From Wellness App to Digital Health Application: Building a Digital Therapeutic in Europe

00:00:00: It gets you thinking, why are doing it?

00:00:02: What's the success.

00:00:06: I think also depends on which stage happened for us.

00:00:10: at a stage where we already had the listing and product that helped We have users, patients or doctors who prescribed.

00:00:16: You've got something in your market And works very well.

00:00:21: So close Exactly!

00:00:25: Now is not time to keep pushing.

00:00:34: Welcome everyone to the Beyond Outcomes podcast.

00:00:36: My name is Andreas Boist, I'm CEO here at GCP Service International and today with me i have Lenka Schombarska!

00:00:45: I am probably butchering that ,but you can correct me in a second.

00:00:47: Lenka is co-founder of Vitalio Digital Health, yeah therapeutic uh...in the diabetes space.

00:00:59: You have quite an interesting journey from your early starts in finance to being a co-founder, switching from CSO to CCO role.

00:01:07: So chief scientific officer or chief commercial officer role the ups and downs of startup life what it takes to bring regulated device that concerns health and patients to the market in different countries as well CE marketing and much more.

00:01:25: I'm really looking forward to the conversation having you here today.

00:01:29: but yeah first I guess let's start where everything began also for you.

00:01:36: What were sort of like your earliest steps after school?

00:01:40: Like, why did you start?

00:01:41: what educational background and what primed you to eventually down the line become a founder of a healthcare startup?

00:01:53: Thank you!

00:01:53: Pleasure to be here with you.

00:01:55: it was quite a journey.

00:01:57: As you said, I have big around in economics and finance.

00:02:02: Then I studied innovation management at Rotterdam.

00:02:05: I started working in pharma... ...I didn't like the corporate environment so to say that my work doesn't matter there.

00:02:13: no matter how hard or efficient your are.

00:02:16: it just got lost somewhere among other teams.

00:02:19: So i was looking for startups On the road, when I was looking for startups to join actually young my current husband asked me help them a little bit with some data science project or data related projects in their startup.

00:02:35: and it's very natural start.

00:02:38: And i didn't plan to join him because at that time its wellness weight loss app It really more focused on exercise and fitness.

00:02:50: But I start with one thing, second think.

00:02:54: Then I got deeper and deeper inside.

00:02:56: then it moved more from this wellness to a more medical and obesity-focused project when they move through diabetes.

00:03:05: And yeah This was basically the time where i was already fully in since then.

00:03:11: It's just that one big journey.

00:03:12: so its very natural.

00:03:14: I never actually planned or go for career as a startup founder.

00:03:20: I was just looking for the next opportunity that it is in front of me, and... It came very naturally.

00:03:27: From a global giant.

00:03:30: you also worked for like Abbott so very large companies to start up this massive step.

00:03:36: there's couple steps down that ladder where you could probably have more secure environment but at same time also more flexibility or opportunities on your own.

00:03:47: Was it coincidental that you immediately went for the polar opposite in a startup?

00:03:52: or was it opportunistic?

00:03:55: Or sort of like what's an inspiration.

00:03:57: That sort of told you this is a path, but rather non-standard to follow and push forward.

00:04:04: I think, like...I never had this five-year plan in my head.

00:04:09: where you want to be for the next five years.

00:04:10: So i've always tried to focus on what's in front of me and try to do it as best way that possible.

00:04:19: Yeah, as I said it wasn't planned.

00:04:22: The plan was actually to take some more control route and go into a more flexible environment but at the same time maybe more stable environment And learn something because you are aware when out of school with very little working experience that You do not have the knowledge or these things That may be need for start business.

00:04:43: So i would say humble in this.

00:04:46: In this part, I didn't expect that i would rock in an own company and it was very rough.

00:04:55: The beginnings were very rough but yeah... It happened this way!

00:05:01: And from getting a supportive role working for startup to becoming co-founder what?

00:05:11: Was there point when Your interaction with your co-founders you evolved into something where he said I want to be and play a very active role.

00:05:22: I want To be part of the founding team members, I don't wanna work as an employer Employee.

00:05:28: i want to work us in employer?

00:05:37: Now this one conversation really got me hooked.

00:05:40: Yeah, yeah I think there was a time where we had this conversation that either i Got more active into the into the land fund just roll or That I will find some other things to do.

00:05:54: because when you the more You work and it's when you start in your career?

00:05:59: If nothing but opportunity costs This is basically it.

00:06:02: And, uh... It was a great opportunity.

00:06:05: and when you start really get into the project and see that he would like to do things differently somewhere.

00:06:09: but are there just as an auxiliary position your help with data or something like this?

00:06:15: Do some things That- There were points where I knew if i'd want to do different things I need higher say a more bigger say in the team.

00:06:29: And I think that also, at this point they saw it as having some value for me to bring into the table.

00:06:36: and when you're starting an unit every hand is willing to work.

00:06:42: so... It was very good fit!

00:06:47: When you start working there's nothing but opportunity.

00:06:49: because such great statement.. Is this something now on hindsight or do you realize strongly already?

00:06:57: I think that this was one of the things that i realized.

00:07:00: I didn't realize it as much now, because at a time when you leave school and all your schoolmates work in corporates or consulting companies... ...and start making some money and stuff like these until you have get-a-real job situation!

00:07:20: So yeah.. You feel it but I did not realise how much it mattered.

00:07:26: how you really, what's one direction?

00:07:31: You will take in the years after school.

00:07:33: How it would form new into person who are yeah

00:07:38: okay so at that time but you joined as a full founder and to the team What was like?

00:07:45: what was this state of the company?

00:07:47: What was the focus off the company at the time they did join?

00:07:49: Was is still on there let say health wellness app Obesity or did it already transition over into diabetes?

00:08:00: It was still a new wellness obesity area.

00:08:04: And with this wellness-obesity business idea, we joined EIT Health Actual Exploration Program and during this program when we were validating the idea of seeing how can actually fit in to health care because at that time in this BtoC wellness segment, but we'd like to differentiate ourselves by a product and results and evidence.

00:08:27: And things that actually work which is very different story than what would you have most wellness Btc products?

00:08:39: So at the time... But we still thought obesity was way forward But it was already sometimes ago and at the time obesity wasn't really considered to be a disease.

00:08:50: So, uh... It was unimaginable to get an air embracement for obesity programs or stuff like this.

00:08:56: And that's why we during this EIT actually exhilaration kind of pivoted into diabetes.

00:09:03: The name Vitadio came out.

00:09:05: all these things so

00:09:06: I see.

00:09:08: Then what your first core task?

00:09:11: Like, how did you split work between your co-founders as you joined?

00:09:14: And how many were there?

00:09:15: and stuff like... How did you divvy up the task.

00:09:17: And how do you land on

00:09:20: yours?".

00:09:23: We were four co-finders in the beginning.

00:09:28: I think that's most of the startups.

00:09:29: it was one big mistake.

00:09:31: we made very product focused.

00:09:34: So, you had one founder who was very technical on the product and then you have other who did most of the UX UI site.

00:09:43: And I was doing a lot of content that were in touch with customers and we're touched by doctors as well as all those people who created this content.

00:09:55: so it always started from this side.

00:10:01: And then all the data related projects was also something that I had.

00:10:06: Then there were four co-founders and he was doing all these investors relations from where we're beginning in finance, stuff like this.

00:10:15: but yeah for co-finders basically three of them are focused on somehow building a product.

00:10:28: The biggest issue with that or what should you have changed then at the time?

00:10:32: Yeah, I think when building in your product it's good to always start big words.

00:10:41: If you know where is a goal and if you want achieve for this product... ...and then tailor the products.

00:10:47: on this journey You don't only need to think about the product but also about the entire company.

00:10:53: Do you build a company for exit?

00:10:58: some more likely exit journey that's ahead of you and then... then you basically don't want to get much optionality there because optionality is something that's quite expensive, right?

00:11:11: To be prepared for all the scenarios.

00:11:13: Or do you know what it means to build a company for profitability and you want to be self-operating business than maybe you don't wanna get on the VC game And then... The entire product needs to be built around being sufficient from day one.

00:11:26: So maybe you cannot invest so much into some type of research or something like this strategic thinking that in the beginning we didn't really realize, I would say you are building product.

00:11:41: You knew the clinical benefit that he'd like to achieve?

00:11:43: He knew user experience and what they want to achieve And there's some market access way how it gets for patients.

00:11:52: but haven't thought about this long-term view of where do actually wanna go?

00:11:59: And that was, I would say costly because then you can easily end up invest in wrong RS.

00:12:07: So maybe let's take this point and time for you to describe what exactly Vitario currently does or what its aim is?

00:12:23: At which point do you sort of like realized looking back for that this was gonna be the journey you were going to move towards.

00:12:30: So maybe describe us first, sort of like what are doing?

00:12:34: What's your aim and who is the patient population... ...of the device that you're manufacturing

00:12:40: with?

00:12:40: With Ado is digital therapeutics for type two diabetes.

00:12:43: And we're focusing on our type-to-diabetes populations.

00:12:46: so very typical patients I would say men women from fifty years older fifty or sixty main population and not really tech-savvy people, not really fitness mindsets.

00:13:04: People that need a lot of support.

00:13:09: so the app is built for this population.

00:13:11: it's always joking we are making apps for people who do not like to use apps.

00:13:17: So it's very easy and built on this tiny, we try to help patients create these tiny habits that if you are able to flow them consistently.

00:13:27: It can add one step or two in order actually make some big changes into your lifestyle.

00:13:33: so we're covering the main lifestyle aspects of nutrition physical activity sleep mental well-being but also We try to get more into this, how to deal with the social interactions around your disease.

00:13:51: How do you get support from your environment and these types of maybe softer psychological topics?

00:13:56: And yeah we tried to guide patients on their journey in trying help them make easier changes they can at a point where are it and motivate then go further when they follow it, the ultimate goal is to improve blood sugar and reduce body weight if needed.

00:14:20: Improve other metabolic parameters and illustrations or outcomes like quality of life, health literacy and all those things.

00:14:29: And you see that really successful start with a patient on this journey in couple weeks.

00:14:40: You see that they start actually realizing why they are doing it.

00:14:43: That in the biggest issue, we've seen now at the beginning... It's not like people would know what to do and need more information but simply don't see the benefit of this.

00:14:56: Why should you do so?

00:14:56: What could it really bring?

00:14:58: So its a rather complex journey built on tiny nudges and tiny steps.

00:15:04: So you chose hard route for becoming You know, regulated medical device.

00:15:12: So obviously I'm sure in your development past there was a conversation over.

00:15:18: do we want to jump that extra hoop?

00:15:21: It comes with a lot of time and money and energy And delaying getting this also into the hands off potential end users.

00:15:30: What sort of like gave you the kicker to say no yes The challenge is higher But we want to go with that journey.

00:15:36: You said you used it as a way of differentiating yourself, so was there more for company position or was it internally like mission-vision driven?

00:15:44: So what's the kicker?

00:15:47: I would say actually it is combination by those two and one another The other thing being patient population and indication that you are using on.

00:16:01: in diabetes, type two diabetes everything works within an reimbursement scheme.

00:16:08: So there isn't much space for self-pay option, patients are not used to it.

00:16:14: so that means you need go into this fully health care mode full health demo let's say and for this you need to comply with the regulations and stuff like these.

00:16:24: we were... It was a big part of pragmatism Second party, as you said, mission vision.

00:16:33: You will know that you want to do the product in a certain way and this only makes sense when we believe that we'll manage to get past these big milestones.

00:16:48: so it creates great barriers for competitors because many of them cannot be even bought with money.

00:16:59: Because you know, clinical trials are unauthorously tricky.

00:17:06: So it was a combination

00:17:09: and You personally in at the time already role as CSO of company?

00:17:14: You were leading the efforts to let's say approach the regulatory Yeah topic that your inherited by choosing that

00:17:23: yeah no I it kind of like got to my table.

00:17:29: Because as I said, yeah one founder was a technical dad or what's more into the UX UI.

00:17:33: how uh this softer things and then someone has to do it right?

00:17:38: And i was... Yeah.. I studied ,I thought about doing PhDs and stuff like that.

00:17:43: so instead of it ...yeah ..i put all my efforts in different type publications.

00:17:51: So How did you approach them?

00:17:53: because It is, I mean we do this here in our company before living.

00:17:58: But it's complex enough as it isn't and there are many changes that happening especially of course around digital therapeutics because this was very novel field.

00:18:06: so a lot has changing and it has high complexity.

00:18:09: And then they're differences between countries.

00:18:11: So how did you approach the topic?

00:18:13: As someone who wants to bring products from market but needs start from zero or close Yeah,

00:18:22: in the beginning very naively.

00:18:28: We went to the conferences and we spoke with doctors And then found a doctor who was intrigued by the solution and idea.

00:18:35: She actually helped us.

00:18:37: I think that it's also one big thing.

00:18:40: she managed to connect as our people.

00:18:45: Hospitals they will help us to make the study.

00:18:47: So we went for looking into PhD students at relevant hospitals and managed together first studied on this way, but it was really... We had a time.

00:19:00: There wasn't any DIGA, there was no standardized reimbursement path.

00:19:04: So we thought that we would get the evidence and then with the evidence will approach insurance companies for some selective contracts or something like this which is also not a really standard way in the Czech Republic.

00:19:16: And so it wasn't... We'd be building the study for specific purpose as you would do now because... You just had a plan and spoke with insurance companies or other players who said, yeah we'd like to work with it.

00:19:34: The social looks very nice.

00:19:35: We need this certification so that works.

00:19:38: So try find your way around To make it work?

00:19:41: You have no funds at the time to pay for proper studies.

00:19:44: So be creative in finding people with right incentives.

00:19:49: And then first data.

00:19:53: So when did you obtain your CE certificate?

00:19:56: Wow, it was like in the year of two thousand twenty-one maybe or something.

00:20:02: Yeah

00:20:03: so...

00:20:04: It's still MDD.

00:20:06: You got to self certify.

00:20:07: yeah we go to sell certified and I think that Equality of the device or stuff like that.

00:20:17: So we use something like this and it was really, you do a lot of research You're looking...you read the legislative.

00:20:25: If you look into your search for a lot things you find other devices And then pay some fees to consultants.

00:20:31: just check their ideas Because they can't afford to pay them full rate for entire certification And you hustle your way forward.

00:20:40: Yeah definitely sounds like that At the time, it means you didn't need any clinical evidence.

00:20:47: So you selected to go for let's say a post-market study then with the investigators that were already interested in using your device together some data with primary focus on okay we somehow needed to get reimbursed.

00:21:01: so lets gather some evidence.

00:21:09: If I read correctly, your initial study design was to compare the app with let's say an intensive in-person program.

00:21:17: How did you sort of like?

00:21:19: what was the idea behind that approach?

00:21:22: Did you discuss it with investigators and they said this is the best approach and make sense within Czech Republic?

00:21:27: i guess um... To try to compare it like that.

00:21:31: yeah one thing It was the easiest design that we could do with a study center, because they had this intensive program.

00:21:41: And so it was one thing.

00:21:45: and second wasn't that... ...it was very expensive and an inaccessible programme as well….

00:21:52: …because it's so intense!

00:21:53: So although there were good results but not scalable for patients.. ..they had high standard of high mark.

00:22:03: So we thought that if we will be able to match it, We would have a good argument for the insurance company.

00:22:09: That the DTX actually makes sense?

00:22:14: You chose very high bar.

00:22:16: Yeah yeah!

00:22:18: Because I mean... For any normal patient this is not normal care they'd receive.

00:22:25: so then you alluded to it.

00:22:28: A lot of things need to spark behavioural change And so the intensity of the program naturally will be a contributing factor for success.

00:22:39: So that means, it would have been much easier to say well most times you know doctor tells them like we should eat less of this do more sport and find better habits because they help control your disease a little bit better.

00:22:54: Now compare yourself against very intense I think you said yourself a high bar to jump over, so how did it end up for you?

00:23:05: It's positive.

00:23:06: We invented the results and we even have superior results in some aspects.

00:23:11: i think that we were also quite lucky and unlucky because we got into covid period.

00:23:18: So it was difficult to complete this study, it was hard to get patients back to the clinical center For follow-up visits.

00:23:28: And this was the first maybe situation when we realized how data, data imputations are important part of design.

00:23:41: Because what is happening for instance in this study?

00:23:45: Was that successful?

00:23:46: patients from Liwitadio group didn't want to go back because they were afraid of COVID.

00:23:51: so you're not able obtain measurements and stuff like these.

00:23:54: So yeah... We learned a lot with those studies.

00:23:58: I would say

00:23:59: Yeah, I can very much imagine.

00:24:03: So how did it feel?

00:24:05: It was sort of like your wellness app but that wasn't a different device phase.

00:24:11: But what's this?

00:24:12: the first time you got to really see your device in use by patients and How do they feel as a co-founder say.

00:24:20: actually we created something which is now actual patients having a tangible impact and we can see, compared to very intense treatment that the results are great.

00:24:32: So how did it feel?

00:24:34: And

00:24:34: its' great!

00:24:36: I mean... It's also great when you read reviews or really help some people make difference.

00:24:44: so yeah..it was great.

00:24:46: Now You earlier described for your product A lot of different features from, and generally I mean if we talk about type two diabetes you cannot only... You don't have to approach it on the one side but that's sort of like behavioral changes.

00:25:02: It's about food habits.

00:25:03: yeah there are a lot of elements come together so your product also has a lot different design features.

00:25:12: how did you in defining what your products should be think about which feature might be relevant for therapeutic effects at end And how did that translate then in your study and looking at that?

00:25:28: What did you adjust after, what was the journey of developing hypothesis testing to then adjusting their product.

00:25:38: So basically I think we started with the desk research.

00:25:41: We look into other products that are there.

00:25:45: There were a lot of products especially on DUS in the US, so we were looking into Omada and these big DTX players.

00:25:54: We are trying to get their app which was very difficult in Europe!

00:25:58: And...we were making ourselves a review of features that are used.

00:26:04: And then, based on your assessment and some... There weren't even many to be honest metanalysis or stuff like this.

00:26:11: On app designs at that point there were some but not as much.

00:26:14: now it's quite extensive.

00:26:16: Extensive literature out there But the time they're wasn't much.

00:26:20: So we try to build it based on a Some discussions with nutrition is how do you do it?

00:26:27: Or with the psychologist already doctors How he would see in our common sense did we test it with patients?

00:26:33: than yeah I was running around the main train station in Prague and trying to ask people about how to interact with individual features.

00:26:43: So it wasn't a mixture of those approaches, let's say.

00:26:48: And then when you got through this phase that we have designed kind of that is equivalent to the design or other data and our products.

00:27:10: And based on user-data, we had to do usability testing basically for CMARC.

00:27:16: in this how it started you made an assumption if the other CMARCP device with same features as you have had a set results then also should have the result.

00:27:30: You shouldn't at least, I mean it's all body intended to use right?

00:27:34: And we didn't have an intent is used anything on and if anything more than supporting patients in self-management... ...and then with this we actually go for yeah studies.

00:27:49: Okay, so there was enough guidance that you didn't end up falling into like a design creep trap where all of the sudden You have a lot of ideas.

00:27:57: Yeah But it also means long development and long validation.

00:28:01: Exactly exactly I think You diverge, you collect a lot of things.

00:28:07: Then try to converge little bit and do it several times And then important features got crystallized.

00:28:13: Also when you're doing user testing... ...you see that what people tend to use and where they are It's cool.

00:28:18: I would actually decide this is something i'm looking for.

00:28:21: or also When you tried yourself Because at the end of day your patients are person like you Are.

00:28:30: so if its something obnoxious for them So you do a lot of approaches and then try to also mimic somehow what happens in the clinical practice, so when you have nutritional therapy.

00:28:45: what do they do with the patients?

00:28:47: What type of methods did I use.

00:28:48: Do they count calories or are you not counting calories because they don't believe in it, how do they try to monitor their food and when... How does physical activity include physical activity at all so that we can get this information from clinical practice added into your mix-of research.

00:29:08: It

00:29:09: makes a lot sense for me that's culminating as CSO title there!

00:29:13: Because as you said, it's pretty much like committing to starting a PhD thesis.

00:29:20: So yeah... You have to jump into a lot of details.

00:29:26: And so if there is an e-mark and clinical evidence to support that then the next step was already looking over towards Germany and DIGA or what sort of the next evolution?

00:29:41: We tried a lot of different models.

00:29:43: We worked with pharma companies, we had this idea of combining DTX and drugs to actually enhance the effect of medication.

00:29:53: We work with selective contracts on Slovakia markets... ...we work with life insurance companies in Chicago from the clod of different things.

00:30:03: but the trouble that every of these model was it wasn't scalable Because you have a partnership that limits on certain patient population and your hundred percent dependent on their ability to push it into the market.

00:30:17: You cannot do any marketing on your own because then, only every fourth patient in the country would be able to get it or... ...because only this patient is actually client of these insurance companies or stuff like this.

00:30:30: So we were looking for our scalable model That will allow us to get to the interpatient population And it was the time where we found a bodega on one lunch in Erlangen, I think.

00:30:44: During one lunch at Erlangend and... We thought that absolutely cool because this is The Holy Grail for DTX in European space!

00:30:53: Then basically got all our efforts pushed into this direction.

00:31:00: So how did you perceive the bar?

00:31:05: of moving into DIGA?

00:31:06: compared I mean you basically went with no need for clinical evidence from a clinical study.

00:31:16: Of course, you need clinical evidence in terms like written summary of your design features tests that have already done UATs and so on but at the end of today didn't really need to provide a lot of medical evidence.

00:31:30: Now you approach the behemoth of the beef farm of the digger.

00:31:35: How did it do that?

00:31:37: When did you learn what requirements may need to fulfill?

00:31:42: Yeah, I think we were in touch with some consulting companies or some research facilities via EIT Health.

00:31:51: at first and again a lot of desk research.

00:31:54: We read all those guidelines.

00:31:59: We tried to apply it first with the check data into the preliminary listing, which were declined in Ireland because they are checked data and there is also other reasons.

00:32:12: So we knew that we had to make another study but BFARM was very reasonable at a time Because they ask us to have data that would show the results we achieved in Czech Republic, which is also feasible for Germany.

00:32:34: We were very angry about it because we had a data on RCT and those things, but looking back makes only sense right?

00:32:40: Because you don't know if the product in German language is a translation.

00:32:46: If you see how intangible are these design flaws of behavioural change so that make only sense to also test it officially in a language through population that your aiming for.

00:33:03: So we were looking for a partner in Germany who would help us to do this observational study, which will show some data.

00:33:15: And we're very lucky.

00:33:16: by absolute brute force attack on all the clinical centres and all the professors and everyone We got into touch with Professor Schwartz from Gresden Who was like maybe they have something let's call them.

00:33:33: I think that he was very surprised when we got to him at first.

00:33:38: And with him, we've been cooperating in all the studies since then and... We pushed for the first.

00:33:50: You got input from The Beefarm as well regarding their design they wanted?

00:33:57: the endpoints that they wanted and how many patients.

00:33:59: So, that gave you clarity of what was necessary?

00:34:02: Yeah exactly we went through their kickoff meeting with them And this is where we were presenting the check data during... This was already done by Prof.

00:34:12: Schwartz because We knew he needed someone for a big German RCT.

00:34:17: so we are looking at him as our partner During the Kick-Off Meeting.

00:34:20: actually They before indicated these data won't be sufficient and he very wisely, I think got into the discussion of what would be the sufficient data.

00:34:32: And we basically got some preliminary agreement on what type of design will be sufficient to get a preliminary data during the call.

00:34:40: so that was very helpful in this entire process.

00:34:43: with BFARM it's not easy.

00:34:46: It is demanding but compared other options at different markets its structured i'd say very transparent.

00:34:57: You may not agree with some steps or some requirements, but at least you know that they are these requirements.

00:35:03: Yes

00:35:05: And then you ran another RCT?

00:35:06: Yeah With only the site in Dresden.

00:35:12: Or did you expand it further beyond there?

00:35:15: We had two sites and before the RCT we had a German observational study which was fully digital virtual.

00:35:23: so this is also learning for us.

00:35:25: It was actually very good to have it.

00:35:27: And then with two study centers, we're on the big R city

00:35:32: and this time you compared against standard of care right?

00:35:35: What did standard-of-care include in Germany?

00:35:38: Did that differ from what you did for your first study?

00:35:41: Yeah here is participation in DMP or the standard treatment in a practice.

00:35:51: so... It's for most of the patient, it was some type of education.

00:35:58: Okay so naturally you could lend itself to a bigger difference because you had an opportunity now.

00:36:09: Well, impact on the patient over-the usage of your device compared to a standard... Okay.

00:36:15: Maybe here is a leaflet?

00:36:18: Exactly!

00:36:19: So this was the idea that we would be able to show superiority in this study

00:36:27: And you got permanent ego listing which is high bar to jump over.

00:36:33: I mean congratulations Of course Thank You.

00:36:36: Did it feel...?

00:36:38: like reaching the end of the journey for you at that time?

00:36:40: Yes.

00:36:43: We thought now it's done!

00:36:49: Saying this indicates to me, but wasn't as clear kinda... So naturally getting into D-Guy has a couple advantages.

00:36:59: so first get your prize year to two

00:37:03: about them.

00:37:06: And then eventually you agree and negotiate on a set price, but this is generally applicable because no longer have to negotiate with each individual, which there are lots of in Germany unfortunately.

00:37:20: So reimbursement problem solved.

00:37:23: But was that the problem at end or?

00:37:28: Yeah I mean they basically were I don't want to say at a point zero but you were in the beginning of journey that every normal startup, it's not in healthcare would be at right.

00:37:40: Now we have to start selling the device.

00:37:42: or i mean... You can sell them or you should sell on the device during the preliminary listing as well.

00:37:48: But for us and our company size Everything was focused on the study.

00:38:00: So you do not have much spare capacities and so now, You can start telling And you can start exploring all other troubles.

00:38:16: Is this where you went back to the roots and shifted pivoted again from sort of like science, to commercial yourself also?

00:38:23: Yeah basically.

00:38:25: Exactly because in parallel we were still completing price negotiation but already we are setting up a house commercial team.

00:38:40: at the beginning We thought that we would go with a B to C approach and have in-house marketing theme for the BtoC approach.

00:38:51: And then if you'd like do something with doctors, we'll rely on partners... This didn't work at all!

00:38:59: I think looking back it was big mistake not also owning this channel internally from very beginning maybe not for scaling but learning as well being currently present in the market and really knowing these things firsthand, because with partners they have sometimes very different interests than you.

00:39:22: Even when you think that it's aligned.

00:39:26: so this was a time where I switched to or switched... It was gradual since i was doing it at the beginning in Czech Republic as well.

00:39:33: now It

00:39:36: felt like a more natural extension back to the roots, but something...

00:39:41: Exactly.

00:39:42: And it was actually very valuable that you were part of the scientific journey before and knew the arguments all the time in discussions with doctors.

00:39:52: so we kind know about environment

00:40:00: For yourself.

00:40:02: at beginning there's sort of B-C consideration In this setting.

00:40:07: Who is who's your customer?

00:40:08: Because I think, you know from an outside perspective they're like well.

00:40:10: You have a device that treats patients but That's probably not the perspective if you see when you look at it from a commercial side.

00:40:17: So how did you approach that topic?

00:40:20: How did you define who should really approach and which channels there even are in which ones to use how To prioritize Which one?

00:40:30: And then was quite a puzzle You trick patients, your patient is your target.

00:40:40: That when you are not able to get fully online full digital journey because you need this step where a patient goes back to the doctor and gets the prescription... work.

00:40:52: or we were not able to work with fully online journeys, because you're losing the patient in the middle of a journey.

00:40:58: Then they are coming back for two months until you need to manually attribute them and you weren't able to optimize things.

00:41:05: so at that time... We thought that acquisition costs simply there was too high to have this as the only channel for us.

00:41:19: So we also decided on other channels in terms of GPs, in terms diabetes nurses and other relevant healthcare professionals that work with patients.

00:41:33: But for this you need very different types of organization Yeah, and there are so many new options that open up when you enter these channels.

00:41:44: You do it with a Salesforce physical or with the inside of lead-aided partner?

00:41:50: The partner would be Mettec or Pharma Or Would It Be A Distributor?

00:41:54: And Then Or Would You Do Combination?

00:41:56: So yeah

00:42:00: Yeah, its seems like very complex question.

00:42:04: That and you mentioned earlier is sort.

00:42:07: One of the challenges with a startup is if you go too broad in terms all your options and try to hatch your bets, it doesn't really allow for focus.

00:42:18: And maximize that channel which may need to do so as team of owners coming back again together.

00:42:26: how can we evaluate those decisions lacking clear experience or understanding?

00:42:34: clear models would be the most feasible, where do you have to write contact?

00:42:40: Did it move back into something that was opportunistic is like okay which leads we already have for which channel or how did go about.

00:42:50: Yeah I will say partially and also look in a market what other companies are doing works with them.

00:42:57: try implement test within your environment.

00:43:01: this sometimes provides use of shortcut.

00:43:05: Sometimes it's could be misleading because they have maybe slightly different indication and the behavior in this different indication Could be slightly different than yours.

00:43:14: But big part of what we had is was or would we done?

00:43:19: Was opportunistic that you see that You have certain types of leads did work well And you try to build on those an expand those and learn from those why day Why it worked.

00:43:28: Well, and scale something Yeah rather than enter a totally new channel.

00:43:38: And did you at the time sort of like shift your attention primarily then to Germany because that was a reimbursement channel already and put Czech Republic, despite your roots being there?

00:43:52: To decide or did you try to have multiple channels different systems different approaches

00:43:58: Exactly, as they say.

00:43:59: I mean in the beginning we tried to also be present at the Czech Republic so here were also entering the Italian market and stuff like this.

00:44:06: but when you're doing... yeah use prejudice when you do some many different models basically because then also product is different for the very markets although it works the same in a clinical way.

00:44:21: The onboarding of entire communication around could be very different.

00:44:27: So this was the time where we really focused on Germany and basically put all of other things.

00:44:34: And is that step off going into commercial, then also a step-off stopping further developments or device yourself?

00:44:44: Because you need to refocus your attention.

00:44:48: You have product first so push for it.

00:44:50: Or let's say customer end user feedback that you are then getting, you know.

00:44:59: You see behavior in the app or stuff like what's happening?

00:45:02: What is working and not working?

00:45:04: A fuel for more development.

00:45:05: how do we balance it?

00:45:06: because both our time-and resource consuming...you cannot really push at least not clearly on core founding team.

00:45:14: so..how to approach this?

00:45:19: I mean naturally when you got feedback from users you get a lot of new ideas about could be done better And it's very tempting to start developing all of them.

00:45:30: But I think one thing is that you try to evaluate what would be the impact for a new feature, or upgrade some features?

00:45:41: Would it bring higher engagement and longer retention?

00:45:46: Will this actually translate into commercial impact Or will people not say these things anymore?

00:45:52: The other thing is also when you got into DIGA, you were quite limited in what to do with the product.

00:46:00: Because every significant change needs to be approved by BFARM as a significant change.

00:46:10: and with all of that uncertainty BFAR might say, oh this is too significant.

00:46:17: It significantly changed the device and it may affect clinical benefit.

00:46:22: you need to extend your clinical evidence if... You also don't want risk in a way.

00:46:27: so yeah..

00:46:31: It's tough balancing act that we have to strike

00:46:34: but I mean at least on these small usability things improve the app within the healthy scope.

00:46:48: It's like small iterations?

00:46:49: Small

00:46:49: iterations, yeah and you're also... The other thing is that the development starts kind of like freeze on a user side but it does not freeze totally because You have new requirements in terms of the interoperability data security, data privacy.

00:47:06: There are a lot of things that you constantly need to be revolting and developing.

00:47:10: And then when you develop these new requirements, You might easily impair your usability because you're adding new barriers for people to actually log in which is not the best thing.

00:47:23: so it's also that your development team is occupied by this.

00:47:28: thanks

00:47:30: I think from me.

00:47:30: that connects back A topic that I feel is very particular to digital therapeutics, which at the end of day a lot of the therapeutic effect sits in compliance off-the-patient and it's wholly software driven.

00:47:52: Now that it's on the market where you had your study, but we all know understand studies.

00:47:56: You have a little bit more controlled environment.

00:47:59: Maybe there is a doctor behind an app which is more persistent and inquiring whether people are using or not using the device.

00:48:05: so And you know There might be more support very like boundaries for patients in this system to keep maintaining usage of an app.

00:48:17: how seeing your app now in real-world circumstances, getting to track and the background you know adherence usage.

00:48:26: And so on.

00:48:27: understanding over there also new requirements which may adversely impact this and therefore could relate back To the clinical benefits of our device?

00:48:39: The real world usage might also indicate okay We should potentially change something to enhance the benefit because it would enhance usage off our for a device.

00:48:49: How do you balance that and how important?

00:48:52: Do you see also for the clinical evidence part clearly assessing usage behavior, making it almost a soft end point of study.

00:49:02: That we need to have product that's actually user-friendly and usable.

00:49:08: This is very big topic!

00:49:10: This is a very big topic for us and your work evidence is really great.

00:49:14: I think that this actually one of these things are really great about DTX, That you can observe the real world in real time.

00:49:22: You can observe usage, you can see feedbacks, you also have clinical data.

00:49:29: If it's a data-driven company then there will be real-time dashboards.

00:49:32: when you know how to observe seasonality You can observe things like people not being really compliant in December.

00:49:44: And question how to get it back into the process, I think that goes back this appropriate way of integrating these things.

00:50:05: change the nature of your device, but you're only iterating in some... Because a device should work as it is.

00:50:13: You shouldn't be changing it But you might actually find exactly some patterns that you can improve And those could be things like I don't know timing of notifications or stuff Like.

00:50:26: do you get notification for being mindful before and after?

00:50:34: Yeah, so stuff like this.

00:50:38: But I think that ultimately at every... At the slightest stage you always go back to the question if there is any as long as we have some reasonable reward data?

00:50:51: So you see it works but its not like patients would be using it after one week and then there wouldn't be a clinical effect at all.

00:51:00: The effect is there.

00:51:04: You also see that, for instance... There's a frequent misconception.

00:51:09: the patients need to really use it every day because otherwise doesn't work.

00:51:13: and we say its not true.

00:51:15: in data you have to use at certain level but then no affect of using everyday or every second.

00:51:21: they are every third-day once you pass certain levels people who used differently some used it tracking all those things other used rather or reconnecting within the peer forum, something like this.

00:51:38: So it's up to individual usage of the app and you can segment users and play a lot with these data.

00:51:46: but at end-of-the-day if it works somehow... If the effect is there, if patients are happy You do not have bugs which obviously has to be solved immediately.

00:52:00: so prominent clinical and commercial impact on your company to develop it further.

00:52:08: And then you need to make a decision?

00:52:09: To make the decisions exactly if this is...

00:52:13: So naturally as a startup, You could be moving very fast.

00:52:17: If you already indicated that.

00:52:19: I mean there's always conflict in other side of regulatory side Very different paces healthcare regulations being start up wanting move faster.

00:52:31: Do you think that to a certain extent, especially as it concerns digital therapeutics?

00:52:36: That this is a little bit at odds?

00:52:38: or Is it justifiable to want to move a little but slower in the space still because let's say patient health patient benefits are concerned And for that reason It is advisable too.

00:52:51: Just be a bit more conservative rather than just moving forward Especially since you and your end can real-time monitor so you can see the impacts and you could react.

00:53:00: How would you say the system is balanced versus how it should be balanced?

00:53:06: Yeah, I would say that this startup mantra of move fast break things.

00:53:12: It really shouldn't be in healthcare and its actually good.

00:53:16: That's very great.

00:53:22: Because also the fact that you see data and can reiterate, it doesn't mean everyone has to do what they're doing.

00:53:33: because as I said there is one thing about your company The other thing is your capabilities, your abilities.

00:53:43: Do you really have those people in the company?

00:53:45: Can you actually do it?

00:53:46: or decided that he won't build his capability and so we don't have at such a granular level beyond some post-market surveillance which is obligatory If you would see the impact, will actually act upon it or not?

00:54:10: So if really losing regulation totally and keep everything with companies on their own... I think that a regulation is necessary in healthcare.

00:54:32: we need to distinguish where the regulation is, for what the regulations are aiming.

00:54:38: Do they aim at increasing safety of patients?

00:54:41: That's definitely good!

00:54:42: Do they focus on increasing interoperability or this privacy and these other aspects... And there I see that we tend over-regulate things.

00:54:58: Yes, we are in healthcare.

00:55:00: We work with health data but at the end of day if you look into it... The difference between our medical product or wellness products is intended use and clinical data.

00:55:13: There doesn't need to be really much.

00:55:15: You can have this same app as any other DIGA has.

00:55:20: It could basically be out on a free market And it's called Be Mind Flapped With Your Health And you would do pretty much the same thing that we all do.

00:55:31: You wouldn't... and this will be widely unregulated, it'll be widely underegulated.

00:55:39: When you push too much for regulation then you can actually chase more companies into these wildly unregulated space accidentally lower their safety on market.

00:55:53: I would say that it's really again about balancing, not overthinking things and having an app basically meant for taking photos of your meals.

00:56:04: And is more secure than you internet banking because this isn't the case!

00:56:12: So what are you describing at end-of-the day?

00:56:15: from what i've heard?

00:56:16: also something BFAM is aware off as well chasing Many companies that sort of try to wiggle themselves into the, let's say wellness app range.

00:56:27: Although they are more clearly should be a regulated product and obviously this requires countermeasures and checking now also on more off the wellness at range.

00:56:38: not only what information you're getting.

00:56:40: who is self-proclaiming as a regulated media device, but whose also claiming not to be one and like where do we make differentiation.

00:56:48: So clearly it's very dynamic picture I guess from what your saying.

00:56:54: for me the core piece would always be how can we maybe strengthen the self-control within companies and give clear guidance of what is their expectation.

00:57:09: Not switching over from it's either we control or its not controlled, there is a middle ground in between where you say under these conditions you can self-control so that exactly You can roll out let us say small feature changes something like that.

00:57:25: but And this is the key advantage as DTX you are sitting at source data.

00:57:30: We require to very stringently monitor behavior within the app afterwards.

00:57:36: And you need a predefined acceptance threshold for when that change would adversely impact the patient population and reported us, we don't need to approve it but reported to us.

00:57:47: so we have an opportunity to check yeah?

00:57:50: But there are certain steps which let's say pre-allowed.

00:57:53: this is more like the PCCP route that FDA has where you simply at the beginning agree on a plan for future development.

00:58:08: And so they can have their say of, For your app.

00:58:11: we want this specifically to be The Gatekeeper and if both sides agree then implement it.

00:58:16: I feel like there's some hesitancy in making that possible.

00:58:19: Of course In Europe We also Have the notified body versus You are in the diga path but don't need To Be.

00:58:26: Then Bafan Would Be Out And they wouldn't have a say, so how do we solve the conundrum?

00:58:30: Probably it should be on their body.

00:58:34: Exactly

00:58:34: because there you have two authorities right which if you can agree to change things within framework It would also take some burden, some operational burden from the regulators because I cannot imagine that they are people and overworked.

00:58:55: And you know it when you speak with them or write to them.

00:59:02: I can also like relate to their situation that if you are actually stuck in regulation, but that force you to observe every single movement on the Digamar market.

00:59:14: You're not able ensure quality of follow-up until you had to cut some corners, I guess.

00:59:22: Or it takes years to implement any change and then you can end up easily in a situation when the apps that are on the market definitely not state-of-the art because they're already somewhere else but you cannot develop further And then you could end up with this situation where there's new wellness products coming into different or even medical device product But also outside of the DIGA scheme.

00:59:46: so we have Reimbursed Apps not as a high quality, but the apps that are not reimbursed.

00:59:54: Maybe it's not advisable to get the reimbursement then, because you know that you would be lagging behind your competitors.

01:00:02: And then patients will come and say hey these apps from App Store they already have this or that... ...and why do I don't have them?

01:00:10: It takes a couple of years.

01:00:12: Exactly!

01:00:13: We'll be there in two thousand twenty-nine

01:00:15: exactly but at time everything is going to be outed.

01:00:21: so yeah It's very long.

01:00:24: Yeah,

01:00:25: it is long and at the end of day I think Is very well recognized that we have when we need a risk-based approach in clinical research.

01:00:37: We have this very strongly on all of our guidance for how to conduct clinical trials and clinic investigations And That Fundamentally should also be part of how how devices are regulated?

01:00:51: Yes its digital therapeutic.

01:00:53: so unless you completely change things up and let's say request unhealthy behavior of the patients that are using your app.

01:01:04: The impact is limited in scope and risk, we need to acknowledge it.

01:01:08: yes they were reclassified on MDR software now higher-risk class.

01:01:12: You can also debate about that but at the end of day It still just a software.

01:01:17: And so as part of that I feel a mindful discussion over How much is necessary and how much it's too much?

01:01:26: And not only from a, how do we compete with let say you know China and US.

01:01:31: How did we compete and remain competitive within Europe?

01:01:35: but also how to ensure that our patients at the end of day reasonably get the best therapy they can have... ...and its not going to be easier.

01:01:43: We will have less doctors, more longer waiting times.. ..we'll have less opportunity for intense conversations that we might need to have, especially inside.

01:01:51: behavior will change.

01:01:52: As you highlighted it's a lot of cultural and behavioral changes necessary around type two diabetes.

01:02:00: this is getting more prevalent.

01:02:02: so how can be make easier?

01:02:05: To get those devices into the hands of patients without over-regulating.

01:02:09: considering that risk isn't here but the risks are there I think something needs happen.

01:02:18: Probably things will move slow to get us there.

01:02:20: Yeah, as you said it's a pretty intense debate over that this risk-based approach if It would be reasonably implemented and I can also speak because many things That are currently happening in the market You see they go kind of in that direction, you want to assess devices based on real-world evidence.

01:02:52: You have these performance parts for pricing and stuff like this but I frequently feel there are only those isolated elements do not structurally connect to the other parts of the development process.

01:03:08: And if you would take these ideas and also connect them with the other part over a process, then you can arrive at quite consistent framework which will be reasonable.

01:03:18: reasonable for everyone, right?

01:03:19: Because then if you would be able to actually introduce some flexible pricing for performance of the devices at this same time.

01:03:31: You do not allow a reasonable way how to improve your real-world performance we got in trouble.

01:03:37: and uh...you don't have necessarily overthink these things redesigning the studies doing other RCTs or creating this type of evidence because The changes that you do within a device using this risk-based approach Shouldn't influence the safety, shouldn't influence core mechanisms and stuff like these.

01:04:01: Things which we actually try to observe in our RCT's.

01:04:08: You need maybe much easier sources of data, you need to agree on the frameworks and proxies for what it means.

01:04:17: Maybe just too... For some of those changes I think that risk evaluation or what your try-to-introduce could be enough or you could apply some forms of follow-ups on observing what happens, audit rights for observing what happened after you made the changes in the product.

01:04:46: So there are a lot of mechanisms that can be applied and I also believe Because DTX is like drugs, right?

01:04:56: But it's very different.

01:04:57: You have DTx that has more lifestyle change and support in some not.

01:05:03: so maybe... The risks of these things are not too high.

01:05:10: And then there could be DTex where you treat much more serious parts of the treatments.

01:05:18: The thing that works for the one DTX doesn't work on another DTx because fundamentally those are very different products and they only have a common command, you use mobile form.

01:05:28: So also distinguishing DT-X is not one pile of the same product or doing depression or meal tracking but there's lots of use cases where every type can actually exist

01:05:46: in...

01:05:47: that's part of the story here.

01:05:50: Yeah, I think it will take a long time for us to get there because you need someone with very clear vision and set this into motion from an regulatory perspective as it has some complexities in many different stakeholders involved.

01:06:04: then various different ideas and appetite for risk how to define even whether or not they capture.

01:06:13: I mean, it's

01:06:16: the same like if you look into anal clinical practice.

01:06:20: If would be very strict on applying these standardization measures of things such as psychotherapy or nutrition therapy... Everyone follows guidelines and everyone who does that has a certification but at end-of-the-day needs to have some trust in people in the system, that they follow their guidelines as best way it can.

01:06:49: And I think you have to apply this same in some extent for companies and also make sure being compliant actually makes sense from a business perspective.

01:07:04: It's not a burden.

01:07:07: if you would try to wiggle around You'd be better off That's

01:07:13: true.

01:07:14: Now you mentioned something during the conversation there, performance-based reimbursement.

01:07:21: I think as a layperson lot of patients probably assume well this is how it's working right?

01:07:27: You know like something that works better we can get more money for than something doesn't really have the evidence to back that.

01:07:35: Is that reality of digital therapeutics are moving their Or where are we at?

01:07:41: I hope so, yeah.

01:07:42: But it's... It goes back to definition.

01:07:46: what does it mean?

01:07:47: performance-based pricing?

01:07:50: because you should have already some types of preference based pricing right Because when you negotiate the price You show your evidence The quality and size of your effect And base on this you get a prize.

01:08:04: So there is or there should be already some aspect, but what does it really mean and what is the granularity of the performance?

01:08:14: What is the frequency of checking up on the performance?

01:08:20: if you would like to look into individual patient level or Would You Like To Look Into Some Courts.

01:08:28: And If You Will Do It For DTX Just Because You Can!

01:08:32: Would You Also Do It for Drugs You know, and would you also do it for other medical devices?

01:08:38: Because some patients definitely benefit more from the medical device than some others.

01:08:45: So... Do you really create fair conditions in a market when you bestow requirements on one type of device but don't do that to rest?

01:08:56: And then we got into an entire question about feasibility.

01:08:59: what are the data, how you're going to get the data?

01:09:02: Who will actually make sure that providing the data is feasible for the company.

01:09:09: Will other side be able to evaluate the

01:09:12: data?".

01:09:15: It's a very complex topic and it's not only for digas and devices and drugs.

01:09:23: if we look into our entire healthcare system as financed We are frequently working in this performance activities based tariffs.

01:09:37: If Pactors doesn't do something, he gets money for certain activities.

01:09:43: then you have some per capita or DRG codes like these and other elements but entire... health care system, not only digas are really not performance-based in many aspects.

01:09:55: And you see that since it's very complex.

01:09:59: It's not easy to move there because it is clearly clear where the start and You don't want to disrupt something That works fine.

01:10:11: So yeah its a big topic but I think just the thing your discussing with It's first step to move forward.

01:10:25: Yeah, change will take time and as always it is very easy to just say you know a solution is very clear straight forward.

01:10:33: that makes sense but in its implementation there are usually nuances And there was limitations of the system of participants within their systems.

01:10:42: That sort make difficult or put up some boundaries.

01:10:46: definitely

01:10:50: We talked a lot about Germany and Diga now.

01:10:52: Now the German Diga system has sort of like sparked an interest in similar systems.

01:10:58: also other European countries, you know Francis is moving forward on that direction.

01:11:04: Italy's moving forward in a similar direction.

01:11:07: so What's your perspective?

01:11:09: On that especially compared to other global nations Let's set aside Asia or particularly also China and maybe briefly looking to the US, do you think first of all within Europe that we'll make it easier for ourselves by let's say at least nationalizing?

01:11:34: Maybe finding a European solution.

01:11:37: I doubt that but maybe nationalizing various different ways of getting digital therapeutics to the market and other good examples out there, which direction could take that you as a founder would prefer?

01:11:52: Yeah.

01:11:53: I mean it's definitely step in the right direction.

01:11:56: at least nationalize it but always lot things will be hidden.

01:12:05: implementation very crucial that those individual frameworks would be not totally different or kind of similar but different.

01:12:21: So there are several levels to it, obviously the best thing if we could agree on at least some type of harmonization across EU.

01:12:32: like a C-mark is great.

01:12:34: you have c-mark and make c-marks in any country.

01:12:36: and this great concept.

01:12:41: And with why we couldn't have similar framework for clinical evidence, because as I said it's understandable that for the digital therapeutics you want to see some data on a target population in the target country but doesn't really need to be RCT.

01:13:00: is RCT really the best way of collecting data?

01:13:06: see the other frameworks that they are aware of those topics and They technically say that it's not necessary really to duplicate a data.

01:13:19: But then if you look into how we've worked in practice now many companies actually managed To get there with with data critic under another system.

01:13:26: It's not really, its' Not really their.

01:13:28: so some harmonization on European level.

01:13:30: this would be ideal situation.

01:13:33: And yeah but again Europe is very fragmented.

01:13:39: So you have fragmentation on the data, you have a fragmentation in an insurance system.

01:13:45: You have a different type of health care providers and patient journeys... In one country it would be done by GP but another is done at my hospital.

01:13:56: so every level of getting the device to the patients you see fragmentation.

01:14:02: I think that's crucial for removing as many of them and not to create another type of certifications, it would be kind the same but a little bit different.

01:14:14: And you need to cope with this tiny little bit difference documentation which will basically follow the same isologic with the same mark on the same principles that take under half year anyway.

01:14:31: so getting rid off these obstacles are.

01:14:33: they do not really bring Values for the local patients do not really diminish any risk, only make it easier for a system to work with and putting all those costs and efforts on companies.

01:14:48: I think that especially for small countries like Czech Republic when we would maybe Do things like this?

01:14:54: When you will do things like these there wouldn't be much devices coming into the small country because just startup costs are crazy.

01:15:05: And that's something, of course you wouldn't want.

01:15:07: I mean it's clear and i think we're very privileged in Germany.

01:15:11: but okay young people say okay Germany nice France nice whatever.

01:15:15: so like some larger economies western european countries especially um bad have maybe notorious the high healthcare costs.

01:15:24: they have a lot of coverage and embrace new things.

01:15:28: It's great to get those But That shouldn't be sort of like The Determined Effect Of Saying Okay You Know Let's Let's use those as a market and then the rest will see what happens in five years, ten years or never.

01:15:42: Especially when it comes to innovative products such as digital therapeutics.

01:15:47: Definitely agree!

01:15:49: So let's switch pace once because we talked about data evidence pathways and markets.

01:15:59: but I also want captivate the last years for you as a person once of like your personal development, ups and downs, highs and lows in challenges.

01:16:10: I think because that's something very particular to this startup journey.

01:16:16: You start with very little knowledge or high ambitions And hopefully that ambition lasts.

01:16:22: So get from low hands-on experience.

01:16:32: Looking for yourself at that journey, how have you perceived the growth in your self and co-founders?

01:16:38: Because these are all individuals.

01:16:40: They grow on different paces with their own starting points.

01:16:43: And what is one thing would like to know now already from beginning of this journey?

01:16:56: When I start from me as a team going together through these ups and downs.

01:17:07: If you meant to survive them, it will really bring you closer people because this is the only thing that could reasonable happen.

01:17:15: You either got close or you closed a company And you see there are lot of... It's not about experience nor knowledge the environment and industry in processes, what you're actually doing.

01:17:34: There are a lot of other learnings or emotions that you learn to cope with one-of it And I think this is an emotion very underestimated.

01:17:44: It's too get into awkward situations Because when we really bait in this shame and awkwardness It makes you more focused and direct person, it helps to ask the question that he wouldn't do otherwise.

01:18:11: And then there's the obvious thing of being able to cope with pain and endurance.

01:18:18: Enjoying the pain, in a way because doing business is just facing constant threat... ...of being terminated by the environment!

01:18:34: Not really having good odds in survival especially at first it doesn't really make sense that you survive, right?

01:18:40: Because why should do and so being able to let's say stare into this abyss.

01:18:46: And all the things that you need to move forward?

01:18:49: So really wrap your sleeves not feel too high above some work or these type of stuff.

01:19:02: It is quite a particular journey

01:19:08: Would you say the only way to really grasp that is true?

01:19:13: So it's even if you could know something like that, like cognitively not have... Like would be only thing that happens.

01:19:22: Is that you never start?

01:19:23: because cognitively If you knew this before she will not stop.

01:19:26: I think that is what we part.

01:19:28: yeah That if he was no really all the things that you would have to face You wouldn't do it.

01:19:33: It's like with all the big things, right?

01:19:35: If you climb a mountain and how hard would that be... ...and how painful maybe you will decide to do this next summer!

01:19:45: So I don't know if i'd like to think about these things before doing them anyway But I'm not sure.

01:19:58: And to your question, what would be the thing that i'd like to know in the beginning?

01:20:05: Again, if knowing is enough or you really need experience it and feel gravity of a decision It will probably take cuts when something doesn't work When someone isn't fit You should change something You do it.

01:20:27: And you do the cut and you'll do it sooner than later, because frequently... ...you might think that your not staying in comfort zone but try to defend at least some basic level of comfort around you.. ..and may easily get into kind-of biffle thinking this will go well.

01:20:47: there are so many other options But always or need a few steps ahead and be ready to face a lot of different optionalities.

01:20:57: So taking cuts when they need it, this would be one thing that I'd really like know-and feel in the beginning.

01:21:08: Now... That brings us to point where you had ups & downs also Of course In your own company history.

01:21:15: so you scaled and grew alot And then you needed completely pivot.

01:21:19: Can u take us through that journey?

01:21:22: from your perspective, as a co-founder?

01:21:25: As someone that pours so much of yourself and energy into the company.

01:21:30: Into what you can achieve in terms of forming an image or success.

01:21:38: And then having to shift around... How was it?

01:21:42: And how did this impact on your conviction for staying on that journey?

01:21:47: It's fun that you mentioned form of success, like.

01:21:51: what does success really mean?

01:21:52: because this is something that frequently changed or at least for me it's changed over the time.

01:22:00: Yeah, I mean you start with some ideas.

01:22:02: You started it as what would do like to achieve how the company will grow?

01:22:07: What are all these things that he would like to do?

01:22:10: then you got The new.

01:22:13: did you get maybe more realistic expectations based on this experience?

01:22:22: and It's I think that it's very similar story for many companies because when you start and starting from nothing, a new try to build teams.

01:22:33: The company needs different things at the different times And always try to... You're always trying to Build the best company From the function That you need now But these functions change dramatically Being able To switch from one to another.

01:22:53: It's a really tricky part because it is not easy, but it isn't difficult to get rid of the wrong employee or bad employee.

01:23:02: But its very difficult getting rid off good team and you do not need that team anymore.

01:23:10: And when you realize instead having people for your job have done You are making jobs for them.

01:23:18: And so this was for instance, something that really happened to us.

01:23:23: Then with some other maybe unlucky situations got us into a situation where we had to severely downscale the company just to stay above water and survive this.

01:23:43: This really keeps you thinking, why are we doing it?

01:23:48: What's the success?

01:23:51: I think that also depends on which stage happened for us.

01:23:55: at a stage where already had the listing We have a product to help users, patients or doctors who prescribe.

01:24:02: You've got something in your market.

01:24:04: It works

01:24:05: very well.

01:24:06: So close Exactly!

01:24:07: You're so close.

01:24:09: Okay, now it's not the time to close it.

01:24:13: Now you have two keep pushing and yeah...

01:24:18: It's rough!

01:24:20: Especially in a small team like sure.

01:24:24: at certain point I guess we dissociate from all of people that are in your company because its too far away.

01:24:30: but In a smaller team when your employee number one so outside the founding or two three four great people all along there through the journey and then suddenly you have to evaluate whether their participation in a company brings you forward or whether it's an liability.

01:24:50: That must on personal level be really hard because one of things that we also do, is being an employer as a founder.

01:24:57: if your product, your company... Of course its there.

01:25:00: but I think one of the great benefits are not benefits.

01:25:07: be in a position, at least I perceive that very personally.

01:25:10: So it's... ...I get an opportunity to get up on the morning and provide work for people who are really care-for.

01:25:17: That i have stood you know In projects together And then meetings together and made decisions Together with and rely on and trust For years!

01:25:26: Then make decision of saying Okay It is do or die And.. ..that decision You know Is binary.

01:25:33: now There was no longer means of pivoting, or even if you would want to pivot but the person might still not be the right person.

01:25:41: That's tough on a personal level because he cares so much for them and I can fully understand that making those decisions is...

01:25:48: Yeah it's stuff like as you said at time It was binary And this from me big learning maybe when we were more aware we don't have to go through the situation where it would be binary.

01:26:06: But then again, and its new learning that maybe you will do next time with a nice business I dunno... And as they said is on personal level but also on resource levels.

01:26:18: You really think or know That you have good team and invested alot into them.

01:26:24: The teams has very specific set of knowledge.

01:26:27: Maybe not many teams in Europe have unit of people that can actually deliver very good products.

01:26:38: Would you?

01:26:40: Because, always plan for scaling and countries or any product.

01:26:44: so we need those people.

01:26:46: but when things go south it might end up in a situation where things get binary quickly.

01:26:54: It's unfortunate as rough!

01:26:56: And from my perspective the level of perseverance that you and your co-founders have to say, okay at this point there's no return because it doesn't start with the employees.

01:27:13: It starts first... Okay well I'm a founder but i've taken the company so I would take step back first.

01:27:20: maybe not pay myself before you get to people.

01:27:23: So.. To be where you're already saying ok is bad?

01:27:29: We had make those decisions But still we are not willing give up even at this point, we will give it another moonshot and persevere through that.

01:27:39: We'll go back to the drawing board which you had already left a couple of years ago.

01:27:45: I think really shows a commendable strength commitment for your team and co-founders.

01:27:55: You have to grow so close together

01:28:04: Because otherwise, why are you doing it?

01:28:06: And what other options do you have?

01:28:10: because again... It's also the opportunity cost.

01:28:13: But maybe now we see in more white lenses.

01:28:20: that is not just a boat.

01:28:22: Yeah, when you're out of school making career or money and stuff like this.

01:28:25: You also see the other things... The type of work that you are doing?

01:28:28: The type impact that people can have with it?

01:28:32: The types of interesting people to meet.

01:28:35: if I would give up we wouldn't meet!

01:28:37: True

01:28:38: So.. It's a package That you decide to preserve.

01:28:45: Was there point where you said You know what?

01:28:48: Maybe like, I don't know my friends or family or relatives that said Don't do a startup were right and i should go back to you know maybe not the large company but may be a small-sized company.

01:28:58: I never had this moment!

01:29:00: I have to say it...I never had its movement even in these difficult times when uh yeah..you had lot of also personal troubles stemming from the situation of not being able to navigate his financial perils.

01:29:17: But yeah, I never got a moment.

01:29:18: I really found that this makes you the person that you are Yeah and it was ultimately good right for its.

01:29:26: it is

01:29:28: well usually asked as question at the end but i think It's too fitting in those moments.

01:29:32: what gives You hope or maybe even now like?

01:29:35: What Is The Thing That sort of Tells You?

01:29:39: because I feel Like Without Hope You Cannot Stick Through That.

01:29:43: Yeah A Good Question.

01:29:47: I think that it goes a little bit back to the overall mindset of mine.

01:29:54: As I said, where you would see yourself in five-year plan?

01:29:58: If i were ever asked this question on interview... ...I wouldn't have no idea what else was to say!

01:30:04: I always look at opportunity infront me and try make sure that will do my best in the scope of this opportunity that I will really take most out of it.

01:30:18: And when i look at what we have on the Tadio, I still see great product, great data, great usability and great market access starting fractions all those things!

01:30:29: I see great founding themes.

01:30:30: so yeah... It doesn't make sense to go away from it just because now is a little bit more difficult or you're back to the drawing board in many aspects.

01:30:48: Because also, in many aspect, it opens up your eyes and you see things that you haven't seen before like if you get so much again closer with previously where may be done by more teams members realize that you have to reshuffle a lot of things in the company.

01:31:15: And it's not only about scanning, but maybe also sometimes its both fundamental way how your company operates and how do certain stuff.

01:31:24: so It is also valuable learning experience with your own company That actually might lose when working with people because they are their own interests.

01:31:35: They want to keep their seat Yeah.

01:31:42: Again, very commendable that you... I think it really just shows character even more so if we say that was never crossed your mind.

01:31:54: but a lot of people are afraid or failing and obviously It's ideal for the journey to not involve any.

01:32:03: But naturally as he said allows us restart with focus on experience cut mindset and yeah, we can see that you're doing the best out of it.

01:32:16: We

01:32:16: try!

01:32:19: Of course in your position you would have to say that because all... You know everything can happen but

01:32:29: as I said It's a mix of personal reasons.

01:32:43: Now that you're sort of like back to a more restricted point-of-view, and you have already experienced from being Swiss Army Knife with lot different functions too.

01:32:55: And you've moved past it also passed what I would consider always... being sort of a bottleneck, because especially in early development phases and with the founders that I talk with.

01:33:06: That always feels like okay.

01:33:07: to which point am i becoming let's say liability personally?

01:33:10: so the company by being the only person who does a certain thing?

01:33:13: And it means my pace is the company pace in the aspects that I manage versus um Being close enough To really understand the details and be able also provide an adequate solutions to It.

01:33:27: seeing your journey now from Being the bottleneck to no longer being the bottlenecked or again, being a bottlenecker for certain functions.

01:33:34: So where does it lead you on a personal side into the future?

01:33:39: Like what do you think can now with your experience?

01:33:44: What would be recommendations also from new startup founders when went to switch which tasks to not completely keep yourself?

01:33:52: I think that one we will be hiring.

01:33:57: It's really tricky question.

01:34:00: It's all about hiring, right?

01:34:01: Hiring the right people at a right time and hiring The Right People At A Right Time when you do not have the right budget for the right person.

01:34:09: So in the beginning what we did is that he tried to work with what you have.

01:34:16: So, a lot of people... A lot of part-time students maybe?

01:34:20: You've got a lot junior people and try to delegate very specific tiny tasks for the very specific people who may be like little bit.

01:34:28: the overall content context is more than looking at it as an overall context And then end up being the bottleneck because basically we don't do that in real time but there's key to every task why this has been done.

01:34:45: And looking back at this stage, I think that having kind of like SWOT teams have more experienced and motivated aligned individuals.

01:34:59: Even though they wouldn't be on a full-time but they would own some work streams or own some projects we wouldn't do these tiny little tasks.

01:35:11: This will probably the way i'd go.

01:35:16: So this was one learning that by hiring many, many inexperienced players into your company it might look cost efficient.

01:35:28: That you don't have to do every single data input let's say.

01:35:31: but at the end of day You're losing a lot of learnings in it because they see things and should be able to evaluate But not just focus on doing an evil task.

01:35:43: And also the first people that you hire into a company, they really influenced how their company will behave.

01:35:51: What type of structures and values do we have?

01:35:56: So if you hire BC players because you cannot afford A players... ...and these B players would be hiring more C players then it ends up in this situation where there is part that are not so efficient as you maybe would like them to be, it's tricky to break the cycle then.

01:36:17: So really focus on the thing where first people in a company is very aligned with your mindset and values... Are you this move fast break things?

01:36:33: If yes!

01:36:33: You need these people in team.

01:36:36: And if you know someone who isn't with this mindset.

01:36:39: You know deliberately that you're choosing this person for a specific reason, and it's not like these things happen by the way because he just chose to be developer or need the developer but now have him.

01:36:50: maybe he will be platform lead at one time.

01:36:54: This entire section is totally not in sync with rest of company.

01:37:01: So this was quite big learning from me.

01:37:05: And then another thing do not necessarily trust senior people from the senior management of big companies.

01:37:19: Because we frequently... And when you are your young founder, first company.

01:37:24: You do not have the experience.

01:37:25: You have investors at your neck and everyone is okay.

01:37:28: so you should hire someone who does it or understands that you know twenty years of experience.

01:37:32: he will work in big marketing departments with a big e-commerce companies.

01:37:35: why?

01:37:36: Why do you hire such people for what they're

01:37:39: doing?".

01:37:40: Then there's this grey hair man who looks like... He really knows what his'e doing!

01:37:46: very, very fluently about it and eloquently.

01:37:50: And you feel like that what he's saying must be true?

01:37:53: You do not have the bandwidth to look into detail because we trust him with

01:37:56: process.".

01:37:57: At the end of day many people who survive in a corporate are having specific set of abilities which is useful but absolutely useless at start-up.

01:38:08: But due to this set of abilities, you may spend easily months or years before you notice that these could be the bottleneck.

01:38:16: So yeah...

01:38:21: Very applied knowledge here!

01:38:23: Yeah very slight knowledge

01:38:25: That's true.

01:38:26: No no I It needs to.

01:38:30: You kind have seen your people.

01:38:33: Well, a lot of times especially what you describe is that they can very eloquently describe delegate maybe frame vision.

01:38:42: This is something that gets you also into more senior roles potentially Especially at larger companies because it's about communication and being seen in the team And happens through words A lot of time.

01:38:54: So I totally see how this could impact.

01:38:57: where do end up on large company But does allow for you to apply and shift.

01:39:02: I mean, you need to shift gears from a large company.

01:39:04: You definitely should have worked in the large company yourself.

01:39:07: So i've had the fortune To work at gcp servers and understand how quickly we can also move things here And this is something that i want to maintain and move forward.

01:39:17: but if you Have experience with very structured slow moving Very let's say discussion heavy process changes Then all of a sudden you need Naturally going to come with its own, I think opportunity at least for collisions.

01:39:37: Yeah but definitely that was our learning.

01:39:43: It's very interesting to see that from an outside perspective.

01:39:47: a lot of people would say okay most changes are about the product and put that pathway, but you clearly describe the most significant learnings are all with people.

01:39:57: And at the end of day behind every successful product is a very successful team.

01:40:02: managing it's not as easy as it seems.

01:40:08: This I can confirm.

01:40:14: Let's wrap things up From your perspective.

01:40:21: on a personal level, I know you say You don't have a five-year plan but you're also managing the company and you will maybe Have some six months aspirations or what not?

01:40:30: Maybe even for yourself.

01:40:32: Maybe even just like in Five years.

01:40:34: i would liked For things to be a bit more relaxed for me than they are now.

01:40:38: Where is it taking you?

01:40:40: where's it taking the company like?

01:40:41: What is yeah one of next steps?

01:40:44: Yeah Over the past years, we really switched from this idea of building VC-backed venture that is basically in for a build product.

01:40:59: Sell the products to build a company that can survive and it's going to be profitable.

01:41:13: The journey is still the same as we envisioned.

01:41:15: It's just a little bit maybe more realistic, so we want to grow across indications and new markets that will open up similar to the gas schemes.

01:41:34: And as you said, I hope that it will be more relaxed.

01:42:04: Now your chances are gonna be quite different to the first time running into it.

01:42:08: I hope so.

01:42:12: Is there anything from a regulatory perspective?

01:42:15: Because of course that heavily impacts you and the company, but he would say if this were to change That will be great for us.

01:42:23: But also four let's say ecosystem in the patients.

01:42:30: I would surely say that the harmonizations across EU, because we are a European country.

01:42:35: We're a European company and we'd like to work in Europe.

01:42:40: It's not like...we can try get into some projects into the

01:42:47: U.S.,

01:42:48: to be honest, I don't know...I see most other companies that try it coming back with a little bit less funds and more wrinkles.

01:42:58: so given our past experience we would like to stay in Europe.

01:43:01: So if there were this regulatory shift allowing faster market access across other European countries That will get you closer the tech startup scale-up, that you translate a product.

01:43:20: You maybe optimize the product and adjust it for local users right?

01:43:25: And then you optimized patient journey to the local system but don't have completely start over on all of other rotary aspects.

01:43:40: This would help us because this will allow freely move between the countries, between markets.

01:43:48: And it would be so interesting also from the scientific perspective, because then you'd have such diverse data across different populations.

01:43:58: It was allowed for you to optimize your products further and maybe it will give you a very interesting insight into health care systems of individual countries Because what you as a digger can see is a very detailed view on how the healthcare system works.

01:44:16: So, there could be so many benefits that would also beneficial for the public sector and regulators itself if they allow this increased mobility across countries.

01:44:30: I think it's worth a try!

01:44:35: Let us keep our fingers crossed... A lot of unification is considered to certain extent moving forward And we know countries look left or right intense exchange also between local regulators on individual country level, so hopes remain that some things would change.

01:44:56: I'm sure they will not fully be harmonized or easy but if we can reduce a bit of the hurdles it means the journey will get much smoother and as you said we have done it for across Europe.

01:45:12: We could

01:45:12: do this Technically, we can do it.

01:45:15: We just need the right people to set their mind to it and then move it through.

01:45:19: there needs To be a willingness And I guess an acceptance that this is in fact An issue That Is worth addressing and Worth putting effort into for The sake of harmonization For the sake Of being and or remaining competitive In Europe.

01:45:35: Once i think that It's quite clear.

01:45:38: Then we Can also Move the Right Levels and Move in the Right Direction push the perspective forward and saying that, hey this is in fact something that needs addressing.

01:45:48: This a topic?

01:45:49: This isn't it from companies or patients?

01:45:53: Awesome!

01:45:54: Anything else you would like to touch upon that we haven't touched today?

01:46:00: Not really... It was very extensive.

01:46:03: Well,

01:46:05: thank you so much for stopping by here in Bremen.

01:46:08: I know this was not quite on your way but very much appreciate you being here and the inspiration that you've given also showcasing it's always just going to go up one direction But take a lot of lessons from it and perseverance is gonna carry forward eitherway for showcasing that it is in fact possible to bring in digital therapeutics also through the German market and you know be deagle-listed despite the hurdles might maybe being higher.

01:46:37: And yeah, bringing better care also to patients here in Europe.

01:46:43: overall continuing on this mission not forfeiting it sticking towards us was really pleasure having a conversation with today.

01:46:51: Pleasure.