Many medical device companies experience challenges with managing clinical trials even in the most ideal settings, so what happens when big changes occur, like COVID-19 and new regulations, that compound those challenges? If only there was a solution to this problem...
In this episode of the Global Medical Device Podcast, Jon Speer talks to Pall Johannesson, CEO and co-founder of SMART-TRIAL – a digital platform that helps medical device companies manage many, if not all, clinical data activities.
Listen to Pall’s story about his solution for managing clinical trials, which has many similarities to that of Greenlight Guru, as he discusses his vision and the problem they're attempting to solve to help manufacturers, as well as patients, save time and money with clinical trial management.
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Some highlights of this episode include:
- Pall started SMART-TRIAL as a solution to solve the problem of the medical device industry being underserved. The technology being used to generate clinical evidence and collecting clinical data in clinical studies was outdated.
- SMART-TRIAL empowers medical device manufacturers to be in control of their own clinical evidence. Data is becoming more valuable, so companies need to control and access their own data.
- EU MDR has increased the need for clinical evidence and ongoing clinical data for products. Pall discusses how some companies adopt and adapt to it by taking advantage of collecting data and clinical evidence early on and doing it well.
- Pall describes similar challenges in the United States and EU. The MDR has pushed companies toward the United States as far as where to start with your market access and different directions to develop clinical evidence.
- SMART-TRIAL’s products and services streamline the clinical side of things. Pall works with startups to well-established corporate medical device companies. However, the complexity of the device comes with complexity of the studies.
- Pall agrees that the medical device industry is moving toward integration of AI, machine learning, and other intelligent technology. It’s better to find experienced partners to make smart decisions that benefit manufacturers and patients.
- A big mistake made by medical device companies is collecting too much data. Start small and be specific. One of the best practices is to involve analysis of clinical evidence by a statistician.
Pall Johannesson - LinkedIn
European Union - Medical Device Regulation (EU MDR)
U.S. Food and Drug Administration (FDA)
FDA - 510(k) Premarket Notification
Halo by Greenlight Guru
Greenlight Guru Academy
MedTech True Quality Stories Podcast
Greenlight Guru YouTube Channel
Memorable quotes from Pall Johannesson:
“The technology that they were using for generating clinical evidence or basically collecting clinical data in clinical studies was outdated by far.”
“We empower medical device manufacturers to be in control of their own clinical evidence. Data is becoming more and more valuable.”
“Medical device companies, today and in the future, will have to rely much more on having control and access to their own data.”
“The biggest impact is definitely companies that wait too long.”
Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.
Jon Speer: On this episode of the Global Medical Device Podcast, I had a chance to connect with Pall Johannesson. Pall is the CEO and co- founder of an exciting company SMART-TRIAL. Check it out smart-trial.com. It's basically a platform to help you, as a medical device company, manage many, if not all, of your clinical data activities. As I read the story about SMART-TRIAL, I was like that sounds really similar to the Greenlight Guru story. And I think, as we see things like EU MDR come to fruition, the challenges that many companies experience with clinical trials during the pandemic, and so on, and so forth, the need for this type of solution is here today. Enjoy this episode of the Global Medical Device Podcast. Hello and welcome to the Global Medical Device Podcast. This is your host, and founder, at Greenlight Guru, Jon Speer. Joining me today is the CEO and co- founder of SMART-TRIAL, Pall Johannesson. Pall, welcome.
Pall Johannesson: Thank you very much, happy to be here.
Jon Speer: Absolutely. I was doing a little bit of research before chatting today, and as I was reading a little bit about the SMART-TRIAL story, I'm like, "Wow, that sounds really familiar to a story I'm very familiar with." That story that I'm familiar with is the Greenlight story. Maybe that's a great place to start. What vision did you have, or what problem were you trying to solve by starting SMART-TRIAL?
Pall Johannesson: It's quite similar to yours, actually. It's the same problem that the medical device industry we saw was quite underserved. And the technology that they were using for generating clinical evidence, or basically collecting clinical data in clinical studies, was outdated by far. And whatever was out there for them, was not intended for medical devices. It was intended for something else, and they were trying to make this work. We quickly realized that there was an opportunity here, and some space to do innovative work and bring good technology to assist these companies.
Jon Speer: Absolutely. How long ago did you start the company?
Pall Johannesson: We founded it back in 2013, and we went basically all in on this idea around 2015- ish also.
Jon Speer: Okay. What's the big idea? Why should I reach out to you and your team at SMART-TRIAL? What are you going to help me with?
Pall Johannesson: Basically, because we empower medical device manufacturers to be in control of their own clinical evidence. Data is becoming more and more valuable. Medical device companies today, and in the future, will have to rely much more on having control and access to their own data. And also because you might change CROs, you might change consultants, so being in control of your own tool or system can be very beneficial for medical device companies. And if you use a tool, like SMART-TRIAL, which is thought of in a more modern way to generated the clinical evidence, you can also do this faster, and thereby safe time and reach your patients faster with your devices.
Jon Speer: Okay. Pretend like I don't know a lot about what you're doing. Let's imagine I'm doing it the old way. What does that old way look like?
Pall Johannesson: The old way was paper and Excel, making your own databases somewhere in the corner. Or if you had a lot of money, you could buy one of the pharma- based EDC tools that were designed for bigger trials with thousands of patients. But the main difference here is that medical device trials and medical devices, in general, don't have the same volume. You don't need to test the same amount of people, and thereby it wasn't a good fit design wise for the device companies.
Jon Speer: Yeah. Events of recent times have probably sparked, certainly, the need and, probably, a lot of interest. I guess the first thing that we'll start with is EU MDR.
Pall Johannesson: Yeah.
Jon Speer: EU MDR that's the need for clinical evidence and ongoing clinical data for products. It's increased. I mean, I guess to keep it simple. What have you seen in the industry? I mean, how are companies adopting, or adapting, to the new EU MDR?
Pall Johannesson: I think there are two groups of companies in terms of that, if you'd like. There are some companies that really see the advantage of doing this early and well, because they've recognized the value of data, and they want to go and go ahead and collect their own clinical evidence in the best possible way, and use it, really, for market access and other activities, as well, not only regulatory side, and clinical safety side. And then you have the companies that have been on the market for some time and might have legacy devices that might be in a very different position, where they're going to have to go and generate clinical evidence with devices that have been used, maybe, for 10, 20, 30 years in the market. And that's a task. It's uphill to say the least.
Jon Speer: I know when we first learned about the EU MDR a few years ago, that last little bit was one thing that I heard from a lot of mature companies is they have a lot of these products that have been on the market for a long time. MDR is like, " No, there's no grandfathering, especially on the side of clinical evidence." I was like, " Oh my goodness." I mean, I guess it's still pretty early in the official implementation of the EU MDR, but what have you seen over the companies that have done well in transition? What have you seen? What are some examples of things that they're doing to make them successful in, I guess, transition to EU MDR?
Pall Johannesson: Yeah. I would say, on the clinical side, it's mostly to start planning early, because there is this grace period. You have this concession period, where you have to, in one year-ish time, you have to start producing some of these post-market clinical follow-up reports. Which are now an extra mandatory step for them to stay with their devices on the market. And a lot of companies have seen the opportunity to start small and grow from there, because there was a lot of unexpected things here that we don't really necessarily know how to handle. And we might not even have a hold of our end users. We might have used distributors before, and how are we going to get hold of this data that we now need to have, and need to be in control of? Starting small and early is something we've seen that can generate really good results, because you will learn a lot in these early days. I would say, definitely, adapting other methods than only clinical trials. We have companies that are doing post- market surveys for usability purposes, for example, with clinicians. We have companies that have started their own registries, and started generating data that way. And, of course, some of them have to do clinical studies. That can't be avoided. But I would say the biggest impact is definitely companies that wait too long. It's probably similar with QMS.
Jon Speer: Awesome. I think there's a lot of similarities, for sure. Let's imagine I'm one of those companies that, maybe, I waited too long. Maybe I didn't do a lot of planning or preparation. Is it too late? I mean, is there something I can do about it?
Pall Johannesson: Yeah, definitely. It's never too late, and the sooner you take control the better it is. And, of course, there are a lot of advisors and consultants out there, as well, that can assist with, I would say, the regulatory side of how should it go about this. And then you can use companies like us, at SMART-TRIAL, where we can assist you with generating the data as fast as possible so that you're ready for your inspection.
Jon Speer: Yeah, okay. The other thing that's been coming over to this side of the world, the United States side of the world, has been... I don't know if it's quite as hot of a topic as EU MDR, but I think it's been an interesting topic that's come from FDA, things like real-world data, and real-world evidence. Do you see the challenge in the EU and the challenge in the US as the same or different? And why?
Pall Johannesson: I think there are similarities, but I also do think it's different. I think the MDR has push a lot of companies towards the States, in terms of where to start with your market access, where to start with. It might be a little bit easier route now. And when it comes to generating clinical evidence and bringing that back, for example, post- market evidence from the States will, in many cases, be accepted in EU. Therefore, if you have access to, and can generate, for example, real evidence in the States, that can be really beneficial for you. I do think it's kind of the same, but, then again, pushing companies in different directions definitely on the regulatory side. But, of course, also in at least the last 12 months, times we've had with the Coronavirus pandemic, of course, has now also pushed many device companies to start doing decentralized, or hybrid, clinical trials, as well. And that's a way where the regulatory bodies are always going to be behind. They can really never be ahead of innovation or the industry, if you'd like, so everybody's trying to catch up there. And the good thing for device companies is that a lot of them have been doing these hybrid trials for quite some time. You can see longterm follow-ups for hip implants, for example. They're done remotely.
Jon Speer: That is the next topic I wanted to dive into a little bit too. I've talked with a lot of colleagues, and partners, and other folks that are in this space who are involved in clinical trials, and you mentioned COVID and the pandemic. I know there was a period of time, certainly in the first few months of the pandemic, where pretty much all clinical trial type activity was on hold, pretty much. And it seemed like, fortunately, things eased up a little bit, at least, with the opportunity to conduct clinical trial, but the practices had to change. I can imagine that a little bit of time, I know about SMART-TRIAL, that the COVID situation, you probably were a wonderful resource and an asset for a lot of these companies during that period of time because of your products and solutions. Can you talk a little bit about some of the success stories that you've seen, or some other tidbit, or experiences, that you, and your team, had as part of this process?
Pall Johannesson: Yeah, absolutely. On one hand, we were happy to have some excellent functionality for gathering patient support outcomes, so directly from participants in the trials. That's on one hand, and on the other hand, we were really happy that it became much more accepted to collect this data in a different way than we were used to. Even a lot of our clients were still collecting paper- based forms, even though the main data in the trial was digitally collected on a web app, such as ours. Then they were still using paper forms next to it, and then transcribing after the trial. All of a sudden, things like that became really good to move to a digital platform, because you remove the contact between people. And we're trying to avoid as many touch points as possible. I would say that some of those things were really beneficial. And then we also got the chance to participate in quite a large epidemiological trial, as well, on the side, where our solution was used for, I think it was, about 30,000 participants over three months time in a cohort follow- up study.
Jon Speer: Had you guys had an opportunity to work with any IBD companies, or others, that are developing products and solutions to either, help test or with the pandemic, in some way, shape, or form?
Pall Johannesson: Yeah. I think we've had two trials, actually, with the medical device products. One of them was, I think, a test kit, and the other one is some treatment for the virus.
Jon Speer: I mean, Greenlight has had a few customers, as well, who have been, if you will, in the front lines of dealing with this pandemic. At least from my perspective, and I can imagine, you probably feel the same way, it feels good, and it's heartwarming to know that something that we have been able to do is helping these companies address a need the world is facing right now. Pall, it might be a good time to take a short break, and I want you to talk a little bit about you and your background. But I want to remind folks, I'm talking with Pall Johannesson. He is the CEO of SMART-TRIAL. Pall, talk a little bit about your background and how you even started SMART-TRIAL. What was the big idea, as well as, where people can learn more about your company?
Pall Johannesson: Yeah, absolutely. Thank you very much. The idea behind it was the missing technology designed for the purpose of generating clinical evidence for medical device studies. We saw that a lot of device companies didn't really have the same resources as the pharma companies. They did not have as big teams in house, or the ability to work with CROs, for example. So a lot of them were relying on their own capacity, own staff, to build trials and manage them on paper and Excel with other non-digital, basically, analog tools a lot of the way. What we really were motivated to do was to give the power to the manufacturers, if you'd like. Even the ability to manage this themselves, and give them some digital tools that are easy to use and you can reuse a lot of the work that you're doing. Because a lot of the device trials, you'll see that, they don't change quite a lot from phase to phase, if you'd like. You start small and then you might do more pivotal studies, and they grow a little bit bigger, but it's usually the same setup. The ability to reuse what you're doing is really important. And we really saw that, with proper technology, we could save a lot of time for these clinical studies, and thereby also costs. And that cost just increased with, at least, the EU MDR and those extra requirements there for more studies. We really see that we are able to really save these companies time and money with getting to market and getting their devices to patients as fast as possible. And in terms of my background, I've always been naturally attracted to devices, I would say. It's really nice to be in an industry where you see the work that you're doing is directly impacting patients. We have some fantastic companies we work with that are making technology I wouldn't even have imagined existed, and you probably have the same on your end. But we see some companies making trial results that are... Yeah, you don't even read about them in the news. That's the next level of care and of healthcare, in general, in my opinion. We can move so much with devices going forward, really motivating. So that was a natural attraction for us. And then, once we saw we could really save time and get these devices faster to market, that was just an extra motivator and kept us going to develop this technology.
Jon Speer: Yeah. Folks, you can learn a whole lot more about SMART-TRIAL by visiting their website, smart-trial.com, very simple. I'm on their website now, and I see that they have a lot of different product offerings or services as part of their platform. I would encourage you to check that out and learn a lot more about all the different products and services that they have available to you. While I'm taking this short break, I also want to remind you about Greenlight Guru. We are the only medical device success platform in the medical device industry today designed specifically, and only, for medical device companies. We built this with actual medical device professionals providing input and their experiences into the platform, so we can help you manage your design and development, your risk management, your documents, your records, all of your quality events, things like CAPAs and complaints. If you'd like to learn more about Greenlight Guru, then I would encourage you to visit our website at www.greenlight.guru. We'd be happy to have a conversation with you to understand your needs and your requirements, and see if we also have products and services that can help you. Pall, looking at all the products and services that you have, there's a lot there. I realize there's probably a lot of similarities between these sorts of things. I'm curious, obviously, you're trying to streamline the whole clinical side of things or, at least, a large part of it. Is there a certain type of profile of company, or profile of device, that you find works better withSMART-TRIAL products and services, or they all are applicable?
Pall Johannesson: We do work with, I would say, almost all shapes and sizes of companies. We have everything from the startups to the corporates with thousands of employees. But we also see that with the complexity of the device, comes the complexity of the studies, and that's where we can really assist with some things that are more cost effective than what you would get from other product and platforms out there. Increased complexity we can even do more savings, but it does work really well for anybody that has the minimal skills of working with clinical studies and clinical operations, and we can really accelerate that process for the companies. We do see that the higher the class of the device, and thereby the more complexity we see in the trials, the faster we can assist, and the more benefit they can gain from it.
Jon Speer: Yeah. I notice one of the products that you offer that caught my eye is the ePRO, and the brief description it said something about collecting data directly from subjects via email and SMS. And it sparked a thought, every day, maybe not every day, but every week, certainly, I read about some new gadget that's going to take up risk space, or be on my phone, or something. There's intelligence or blending everyday technology with medical device technology. I have to wonder, where's this going? Because I think the needs, or the interesting thing, anyway, or one of the interesting things about our industry is there's conversations about AI, and machine learning, and intelligent devices, and that sort of thing. I'll just leave it there. Do you have any thoughts or experience about where the industry is going with respect to that?
Pall Johannesson: Yeah, absolutely. I do think that we will need to look much more towards integrations and communications between tools and devices and whatever is out there. We don't need to invent the wheel every time. We could, probably, expand into different areas with our product, and you could probably do the same. But, usually, what we find is it's better to find partners and companies to work with, and do this integration together. Make sure that the experience for the patients, especially in clinical studies, is as smooth as possible. Because that would, then again, generate the most benefit in the end for the manufacturers. We do also see that we've been a bring-your-own-device tool for generating patient report outcomes from the beginning. Because, again, we're working with companies that, maybe, had limited resources at that time for clinical operations, and by enabling participants to bring their own devices to trials, the manufacturer didn't have to buy the devices or rent them for the trials. We also have done integrations to wearables to other devices where its real benefit, and where that is applicable, to generate these, I would say, real world evidence data, or data directly from the patient, as well, in different ways. But we do take that approach from time-to-time and say, "Where is this taking us? What's the real benefit of either, using a device here or making this integration?" Because it needs to save either, time or money, for it to make sense. Those two parameters are real drivers for the decisions that we make, of course. The regulatory side is as well, but if it doesn't really save time and money, you probably won't do it. But we do see there is a huge push for using technology for technology's sake, and that's also where we are going to try to advise our partners and clients in terms of making some smart decisions.
Jon Speer: One of the things I've seen, it's an interesting challenge, because sticking with the AI side of things for a moment. The FDA seems like they're trying to facilitate a regulatory model to be able to accommodate and handle products with AI and machine learning, but there's a weird twist to it. If the model needs to be updated, it oftentimes requires a new submission, and that sort of thing. It just seems like products, like you offer at Smart- Trial, maybe those will be great ways to help build a stronger bridge so that we could better leverage the model and that sort of thing. Do you have much experience working with companies and AI and machine learning space too?
Pall Johannesson: Yeah, we actually do. We have facilitated quite a lot of trials and projects, where the product, if you'd like, has been as a medical device as a software, including some decision support or AI, if you'd like, with some of the more modern technologies. And there we've, sometimes of course, fed data into the model, so from the ECRF, or the clinical trial platform, which we are replacing, and then you have the device here. And sometimes these two are communicating together to generate the learning mechanism in the AI. And it is definitely, I would say, not easy regulatory wise. And not a lot of, again, the regulatory side will probably always be behind, because technology is moving so fast, and we have these methods. But it's been quite interesting for us. Of course, we also work with AI in some ways, but we can't really start predicting the results of a trial, or something, because we're just in this space where the regulation controls a lot of the work that we're doing. And you need to have a very controlled way of generating the clinical evidence. Where I believe, for example, you guys have made something really fantastic with Halo. You'd have a different opportunity to work with this than we do. But it's really interesting, yeah.
Jon Speer: Just thinking, as we're talking, and it seems like some of the things we have been able to do at Greenlight with Halo, providing more of the machine learning aspects within a company's quality management system, and feeding them information to make better decisions. Maybe this is premature, but it seems like there may be an opportunity at some point in time for Greenlight and Smart- Trial to figure out how to sync up together too. Because all this data, the data that your customers are getting during their initial clinical studies, and trials, and investigations, there's a need for that ongoing, as we've already talked a little bit about. Having all that synced together in a ecosystem could be a really interesting thing.
Pall Johannesson: Absolutely. Also, if there are some warning signs, but definitely could be drawn earlier in terms of premature results, so not predicting anything, but having ongoing analysis at any given time point, and then feeding that back into the technical file, which then would be, on your side, making a flag for the regulatory department and there saying, " Hey guys, you probably want to start doing something about that product, because the trial is not going in that direction, or something like that," and making, again, the right decision faster. Definitely an opportunity there.
Jon Speer: Absolutely. Pall, as we wrap things up today, you picked a side of the coin that makes the most sense. What are the biggest mistakes that you see companies make in this space of clinical data and trials? Or what are some of the best practices, or maybe you can pick and choose a combination?
Pall Johannesson: Yeah, I'll definitely make a combination there. One of the mistakes we see a lot of medical device companies, because they're driven so much by engineers, and by engineering, in general, innovators, if you'd like, in devices. Usually, when we empower them to manage their own clinical studies, or manage their own clinical evidence, they want to collect too much. They will just go all in. They want to do everything in one go. And usually we see it fails. A lot of trials fail, because you're trying to do too much at once. It's better to go small, go direct, and to be very specific, and then rather do multiple small projects than one big one. That's definitely one of the pitfalls we see. And then, I would say, the best practices is to involve, for example, a lot of the clinical evidence we're generating will need to be analyzed by a statistician. I would say most of it needs to be, because you need to have statistically sound results from your trials in order to have them ready for regulatory submission and going to market. I would involve, really early on, if you don't have the skills yourself, try to get a statistician on board to work with you on the format of the trial. Because the way you collect the data, definitely affects the way it can be analyzed. Those would be the two main takeaways I would say. Then, of course, think about things other than medical, just clinical safety in your trial. Think about market access, for example. Consider what will the driver be behind getting this reimbursed in different locations in the world? Or what will be the main driver for governments to actually choose to work with my product and not the competitive product? And sometimes we can generate some results towards that, as well, in a clinical trial.
Jon Speer: Those are all great tips and suggestions. I think one other thing that comes to my mind, anyway, is from a company in development. I usually think about clinical with blinders on. I'm only thinking about that next thing, that next milestone, whether it be a clinical study to support a regulatory submission. But I don't usually think about the total lifecycle of my product, and I think clearly today, in this era of med device, you have to think about the total product lifecycle. Not just from a design and risk perspective, but also from a clinical data perspective. You have to build a plan and strategy that addresses your current needs to support your submission, but then after you go to market, and maintain the product in the marketplace too. I see a lot of companies struggling with that.
Pall Johannesson: Absolutely. That's a very, very good point. The holistic approach to making the device and, of course, developing the device itself, but also developing the clinical and go- to market strategy.
Jon Speer: Well Pall, this has been great chatting with you. Of course, folks, again, visit the website smart-trial.com. Pall, is there a better way, a preferred method of contact, other than just having folks go visit your website? I'm guessing there's a contact us form or something of that nature, right?
Pall Johannesson: Absolutely. You can contact us or view some of the other content that we produce. We produce a lot of educational content that's freely available on our website for companies to learn more about what they should think about when doing X, Y, and Z within this space.
Jon Speer: Absolutely. Check it out, folks. This is really great stuff. I learned a great deal by visiting the website, and I've learned quite a bit by talking with Pall Johannesson, CEO and co-founder at SMART-TRIAL. As always, thank you all for being listeners, and watchers, hopefully, of the Global Medical Device Podcast. If you are listening, that's great. If you haven't had a chance to watch it, go check it out. These are being shown on YouTube, so you can subscribe to the Greenlight Guru channel. You can click the bell icon to get notified when new episodes are available, so be sure to check that out. I've enjoyed having the video element, personally, because it gives me a chance, I think, to better connect with the guest, and in this case, Pall. It's because of you that we're maintaining our number one position as most listened to podcast in our industry, so thank you so much. I greatly appreciate that. As always, this is your host, and founder at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.
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