometimes the post market study is going to be going to be there for again, for regulatory purposes, sometimes it's for marketing purposes. It's different types of studies. You also have registries that you can you can capture capture data for. So there's a lot of different types of studies in the post market side of things. So how is the data capture tool different in the post market setting than it is in the pre market setting?
Jon Bergsteinsson 37:42
That is a very good question, because it's something that I'm trying to answer every single day when I talk to companies embarking on their first journey within the medical device regulation in Europe, especially if they want to initiate some kind of P MCF study or activity. The definition of a clinical investigation is fairly straightforward, you have a device that's new, you're intervening with standard of care by introducing this device into center of care with a new type of treatment. If that's the case, you conducting clinical investigation, under a protocol that's designed by the sponsor, or CRO whatever, for most devices, clinical investigations just are done in the face way that you have some kind of screening protocol, you have an inclusion, then you use the devices one or the way, and then you might have follow ups or you might not. Post market studies are very different when it comes to the design of a study or investigation because of the fact that this device is now a part of standard care. And what you're looking together is not interventional data or data about the intervention itself, but observational based data about the device being used in standard practice. So let me give you an example. You have a high risk device that you're getting to market, some kind of a cardiac implant. In your clinical investigation or pre market setting, you will need to collect certain endpoints that are defined in the literature to be significant for illustrating clinical efficacy and performance and safety. That just has to be collected, because otherwise you won't be able to illustrate that it's safe. In a post market setting, you don't need to do that. If you've already conducted a clinical investigation that illustrate that it's safe and you might be conducted a study or investigation over the course of some years, and there was nothing wrong. There's no need for you to continue necessarily to conduct an investigation in an observational manner, gathering the exact same data points. What you might more be interested in is higher level data points that relate to the quality of life or the patient's experience or, you know, time from, you know, zero to five, for a certain measurement. So the types of data points you collect in a postback setting are very different. And that brings us to the types of data collection studies or studies in general. So you mentioned, registries, you mentioned the postmarket study, but I didn't hear you say, surveys, service is become quite popular within the European Union, at least for those companies embarking on the medical device regulation, because it's mentioned as a possible method for data collection in the medical device regulation. So now you have a lot of companies that need to conduct some kind of a post market study to continue illustrating their performance, the safety of the devices performance and safety. And they're seeing service as a way to address that.
Patrick Kothe 41:07
So Yan, are these companies typically for like lower tech devices, like let's say it's a scalpel, or it's it's some some type of device where you typically would not see a clinical trial on that device, but it's still covered by MDR.
Jon Bergsteinsson 41:24
But I'm also seeing companies very, very big companies, using or thinking about using surveys for high risk devices as well, whether you can use a survey or not to get the data depends on the type of data that you collect. Because the difference in endpoints is basically what should define the type of activity you want to initiate. So if you need to gather two or three endpoints, and that's it, these three endpoints will illustrate the safety and performance of your device. And the way that you collect them is just after the physician has used the device, implanted it, or I don't know, use the computer, whatever it might be, you don't have to conduct a clinical investigation, you might only require the physician to complete a piece of paper questionnaire with these three questions. And that's it, what do we call it, then? Then I'll then I probably give it names and convey name like a case series study or a case study. It could could be a survey. However, when you think of a survey, a survey is something that you receive via the, you know, email or a text message, you click a link, and then you complete a survey. And then it's like general data, what do you think, what's your opinion, what is your experience, and so forth. It's not based on a single patient necessarily, whether you want to do a survey or case series study, or a clinical investigation, or even initiate a registry, which in my mind is more just like another way of saying I want to collect observational data over a long term period of all my devices. It all depends on the kind of data that you want to collect. Where in the clinical pathway that data originates, from whom? And for how long do you need to observe that device being used in practice?
Patrick Kothe 43:17
So yeah, let's talk about smart trial for a second and exactly what the product is, and what it's designed to do.
Jon Bergsteinsson 43:25
Smart trial mission is very simple. We want to enable meta companies together clinical high quality clinical data, no matter the size or budget. It's a very tough mission to accomplish because you have very, very, very small startups, and then you have large corporates. However, what categorizes or characterises all of the devices is that they're usually collecting data in a very similar manner. They have a physician or a patient that is interacting with the device in one or another way in the clinical pathway. And there's some data that needs to be gathered from the physician or a patient. So what smartphone is offering is an electronic data capture platform, which is the first of its kind being designed specifically for medical devices. That enables you to set up your own study your own survey your own registry, your own and case series study, by using very simple pre configurable modules and questionnaires and templates to gather data from by the physicians or patients or both in your own study. So companies are using Smashville as an electronic data capture systems in clinical investigations and pre and post market studies of all sizes and types, where manufacturers have been trained. So we've trained Clinical Affairs experts for clinical trial, clinical study managers to set up their own questionnaires, their own forums, inside a small trial using all these pre configurable modules, so you don't have to program anything. And they're gathering information live from these hospitals from these sites from these end users using these different components and sportsball. So to put it simply, it's a question of tool on steroids.
Patrick Kothe 45:31
So it's a common platform, people are within a company are going to be utilizing the same platform, the same user interface for different types of, of data capture, activities, whether it's a survey a trial, etc. So there's there's real nice commonality between those.
Jon Bergsteinsson 45:52
And I like that you said, data capture activities, because when you think about devices, or when you think about pharmaceuticals, data capture activities is a clinical trial, there's nothing else in the pharmaceutical world, there's just clinical trial. And then you have phase 1234. That's it. Devices, you have a survey, you have clinical observational, observational study, you have a user experience, you have human factor testing, you have usability, you have clinical investigation, you have a registry, you have a P MCF observational study, you have all sorts of these different data collection activities. And that's really what we're trying to do, we're trying to offer a one stop shop for data collection, so that you don't, don't have to go elsewhere to collect the data. And what we're offering is basically, the complaints packaged into that everything as well. So it is a validated solution, it's pre qualified by us, we've gone through extensive quality assurance testing, so that when a company starts using smartphone, they don't have to worry about the fact that if somebody enters data point into a number field, it does is not going to be a common text. At some point, it's going to be a number no matter what.
Patrick Kothe 47:12
So yeah, each one of these activities, whether it's a trial, or survey, or whatever, they could be gathering information on one product. And they've all got different protocols, different confidentiality pieces. But sometimes looking at all of the data on one device, could be very interesting thing to do. And you can mine that data that exists for that particular device. So you also have other things that are going on at the same time you're getting complaints, you've got a capture system that captures different aspects of a particular device. So as you're going further on with your product, and as time goes on with your product, you've got this data system that's building and continuing to build. So how does how does that work with your system? Is it an independent system, it's only for those particular items? Or can you mine that data in support of a kappa, or in support of a new clinical trial?
Jon Bergsteinsson 48:18
When it comes to surveillance data, for example, it's very easy for you to set up those kinds of data collection projects in smartphones as well. So we actually have examples of medical device manufacturers that are using smartphones as their primary source of data collection when it comes to surveillance as well. However, depending on your existing infrastructure, your master data structure, your QMS structure and everything, it might either be the fact that SmartCloud is just the salt and pepper of the whole equation or that smartron. And all the data that's captured in there is the main domain of audit data where the information that you gather around your devices. In the future, I see a huge potential in starting to accumulate that all into one bowl of some sort, or a registry. But as it is today, the fact that Kappa and a lot of the surveillance and regulatory heavy sort of information that needs to be gathered, is so different from what you thinking about doing when it comes to clinical investigations. I see it as somewhat as a separate thing. There are post market surveillance systems out there that handle that, that take care of that well and do that together with an EQ mes, for example, electronic quality management system. And I see that as a potential for integration. Definitely.
Patrick Kothe 49:43
The system that you're providing, what's the business model look like? Is it are you licensing it on a per trial basis? Is it a software as a service? How are you set up?
Jon Bergsteinsson 49:55
It's actually super simple. The reason why it's simple is based on the fact that we know the medical device companies like to keep things straightforward. When you have a study in mind, you subscribe to a smart trial license. During the course of your study, we pay a base fee based on the product that you select. So we have a couple of different products to select between, depending on what kind of data you're collecting. For example, if you want to collect data from both patients and physicians, at the same time sending questionnaires, we have mobiles, we SMS and email and gather data from your own device through our API as well, or only physicians, you can select different products, and then you pay a base fee per month for that product during the course of your study. And then we don't think too much about users, or patients or data points. But if you have a multicenter study, you pay a small additional fee per site. And apart from that, it's a very flat based fee, per month. So you can, you can very easily budget that you have to run a study for at least 12 months, for example, you know that you will need SMA trial for those 12 months, maybe plus two or three months for analysis. So it's very easy to determine what is the required investment for subsidy subscription?
Patrick Kothe 51:25
What is the range of pricing for a trial like that,
Jon Bergsteinsson 51:30
for the smallest trials that we support, you know, we're talking about a couple of $100 per month. So we're not talking about, you know, 10s of 1000s of 1000s of dollars for a small study. And then we do have these promotional deals for small companies. They're embarking on their first inhuman trial or, you know, they've just recently got the first funding and they're just starting on their clinical investigation adventure for the first time.
Patrick Kothe 52:00
Yeah, and this has really been a interesting conversation, because so much has changed, as we said, so much has changed in, in the regulations in Europe and, and people's understanding of what's going to be required post market for to have a worldwide presence. So seeing your kind of where we sit right now, as a medical device industry, what do you think the future is gonna look like?
Jon Bergsteinsson 52:26
When you think about the world as it is right now, with the pandemic, still ongoing, almost anything can happen. But what I'm seeing right now happening is that people are starting to look at decentralization and the application of blockchain technology or decentralized technology as a more viable option for securing and ensuring continuous transfer of information throughout the internet. So in the next couple of years, we're probably going to see a lot more clinical studies and clinical study data, migrating over to some kind of a new technology base that will enable maybe participants to be more control of their own information. That's kind of what what I'm experiencing right now, you know, looking around me in the industries that are starting to apply this technology already. But then we have the concept of decentralization as well, which is kind of like a bad terminology. But the focus on the patient and the individual, himself or herself. In this study, how can we improve that experience? When patients are participating in device studies? How can we make it easier for manufacturers or patients to participate in studies that they might not otherwise have the chance to participate in, because they live, you know, far abroad or in countries that don't have a hospital that is required to perform such a procedure and so forth? That kind of inter interlinks a little bit with the blockchain decentralization technology concept as well, because you're giving the power to the user to be in control of their own information. So what I see coming from a company like ours, we're probably going to have to start investing and focusing more on how can we make the experience for the participants better.
Patrick Kothe 54:30
So you've had a lot of experience dealing with large companies, small companies, and I'm assuming that the large companies have more of their act together than the smaller companies. So what kind of advice would you give a small company relative to getting involved in their clinical trial and data capture associated with it?
Jon Bergsteinsson 54:50
One of the things that I see again and again, speaking to young medical device companies, young founders, companies embarking The first clinical trial is that they're evaluating whether or not they should conduct their study on paper, or using modern electronic data capture system. It irritates me a little bit that the concept of data collection, the data capture hasn't been presented well enough for medical device startups just like anything else. And the fact that that is something other that can assist them and help them improve the quality of their data going forward. But starting off on the right pathway, what I would like to probably suggest that most do is to start participating earlier and sooner in some of the regulatory clinical focused conferences, webinars that are offered to medical device startups around the world in hope that they will be enlighted, around what and how they can improve their clinical strategy going forward. This is something that most of the time only large corporates experienced in people do. They go through these conferences, we need to start getting the younger companies into these conferences as well, because there's so much valuable information there that could prove invaluable for a lot of these young companies embarking on the first study to get experienced.
Patrick Kothe 56:22
We all deal with clinical trials so frequently, and they're so important within the medical device industry. And I'm really glad that Yan gave us a better understanding of some of the current issues, a few of my takeaways, first of all, scoping your trial correctly. And we discussed about trying to jam too much into one trial, it's really best to prioritize your endpoints, prioritize which ones you really need for this particular study, and then edit, we all have a tendency to try and put everything down on a sheet of paper, but edit that and just get to the endpoints that you know, are critical for this particular study. The second thing is, we discussed that electronic data capture is not only important for the trial itself, but also for questions that may come up years later. I think we've all been in a situation where you're trying to recreate something from something that happened in the past, and you may have been involved in it or you may not have been involved with it. And it's so difficult to recreate those things, having things in an electronic format that you can readily get back to him is real a real benefit. Finally, we discussed many different types of trials, MDR, trials, registries, case series, and even surveys. And the key point here is design what's appropriate for the your desired endpoint. That's what Yun stressed with us what's appropriate for the desired endpoint. It may not always need to be a trial, it could be a survey could be a register could be a case series. Pick the tool that's most appropriate for the job that needs to get done. 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 has interviews like today's can help you become a more effective medical device leader. Work hard. Be kind
