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#18 - Hester Knol - From App to Medical Device: Why Certification Takes Forever
30 Plays15 days ago
What does it really take to transform a health app into a certified medical device?
In this episode, I sit down with Hester Knol, a clinical research expert with extensive experience in medical device regulation. Together, we delve into the complex journey of getting a digital health app through clinical trials, the hidden challenges faced by startups, and the rigorous planning and evidence required, even for low-risk tools, to ensure safety and efficacy before reaching patients.
Key highlights include:
- An in-depth look at the process of developing a medical device, from initial idea to regulatory approval, focusing on digital health applications.
- The necessity of systematic literature reviews and the importance of generating evidence through clinical trials to demonstrate safety and performance.
- The role of clinicians and healthcare professionals in shaping and legitimizing digital health solutions, including how their acceptance can significantly impact the success of new products.
- The regulatory landscape, including the distinctions between different classes of medical devices and the implications of strict compliance requirements.
- Insights into navigating the commercial landscape, how to engage with healthcare insurers and understand market dynamics to ensure viability and demand for new health tech products.
If you're interested in the intersection of technology, healthcare, and regulatory challenges, this conversation is a must-listen!
Recommended
Transcript
Introduction to the Podcast and Guests
00:00:00
Speaker
Hey, what's up everyone? This is Ajmal Savary and welcome to another podcast episode. Let me ask you this. What does it really take to turn a health app into a certified medical device? And why is that journey so daunting?
00:00:11
Speaker
In this episode, I'm joined by Hester Knoll, a clinical research expert with deep experience in medical device regulation. We unpack the grid reality behind getting a digital health app through clinical trials, the invisible hurdles startups face, and why even low-risk tools require a mountain of planning, money, and evidence before ever reaching a patient.
00:00:32
Speaker
If you ever thought building a health app was simple, this conversation will change your mind. Enjoy.
00:00:53
Speaker
Hey everyone, and welcome to another podcast episode. If you're new here, my name's Ajmal. I'm a neuroscientist and entrepreneur. On this podcast, we explore the links between science, technology, business, and the impact they have on all
Hester Knoll's Career Journey and Insights
00:01:08
Speaker
of us.
00:01:08
Speaker
Today, we talk to Dr. Hester Knoll. Hester is the Senior Clinical Operations and Regulatory Affairs Manager at Herodikos, where she leads clinical trials and regulatory strategy for digital physiotherapy solutions.
00:01:22
Speaker
With a PhD in human movement sciences and a background that spans neuroscience, clinical research and medical device regulation, she bridges the worlds of academia and health tech with rare depth.
00:01:33
Speaker
Before Herodikos, she headed clinical operations at Lendera, guiding their applications through the rigorous German healthcare system. She also worked as a lecturer, a postdoctoral researcher and even led international youth NGOs in her earlier career.
00:01:48
Speaker
Her work centers on making sure digital health products are not just innovative, but actually safe, effective and grounded in scientific evidence. All right, enough background. Let's get into it, shall we?
00:02:01
Speaker
It's great to have you. ah We met quite some time ago and back then it was at the Autumn School of the Donders Institute in Nijmegen in the Netherlands. And, you know, i mean, sure, you know, back then it was all about research.
00:02:14
Speaker
Times have changed a little bit. and After that, we got in touch again by pure chance. It was during your time at Lendera, which was funnily then also my starting time at Lendera.
00:02:27
Speaker
You were heading the clinical team and I was planned to become your replacement during your parental leave. Now, that's also been now again, what, four years again?
00:02:38
Speaker
Yes. i It's crazy. Yeah. And you know my starting time at Lindera was I got into the med tech and pharma field a bit more. From research perspective, I was a bit more in pharma, but then med tech.
00:02:53
Speaker
And the more I realized how long it takes until something actually becomes a product and accessible during that time, it reminded me of you know how long it took to publish scientific results in the first place.
00:03:07
Speaker
However, now the reasons are a little bit more different, I would say. And um as you've been in this field for so long, I thought it'd be super interesting to talk to you about this.
Developing Digital Medical Devices
00:03:18
Speaker
So can you tell us a little bit about the process of getting a medical device and let's just maybe stick to a digital side of things to the users and why does it take so long?
00:03:30
Speaker
Yes, sure. Yeah, sure. So my journey started in science, as you have said, when we met, I was a master's student finishing my master's. And afterwards, I continued with my PhD.
00:03:43
Speaker
I did my PhD in Southern France in Marseille, more in the direction of movement science and neuroscience. And I worked at universities afterwards. But after a while, like a career in academia is not so easy, um especially when you have a partner also in academia.
00:04:00
Speaker
distances are long and we wanted to stay together in the same continent, same country, same location, same city, ideally. and So like, yeah, that was a little bit problematic or challenging at that moment. um And I found science very interesting.
00:04:18
Speaker
I found the the questions I had always very interesting. um But the whole hassle, what you said with it takes forever before something is published. And it's a lot about Writing, setting up, testing, testing again, testing again, writing again, rewriting.
00:04:37
Speaker
So before something is published, it takes a long time. So project from idea to a scientific publication can easily take a year or more. um And this is very repetitive as well. So each time you start with a research question, ah you have to do the whole road again.
00:04:56
Speaker
um and I found this sometimes also yeah not boring. I found it still interesting, but it simply takes a very long time. And I always had very fundamental questions. And sometimes I was also lacking.
00:05:08
Speaker
What does this mean then for the people? Like, what can you do with it? Was often the question that was asked to me. there was a moment when I thought, hmm. Maybe it's time for a change. And I was pregnant at that time. So it was a good career break anyway.
00:05:23
Speaker
um then I thought, okay, I'll quit my job in academia and I will see what comes next. And that was actually the moment that I thought, hmm, actually, what am I going to do? I would like to do something with my scientific background in movement science, which is still what i find fascinating and interesting. And I have not done all this work in academia for nothing to put it in the bin and do project management.
00:05:45
Speaker
But Project management was interesting. um So this was the moment that I was started looking and then ah people actually found me that said, hey, your profile is interesting. We should have a chat.
00:05:57
Speaker
And then I ended up with a conversation with Lindera, fall prevention for ah elderly, an app for fall prevention, yeah to help elderly and to reduce falls. And I found that very interesting because it fits my scientific background very well.
00:06:14
Speaker
um And I ended up there, or I started there my career in the digital health sector. um And what was your question again?
00:06:26
Speaker
How I ended up there. That is
Regulatory Challenges in Digital Health
00:06:28
Speaker
how I ended up. That was my first step into the digital health world. and So rather by chance, actually, that I ended up there. um Yeah, and then I started diving into what does it mean to be a medical device?
00:06:41
Speaker
ah What is a medical device? What regulations do you have around medical devices? ah What scientific work needs to be done? What do you need to do to develop content for a new device or product development, for example?
00:06:55
Speaker
What does it take? you know What does it take before you have an idea? Say, OK, I want to do motion tracking. Very nice. Good idea, it works somehow it works somehow, it's not good enough because you have to be sure that it works stable, that it's safe for patients, that no accidents can happen when a patient falls.
00:07:14
Speaker
And if an accident happens, you need to know exactly what to do, how to act and how to adjust, like do the risk management and see, okay, how can we reduce this risk in future?
00:07:26
Speaker
And how do we do deal with the patient? What needs to be communicated to whom do we need to inform BFARM, for example, in Germany. um So this was completely new to me because I had no idea about medical devices before and what it takes.
00:07:42
Speaker
um Yeah, and I did that more than the the clinical background. So everything that has to with something with, okay, we need to get evidence for the device that it works. We have to continuously prove that medical device works for this patient population, is safe to use for this paper patient population.
00:08:01
Speaker
So safety and performance you hear all the time in medical devices. And there are very strict regulations around that, how to do that, what needs to be done, and what this evidence should look like.
00:08:12
Speaker
I mean, when we look at scientific publications, there isn't much, let's say, regulation in that sense. so You're supposed to do your scientific study. um You write it all up.
00:08:23
Speaker
Then you have your peer review process, which is annoying as hell, but it's therefore a quality check. At least that's what you would hope for. And then you get your reviewers' responses, which...
00:08:36
Speaker
when you read them sound as the harshest things you ever read, ah judging your work. um And that process can take quite some time. right So even even when it just comes to writing a scientific publication, irrespective of the study,
00:08:51
Speaker
Just writing the scientific publication can take forever. if If a journal rejects you, you then, well, then you try to go to another one. yeah and And I still remember, I think my first publication, even though the study was finished, took three years um because they still wanted us to add another study to it, which, well, which took forever.
00:09:15
Speaker
Now for the medical device, um,
00:09:20
Speaker
section when it comes to health tech of course you say there's a lot of regulation going on right the devices should be safe um when it comes to safety people often think about okay well um it's a it's a software so how dangerous could it be right it's a it's not like a defibrillator if it's not working properly well you definitely die while using it or not using it properly um or pharma when it comes to um When it comes to drugs, but medical devices have safety issues as well.
00:09:53
Speaker
yeah So if you just think about software, which is supposed to um tell you a bit more about your insulin levels or things like this,
Medical Device Safety and Risk Assessment
00:10:04
Speaker
right? The sensor might function properly, but if the software is not working properly, you are wrong.
00:10:09
Speaker
making wrong decisions based on the information it displays. And that can then result in death. So all of these things you have to go through when it comes to your medical devices. Risk, risk obviously, is not the same for every device, but that's why you have to go through every single piece of it.
00:10:30
Speaker
Yeah, the classification, we have different classes classes yes there are classes of medical devices. and So for example, i work now at Heroicos, where we have an app for digital physiotherapy.
00:10:41
Speaker
um And we are a class one medical device, which means the lowest risk class, so to say. and But the same regulations apply. There are some minor things that we don't have to do as thorough as if we would go up to class But and but In general, the same regulations apply to us. We still have to ah do exactly the same steps as ah devices that are have a higher risk class or are even invasive. I mean, sure, they have to do maybe a little bit, ah they have to do some more work.
00:11:13
Speaker
And mainly then the jump from class one to two ah is that you have a notified buddy involved when you're a class two device.
Data Management and Compliance Issues
00:11:20
Speaker
That means that and notified buddy has to do audits with you, has to come and check is your quality management system okay? is your Information security management. Okay.
00:11:31
Speaker
um So ah for example, not they are checking quality management and information security, cybersecurity. um And also then they are also checking, ah is your device conformed medical device regulation, the European legislation.
00:11:48
Speaker
But yeah, this all comes to it. And same rules apply if you have a very high risk device, something invasive. ah This can be from screws ah that are used for an operation when you have broken your leg and they need to ah fix it with a plate and screws and to defibrillators or whatever, something invasive that is implanted ah in you during an operation, or but also an app.
00:12:17
Speaker
And for example, we have to make sure that if there is a power shortage, there is a power cut, or we are having data in a cloud and the cloud is not working, how long is this OK? And it' like when does it start to be dangerous for patients that they cannot access their ah app or their data?
00:12:36
Speaker
um hope yeah It goes really far, to but the same rules apply for whatever, if it's a screw or if it's ah an app. yeah Yeah, exactly.
Regulatory Impact on Startups and Innovation
00:12:45
Speaker
And I mean, now coming to the cloud example, I mean, if it's, let's say it's, to and quote unquote, right, if it's just a standard app where I do a regular daily check-in to see how I'm feeling, and this is just for simplicity's sake argument, it's not that bad if the cloud is out for, let's say, four hours. yeah
00:13:07
Speaker
But if you have an, imp which exists now, if you have an implanted defibrillator, It's very bad. This can result in a very, very dangerous situation.
00:13:19
Speaker
yeah Or a even if the cloud isn't potentially down, but if there's a hacking attack, let's say, and somebody just decides to give you a voltage boost, which, well, that will be terrible.
00:13:34
Speaker
Yes, definitely. Yes, definitely. And these are things that we have also if you're a load low ah risk class device like we are currently or at Lindera was also not such a high risk class device, um then still you have to go through the same procedure.
00:13:52
Speaker
Which is sometimes it feels a little bit like, okay, we're sometimes a little bit exaggerated. Like what in the end is different. Like if I would do training at home with my fitness app, for example, in Corona times, a lot of people were doing it. They were downloading an app and doing some exercises with a,
00:14:09
Speaker
trainer, um which is then just a health app. um And we would do the same, but we do it for patient population. And we claim that we treat patients with it.
00:14:21
Speaker
Like for in the case of Herodikos, for example, people with back pain or knee pain, um then suddenly you're a medical device. And then you go through so many more hurdles, which is not bad. These also help you to have ah you assure that you deliver high quality, but it definitely slows down a lot.
00:14:43
Speaker
It does. And yeah, I mean, it makes sense, but it's definitely a big challenge to do it. And especially as startups, if you say we have a good idea, here is something missing. What we hear also often from, for example, medical doctors or patients that we are treating that say, Hey,
00:14:59
Speaker
ah It would be good to change this and that or to add this and that to the product or to treat this patient group as well that we say, yes, in general, we could.
Clinical Trials and Patient Engagement
00:15:07
Speaker
Would make totally sense. But before you're there, you have to go through all these.
00:15:12
Speaker
and It's not just we shoot a video or we add some ah exercises and let's go. ah Normally requires way more. It does. And this is what also patients or ah medical MDs, physicians,
00:15:30
Speaker
or therapists don't always understand what it then takes, why it takes that long. Because, yes, scientific publications take forever. ah Medical device development also takes forever.
00:15:43
Speaker
i mean, yeah, of course, you can speed up certain things, but um especially once you have the the basis, like the foundation is done, like once you have your quality management system in place and you have your ah information security management system in place.
00:15:59
Speaker
and It can go a bit faster, but If you start as a startup with a new idea and say, okay, let's develop a new device. Let's make it a medical device, an app to treat, like if you stay in a digital world, to treat a certain ah patient population and before you're there to that level that you have everything in place and functional, not just saying, okay, we have all these procedures, but also living the procedures and integrating it in your daily development, product development life.
00:16:28
Speaker
ah That takes quite some time. And even then, if you have it in place, then to go through all these steps before you can release it, um then you're quite some further.
00:16:41
Speaker
Yeah, for sure. And just for the listeners to understand, i mean, you're class one, right? Herodicus class one, which is the lowest risk class. Then clu comes class 2A. And at class 2A, we're already talking about diagnostics.
00:16:54
Speaker
Yes. So there's ah there's ah there's a sharp jump up. Yeah. Yeah. As soon as you do interpretation and you do something diagnostic and you give advice to, for example, physicians, what treatment would be best, or and so as soon as you give these kinds of recommendations or diagnostics, and then you are automatically to a, yeah there's a lot of debates currently if class one medical devices like we are now can still exist or if they should become two way.
00:17:24
Speaker
because the it's a bit of gray area. It's not so clear. And of course, it's for us more beneficial to stay class one device. But there is currently a lot of debate.
00:17:35
Speaker
The medical device regulation um has been implemented not that long ago. And um now you see that there are quite some points that are readjusted. And there currently a lot of discussions on what is exactly a class one device.
00:17:52
Speaker
And can apps like ours still ah stay a class one device? Yeah, yeah, you're right. and And um which I think is already you can, this debate, I can already see it being slightly put in practice where even if you apply for a class one, they try everything to push you to Yeah.
00:18:18
Speaker
Which I find sometimes, i mean, in in essence, if you really don't do any diagnostics or any recommendations based on a specific diagnostic, which that's, I think, the critical aspect here, then, well, by legislation, it should fit into class one.
00:18:36
Speaker
Yeah. Yeah, for us, for example, it even said that we at Heroicos, we work with physiotherapists that are treating you um or or um orthopedics, physicians that are treating you.
00:18:51
Speaker
So you have we have two different types. modes basically how patients can be treated and in the end they are still responsible so to check if like what trainings suit you it's not like it's not an AI generated program that we offer it's tailored by a real person physiotherapist or and or a physician so they are also qualified persons to decide what is good for you or what's not so
00:19:21
Speaker
Even we had somebody saying like, yeah, are you a medical device at all? Because in the end, it's ah ah software, so say that it can help therapists to guide you and um or physicians to guide you.
00:19:37
Speaker
um Yeah, we are not, I would say we are definitely a medical device because we also do a little bit more than that. um But the diagnostics and stuff, we say we're not doing. So why then the class two, but we're not allowed to give any, you know, we're not allowed to calculate, for example. So we're not allowed to give out certain scores or something because then we would manipulate data. Right.
00:19:58
Speaker
Yeah. yeah yeah yeah Long story and ah a hot debate at the moment, but I would not see a reason why these kind of apps would become a two-way medical device. It doesn't, for in my, like, i don't think it really makes sense.
00:20:15
Speaker
Yeah, yeah, exactly. i I also don't think so. um Especially it's, as you said, it's the... um the um Who's it intended for? all right what's the What's your and and population, your intended target population? And is it tied to a specific disease diagnostic?
00:20:40
Speaker
And if that's not the case, well, I mean... Yeah, and it's also the same for example, when Germany digas, digitale Gesundheitsanwendungen...
00:20:51
Speaker
um It's a medical, and so it's a clinician that is telling you, i give you a prescription for, to use this because I think this can help you. So it's already an MD that takes a decision. Yeah. You have this diagnosis.
00:21:05
Speaker
I think this would help you. Like I would give a drug or I would say, okay, go to a physiotherapist in our case, for example. And somebody goes to a physiotherapist. We don't know exactly what happens there to the physiotherapist.
00:21:18
Speaker
And maybe this person, ah the patient comes back to the, to the clinician at one point or not, but it's this black box, so to say, but it's a key in the end, the clinician or a physiotherapist deciding what's good for you what's going on. And, um, the diagnos like the diagnosis has already been given by the physician.
00:21:41
Speaker
Yeah, exactly. So we should also not exaggerate because we make it like, yes, patient safety, definitely first. I fully agree there. And there's no, for me, no debate about that. um but we should keep a realistic eye on what is helpful, what's beneficial for patients and, uh, to what extent are we sometimes over-regulating things and make it extra hard.
00:22:04
Speaker
Um, yeah. yeah It's definitely sometimes, Out of proportion. Yes. Definitely. Yes, definitely. I'm sure we will get into this in a little bit again. Yes. But let's let's go a little bit back into how the process of getting a medical device actually and being a medical device.
00:22:27
Speaker
And one of these aspects that you mentioned, I mean, you you were talking about You're mostly taking care of the clinical side of things. um Can you explain ah little bit what evidence generation is all about in clinical trials and why it is so important?
00:22:44
Speaker
Yeah. um Yes, I can do. So normally the first step when you have a new idea, let's say either you want to develop a new product or you do product development and you want to add something for a new patient population.
00:22:59
Speaker
The first thing you have to do is check in literature. So you do a systematic literature review. What is ah science saying is useful and what is working for this patient population? Can we rely on scientific results from similar devices?
00:23:16
Speaker
So you look for what similar devices are on the market. What do they do? And um is this evidence already saying, okay, This way you can treat patients in an effective way.
00:23:28
Speaker
This is safe and it's performance. So safety and performance again. So this is the background check that you need to do first, which is already quite a big job normally because it's a systematic review. That means if you look for but publications in a certain area. For example, if you look for back pain and you start doing their checking how many scientific publications have been published in that area.
00:23:52
Speaker
yeah the plug in i can tell you that's quite some. So you have to screen all this literature already. So that means that you have to go through, know, sometimes more than 400 publications or you yeah You boil it down to very specific questions. and right But whatever, this is quite a lot of work. And once you have done that, then, you know, okay, my device as I planned it could potentially work.
00:24:15
Speaker
Then I just know that hypothetically could work. Then I have to set up the whole device, how I think it should work. I have to develop an app, for example. and We'll not go into that now. But then um you need to generate data. You have to prove everything.
00:24:30
Speaker
Like if you want to become a medical device under the medical device regulation, you have to show evidence that the way and your app is working, are you treating patients the way you should? Is it safe? Is it performant?
00:24:44
Speaker
can you Do you have a benefit for the patients for what you claim? So you cannot just say, ah, we're going to reduce back pain. And then they say, okay, show it. So that means that you have to set up a study.
00:24:57
Speaker
um So the first step would be, if you're not a medical device yet, you have to ah first generate, there's a first new, like relatively new hurdle with the medical device regulations, which makes makes it tricky because you need to have data before you can normally become a medical device.
00:25:15
Speaker
um So you set up a clinical trial. um This involves the ethics committee. Normally, first step, you go to the ethics committee and say, okay, this is the protocol. So you set up a whole protocol and you describe exactly how many patients do I need? What am I going to do with it?
00:25:31
Speaker
What are my inclusion and exclusion criteria? So only men between 35 and 55, white men between 35, 55. And then I'm going to treat them for 12 weeks. Every week they're going to do this. And ah we're only contacting them at these moments.
00:25:50
Speaker
and He needs to be very detailed and you need to know exactly how are you going to do this? How are you going to analyze the data that you generate? How do you recruit the patients? um Who's involved? Are there met like clinic clinicians involved or not? um All these steps you need to fix in a protocol.
00:26:09
Speaker
and Then with this fixed protocol, you go to the ethical committee and ask them, Do you agree with this? Then they will come back with questions and say, medical device, tricky. First question, like if you go to the university, ah the medical ethical committee of the university, they say, okay, this is not our cup of tea. You have to go somewhere else. Then you go to the other medical ethical committee.
00:26:34
Speaker
And if you work in different regions, then yeah then most likely you have to contact for each region, a different ethical committee. So they will have to agree. Right.
00:26:47
Speaker
Yeah, so but let's say you got the ethical clearance, they say, yes, let's go. and you have all your partners set up. That's the next step. um You normally cannot do it alone as a manufacturer, because I would be biased. I want to have, if it's my product, I want certain results in a certain direction.
00:27:07
Speaker
So normally, it's good that you have some scientific partner from academia. or a CRO clinical research organization that you give the the job to do perform your study.
00:27:19
Speaker
Um, like if you keep in mind that this is quite a lot of work, then you also can imagine that this is also quite some costs for new, uh, new companies. So startups, um, but then you said so far, how, I mean,
00:27:37
Speaker
We're not talking about three weeks of work, what you what you already mentioned. And we're not even we're not even at starting the study yet. No. what What do you think is like it's just just a ballpark? and And I know this is a lot to ask because every study is obviously different.
00:27:53
Speaker
so But let's say you, let's start with something simple. Let's take class one medical device. ah That's the aim. um Just...
00:28:05
Speaker
writing the protocol and having ethical trying to get ethical clearance assuming you're you're knocking at the door of the correct ethical board at the beginning yeah so you need already to have the scientific evaluators and probably statistician maybe external involved so um you need mds already involved normally to that point. so you need to already have So you need to have set up the network already and you need to have an exact idea of the study.
00:28:34
Speaker
um
00:28:37
Speaker
If you're very fast, maybe six months, but that would be really optimistic. I think rather more a year, realistically. Yeah, it depends a little bit of you if you already have some experience, of course, like I've seen now a couple of times i have set up studies and I know approximately how this goes. So I think now i and I have already some network so I know which partners I could contact so and ask for help or CROs, for example, or university ah members, scientific, yeah, some professors that I could contact. So then it can go faster. and
00:29:17
Speaker
um But still, it's a lot of work. yeah Yeah, every detail needs to be said in advance. That's the idea. Like, because once you start running the study, you're not allowed to just make adjustments. you You cannot say like, ah, I mean, you can make adjustments, but it needs to then be always, it needs to go back to the medical ethical committee.
00:29:37
Speaker
Um, because these are, so to say amendments and they need to be checked. And, um, every change that you make on the way is, uh, potentially a problem later on.
00:29:49
Speaker
Yeah. Yeah, definitely. And if the change is too big, it's in theory completely. What do you think, Ajmal? You've also seen this with like a year, like between half a year and a year. I think this is, would be realistic.
00:30:01
Speaker
I mean, and if you are very clear on, and there's a lot of ifs involved, um assuming you have your app ready, you're very clear in what you want to um
00:30:19
Speaker
investigate, then it's, ah from my perspective, it's always a matter of ah reverse engineering it. um You have your, um let's say, back pain. Yeah, let's let's stick with back pain.
00:30:34
Speaker
That's what you want to assess m as in whats what's supposed to be an improved outcome. Well, then you have to look into, okay, which assessment tool can I use?
00:30:46
Speaker
and And that, of course, needs to be a... um um a clinically proper assessment tool. It cannot just be, a I don't Validated in the right language. Validated.
00:30:58
Speaker
Exactly. alice Yeah, let's validate it. I really don't like this word, but well, we're in the medical field. not much. science going on as I would like it.
00:31:10
Speaker
But okay, yes, validated. It needs to be a validated tool um and that can't just be anything. So then you have to go through your validated tool list and check which ones fit your potential um study type because each of these tools comes with, of course, their own set of problems and advantages.
00:31:32
Speaker
And after you did that, you roughly do your stats, you check your patient population and in parallel you check also the feasibility of this whole process because assuming you have your entire network and all of this is ready to go, um you still have to write the protocol, which If you did this a few times, that can go rather fast and fast. I don't mean it's still weeks, but still.
00:32:00
Speaker
um you still have to wait for the ethical committee to actually have a look at your you're proposal. um So you have so many third parties involved which slow things down.
00:32:12
Speaker
data Because this doesn't run in parallel, this runs in series. And that's a little annoying. And assuming all that goes, you still have to go through um the process of actually finding your purpose patience you have to You have to recruit patients that actually want to participate and that's something that's also often overlooked.
00:32:35
Speaker
And the recruitment is, ah I think, the most tricky part as well in in running these studies in the end. and We had now a lot of discussions of setting up a randomized controlled trial, which is and yeah you have a control group and a patient population, the experimental groups, let's say, where you test your new device or whatever it may be.
00:32:54
Speaker
You test something new against something that is staying stable and is the In Germany, we would call riga aor understand it the standard care that the patient would get. For us, would be, for example, we have a patient population that receives physiotherapy and we compare them to the patient population that we treat with the Herodikos app.
00:33:13
Speaker
Right. Um, and, but we had done a lot of discussions. We had a scientific partner on board, um, ethical committee with also in mind, we were setting up the the protocol, but then with a lot of discussions, okay, how do we get our patient populations?
00:33:27
Speaker
Because we have to randomize. So we have to. When a patient is in the study and says, yes, I want to participate, then we need to randomize. We need to give them either, they get the control group, and they get into the control group and they get physiotherapy or they get the intervention.
00:33:45
Speaker
So the hit already goes up in this case. But this is not so easy because you need to include them. Who is allowed to include them? Like give them all the information and it says, okay, hey, you're a patient. Ah, you have back pain.
00:33:58
Speaker
Who knows this? This is normally the ah the physician, maybe your ah general physician or an orthopedic doctor, whatever. i mean, these babies see the patients first and say, hey, Ajmal, you have back pain.
00:34:16
Speaker
hey, would you like to participate in the study? That means you ask a medical, a healthcare care professional um to invest time to explain like, hey, there's this study, would you like to participate? Do you know what it is about? Can I explain you? you the healthcare professionals should explain what it's about and and then send basically the patient first home with the information about the study ideally that they can read and then they can say, yeah, I would like to um because I need some time to think about it.
00:34:50
Speaker
You have to oblige patients to think about it. Normally it's like 24 hours that they should be able to think about it, reflect, do I really want to participate? Then if they say yes, then they would need to probably go back again to the and the physician. So that means extra work for a patient to say, yeah, I would like to participate. ah First, I have to go again back.
00:35:10
Speaker
I have back pain. It's annoying. Actually, I want to be treated now. But no, then you go back to the physician, say, okay, yes, I would like to participate. I would like to enroll in the study because then you need to get...
00:35:21
Speaker
you need to do the randomization. And the randomization is not the doctor that is randomly assigning normally. This needs to happen somewhere else. So somebody else needs to tell the doctor, this is a patient for the control group.
00:35:32
Speaker
um And then the the physician needs to give this patient then a prescription for physiotherapy. And then the patient needs to go to a physiotherapist.
00:35:43
Speaker
And we need to get in the data to analyze what has happened in this time that the patient was treated by a physiotherapist. Has there been something else? So we need to get data from this patient. How do we get this data from this patient?
00:35:57
Speaker
um So already there, this is just the first steps before somebody can start, a patient can be enrolled in a study. This is already not so easy. It's really hard to recruit patients and not because we have a lack of patience patients with back problems, not at all.
00:36:14
Speaker
But it's just the steps that you need to go through and the people that are involved and the extra time that you ask from a patient, the extra time that you ask from a healthcare professional, be it the MD or be it the physiotherapist, but they all need only to be involved somehow.
00:36:31
Speaker
Right. and So you need to set up a local network of people that are then involved because it doesn't help if I have a physiotherapist in Osnabrück that wants to participate in the study and I have an MD in Hamburg, for example.
00:36:44
Speaker
and This doesn't really work because the patient is probably not living in Osnabrück but in Hamburg. So um it's not so easy to start. It's very complicated. And the recruitment is the most tricky thing.
00:36:57
Speaker
And this all needs to be thought through before you go to ethics committee. This needs to be fixed. How exactly are you going to inform your patients? How are you going to recruit them? Who's recruiting and them?
00:37:10
Speaker
You need to know the names, ideally already, of the healthcare professionals involved. ah They need to probably sign documents. So you need to check this all with the healthcare professionals. They need to know what exactly they need to tell patients, how this works. This is extra time. This means that you need to pay them.
00:37:27
Speaker
yeah But not too much because you are not allowed to bribe them. yeah so is it yeah Same for the participants, right? They're also supposed to get some type of reimbursement, but but not payment yeah in that sense.
00:37:40
Speaker
Otherwise, it could be seen as, well, yeah you basically paid them to be in favor of your solution. Yeah. Yeah, you're not allowed to buy their vote. Yes, exactly. exactly It's a tricky balance all the time between um keeping patients and keeping ah clinicians, for example, motivated to participate because everybody is already overloaded. If you think at the german about the German healthcare system, which physiotherapist says, yeah, sure, we have a waiting list, but sure, I will participate in a study. Yeah.
00:38:16
Speaker
difficult. And if you think of the clinicians, it's the same. Like if you try to reach them by phone, you're not getting through. And then I'm coming with a new device and say like, Hey, I would like to do a study. Yeah. yeah You need to have really motivated.
00:38:31
Speaker
i mean, you're then recruiting automatically already the clinicians or the therapist that's know bit how this works with studies that are interested in bringing new therapies forward and to develop medicine because they see a benefit of it.
00:38:48
Speaker
Yeah. Yeah. And I think what what also people need to to know is that while you are executing all this, you need to protocol everything.
00:39:02
Speaker
Yep. Yeah. Every contact moment needs to be documented. Yes. And this you can do with an Excel file, which is really tricky. I could yeah recommend this to anybody. yeah We speak about 300 patients for a randomized controlled trial.
00:39:19
Speaker
If you have two groups, not discussing the subgroups yet, but let's say we have two groups, a control group and an intervention group. And if we then speak about patient populations of like, let's say over 200 patients, you need to track each patient. You need to know what so stage to run, which questionnaire they need to receive, if they have already filled it out or not. I mean, this you could do with an Excel file, but this is going to be a mess. I would not recommend it.
00:39:43
Speaker
But then you can have software that is supporting you. But of course, this is also not for free. So yeah next every step ah is involved with, ah like money is involved with every step.
00:39:55
Speaker
Yeah. Yeah, yeah. And if it isn't money you pay someone else to do it, it is certainly money you spend on the time invest you have to make. Yes. Yeah.
00:40:06
Speaker
and I've seen more often than not, if you take shortcuts in the setup process, you are going to pay for it. Yes. It's expensive to fix it.
00:40:17
Speaker
If you can still fix it. if let's So that's a problem. Especially if I think of small companies, so ah startups, or already a little bit further, we are speaking of, I don't know what you would expect or what your estimate would be, but a randomized control trial, which is seen as the gold standard of studies that you need for basically for any procedure. If you want to become, for example, a digitale Gesundheitsanwendung in Germany, you need to have an RCT. There is no way around it.
00:40:51
Speaker
There's no way around. Yeah. And an RCT... well easily 200,000 euros. Oh yeah. like Just additional costs, not even the personnel costs. I think that are of a company involved, easy 200,000 euros for just a study. And once, so that means you have one shot, you can, you start the study, you have to set up, set it up well, because if, for example, you made a mistake in your protocol or something is not working out because you have to predict your outcomes, you basically have to know already your outcomes before you have started.
00:41:24
Speaker
Because if you make a mistake on the way you take the wrong scale, or you take the wrong, ah whatever the the wrong goals, you recruitment doesn't work for this patient population, you want to change it.
00:41:37
Speaker
so Whatever can happen on the way, once you have made a mistake in the beginning, And you have already started, you have the study is running, you have patients and enrolled.
00:41:49
Speaker
um You cannot easily start a new study and because there are so much there are so many costs involved. So you have basically one shot and you have to do it right. And you need to know a lot already in advance, like how, um if you, now you shortly spoke about which measures, like how are you going to measure what you want to know?
00:42:08
Speaker
um You need to know in advance how, for example, if you it's a questionnaire, a validated questionnaire, validated in German language, all fine. But if it doesn't measure as well as you thought, you have a problem.
00:42:21
Speaker
Because then the conclusion can be that ah your performance is not good. so It might be a problem of the scale. You simply took the wrong measurement tool.
00:42:33
Speaker
Yep. Then you have a problem because then you're um from probably, maybe your product might be off the market or have no chance anymore to become a DIGA, for example, which can be killer.
00:42:47
Speaker
Yeah. and then And now some listeners might think, well, then um I might as well just take three validated questionnaires. ah Well, you can't yeah because you the thing is, when it comes to statistics, if you flip a coin, it will be heads.
00:43:05
Speaker
at one point and and that's basically what they want to avoid. You have to pick and choose from the start to make sure that your result is not coincidence.
00:43:17
Speaker
Yeah. And you need also to have your primary objective, like what is the main important question? And if this main important question, for example, for us, it would be reduction of pain. yeah Or functional functionality, that can also be, that's like these two would be, I would say, the two ah ones that we could pick from.
00:43:35
Speaker
But let's say we go for pain and we say, okay, we're going to reduce the pain ah with ah two points on a certain scale or 30%.
00:43:46
Speaker
Okay, ah but if this turns out to be 29%, then and my hypothesis is not, basically I have to reject my hypothesis, although I might be close, but still not rejected.
00:43:58
Speaker
But normally it's a pyramid. If the upper one, your first primary objective is not working out, the rest underneath, you can discuss it. Nice information, but nothing really to work from, to work with.
00:44:11
Speaker
So then basically your whole study falls apart. Falls apart, yeah. Yeah, yeah, exactly. And that's,
00:44:22
Speaker
it's I think it's mild to say it's a gamble because it's so much money involved and so many people. ah it And I think this this this brings me to you know one of the next things is what do you think are some of the most common pitfalls ah you would warn medical device manufacturer about when it comes to clinical trials? I mean, we talked about quite a few things now.
00:44:48
Speaker
we're we're not even we We didn't even get to the data analysis yet. Yeah. data analysis and then trying to apply for um and handing it all in at their and and um the in Germany it's the Bayfarm in the United States it's the FDA um right after photograph and drawing yes it's the FDA um as a man what what should I ask myself as a manufacturer if I want to get into this business what what what do I need to ask myself
00:45:21
Speaker
It's funny, I had just had a discussion last week about with a university, like a scientific employee that had they had this really nice ah research and development. Oh, yeah.
00:45:35
Speaker
Wait, I'll start again. and So last week I discussed, I met with a university employee and they had this very nice research and development project that is still ongoing.
00:45:48
Speaker
And they are developing basically something that goes very close to a medical device. And everybody advised them, like, don't go to the medical device. Don't go there because then you have to do all this medical device regulation.
00:46:02
Speaker
basically need to ah set up a company because the university is probably not going to do it. ah It will be a spin-off of the university maybe, there are ways, but don't go there, stay in Health App if you can.
00:46:14
Speaker
And they're like, actually we cannot stay in Health App. So um a lot of people say, just don't go there, it's too complicated. It's complicated, it's very tricky and it's hard to make money in this business.
00:46:29
Speaker
which people often misunderstand. They think, ah, you have an app, you bring it on the market and you earn a lot of money because an app is really expensive. Like Adiga easily cost more than 200 euros for just an app for 12 weeks, two hundred more than 200 euros.
00:46:43
Speaker
Yes, for a reason, because everything, like the little part we have just talked about, costs a lot of money. you can curse. It's fine. I'd curse for you. A shitload of money. Yeah, yeah, yeah. Yeah, and a lot of time and a lot of dedication.
00:46:59
Speaker
So it's not so easy to make money and you need, like, there are different ways to make money, but you have to know this all in advance. Like, you have to have a very clear plan Do I want to go there?
00:47:11
Speaker
What are the requirements, the legal requirements I have to go through? What do i need to set up in advance? Like you have to set up a company. ah you have to have the personnel that is doing this. Um, so it takes already quite a long time before you can be even on the market and then you still have to make money. So you need to have already quite some money to be able to go on the market.
00:47:35
Speaker
um and So that you need to have very clear, you need to have a very clear idea. What is my patient population I'm targeting? Because for this patient population, you need to get the evidence.
00:47:47
Speaker
Um,
00:47:50
Speaker
Yeah. And then when you start, like we'll start with clinical trials and so on. I mean, probably in the research and development project, you could already, I would advise at least to generate some evidence.
00:48:01
Speaker
So pilot wise, start checking, is this working or not? Which tools can I use? Because there you can still explore tools. You can explore patient populations. You can see, u okay, what How is this working? Is it usable, like the usability studies you need to do?
00:48:19
Speaker
um What works? What works? What does not work? Is my message coming across clearly? Do people understand what I'm saying? Or are there misunderstandings? Whatever, all these things you need to check in advance.
00:48:32
Speaker
And then When you say, okay, yes, we really see the need. We really want to go there. I would advise talk also to healthcare insurance already because you need to have probably contracts with them.
00:48:46
Speaker
Maybe have a chance to read get in touch with them, maybe in the research and development project already, but check what is the market like? Like, would they, would they pay for it? Um, because you need somebody that, uh, is paying in the end.
00:49:02
Speaker
Um, get in touch with other, get in touch with manufacturers and ask how, what their road was like and if they would recommend it. ah This can be, um, and newtons in Germany, yeah yeah yeah, quite a bummer, but because everybody thinks, ah, I have the amazing idea, but then you come with like, oh, this and that and, um,
00:49:26
Speaker
Yeah. And then when it comes to study wise, like what we have just discussed, you need to have a very clear plan and keep in mind that what you're doing in a study If I say i only measure men between 35 and 55, that means also my medical device is right only safe and performing for patient population.
00:49:48
Speaker
So if you have a very diverse patient population, um you will probably have a lot of subgroups. um This can be very tricky. So this you have to keep in mind when you set up a a study clinical trial.
00:50:05
Speaker
Yeah, recruitment. yeah your had um Yeah, I can only then advise like, with like that was a discussion I had last week with an employee of the university.
00:50:16
Speaker
um He basically asked me like, would you recommend us or what, what does it take to become a medical device? Well, I can share some, some insights, it takes quite a lot.
00:50:30
Speaker
It takes a lot. Yeah, it takes a lot and you need money, you need investments, you need money to start. Otherwise, you're not going to, um you cannot do it ah on the site, you cannot just develop something um on the site, you need to be sure that you are online. I don't know exactly how to say it, we can skip that.
00:50:52
Speaker
Yeah, I mean, it' a you you're right. you can it's it's not It's not a side hustle, let's say. No, maybe the beginning. you know It's a main hustle. Yeah, the the beginning might be a side hustle, like first to see like, oh, you know, let's do a pitch.
00:51:06
Speaker
Might this idea work? ah Try it out with some investors, see if they're motivated. I mean, setting up a very good pitch first, but that means already that you need to have a very clear, what is the problem?
00:51:20
Speaker
what is the patient or What is the patient population? What is their problem? And what problem am I going to solve? And what does this problem actually cost? And what cost do I reduce with my...
00:51:32
Speaker
how I want to solve it because you have to prove that you are not just safe and perform performing. That's all nice, but it needs to be cost efficient. Otherwise ah no healthcare insurance is going to pay for this.
00:51:44
Speaker
yeah So you need to jump in a gap ideally where normally a lot of costs exist or start existing need to get this like health, health, economic studies basically.
00:51:58
Speaker
Let you know what are the costs of this patient population and what and to what extent can I reduce this? And how i do it how do I think I'm going to do this? Now, you said you talked to someone from from the university. I mean, how is your scientific background helping you navigating this industry?
00:52:17
Speaker
I'm sure there are some, I mean, I can speak for myself. um There are some advantages having had that background, but how is it for you? Yeah, a double actually. Yes, it helped me a lot. um I think first I had to also and get used to the resistance that I automatically receive but um with being an industry, the skepticism that people have.
00:52:39
Speaker
Like when I come and say, okay, I want to have ah do a study, then they first think, yeah, you want to first you want to get the best results out for you. um Yeah, this is true, but it doesn't mean that I don't have a brain and I don't have a scientific background and I can think about it.
00:52:57
Speaker
And at the other hand, you have industry that is, oh, there you have a scientist again and scientists are taking forever. They are just talking and they are not goal directed and they are not thinking about the medical devices and how to make money with it.
00:53:12
Speaker
The business, they don't care, they just care about quality and not about business and it takes long. um So this I found a little bit tricky first to navigate ah these balances. Basically you have both sides that are thinking, what are you doing here?
00:53:27
Speaker
And a little bit, some skepticism from both sides. for sure but what helped me a lot like in science you're managing projects all the time right you're setting up a new study you have multiple parties involved normally you're you run experiments or i was running experiments with students but the same principles hold for the clinical trials that i have to set up and the statistics background helped me a lot to understand ah What does it take to analyze studies so that I can talk now to statisticians, statisticians for example, that are doing in our analyses?
00:54:04
Speaker
Or I can talk to clinical research organizations because I know what it takes for them to set up a study. I can help them. I can take over quite some work for the company I can, they're lower also costs of others because I can write these project proposals or I can write ah protocols.
00:54:25
Speaker
Yeah, and I'm a bit of spider in the web, I would say. yeah, yeah. That is not much different than in my scientific career. um Sure, different, different stakeholders, so to say, and different ah interests. I mean, I had mainly, the biggest difference, I think, is at the university, my interest was to publish my research so that I could get my PhD, for example. I had a clear goal, and if I didn't do my work,
00:54:54
Speaker
everything took a little bit longer, but it was basically, I was just ah my own hurdle, so to say. Yeah. And now I have, of course, way more, yeah, there is way more involved now. I have, there definitely more um pressure and challenges because of course, ah yeah, when a study is not going well or yeah, a lot of,
00:55:19
Speaker
A lot of it depends on the work that that we are doing as clinical researchers in this field. Yeah. Yeah. yeah And I mean, when you were doing your own research, you could the research question was only motivated by your intrinsic curiosity.
00:55:35
Speaker
Whereas now, is sure, it's also the curiosity, but more as in, let's try, and this brings us back to risk, let's try to minimize the risk of a failing clinical trial.
00:55:49
Speaker
Yeah. yeah that's That's different. Yeah. And like what I find really nice now, like I'm really happy that I made this transition from academia to the work I'm doing now, because in academia, you're working ah or I was working on a very theoretical level, like, uh, how does the motor system control movements?
00:56:09
Speaker
Super interesting, super fascinating how you can grab a cup without crashing it or without dropping it without knowing how heavy it is. I still find it super fascinating and we know nothing about this. Right. We know nothing about how the brain works. We know nothing about how I'm exaggerating a little bit. We know some, but I would say the nothing is, we know very little.
00:56:29
Speaker
so We know very little. Um, um And now I have like of my work now I'm working directly to improve patients well-being or to have to find the improvements for the German healthcare system so that patients don't have to wait that long to be treated. Um, and.
00:56:51
Speaker
and That's not just for my the company I'm working for now, for Herodikos, but in general, and I think digitalization in healthcare, there's so much that we can improve there. that Not saying that you don't need to see physiotherapist anymore.
00:57:07
Speaker
Not at all. and Not at all. right Don't misunderstand it because that's often what people think. Like, oh, now an artificial intelligence takes over. No, not at all.
00:57:17
Speaker
But we see that the patient population is huge. It will not get less in the next years. Everybody's overloaded. This goes from um care care homes, elderly homes, where at Lindera, for example, we were mainly ah active,
00:57:32
Speaker
to waiting lines for physiotherapy appointments or whatever. If I try to get a doctor's appointment, yeah I have to wait if I want to see a specialist and if it's not urgent, very urgent, so or even if it's urgent, and depending on your type of healthcare insurance, you might not get an appointment because they don't take new ah new patients, blah, blah. The system is overloaded and a lot of it can be solved or at least for help to give he to give different kinds of therapy.
00:58:04
Speaker
And a lot of it can, like, if you see now, um you go to a clinician, and you have back pain, then the clinician may say, I i see you have back pain. I give you physiotherapy.
00:58:16
Speaker
Nice. But what do I know? i had back pain myself. What do I know about my body, how it works, of what impact what has impact on back pain? I just think, okay, mechanical problem, maybe. i was sitting too much, maybe.
00:58:30
Speaker
But do I know what impact my food intake has on pain, for example? Or stress and pain? Or sleep and pain? All this education, there is no time for education in the system at the moment.
00:58:44
Speaker
so And these things you can do very well with an app, for example. Yeah, yeah, yeah. That's why I think these digas are absolutely valid. They're a good tool. Yeah.
00:58:54
Speaker
a super good tool and will be enough for, I think, a big part of the patient population. And then you can be way more efficient and you can still have ah medical doctors and physiotherapists or other therapists involved.
00:59:07
Speaker
Absolutely. yeah For sure. I think so too. um
00:59:17
Speaker
The system is certainly overloaded. And i think what I find that... i mean, everybody knows this. It's become a bit of a joke now, almost like the punctuality of the Deutsche Bahn. It's become a joke and it's now people started to just be like, yeah, well, that's just how it is. And well...
00:59:38
Speaker
And that's kind of sad. And yeah you know when it comes to the logistics of of of trains, it's one thing, but I think when it comes to the health of a population, that's something else.
00:59:50
Speaker
And um it's not like we can't do it. It's not like Germany is and speaking for Germany now. yeah It's not like we're a poor country. That's not the case at all. um So I'm wondering, you know based on based on everything you said, i'm i'm I'm curious how you assume there is a new idea, right? You have a new idea and you already know based on some initial research and development, this is a valid idea. This will help a specific patient population um with with a specific intervention.
01:00:26
Speaker
Now, based on everything you know, right, when it comes to this network, when it comes to the clinical study, when it comes to other types of ah regulations, what do you think is the best strategy, at the moment at least, to develop something in digital health?
01:00:43
Speaker
And now just speak freely. Assume you have a blank check, but the blank check is, um it is blank, But you should still have, ah let's say your objective is to be cash flow positive as fast as possible.
01:01:04
Speaker
And I know that's a big thing. Yeah, it is a big thing because actually that's a very big thing because it's not so easy. And we see even with the ones that made it to become a and digital health application, DIGA in Germany, that there are the first DIGAs went bankrupt. I mean, and they have already gone through all these hurdles. They have probably gone already through multiple, ah what they call, xti fitria so when when you start probably like
01:01:35
Speaker
I would suggest that you first go and contact healthcare insurances and say ah see if they want to set up a contract with you. there are These possibilities you have, so it's called Selectivvertrag, where you make a di direct contract with a healthcare provider, the insurance.
01:01:54
Speaker
um but so these There are DIGAs that have went probably first to selectivverträge and then they have made it to, they have shown that they are safe and performant and they have done this randomized control trial to show BFARM ah we are working and it's working well. We have a benefit.
01:02:16
Speaker
We work better than the usual care in Germany. So they have proven already all that. They had to show that they had this whole quality management system, which is not a minor thing. This is a huge thing.
01:02:29
Speaker
and They had that in place. They had the information security measurement system in place, which is also not an easy thing and a big thing. and big things cost a lot of money. yeah um And then they had on top some additional requirements that came underway, like BSE certificates.
01:02:47
Speaker
um Anyway, they had they have gone through all this. They have shown they have a benefit for patients, but they went bankrupt anyway. um So it's not a very easy market to make money.
01:03:03
Speaker
It's not an easy way to make money. So um if I would start new, I would... You asked basically what what I would suggest if you start company new, right?
01:03:15
Speaker
Yeah, yeah.
01:03:19
Speaker
I mean, I don't want to be too negative. I would not say don't do it. i would say do it, but get in touch with healthcare. Like get in touch with... Clinicians see if they would ah see a benefit there, if they would use Try to talk as much as possible to those that are involved. That means check with patients if they would see the benefits of like the patient population that you have.
01:03:43
Speaker
Don't make it theoretical. Talk to people. Talk to patients. Would you see a benefit and what would it need? So what are their requirements? Talk to physicians or healthcare professionals in general that are involved.
01:03:55
Speaker
Check what are your expectations? What would be your requirements? And where can I help? Where can I really make a difference for you? How can I um support you and reduce the burden in your daily life?
01:04:08
Speaker
Because else this is not going to work. They're not going to use it. If they are not going to prescribe it, you're screwed. You're not going to get your patients involved. You're not getting money.
01:04:19
Speaker
and So that's what you first need to do. So what are the requirements? Then um you need to talk to the ones that are paying for it. And in Germany, that would be the healthcare, the insurance, the different healthcare insurance companies that we have. We have quite a lot.
01:04:34
Speaker
um So you need to see with them if they would be interested. um And you need to think of the long run. Do I want to become a digitale Gesundheitsanwendung?
01:04:45
Speaker
Like if you want to get in the usual care, Then there is now one way there is DIGA or DIPA for care applications. Yeah. Nursing application. Nursing applications. Yes.
01:04:58
Speaker
Thanks. um So there are these two, two ways, um or basically it's one way depending on your patient population that you're targeting. Yeah. You have to see what are the requirements of DIGA because there are also a lot of requirements. For example, we, with Heroicos, we cannot become a DIGA at the moment because we have um real humans involved. We have physiotherapists or clinicians involved that are supervising and monitoring patients and that's not allowed. So if it would be an AI that is making your training plans,
01:05:34
Speaker
and monitoring your activity or adjusting your training plans, that would be fine. But if a human is doing that, um that's a little bit more tricky. I hope this will- not digital enough.
01:05:47
Speaker
Yeah, it's not digital enough. and then it's the question, is the benefit, ah like if I do it in a trial, then I have to prove, is the benefit coming from the person? Right. Because then I can also send you to physiotherapist.
01:05:58
Speaker
Or is the benefit coming from your device? And that's what I have to then prove in a study. Yeah. um This is doable, but at the moment, Bfarm is not so far yet in that development. They're working on it. We had discussions with them.
01:06:12
Speaker
So that's another thing that you should definitely do if you think of launching a company and if you want to become Dika, you have to involve Bfarm soon. You can do these consultations with Bfarm, talk to them.
01:06:25
Speaker
Yeah. ah Talking to them costs money. um so Also, this is not for free. It's not just that you can get a free consultation. um And you have quite some consultants on the market that can also help you getting on the market. So I think it's beneficial first. I think it's important investment before you go down this road.
01:06:45
Speaker
Yes, definitely. Get a clear and realistic perspective on what it takes and ah what it costs and what you need to provide if you want to become that company that is launching that digital so device.
01:06:58
Speaker
And then you have to get, ah pretty shortly, you need to get investments. You need to get investors on board. And they have been also like there has been a time where investors were very interested in digital health and they were putting a lot of money in it.
01:07:12
Speaker
um When DIGA started to run and the first difficulties popped up, this was, let's say, a little bit more difficult. Yeah. And it has changed. So now apparently there is again, ah there are investors that are interested, but mainly in the the bigger companies and or pharma is taking over, pharma industry is taking over companies. So um yeah, but I think. But let's say let's say you don't want to, because
01:07:42
Speaker
with every step there different degrees of um hurdles involved. I think the holy grail and would be something that can be prescribed, which is then the diga, if we stick with that for the moment.
01:07:56
Speaker
that then comes with hurdles of you know the quality management system, the IS information security management system, um BSI related cybersecurity aspects, GDPR related data privacy certifications um that needs to be involved. And then, right, you have to...
01:08:21
Speaker
get it certified, et cetera, et cetera, et cetera. And then finally you're you're on the list yeah and you can get prescribed, but maybe you won't, maybe you will.
01:08:31
Speaker
Well, who knows? You got to see. Or another thing is, as you already mentioned, the the contracts directly with health insurance providers. Yeah.
01:08:42
Speaker
I mean, there, i would assume, i don't know if that is true, you don't have to come with all these certificates in the back. Or do you? no you don't have and it depends a little bit so more and more this is i think everybody's learning with whole diga ah wrote everybody's learning of course like about the certificates and so it depends a little bit on the ah insurance ah healthcare insurance companies what they require right we see that there are more and more requiring for example
01:09:15
Speaker
that you have your information security system in place that i can understand this is coming and i i find this also this is a yeah i find this also logical actually that this is happening um yeah but that it's not sufficient good you're still a well let me say the health insurance provider would still want you to be a medical device in that sense Yeah, mostly yes. I don't know exactly if it's possible without being a medical device.
01:09:46
Speaker
Right. I'm not sure. I don't think so. It probably depends. I don't know. So after hearing all this, i would know, say, what if you just go direct to consumer?
01:10:00
Speaker
Yeah. I mean, if you have to spend all this assuming, right? Assuming. Let's assume. Let's assume. Let's assume you have to run ah clinical trial, as you already said, goes for 200K.
01:10:16
Speaker
And that means app and everything is ready to go already before you even start, not taking into account all the preparation and the documentation and ethical blah, blah, blah, blah. bla All of that stuff.
01:10:28
Speaker
Now, let's say you just had 200K to burn on your marketing budget. Yeah. That's already quite a budget. Yes, it is. And direct to consumer means there is no man in the middle.
01:10:47
Speaker
There is no additional certificate. You have to come in here from the left. You have to come in from the right. ah Sure, you can still go for for a medical device. You go for class one.
01:11:00
Speaker
And fine, you can say you're a medical device, which you are. And that's it. You don't make any further, let's say exorbitant medical claims.
01:11:13
Speaker
Yeah. Well, what do you think that's, maybe that's the way to go? And then yeah there are two things. Like one would be in health app where you're not a medical device, which would be a training app, for example. Yeah.
01:11:30
Speaker
insurance companies themselves are doing this, that they're often offering you certain prevention measures, for example, where you can do a course online or whatever. yeah and This would be possible.
01:11:42
Speaker
Um, this is possible. It's not so such an easy market to, uh, apparently make money. This is what I heard. This is not my field at all. fortunate interesting Fortunately, fortunately.
01:11:53
Speaker
Um, but this, it's a B2C market where you go directly to the customer. So in our case, directly to patients, um, it's not such an easy market to like, people need to be willing to pay for it anyway.
01:12:07
Speaker
So either you have a very cheap product. That would be like a training app or something where if you check on on your phone in the the library of apps that you can buy, there are ah loads of fitness apps, for example.
01:12:21
Speaker
lot. them If you want to treat patients, you get to a medical device. And then with a medical device, you have all the regulations that apply. Whether you're class one or not doesn't matter. You have you need to get everything in place. So...
01:12:35
Speaker
sure um and then let's say you're a medical device um you're not going through healthcare insurances but you go directly to patients uh you need to get to the patients how do you get to the patients they need to have a certain diagnosis already because you're not allowed to do the diagnostic so um yeah yeah but we don't want to invest in 200k it's not so easy apparently but i don't know exactly but i that's what i hear i'd wonder why because it's uh
01:13:06
Speaker
Yeah, people don't want to pay. Like if you have a medical device. That's, I think, the more the more problematic aspect. Would you pay 50 euros for an app i would that you would use for 12 weeks? Yes, I would. You i would do it and you can. 50 euros not a lot. 50 euros is not a lot of money for me to develop and to maintain and to monitor and to check my data and to do all this quality management and to do the information security management, GDPR.
01:13:32
Speaker
Everything, 50 euros. I need to have a lot of patients to be able to get this 50 euros out because I need a team of people that can actually do this. I need an IT department that is developing it.
01:13:44
Speaker
I need medical people to make content or to monitor content or if there are complaints or problems with patients and they they need to be able to contact you. So they say, oh, Hester, I did this in this exercise and now it hurts even more.
01:13:59
Speaker
yeah Somebody needs to be able to judge this. I need to do the risk management. So I need the risk manager, blah, blah, blah. You need all these people. And then I didn't talk yet about the marketing department. so Right. um That also needs to be checked. Marketing, sales. I cannot just say anything.
01:14:14
Speaker
Marketing and salespeople need to know your name. Right. So you need to do marketing. You need people that do that for you or you pay ah companies a lot of money to do it. um You have sales. You need to make contracts with the patients or they need to somehow...
01:14:27
Speaker
ah do something, document something that they are going to use it. and So you have already quite a lot of people that are involved here to get the basics done. So 50 euros, I think you it will be hard to survive as a medical device.
01:14:41
Speaker
I think I would not advise that. And... um So I think it's interesting that you that you point out if if I was willing to pay for it because that brings us all, ah they just a little just a little segue of a side story.
01:14:56
Speaker
um I had, i think it was last year, sometime in October, I um had a shoulder injury and um I didn't go to the doctor for a long time. That's like personal thing of mine, I guess. Yeah.
01:15:13
Speaker
I didn't, it in which is of course compounded on top of, oh my God, I have to get a doctor's appointment. man Oh my God, how do I do this? i have to wait and then I might as well just not go in the first place. It will it will just go away by itself if we look.
01:15:26
Speaker
Maybe, maybe not. it Yeah, this is as normally how it goes. yeah Well, two months went by, nothing changed, which is bad. So I thought, okay, maybe I rested my shoulder enough. It's time to do some mobility exercises and things, right? It's,
01:15:41
Speaker
Coming from this field, I know what to do. So I started to treat myself, not saying I did this properly. I'm just saying it's like I started at least. Things started to get better until I got a little bit too confident and then bam, the pain was back and was worse than before.
01:15:58
Speaker
So then after another two months, I got finally convinced by someone who literally said, you idiot, it's time to go to the doctor and actually check if something's broken. It's been four months. That was a good person. It was a good person. And well, so of course, I then went to the doctor. The doctor checked my shoulder, rotated my arm.
01:16:20
Speaker
saw my face filled with pain, was so shocked that I was running around for four months like this and said, we do an MRI right now, which scared me even more what's going on with my shoulder.
01:16:33
Speaker
Okay, long story short, in the end, I got physical therapy. which was really, really good. I did, and and for people, physical therapy doesn't mean necessarily you just go there, they massage you and it will just go away. You get homework to do.
01:16:49
Speaker
You have to do your homework. And if you don't do your homework, well, there's not much the physical therapy will do for you. um So I did my homework and all that. And then at some point I was asked to pay my part of the physical therapy bill.
01:17:05
Speaker
I was not aware that I had to pay, but it was fine. You know, that it was for my entire regular therapy sessions. I don't remember how many sessions there were. I think it was...
01:17:17
Speaker
12 I think or 8 or 10. yeah So I had to pay 35 euros which when I thought about this about how many basically private lessons I got I thought this was next to nothing compared to what I received in in quality of care.
01:17:36
Speaker
So then I had a conversation with my mom about this and she said oh you had to you had to pay for this. Yeah. Oh, was it expensive? No. No, it was like 35 euros. And she said, that's so expensive.
01:17:50
Speaker
What are you talking about, mom? that's that's who who These people need to get paid. yeah And I got provided with an insane quality of care.
01:18:02
Speaker
And 35 euros is nothing. listen not That's maybe nowadays, if you're still lucky, two visits to the cinema. People don't think about it like that. No, and and and but I just kept thinking about my health in perspective as in in an extreme sense.
01:18:21
Speaker
Would I pay 35 euros right now to make this pain and this shoulder problem go away? Yes. Yes, I would. Would I pay, and that's I think that's the tricky part, would I pay 35 euros for this shoulder problem to go away if I already pay for health insurance?
01:18:40
Speaker
And I think that's the problem. That's the tricky part. Like what do I pay a health insurance for if I have to pay anyways myself still on top? I also fish therapy and I was not aware that I would have to pay and I was a little bit surprised. Like ah why do I now need to pay this also 35 euros or something for six times?
01:18:57
Speaker
a six sessions or was six times yeah something like that yeah whatever normally yeah um and i go to the dentist and i something needs to be done and i get a bill suddenly of no i don't know i had a hole to to fix and i got a bill of 200 euros or something oh i thought this was car covered like i know i pay a lot for my insurance every month um What's going Why?
01:19:22
Speaker
And everything that's prevention, we didn't even talk about that. Everything that's prevention that could keep us healthy, especially those that are sitting a lot, for example, would be good maybe to do some exercises daily ah or to know what you can do to keep your body moving to avoid that you get back pain.
01:19:38
Speaker
um This is also not very well paid for by healthcare insurance, but that's ah another story. ah But yeah, I think it's like we all want to eat bio and we all want to eat eggs of ah chickens that are walking around freely in nature with these nice pictures of a green field with chickens that are happy.
01:19:57
Speaker
um But if you see what that costs, then yeah and you stand in front of the... In a supermarket, then you have a choice between 12 products. You might not pick the most expensive ones, although the chicken might be more healthy. But um yeah, so in the end, consumers want a lot.
01:20:16
Speaker
They demand a lot, but they're not willing to pay for it. And I think this applies also for health. And in health, maybe the challenge is what you said, like, I pay already my health care insurance. Why would I pay even more?
01:20:29
Speaker
Yeah, yeah. yeah and For someone who is already in the healthcare system. If it's like a personal, private consultation that I have to take care, sure.
01:20:40
Speaker
But if I got referred to them through my doctor, why do I have to pay for them? And then this brings me to this point that you made with, let's say I want to sell directly to consumer as ah as a health app and 50 euros won't cut it.
01:20:57
Speaker
Now this this makes me wonder, did as a comparison to these 35 euros that I had to pay, and did we get our priorities backwards?
01:21:09
Speaker
As in digital stuff is supposed to make things more accessible to to everyone and more accessible means also...
01:21:21
Speaker
be affordable. Otherwise, if it's if ah and if an app costs 300 bucks, and it's not accessible to people. But it has to cost 300 bucks if we have to go through this entire process that you described. And on top of that comes even more.
01:21:38
Speaker
But if I want to go to a physiotherapist, the physiotherapist is not allowed to um get that much money because, well, there you have all um other regulations and stuff like this.
01:21:49
Speaker
Which then means, well, that's not how it's supposed to go, I think. I think the people in the system that provide care, direct care, should earn more than an app, and yet the app costs so much.
01:22:07
Speaker
yeah What's going on? this yeah This makes me wonder if we got our priorities upside down. Yeah, we over-regulated something in the fear. I think like we're going through this whole, everybody's learning together.
01:22:18
Speaker
So there's no wrong or right yet. But um I think now we're going, like it's like with the data security and yeah um how to log into an app and that we deal with patient data and patient data is automatically, of course, I would say we should protect it very well.
01:22:36
Speaker
I agree. I agree there. I mean, if I go to my general physician and my name is called with my doctor title that I by accident have, everybody knows my name and ah yeah whatever, um and knows maybe my problem because the counter is not closed and they ask, why are you here? ah Yeah, so, but whatever.
01:22:58
Speaker
ah Different story. But with a medical device, of course, we have to document some of the data and which needs to be very well protected. agree. i agree but it should still be accessible.
Accessibility and Usability in Digital Health
01:23:10
Speaker
That means also for elderly or people that are not so used to using a smartphone, for example, that have one, but,
01:23:21
Speaker
um don't know exactly how everything works that well. It should be accessible for everybody. That should be the goal, accessible for everybody. That means affordable for everybody.
01:23:33
Speaker
That means healthcare insurance should pay for it, in my opinion, if it's a medical device for a patient that should be treated with an app that has proven that it's working. I agree. um But now it goes so far with, like for example, protecting data, how to log into an app that you need to factor authentication, which is already difficult.
01:23:57
Speaker
um Maybe changing your passwords, password very regular, which is simply challenging. These are extra hurdles. ah If you think about APA, I didn't even manage yet to get my electronic patient data I didn't manage because of all the steps and I think I'm not stupid and I know the digital health world a a little bit, but for me as a foreigner on top, like I come from the Netherlands, so I'm not from here and I'm, I'm in the system and paying for the system.
01:24:30
Speaker
ah But it means that with, for example, for the APA, that it's not so easy to yeah um register. i would like to. I'm not stupid, I think, but I didn't manage it because of different hurdles.
01:24:44
Speaker
And I think that's for, like, if you say accessible, it should be payable. It should be accessible for everybody, um for everybody that is able to use a medical um a medical device that is using a smartphone, for example.
01:24:56
Speaker
which most of the people do nowadays. yeah um And should not be made too complicated because if it's too complicated, the usability goes down, people drop out because it's simply too complicated. And that's what's happening now, in my opinion, with yeah we have the information security management system, we have the BSE certificate.
01:25:16
Speaker
ah It's so regulated. We're so afraid of sharing data. ah We're so afraid of what could potentially happen and that we're doing too so many measures that it's not feasible anymore for people to use it.
01:25:30
Speaker
And so we're missing, i think there we should think rethink which is also happening. i mean The companies are in touch with the institutions that are regulating these things. So it's not that it's not working, but changing these things again, once it's written down in a law whatever, it takes years before it's changed.
01:25:50
Speaker
yeah um So these processes take long and requires that companies have an enormous stamina. I mean, you, yeah. And money. And yeah, that means time and money and personnel to deal with it.
01:26:06
Speaker
Yeah. That's simply ah the case. But yes, it has the potential to be, to make healthcare accessible and ideally also not too expensive. But then we need to do something about the regulations.
01:26:20
Speaker
Yeah. Yeah. I think it's... um
01:26:25
Speaker
I often wondered, in speaking now for Germany, um if we ah are standing in our own way, as in trying to, as you said with regulation, for example, trying to think of everything so much. I'm not saying you shouldn't think of some things in advance, but as in every possible thing so much in advance,
01:26:49
Speaker
um
Balancing Innovation and Regulation
01:26:51
Speaker
bringing then down the hammer ah in ah in an area which is, but mean granted, it's still very new, but and bringing down the hammer so much that the ones who are supposed to benefit from the health apps, um, are excluded. Yeah.
01:27:11
Speaker
Yeah. We want innovation at one point. Uh, everybody screams, we want innovation. Yeah. And the other hand, if you want innovation, it should be doable. And now with these regulations, for example, in healthcare, what happens is that companies are looking for other markets where it's easier to get on the market. And then once they are somewhere else on the market, they might make the jump to Europe.
01:27:33
Speaker
Yeah. Um, maybe, maybe, but maybe. And this is now, again, I think the money question is you have to go to another market to be able to sustain your fight here. Yeah.
01:27:45
Speaker
Because if you can't, well, then there's nothing you can do. The market is closed for you. Yeah. And that's the the side of the regulatory side and the certificates that you need. and um But there is also still this digitalization, the skepticism in the society and the fear.
01:28:03
Speaker
um i mean, I think a part of the regulations... they got so strict because of fear of what could happen. Of course, I mean, this is not bullshit. Things have happened in the past where data were landing somewhere where they should not ah go. We should protect that. We should think about it.
01:28:20
Speaker
Yes. um But digitalization, ah can help a lot, especially in healthcare where the system is overloaded. It has so much potential, but we need to do a lot of change management.
01:28:34
Speaker
We have seen it in our times at Lindera where you know there was first a lot of skepticism, like, oh, how should how on earth another thing that I should include in my daily life and how can this ah help?
01:28:45
Speaker
We had to do, you can develop a nice product, but you need to do change management with the society, with the patients. Like how can an app help me? and Like nobody's touching, like in physiotherapy in our field now, nobody's touching me. How can digital product help me doing it?
01:29:06
Speaker
Yeah, because you have to move yourself. You are the one that can mobilize you, that you you are the one that has to strengthen your your muscles again. Physiotherapy is doing massage. It's not evidence-based. It's not working. We know that.
01:29:19
Speaker
So, but um yeah, we have to do change management as companies. So we should not forget this is such an important part to like, yeah, we had the whole regulation. We have the contracts, like how to get money and stuff, but it only works if you get patients involved in this.
01:29:37
Speaker
in this road and if they see the benefit and how this can work, that means that you have to, we had we had multiple patients, we are getting multiple patients in that say, yeah, my doctor said I should go here, but ah I don't believe that this is working. Like how can this work if you're not touching me, for example, if you're not massaging me?
01:29:54
Speaker
Um, so people are like, that's the ones that they jump over their skepticism and say, okay, let's have a look. Um, but you also have a lot of people that have already jumped out there. So yeah yeah. And the fear with artificial intelligence taking over everything, taking over the world. And I mean, uh, comes on top of everything.
01:30:13
Speaker
That comes on top of everything. yeah Yeah. And that if you want to, if you, we think of you want to launch a medical device, a digital medical device, these are things that you really have to think of, like, how can we do this? How can we make it accessible for everybody? Um,
01:30:31
Speaker
and how are we integrating this in processes in people and for patients how are we going to convince them that this is ah actually way to go that this is actually doing good yeah yeah and i think that's that's i think you're hitting the nail on the head it's a matter of you as a patient are now being empowered which often is not seen this way because I mean, patients often go like, Hey, I go somewhere now fix me.
01:31:02
Speaker
um or like, here's a pill, the pill is going to fix me, but you as a patient still have to do something. You you are not out of this loop. yeah And, um, same goes now for the, for the, uh,
01:31:15
Speaker
let's say digital health app for sake of argument, you still have to do something. And for doing something, you have to interact with this software.
01:31:27
Speaker
And harder it is for you to interact with this software, the less you're going to do it. And well, there go your health benefits out the window. And this is now, especially the debate is not very hot. about the latest regulation from the BSI, the TR03161, which now requires, which which puts additional ah regulation and rules on DIGAS and DIPAS. I mean, for them, it's it's now set for sure.
01:31:56
Speaker
um Talking about two-factor authentication, for example. For example. At the beginning, I thought two-factor authentication was annoying. I realized how important it is.
01:32:09
Speaker
However, there are certain ways in which you can implement two-factor authentication which make something just unusable. i I mean, I already feel annoyed by certain things that I impose on myself when it comes to two-factor authentication, but I have the power to change it.
01:32:29
Speaker
For example, how quickly I get locked out of the app or something like this. With this, there's not much you can change. You have to follow the rules and that's that. yeah And users, and in this case patients, have no real say as in, hey, you know what?
Challenges in Digital Health Regulations
01:32:43
Speaker
I like this thing. It is helping me.
01:32:45
Speaker
I don't want to be locked out, let's say, every 30 minutes. Yeah. um So, in a sense, it also feels a little paternalistic as a no, no, you're too dumb to ah to take care of this for yourself or to decide this.
01:32:59
Speaker
No, no, we'll do it for you. For certain aspects, I understand when it comes to you know encryption security and all of this stuff and cloud, et cetera, et cetera. I mean, not everybody has to be a software developer or or a cybersecurity expert ah running around.
01:33:15
Speaker
But at the same time, you also don't have to be a mechanic to be allowed to drive a car. that's i mean, where where is the level here? and that Yeah, and if I can, so if I would say, like, I would, as a patient, I would like to judge myself. Like, I would like to say, i trust this app and how to treat my data.
01:33:34
Speaker
For me, it is enough that I log in once and I do it in a safe way, but then it's fine, for example. yeah um I don't want to change my password every few days and I don't want to be locked out. ever i I personally find it very annoying when I'm locked out and I have my password somewhere because it needs to be these complicated passwords that nobody can guess. That means it gets complicated that I don't remember myself. So I need a password manager that stores my passwords because... yeah with 32 characters and whatever, I don't remember this, of course. And I need, of course, also different passwords for every app or everything where I log in and I log in nowadays and I don't know how many apps and sites and whatever.
01:34:18
Speaker
Um, Very annoying and so annoying that I don't use certain apps anymore because I forget on the password or whatever. um And I don't have whatever.
01:34:29
Speaker
It gets so complicated that it's not usable anymore. And I would like to judge myself like, okay, I log in once, I make an account. ah Fine. I do two-factor authentication if i if necessary. Okay.
01:34:42
Speaker
Yeah. and know That's already a hurdle. We have to admit that that's already a hurdle because for us, for you and me, this is daily, daily life, right? Yeah. But not for everybody. This is daily life. And how do I do this when I, I can just work with my smartphone with the basic setup I manage somehow.
01:34:59
Speaker
How do I do this? yeah i hope people have an email address, but if not, we've also heard these cases where people did not have an email address. and it's got Many cases. Yes, if we think of accessibility for everyone, also for elderly, for example, yeah ah this gets tricky.
01:35:16
Speaker
Very tricky. And I think when it comes to digital health, the benefit comes from using it.
01:35:27
Speaker
So usability and accessibility need to be the highest priority if the health outcome is the main goal. Yeah. Yes. But yeah, I think we got our priorities little backwards.
01:35:42
Speaker
Yeah. And in the end, it's all about the money. So if it gets too expensive, you can have a beautiful app that is working perfectly fine and have multiple healthcare professionals involved because you see that it's actually beneficial for patients' health that this is working. You can set up the most beautiful program and most beautiful app, but if this costs more money, yeah then it can work super well, but nobody's going to pay for it.
01:36:07
Speaker
So I'm wondering, just to to draw the parallel to pharma, right? There you have your, yeah of course, also your different levels of medication, right? You have the medication, which is, you only get it prescribed by a doctor. Then you have medication, which...
01:36:24
Speaker
I mean, took some time, but now you can buy over the counter. For example, um painkillers. There was a time in Germany where you could only get painkillers if they were prescribed by the doctor.
01:36:36
Speaker
And when I was in the Netherlands, I was shocked that you could just buy them in the supermarket. So I stocked up on it because I thought, this is amazing. This is okay, great. I still go to and like, it happened that I thought, can I get this only through a doctor? It's weekend.
01:36:51
Speaker
Cannot go to the doctor now needed for my child. Yeah. I went to the Netherlands. Yeah. Yes. Yes. Um, And I think there needs to be – we're talking about the balance here, right? it's ah Which I can't when it comes to – I bought some ibuprofen lately and they asked me how much, it's like a one pack. I said, no, no, how many milligrams? I said 600.
01:37:12
Speaker
I'm sorry, but 600 you need to be prescribed by the doctor. Okay, what don't I need, prescriber doctor? 400. So can't I just take two 400? What you do after you buy the package is up to you, sir. what like nice three bags This makes no fucking sense. But okay, fine, fine. Give me give me two packs of 400. Yeah. and So there there are levels of... of um rule right You need a prescription, you don't need a prescription.
01:37:43
Speaker
And then we have this massive gray area of supplements. yeah So I'm wondering how long it will end. And the supplement industry is gigantic. Yeah.
01:37:56
Speaker
It's gigantic. And they are not claiming to be any type of pharma drug. No. They might claim certain functionalities. Yes. They did not prove it. So I'm wondering how long it will take until all this, let's just say regulation as it is happening now, will lead to um
01:38:21
Speaker
digital health app supplements style. i don't think it was going to take that long no i agree i think there is already a lot on the market like you have already people writing books with um claiming to be certain therapists or medical doctors that might not be these persons but um you have already people that are doing this this is happening this is happening already now and as long as you say you're in health app you don't need to go through all these hurdles.
01:38:53
Speaker
Exactly. So if you then manage to to reach the patients before they are they are then not maybe ending up fully in the healthcare system because they they haven't seen a doctor maybe or they haven't...
01:39:06
Speaker
Yeah. Or it's not covered by the healthcare care insurance. So maybe this is not popping up, but I'm sure this is happening. And for a lot of things, uh, as long as prevention and stuff, it makes absolute sense.
01:39:17
Speaker
Yes. It makes absolute sense. And a lot of things can be prevented like back pain. A lot of it can be prevented if people adjust their lifestyle, for example, and this doesn't need to be done by a medical device necessarily. Yes.
01:39:28
Speaker
As soon as back pain is diagnosed and you need to be helped, it's then yes but everything until that uh until that point yeah which brings us to and um we didn't even talk about this right you can only be something medical if there is a diagnosis which means you have to be sick in the first place be sick then we pay for you but if you're sick yet we don't pay yes little space for improvement i would say right right which is um and with prevention you cannot earn a lot of money no you can't you can't i mean how do you yeah who's gonna pay for that and then it's always in the end when you do your um health economic study and the what was first the chicken or the egg problem when it comes to um yeah yeah and in a long run i mean if you want to see if it helped in the long run you have so many factors that are having an influence and
01:40:24
Speaker
have things happen, life happens on the way. Yeah. Yeah, yeah, exactly. ah so I don't want to be ah too much. in this No, you not. I don't. mean No, no, no. This isn't, I don't think, I think this is reality.
01:40:41
Speaker
Yeah. And unfortunately, at the moment, it is a hurdle, a hassle. at It's a lot of friction, which, um and I think what's important is that most people that got into this industry wanted to, and this brings us back to the science part, that they wanted some science or scientific insight to finally end up in the hands of people.
01:41:10
Speaker
yeah They know something works, they have seen it in the lab, they have seen it in pilot studies, and they have seen it in the rest, and they know it will help people, it will make a difference in their lives. yeah And that's why most people at least most people that I know that work in this industry, got into this industry.
01:41:30
Speaker
And it none of them went into this to make a quick buck. No. well Well, I shouldn't say none, but most people that I know didn't get into this to make a quick buck. Yeah. Then you should have jumped on a different market.
01:41:45
Speaker
Exactly. Exactly. Then you will definitely do something else because there are so many other ways that are unregulated where you can make money much faster um and get much richer afterwards either as well.
Integrating Digital Health in Clinical Practice
01:41:57
Speaker
And yet it is for them, and that's definitely how it felt to me, more often than not,
01:42:05
Speaker
It feels very frustrating to hear, as you said, oh yeah, we want innovation, we want all this. And yet at the same time you get slapped with these rules and regulations left and right. Sometimes just are so far away from reality and and patient reality that um Yeah, you get very frustrated. And I think it's important for people to understand that, hey, it's not like we're not trying. It's not like we don't want it.
01:42:41
Speaker
It's just, it it takes a lot of time. And I think it's important for the rules and regulators to also understand, like, hey guys, We understand you have a certain job to do, but we need to get our objective straight.
01:42:55
Speaker
come And the objective, you lost but we don't all seem to be on the same level when it comes to the objective. Because we want this to be then good for the patients.
01:43:07
Speaker
We understand your job is to make sure there is data security and everything. But data security just for the sake of data security is not serving data security either because it's in the end again, people at the other end.
01:43:20
Speaker
Yeah, it's not to combine these worlds and to make that. I mean, that's, I think that's why I also don't want to be too negative and I don't want to bash anybody because for everybody, this is rather new, this road that we're going and everybody's learning together, but we are all learning the hard way.
01:43:37
Speaker
That's simply ah the way it is now. The companies that are, have made it to be, get a dig on the market, ah for sure they have learned the hard way and are still learning the hard way and some of them are not even surviving. yeah. Exactly. Yeah. And also I think like the, we should ah think about, for example, for DIGAS, does it make sense to have these ah ah RCTs, these randomized controlled trials, because then you, that comes from pharma. We have the, that is our example that we have to fulfill now.
01:44:09
Speaker
But we don't have, um I don't know if this is fair, because if you look at the real world data that is used, like how is somebody using this at home without being supervised, without having a feeling of being actively enrolled in a study, but just normal people using device.
01:44:27
Speaker
For me, that says maybe even more than if I make it artificial in this RCT setting where I combine a control group or compare a control group to an intervention group and stuff.
01:44:39
Speaker
This gets very ah artificial lab like lab rats. People are not lab rats. People use something in daily life. That's where it should help. And that's super important to monitor that. But this is like real data analysis. It's coming more and more, but this is normally not not ah enough. For example, Bayfarm does not allow that to become a data.
01:45:00
Speaker
So that's not sufficient. But the combination would be good. yeah Yeah, exactly. it's so Same goes when it comes to medication or any type of other aspects. You need to have clinicians involved and all of those things.
01:45:14
Speaker
And well, clinicians have mainly been trained when it comes to pharma and medication, but not so much when it comes to digital health. no And so that's another point of friction where it's just like, you need to have them involved, but you need to train them just as well. which is so And you need to know, they need to know your name. And yeah there are now, of course, multiple digas in the market, like over 40 digas or maybe even 50 already now. I don't know the latest number, but quite some digas on the market. And then for same indications, there are maybe similar digas. So which one do you take? um What exactly do they do?
01:45:50
Speaker
yeah this is quite some extra that... medical, as a clinicians need to know. Yeah, need to be trained on how this works, how to prescribe it. If it's a selective track, then the prescription is a little bit different.
01:46:04
Speaker
It's a little bit more paperwork, how does this work? And yeah, yeah, it's this whole change management for everybody. Hester, this yeah you're right. we can We can talk for hours about this.
01:46:16
Speaker
And i think it's important to take as a take-home message what you said. you know I understand you don't want to be too negative. I am often the cynic. You're more positive than me.
01:46:28
Speaker
At the same time, I think it's important to understand where we are, to have a, this is the current situation. so we can understand where where we have to go and how to navigate it. And not not just us, I mean, we know this industry by now quite well, I would say, but also others that maybe think about getting into it, um what that means.
01:46:50
Speaker
um At the same time, I think it's also important for scientists to understand, hey, there is a bigger world out there outside of academia where you can actually have a massive contribution with all the skills that you have.
01:47:03
Speaker
um do you know i want to thank you for for this fun conversation i asked you already quite some time and it's again it was up to me to actually make the time to find a spot thank you for your time yeah you're welcome um when people want to get in touch with you where can they find you what like um on some someone's social media should they get email Yeah, best is to find me on LinkedIn. um In my email address, we can also share that.
01:47:32
Speaker
um So they can, yeah, feel free to contact me if have questions or if people want to know more about the clinical trials, what it means, or medical device, digital medical devices, ah whatever, ah regarding the topics that we have discussed now, um feel free to contact me. Or also making the jump from academia to the medical device ah world,
01:47:56
Speaker
Feel free to contact me. Yes. Best LinkedIn. That's probably the easiest way to find me and contact me. I'll put it in the show notes. Well, then i can just say thanks again. And to everyone listening, have a great day.
01:48:10
Speaker
Hey everyone, just one more thing before you go. I hope you enjoyed the show and to stay up to date with future episodes and extra content, you can sign up to the blog and you'll get an email every Friday that provides some fun before you head off for the weekend.
01:48:25
Speaker
Don't worry, it'll be a short email where I share cool things that I have found or what I've been up to. If you want to receive that, just go to ajmal.com, A-D-J-M-A-L.com and you can sign up right there.
01:48:39
Speaker
I hope you enjoy. it