How One Founder Turned a Personal Disease Into a Medical Device Company

00:00:00: It was like collectively, eighty thousand euros.

00:00:03: And we calculated and said realize it's enough for three months!

00:00:08: And I was okay... We have the three months to find investors.

00:00:28: It is such a pleasure to have you here as the first guest on our podcast.

00:00:33: We know each other for quite some time and you've been a huge inspiration to me, so I'm very happy to have I'm personally so invested in, and that i feel is such a great lesson learned for the people out there.

00:00:56: That I really look forward to next discussions we're going have here!

00:01:00: So before you get into all of your impact on health patients who are at home care or on buildings, why don't start by framing as person more?

00:01:14: And how did Let's say recapping the time between your studies and then moving into clinical research.

00:01:23: What did you do before you came to clinical research?

00:01:26: What are lessons learned, let's say that you would have taken from all of your times in clinical research until eventually forming Skinovita as a startup?

00:01:39: First off it is my pleasure for being here now so humbled by what you just said!

00:01:45: How did I get to that journey?

00:01:47: So before going into the founded journey, I was working as a PhD student and research associate at The University of Bremen.

00:01:55: At the chair for entrepreneurship.

00:01:57: but to be honest... ...I never thought that i would end up in that whole area!

00:02:03: I grew up in a very small village on our street had five houses And there were lots of farmers with different professions.

00:02:10: But being an entrepreneur didn't even know what it is.

00:02:13: so It came over time growing up in a small area.

00:02:17: We were teenagers, we wanted to do parties.

00:02:19: with that music I was DJing.

00:02:21: suddenly i was booked on the other weekends and it was my first exposure to entrepreneurship.

00:02:25: until i was having lot of uh detail gigs there was the first um stage so to say until i realized what scalability means because i was constantly tired studying during the weekend, having my kicks on the weekends.

00:02:39: And then I thought okay maybe there is a more innovative and another edge to it so that when in the corporate world to airbrush airplane manufacturing than mid-sized company?

00:02:48: Then through the chair for entrepreneurship but... ...I always had a passion and was always there to create things kind of matter To me also other people who may be passionate about creating things.

00:03:03: That's something consistent And even in a highly regulated world like clinical research, there's so much you can do and the impact is so big.

00:03:11: So that's what led me here.

00:03:16: Is there a point along that journey where you realized I should give it a shot?

00:03:23: I should jump in head first not knowing or maybe partially knowing sort of... What were going to get yourself into forming company?

00:03:30: was something that inspired your kickstarted that or was it something that you got exposed to during your time at the universities?

00:03:40: What really planted a seed if you do know whether there's anything specific.

00:03:46: I think its exposure through other people.

00:03:48: in the field of entrepreneurship and startups, i went to a lot startup events talked with a lot of other people And also realising how the corporate world looks like what is too slow for me I never wanted to lose my passion and step-by-step was like, oh this is really nice.

00:04:03: But... ...I didn't just want start a company without knowing what or wanting something that's worth it.

00:04:13: dedicating too much into building up the startup is hard because you need to be conscious about your effort in.

00:04:19: It doesn't have to perfectly planned No startup is perfectly planned in the beginning, but still something that's worth dedicating to and That's kind of where my patient journey came In.

00:04:30: And a moment was like online.

00:04:32: you really gotta do this Is um...that The pandemic happened at the university.

00:04:39: Another project I had Was pretty much frozen because we didn't know what happens This year of the world.

00:04:44: or can We continue into months?

00:04:45: Like an early two thousand twenty was so Interesting, and I used the time to write scholarship applications.

00:04:52: And suddenly we got the first three scholarships... ...and then like one or two weeks later.. ..I was invited to a pitch event in Berlin.

00:05:00: It just an idea!

00:05:01: There's nothing.

00:05:02: We had only three scholarships approved but it didn't start.

00:05:05: so i pitched there.... ....and then suddenly we won the main prize of this event.

00:05:09: Then we offered four more scholarships,... …an accelerator program with condition that I moved to Berlin and become part of this accelerator.

00:05:18: The rest of the moment was like, what more do you want?

00:05:20: Like this is the moment and okay get out off your comfort zone.

00:05:23: And start it

00:05:25: nice!

00:05:26: What was that original idea that you pitched there?

00:05:30: if You also compare It maybe we can lead over to That.

00:05:33: what does skin reader Do now?

00:05:34: how do you see that like?

00:05:36: what Of that core Idea that you Pitched early still exists in the foundation of skin reader as it Is today?

00:05:44: Yeah, there is the idea but I think more relevant.

00:05:46: it's a problem.

00:05:47: What does the common problem?

00:05:48: because ideas change But can be very consistent when it is about solving certain problems.

00:05:53: and the problem was very Very relevant that always they're not.

00:05:57: always wonder why is there no solution in this for people with skin disease like psoriasis anatopic dermatitis diseases that are no fun.

00:06:05: And if you cannot get under control with topicals and creams, the next step is usually a certain type of phototherapies like radiation on skin.

00:06:15: patients need to drive clinic four or five times per week during opening hours so anyone who has full-time job or lives in rural area as kids can't do it.

00:06:25: So there's very effective therapy for good clinical data The main reason why Many people don't do it.

00:06:35: It's a practical reason, so I was like okay patients cannot go to their therapy.

00:06:40: Can we just bring the therapy?

00:06:41: To the patient.

00:06:42: and then different ideas emerged.

00:06:44: The first idea was too Okay Let's just rent out professional therapy lamps to the place at home.

00:06:48: Then we realized oh well they could harm themselves.

00:06:52: It's A professional Therapy device maybe not such a good Idea.

00:06:55: ok We need to change.

00:06:56: how can we make it safe And this is like our software if we transfer the dosage Automatically that patient Cannot get an overdose.

00:07:03: Oh, and the doctor needs to see how does this skin progression?

00:07:07: Is it working or is not... ...is patient burned after a session.

00:07:11: So okay telemedicine.

00:07:13: we can transfer photos information from patients to doctors but then also they can change dosage step by step.

00:07:21: the idea developed was always about same problem.

00:07:26: The problem's still the same interesting thing.

00:07:29: now like are on market with that solving their problems and there's still some homework to optimize, but the great thing is that now we tackle that.

00:07:37: Now you can even think of more problems.

00:07:39: I think bigger like it may be not only for psoriasiotopic bematitis people who need radiation therapy But maybe see what if... get the diagnosed for the first time, maybe need some education.

00:07:53: Some online training just with your life so you can change so many things.

00:07:57: So we're thinking about expanding.

00:07:59: and what are more severe cases that need injections that inhibit their antibodies of their immune system?

00:08:04: Okay How can we help patients?

00:08:06: You know Maybe have there lab data in one area etc.. Now it's growing but The core foundation has always been the same solving this problem And helping people because It makes sense to make it accessible

00:08:21: And I can completely see that in your business today.

00:08:24: It's a great lesson and i never really thought of it.

00:08:28: clearly, the problem needs to be consistent... ...and you can develop a lot ideas around this.

00:08:33: That is good to know!

00:08:36: You have a lot bad ideas stucking into the tension.

00:08:40: but the good thing about having space for learning because then it doesn't block you because it's rather like, okay that what I thought is my idea to be the solution.

00:08:52: It's not the right thing to serve the purpose.

00:08:55: so yeah but there was a learning over last five years do you know?

00:09:00: Be so attached with your idea and rather than like What's The Purpose That You Want To Achieve Was A Big Learning.

00:09:06: Yeah

00:09:07: Now we opened the topic of Skinovita And What You Do Now.

00:09:12: So maybe if could give us in brief structured way, a little description of what exactly is it that you do.

00:09:20: So I mean your medical device manufacturer class to A. so can you tell us a bit about?

00:09:26: What's the device and sort like whats your product?

00:09:30: Whats your labeling claim for everyone?

00:09:33: thats listening in.

00:09:35: yeah we have different roles.

00:09:37: there are products developed then an entire kind care model implemented The Care Model itself treatment to the patients and for that we have dermatologists who supervise patients, do digital therapy plans in our software.

00:09:52: That's a product part of it.

00:09:54: so they can set up tools with remote monitoring.

00:09:58: The patients get their app where they are guided through the treatments but also a therapy lamp or radiation device.

00:10:06: We decided not build an irradiation device ourselves because there already existed.

00:10:10: just needed them home care ready.

00:10:12: But this is also something that we integrated here.

00:10:15: And last but not least, it's very important also that this is covered like... This is quite costly if you have a dematologist specialist supervising the therapy device brought to home than an entire software system that has MDR-II AI certified.

00:10:31: so um That Also, a lot of our work to make contracts with health insurance that cover the costs and different types cost payers.

00:10:41: But as a manufacturer it is mostly software side-of things in little bit of dosage transfer IOT to therapy devices.

00:10:51: Very nice!

00:10:52: So you have described your product?

00:10:56: You've described problem And there was couple scholarships back at beginning of pandemic saying You know what?

00:11:06: Let's just do it.

00:11:09: What came after that, like how did you even come to find other people who were crazy enough to go on the journey with you and say I so strongly believe in a problem that is describing me as part of this solution.

00:11:26: How did that come about ?

00:11:28: How did you recruit the core team which started your journey?

00:11:33: Yeah, it's so wonderful to find people who dedicate with that mission.

00:11:38: And the key was talking about it and... It sounds so easy but I lost a lot of time-I could have found this company earlier maybe would've been too early or maybe wouldn't be perfect because then in the pandemic we're definitely already on the market.

00:11:54: But i had some like mental blocks Because, you know such a skin disease.

00:11:59: I had it since my childhood and It was no fun.

00:12:01: And i felt rejected many times and Was embarrassing to talk about the disease?

00:12:08: And then suddenly going wherever You go talked like I have psoriasis its itchy and it looks bad and you want To get rid of it and there's a treatment.

00:12:16: but if she basically needs to Go through the clinic every day and that sucks and just do it from home and There needs to be solution i thought Like who would Be passionate About That?

00:12:25: Who?

00:12:26: Yes, every patient understands.

00:12:27: But yeah somehow I underestimated people's ability to really see the value in something and dedicate it.

00:12:38: And once that was broken It was rather like where do you find the kind of people we need?

00:12:43: So i had a business background but We needed different skills there, complementary skills.

00:12:49: So I need it to find software developers designers health economists and that literally came from talking about like our CTO Jens.

00:12:58: It started by being in the gym And talking to a guy they're who?

00:13:02: When i found out he studies computer science almost Like I have an idea.

00:13:07: so I pitched their duty him but wasn't right thing for him.

00:13:10: But we exchanged phone numbers and here at the job of University and talked with supervisor And that supervisor was like, oh man I'm about to finish my PhD.

00:13:19: It sounds really interesting.

00:13:20: also wanted do something with purpose.

00:13:22: Can you give me the phone number of that guy?

00:13:24: You met in a gym and Mike Ophoniens isn't there.

00:13:27: The first one too approach new people.

00:13:29: but somehow it had the gym guy Pitching this startup after I pitched starting.

00:13:35: what's convincing enough for the Supervisor to give me a phone call.

00:13:40: That's how he started.

00:13:41: With many other things, it was just like that talking about spreading the word and then things come to you.

00:13:47: Not everything works but if there is a ninety percent probability of failure... Do twenty times!

00:13:55: Most likely we'll find someone.

00:13:57: so even do ten times.

00:14:01: So breaking that fear of rejection or fear of failure That was the game changer in early stage.

00:14:13: And then you had your initial funding, you're at your initial team ready?

00:14:17: The people that from for whatever reason and from whatever background they came together said You know what we are already unwilling to contribute.

00:14:26: but Then where do you start?

00:14:28: it feels like so understanding the problem is great But getting form from their problem and a potential idea knowing that its one of probably ten, twenty-fifty iterations that you need to go into get there and building a system around it.

00:14:44: And having in the back of their mind are they're lot of requirements?

00:14:48: You already mentioned this initially.

00:14:50: why don't you just ship them to immediately identify?

00:14:52: no It's not so easy.

00:14:54: So how do we even approach a problem That is so large that requires an entire multi here development path?

00:15:03: Yeah What was your first step?

00:15:08: where Is this step too big for us to take?

00:15:11: Or did you just say, let's... Let's take the first small step and see where it takes us.

00:15:17: The head can be really overwhelming.

00:15:20: I think.

00:15:20: was the enthusiasm at the opportunity or is like lets do it?

00:15:26: It was impossible to have the overview.

00:15:30: To be honest we had no clue about clinical validation.

00:15:32: We didn't even know if were a medical product of what kind And how all that works also about payment systems in the healthcare system.

00:15:42: And it was evolving at that time, and COVID all these telemedicine solutions... Also government introduced new payment models.

00:15:49: So where do you start?

00:15:53: There's so much.

00:15:54: I think The first thing this was like this parallelism Where a lot of coaches and consultants told us many things.

00:16:01: If we talk to the patent attorney they say don't say anything about technology.

00:16:05: Then you talked with marketing guys.

00:16:06: You have to talk about it first every specialist, I mean it makes sense what they say in their domain and then you just frozen like oh i need to do this but also needed that.

00:16:17: And there's like pfft... What helped was think of the key assumptions that needs true.

00:16:26: so there needs a value for patient.

00:16:28: if no pain doesn't make sense.

00:16:30: There needs to be value for dermatologist who prescribes and supervises it.

00:16:35: There is a cost-period and health insurance.

00:16:38: It needs to be technically feasible and also the regulatory part doable.

00:16:45: And there needs to a way how to finance it, then evaluating everything at once is pretty much impossible but going step by step what's the most urgent thing?

00:16:57: Then go step-by-step And once you're all in, so there is no alternative.

00:17:02: Or are you a bit okay?

00:17:04: I go out but why would you get just because it's overwhelming like... You can validate these things and the thing is whenever we had a problem ...and dedicated to it We learned a lot, we adapted It worked!

00:17:20: Oh this was really critical.

00:17:23: This might be the end.

00:17:24: Ah, we can do it like this.

00:17:27: You don't have it solved overnight so you'll get a lot of sleepless nights in between and be like oh man!

00:17:31: We've got so far... And no I don't know.

00:17:35: maybe this is the final thing that will prevent the whole thing.

00:17:39: but if your creative everything makes sense?

00:17:42: If you're large people who want to dedicate or contribute there's lots potential for solutions.

00:17:50: So just continue.

00:17:52: Here we are still you know, there's still a lot to do and they're still.

00:17:57: things were thinking like oh man skatable sales structures.

00:18:00: I have never set up such systems But already no.

00:18:04: I have great um You know investors coaches mentors who?

00:18:10: Yeah Who support in that?

00:18:11: then we already know that we have the proof of concept founder driven sales work.

00:18:15: So I am may have the ability To bring in profitable sales.

00:18:19: so i just need to learn how to train other people.

00:18:22: copy what is already in the mind, just as an example.

00:18:25: This is a current thing like we want to scale but this is now the new thing.

00:18:31: every two or three

00:18:32: months there's this like oh...this is not how it should be and how could it be?

00:18:39: And you also need to be okay with always having one thing where your unsatisfied how it is and have enthusiasm.

00:18:47: set that up make it good leave it do something new.

00:18:51: another problem

00:18:53: Yeah, yeah.

00:18:54: It doesn't end and I'm sure it hasn't ended to this day.

00:18:57: now then

00:18:58: you lose the ambition And then your?

00:19:00: Then exactly i think as a company if you loose that explorers Ambition than its only matter of time until you're replaced by an innovative player who has his enthusiasm still.

00:19:13: So was there first focal point for the development Of skinovita?

00:19:19: is whole or product itself that you focused on?

00:19:23: or did you say, well we have now two three four people.

00:19:27: So each one gets one area and this is how we just have to do it?

00:19:31: Yeah I was thinking a lot about this question.

00:19:35: when there's many things to do...I think initially um i always had the impulse to do Many things at once but still have the tendency.

00:19:45: But learning is to do things one after another.

00:19:49: It's faster And leads better quality.

00:19:53: On the software side, however there were some things that like if you have a telemedicine system.

00:19:58: You know doctor and patient needs to be in exchange but need two interfaces.

00:20:04: But it was rarely that we put an equal focus on both Interfaces.

00:20:10: It's more like First of all We needed therapy plan.

00:20:13: for that you need the Doctor tool.

00:20:15: There is no therapy plan.

00:20:16: Patient app has used us.

00:20:18: And then he said okay this good enough the patient needs something and we wanted to start a clinical trial.

00:20:24: So then, when is it good enough?

00:20:27: To risk putting in a clinical trail thinking that will lead to good results versus doing the clinical trials nine months later but maybe running out of money between them.

00:20:37: so this really risky.

00:20:39: And after they tried was like oh yeah.

00:20:40: But now we neglected the doctor thing.

00:20:42: It's always jumping a bit.

00:20:45: Not everything all at once In small teams not possible.

00:20:48: If you were an organization Team app, team therapy management and team hardware.

00:20:55: If you're early stage startup everyone is kind of doing everything then rather focus yeah.

00:21:01: And so did you feel at any point that You were always getting to the like eighty ninety percent which was done maybe in twenty percent Of time but really crunchy.

00:21:09: last ten percent?

00:21:11: You are piling up a lot those.

00:21:14: Was that ever a concern to you during the development?

00:21:17: or did you feel, we just need the MVP so the minimal viable product and That is good enough To a certain extent.

00:21:26: And we can live with it was there.

00:21:28: Yeah How did you move through?

00:21:30: Also I think Emotional journey because yourself get attached your product then you want to see perfect by.

00:21:35: at the same time You need to balance it.

00:21:38: yeah.

00:21:40: So there's what you emotionally want to do, and then the rational part of it.

00:21:43: We really forced ourselves to follow that AT-Twenty principle because... ...the price for making one thing perfect was not doing three other things up to an eighty percent stage.

00:21:55: And It is not so easy Because You identify too much with it and you wanna do things great!

00:22:01: So you constantly have things That are not at their full potential But For The sake Of Speed You go on to the next thing.

00:22:10: So I think this is right way, so you need be able live with it?

00:22:17: There's also one thing which has a technical depth and especially in IT infrastructure

00:22:24: etc.,

00:22:25: if things are stacked on top of each other they really make sense because we have good foundation that gets harder.

00:22:33: but on some others for instance take design elements, et cetera.

00:22:40: There it doesn't hurt so much.

00:22:41: you can rework and replace an illustration or tweak a pitch deck later on many other levels.

00:22:51: I think You need to be okay with that but its never forgetting like the high ambition But is always saying ok once we can afford then will get back to that.

00:23:02: Now lets release this move forward.

00:23:06: We need speed.

00:23:07: It's always also the promise and once we made it, then make it perfect.

00:23:11: Exactly!

00:23:12: Maybe

00:23:12: were lying to ourselves but I think is okay.

00:23:20: Probably for you was a little bit easier...I mean i know your team.

00:23:24: so probably maybe for Jens or for Janina it was harder say let's stop at eighty percent than might be for you.

00:23:33: So probably there was also convincing on your end to say, but we need to move in that pace.

00:23:38: Was it a more continuous conversation point?

00:23:42: Yeah this is like very typical conversation we have.

00:23:45: Do you dedicate time or isn't good enough?

00:23:48: and what about the other thing?

00:23:49: now has its higher priority And I don´t claim to be perfect position.

00:23:55: if Jens or Elina would sit here maybe they would... No no i think they will stay the same because It's the logical conclusion over time that you get.

00:24:05: Like doing, maxing out a comes at the cost of not doing the other things and I think now we got really pragmatic about things.

00:24:15: We have good common sense.

00:24:17: The only thing when we need to think is like what are things where they stack on top each others?

00:24:22: so later it's harder to get back to them.

00:24:24: This is something that needs to find out.

00:24:27: That's

00:24:27: great perspective.

00:24:30: So Developing the app, you said there were many times when you sort of like got to a point where he said well we have come this far but it feels Like There is This Hurtle which We now Have To Really Push Through and We're Not Sure if We're Gonna End Up Getting through It.

00:24:48: Are There Some?

00:24:50: Like some Early Hurdles That You Ran Into Which You Still Recall Now that Have really Caused A lot Of Sleep This Night For You?

00:24:58: And If So Is There Sort a theme to it where there's similar topics or like all regulatory elements of it, simply external hard requirements you need to meet.

00:25:10: Or whether mixed designs were basically said well... It has to be useful for our customer and I'm not sure how we can make that work while meeting XYZ requirements.

00:25:25: There are lots of hurdles And maybe I can go through the chronologically, so we had these scholarships and it's quite comfortable to have.

00:25:36: One scholarship line was for twelve months The other one is nine months.

00:25:41: By coincidence they started three months later.

00:25:42: So all seven ended in that same month.

00:25:46: You come from a position most of us worked at university before.

00:25:50: We're used to having grants or public funding etc... So you are on your comfort zone.

00:25:58: We didn't even found a company like also for some regulatory reasons.

00:26:02: It was better to not find it.

00:26:03: and then by the end of the scholarships, you do things.

00:26:08: You get your scholarships on the bank account ,you can pay your bills .You will not get rich but its enough for rent food and basic lifestyle.

00:26:17: And all seven scholarships ended in same month!

00:26:20: And we had an amazing team I was like.

00:26:23: But now every month we need x thousand euros Like.

00:26:29: we already knew that it will take time.

00:26:31: And of course in advance, when you talk to investors.

00:26:34: but at the moment was like okay We are not rich and my our parents don't have that money and we don't heaven established investor network and banks Are not funding?

00:26:47: That kind of things they're not really understanding what is needed to bring into market.

00:26:51: It's too risky for them.

00:26:53: then we said ok That's everything we have.

00:26:57: It was like collectively, eighty thousand euros.

00:27:01: and We calculated is that realize it's enough for three months And I was okay?

00:27:08: We have the three months to find investors.

00:27:11: We don't really know how and where but we have this accelerator with pitch events and let spread of a word and that worked.

00:27:20: and that Was wonderful.

00:27:21: and that's our GCP service came in You know, as a early stage startup investor but also someone who gave us so many insights and coached us.

00:27:32: So much this was so valuable.

00:27:35: But the question will we get funding?

00:27:37: Was fundamental at that stage.

00:27:40: Also until the end of the scholarships there was nothing to lose.

00:27:43: The moment we invested everything like it was At least financially.

00:27:47: you're

00:27:49: Yeah

00:27:50: Everything gone.

00:27:50: That's it.

00:27:52: No one dies but still going bankrupt is not so nice.

00:27:57: And that was one point.

00:27:59: Then the second point came a bit later, which was when we handed in everything for The Clinical Trial.

00:28:05: We had to face German-slash European bureaucracy and we had to wait so long For approval.

00:28:15: if there's an established company That is profitable it Is okay.

00:28:17: they can Wait but right.

00:28:18: But we Had the salaries To pay every Month.

00:28:21: Every Week Costs Money.

00:28:27: It cannot fail because of that.

00:28:28: Like literally, no!

00:28:31: Also we got more and more persistent... And this

00:28:34: was horrible on there

00:28:37: also.

00:28:38: it doesn't help any like why?

00:28:42: And we had it twice, such a situation.

00:28:44: One thing for approving the clinical trial and our therapy has seasonal component.

00:28:48: So so we lost almost an entire season.

00:28:51: Yeah, and it happened later after the clinical trials We had it for the MDR certification.

00:28:56: I mean...we thought oh now we have clinical data Now we get this certificate in next two months then we can start.

00:29:02: It was one thousand pages of tech doc Including all the clinical tri-data but also technical documentation The risk management quality management Then audits And we submitted everything.

00:29:15: In the end, We had no major non-conformity.

00:29:19: so we had really smooth submission.

00:29:22: but between submission and everything here it works!

00:29:27: Getting the certificate took a year A year of paying people also... We couldn't do marketing or develop product further.

00:29:36: therefore now with market entry really well-developed and polished product, but that was so frustrating.

00:29:43: And again with this thing like... But we came so far in such a stupid reason to fail?

00:29:49: Like no!

00:29:53: We are allowed to fail if not once they have it on the market because an institution doesn't have time for us.

00:30:02: That person is now sick.

00:30:03: there's no sick leave deputy.

00:30:08: That person is four weeks on holiday and then that person really busy.

00:30:12: And like now I'm making this out to, our auditorium's amazing.

00:30:15: the problem is they just overloaded their far more requests than auditors.

00:30:19: but oh no those two moments were.

00:30:28: it was not an option failed because of that right?

00:30:32: No It makes me so angry because I know that innovation style, and it's so stupid.

00:30:39: There are things could help other people just because of the long waiting times.

00:30:44: they go bankrupt in between.

00:30:47: We were very personally invested especially at the clinical trial part but also we were chatting a lot when you were waiting for order to finally move through.

00:31:00: now in hindsight, you know everything was fine.

00:31:03: So it just the waiting time for no impact.

00:31:06: and the same was true when we had the BFAM application for the trial.

00:31:10: but at the end of the day... The only reason you had to wait is because they found a legal loophole where they disagreed with risk classification For No Reason And accepted that at the End Of The Day.

00:31:20: Anyway I mean It Was Such A Clear Cut Case That The Lamp Is Defining Your Risk And so it's two A. So yes, Bayfarm doesn't need to look at it that... To this day.

00:31:33: I do not understand why there was any pushback and why we had dozens of calls?

00:31:42: The inflexibility also was striking!

00:31:45: We discussed just going there giving them a demonstration or sitting down with him.

00:31:49: if they would only listen he'd have been happy to accommodate anything.

00:31:54: but by the end You're on the short end of a stick and ends.

00:32:00: This

00:32:00: is start-up thing, so as a startup you don't have lot leverage because it doesn't have your army of lawyers maybe younger or more inexperience in there from not as energetic but persistent cause.

00:32:18: you are afraid of losing their There's sympathy because in many moments there is one person, especially the regulatory.

00:32:27: One person who has all of power about this entire thing and these dependencies really... And if that person doesn't even talk to you or they have other things but are just not important for them it's pretty frustrating.

00:32:46: Now maturing as a company we have less dependency.

00:32:50: It isn't only good.

00:32:52: But as a startup, you have these situations where we're just like okay how can I get this person to look at it in the timely manner?

00:33:01: How can i speed up?

00:33:01: should put pressure on that person or Should there be really sympathetic?

00:33:06: What should they do?

00:33:08: and then also in the timeline expect.

00:33:09: Okay This is the legal deadline until their need To respond.

00:33:12: so I expect That They Do It Within Their Own Deadline And Then Oh No There Are.

00:33:16: They Found A Way How To Play On Time

00:33:19: Exactly

00:33:22: You need good business angels and this is like, there was one phone call that made the difference.

00:33:29: And it wasn't not by me but from your side.

00:33:32: Yeah

00:33:34: That helps a lot as startup being backed having people who believe in you also on their shareholder and partnership.

00:33:43: I have to say This...that's how i perceive GCP service as an institution.

00:33:50: One thing is your business and what you do, but it's also the high conviction where you really go in.

00:33:58: It comes on sense as if just like I will not tolerate this!

00:34:03: Yeah...it

00:34:04: makes sense and we need to clinically try.

00:34:06: then people would benefit from it.

00:34:07: And now we do over hours and Go through it?

00:34:12: This is why i appreciate so much about this partnership.

00:34:15: yeah at end of day you know, you visited our team.

00:34:20: You gave presentations on like.

00:34:21: this is what we do and... And we feel that as a person with your company an we love those relationships where it makes easy for us to personally be invested in the joint journey and feel like were part of if we can actually contribute them into.

00:34:38: its so apparent of the negative impact that you have if things go wrong, for us it's more comfortable.

00:34:44: You know again... It is a mature profitable company and our employees are just employees so they could say back as I was none my concern but its very easy to feel the impacts every passing month especially given seasonality.

00:35:01: this was really heartbreaking to push.

00:35:07: We were very surprised, because usually things go much more smoothly and you have timelines for a reason.

00:35:13: And it's adhere to.

00:35:13: but we are so caught off guard by this loophole turned out since we're over invested sort of emotionally into the project working.

00:35:25: It was really... I know how much time spent in regulatory team at that time of like strategizing.

00:35:32: How can make us possible?

00:35:33: What means getting through?

00:35:38: We made it.

00:35:40: And then you treated your first patient, so this was how many years into your development journey when the first patients... In clinical trials?

00:35:48: Yeah I think that's about two thousand twenty-three.

00:35:58: Yeah, time flies.

00:35:59: But in a clinical trial we couldn't see those people and they were numbers.

00:36:04: So, like we always wanted to see the results and in skin disease also you have a lot this before after so but it was pretty exciting.

00:36:12: Also You built this thing Yeah And do think everything works?

00:36:15: But still It's like now someone will be radiated And if we've screwed up They might burn their skin.

00:36:27: We did everything.

00:36:28: there is no...we thought of everything Exciting.

00:36:36: No more good bird!

00:36:39: Yes, let's do it of course and the results were really amazing like an improvement in quality life and patient satisfaction even though we couldn't talk to those people due to the pseudonymic thing.

00:36:56: It was a mix... Of course it helps.

00:37:00: And on other side I thought that now is real.

00:37:05: And that gave us also the push then, you know with the MDR to have patients for that and to convince health insurance in the middle of our recession.

00:37:14: We now have nine public health insurances who are covering it and we had the next deals on pipeline.

00:37:19: Nine Public Health Insurances within first year market!

00:37:24: We've got forty dermatologists signed under contract.

00:37:28: as a patient I need to wait half-a-year just get an appointment.

00:37:32: And yes, we want more of course.

00:37:34: Everything.

00:37:35: and why do you want more?

00:37:36: Because it brings more impact to the people.

00:37:38: but It was this initial... We worked so hard for that moment!

00:37:44: It's like we need to celebrate it more.

00:37:48: GCP Service is good at celebrating services because we need learn

00:37:50: from them.

00:37:51: This will be learned through twenty years.

00:37:53: every listener that the

00:37:54: innovative team loves to be a GCP service somewhere in Christmas parties.

00:38:00: But yeah, there's also a good quality of an institution too.

00:38:04: You know you work so hard for goals and then also say okay we are ambitious but maybe this evening or the day?

00:38:10: Yeah let's appreciate that we finally made it!

00:38:15: This is... And I know from myself they're things he worked really hard for.. ..and then happened and week after ...you realize Actually, it happened and I never even paused for a moment because... ...I knew like long ago as this was approaching that.. ..this is what's going to be just stepping stone.

00:38:36: For the thing that comes after anything that comes up then things that come after being mindful also of those positive moments Is indeed something that i think takes time To get into your head.

00:38:50: I totally agree.

00:38:51: And this is really important also for mental health, especially everyone who has a lot of enthusiasm and it's really ambitious because for me was often like we achieved it... ...and then i felt like yes!

00:39:02: Of course We achieved

00:39:03: It!!

00:39:03: I always knew you would achieve it but.. ..I thought You would achieve For earlier.

00:39:07: so finally just done that.

00:39:08: now we do the next thing.

00:39:09: So.. ..and forced myself to be Like Yes He Always Knew That You Would Achieve But I appreciate all The work.

00:39:21: Now you deserve to do something.

00:39:24: You reward yourself in any sense.

00:39:28: We also privately talk a lot about these kind of things and I think this is kind of mental health mindset topics on really, really important And really powerful even if you think as an Even if you just want to think about productivity right?

00:39:41: Then there's the smart Exactly to celebrate our successes.

00:39:45: Yeah, yeah have a return on invest for doing things that you like in between has a reward exactly for your

00:39:52: hard work.

00:39:52: Exactly, yeah and I know it's really easy to just you know brush over and say i'll do it!

00:39:57: I catch up and there will be a moment when but...I think we both know that that moment rarely happens unless you really put a focus on it and say no..i will allow myself to pause....and I would not feel bad for doing that and then move on now very nice.

00:40:14: so maybe from from your product development journey and moving into the clinical trial.

00:40:21: Now, that's of course essential to collect data but behind it is a question what type of data do I need?

00:40:30: And there are various different requirements in source information.

00:40:34: Of course you have some regulatory requirements.

00:40:37: at end-of-the-day turn out You got your C certificate without needing formal data But also use the data for health insurances investigators, or doctors that you want to convince of your product.

00:40:52: So how did you sort of like frame the question starting and moving into the clinical trial?

00:40:58: Of what type off-and level of information do we need To collect?

00:41:04: And in hindsight Would you say there were any things that You might have missed now That you are using and leveraging their data that you could've collected at the time?

00:41:18: I think it has two stages.

00:41:20: The first thing is when initiating, you need to know why?

00:41:25: Why do we even do that?

00:41:27: This was obvious for us.

00:41:29: We

00:41:30: saw a very high likelihood That we will need data on clinical safety because we take professional therapy and bring them into the home environment.

00:41:39: There were some kind of cases in which Home Therapy was already there but from our perspective It wasn't safe.

00:41:46: put a professional therapy lamp to patients home and let them do whatever they want.

00:41:51: What about kids in the household who could activate their lamp, what am I overdosed etc?

00:41:55: So that was the anchor point.

00:41:58: but doing things with trial is also lot of effort.

00:42:03: so if you did anyways think off what are the easy wins of data you can also get then use for other purposes.

00:42:15: later we realized how valuable they are.

00:42:18: So that was the first stage, it was intentionally doing something but also retro-perspectively seeing oh there's another data point and since we had a software product We also have a lot of Data that need what needed to be there for the product to function.

00:42:33: one The two things were realized is really valuable.

00:42:38: One thing was We retracted adherence and it was about patients if they do their treatment or not.

00:42:47: And then we stumbled across one thing which wasn't a main endpoint, but at what hour of the day did they actually do that?

00:42:56: We had it!

00:42:57: Every therapy session has database entry... Then we analyzed this and realized that ninety-two percent of sessions were done outside typical clinic.

00:43:07: opening hours prove to show that we can reach different target groups because the majority of our type group cannot go into a dematology center during working hours.

00:43:22: It sounds so logical, but with that data... We were much more convincing than for the certification side.

00:43:31: it took time and went through very smooth.

00:43:33: So the safety data was fundamental but also on other levels.

00:43:38: That's what we realized with customers, especially without insurances and for instance statistical data on the improvement of life quality.

00:43:47: For me it was always so logical like Of course improves live-quality.

00:43:52: Just think about that.

00:43:53: there is a patient Imagine single mom who has full time job.

00:43:59: How should that person go twenty five times?

00:44:03: to a dermatology center four times a week during the opening hours.

00:44:06: Of course, this improves life quality but we realize it makes huge difference.

00:44:12: that we can just say eighty-two percent of patients who receive Skinnovita have an improved live quality and this is clinically backed.

00:44:21: It made a huge difference!

00:44:25: And I also had a bias because i had pain... It's not so easy to relate with that.

00:44:34: And also, if you're in a big institution and need make significant decisions especially at times where there is recession the health care system has cost problem.

00:44:47: it needs be really convincing right?

00:44:49: Having high quality data... ...and trust of all these institutions.

00:44:54: they take time but when there is a German clinical trial or like Europe this is representative.

00:45:02: That is powerful.

00:45:04: When we internationalize, maybe we will also see that the fact that we did things here and people know how difficult it is... I think this can lead to an advantage in the future because there's a proof-like quality sign like a quality label.

00:45:22: And when approaching the clinical trial what regulators ask for?

00:45:28: more and more.

00:45:32: Now, we're basically wearing two hats there.

00:45:36: At one point you have a product and want data that really supports the marketing or market readiness of this Ginovita device.

00:45:47: On the other hand You also understand as a patient from the perspective of our day-to-day application... ...you can only ask so much for patience where we want home treatment, so we cannot ask for this or that's frequency and you need to give some leniency.

00:46:07: So was there ever a point when you felt like you were pushing the boundaries of how much should be asked from patients who are joining in trial?

00:46:16: And donating their time... ...and data on your cause?

00:46:22: Was it more challenging for them because they had positive impact on the treatment?

00:46:30: is something that was so easy for you to grasp yourself, it made it easier to say no the benefit's clearly there.

00:46:36: And a donation of data even if its additional assessments we do in our clinical trial Is well worth.

00:46:43: I know this because i would also want donate more.

00:46:48: Yeah... I think being founder and patient or health tech have care provider or just being a founder and at the same time, person who has experienced problem is big advantage.

00:47:05: So also like.

00:47:07: I think therefore we've been really consistent on patient side to max out there what they need And i think lot of startups fall in love with their product but be honest how I perceived it.

00:47:23: many others as patients.

00:47:24: you want live your life.

00:47:26: How many people are passionate about brushing their teeth?

00:47:30: We still do it for health, you know But you want to be empowered to live your life and be healthier.

00:47:35: So therefore we had a very consistent line of Giving people freedom in the daily life not overdoing It but rather being on point what two people need.

00:47:43: and with the clinical trial I think we've been also quite mindful About that because when needed data, but when we compared it like In the the clinical trials patients could already do at home.

00:47:55: So there was like maybe filling out some paper sheets, versus twenty-five times driving to a clinic back and forth.

00:48:03: And then we could comfortably say if they're someone who would rather do the other that it will never be our target group because than they don't have problem with driving at the clinic.

00:48:16: This is okay!

00:48:18: It's great for patients who live next to clinics can feel most comfortable here.

00:48:22: There still one thing about being patient and founder It's always very important to see that you're not so much thinking, That YOU have the most representative opinion or position.

00:48:38: And this is something I think in life happens a lot.

00:48:40: Oh!

00:48:40: i think it like THAT and therefore for everyone who has this problem.

00:48:45: Therefore was really important talk with other patients and to get feedback there.

00:48:51: I think this is a bias in the risk that you have as patient.

00:48:54: wonder, That make it so much than about your personal perception of the problem... ...that might not be representative to others

00:49:02: Right!

00:49:02: It's powerful perspective.

00:49:04: if i didn't thing about

00:49:06: Yeah.. You need to critical yourself on that one And

00:49:09: that can be tricky because its also....I mean This what you live and breathe every day, and that's not because you're a patient but also it is your entire life.

00:49:19: You are startup founder so obviously its your whole life.

00:49:22: So I think it easy to get sucked up thinking no one has spent more time thinking about this problem But still in the head than from perspective.

00:49:38: Would you sort of Thinking back About where now Not only having had clinical try patients, but also patients outside.

00:49:51: And maybe as an anecdote if I recall correctly you hand delivered the first device to the patient once you got your CE certificate.

00:49:59: do i remember that correctly?

00:50:00: All of our devices were hand-delivered...I don't know.

00:50:02: it was the very first because someone else hand-dilivered them But I really wanted so and all the first devices are hand-Delivered.

00:50:11: We started in our hometown Bremen with the AOKA.

00:50:19: it was a privilege to do that.

00:50:21: And you know, I was really nervous.

00:50:25: the other person didn't know.

00:50:26: so forever they're like oh now my therapy device arrived and he's been like oh!

00:50:31: So many years.

00:50:33: i ringed that bell and I don't know who opens the door and she didn't know who I was for her, maybe it's the logistics guy that just brings a package.

00:50:43: So one of us is like hey my name is Jan, i'm from Skenevita here with a therapy device.

00:50:48: She was so happy!

00:50:49: She invited me to be for tea And this happened a lot.

00:50:52: we got invited for so many teas and coffee.

00:50:54: people were so...and they loved hear everything.

00:50:57: They appreciated it alot then brought nice reviews.

00:51:00: This was such rewarding experience.

00:51:07: It turns it from like an idea into reality.

00:51:10: You mentioned that in the Kineca trial, if at weird and very much resonates to me I mean for years i have analyzed data as a statistician.

00:51:18: so you see just you know subjectly, subjectly... That's it!

00:51:21: You don't really see the person behind it.

00:51:23: The first time I got called by the daughter of a patient who wanted to participate in the kineca trials we were managing as a sponsor.

00:51:31: That made it so personal that there's a person on the other side.

00:51:34: And of course, I took all the time they needed to discuss options what was possible and wasn't possible.

00:51:39: So i can resonate.

00:51:40: but for you Suddenly rather than seeing numbers on the screen in an database You see your patient at another site?

00:51:46: Then you see smile.

00:51:47: when someone receives something which will improve its.

00:51:51: Yeah It loads it emotionally also like we have really high satisfaction rate But sometimes things don't go perfect.

00:52:00: I really gotta solve this.

00:52:02: We need to be better in that, but it's such a strong why and it sets us as a strong

00:52:07: reminder.".

00:52:08: And i think i should tend deliver some more devices now again because... I love it!

00:52:13: It is also part of the journey.

00:52:14: Some things are connected with hard work But there were parts from the founder experience.

00:52:18: At least once you have to sleep at office Do an all-nighter screw up, bitch.

00:52:27: At least once you have to do something really embarrassed.

00:52:30: it's all part of the journey and I think some things might be discomforting but this is what you choose

00:52:39: right.

00:52:40: yeah maybe i would even feel like a bit of imposter if things were too easy.

00:52:44: Like This Is Like Right.

00:52:45: Yeah!

00:52:45: This is probably the whole experience All ups all downs.

00:52:49: The Whole Thing

00:52:51: Did It?

00:52:52: become real for you when you handed it the first time over and was that a point where you said, okay now this is success?

00:53:00: And maybe let me preface that.

00:53:05: Do you feel already that this is a success?

00:53:08: because I know sometimes can be really hard to connect with?

00:53:16: so do you feel like success or wasn't this part made easier for you to grasp?

00:53:27: So that moment was really, really fundamental.

00:53:31: It's very important for me because it was a milestone and kind of success to be there.

00:53:41: but always the minimum expectation is at least one person with all these things in their song.

00:53:49: That was great!

00:53:50: Do I think this is a success?

00:53:56: This is a really good question.

00:53:57: It comes, I think it's close to this kind of celebrating achievements etc... ...I would rather say we will be a success and i'm one hundred percent convinced of that but.. ..i see homework probably- I'll always see it so its bit risky But we're starting fresh in the market.

00:54:16: We are not profitable yet So we cannot self sustain And I think this another minimum requirement Of company being successful.

00:54:24: Yes there are many startups working not profitable for twenty years, but for us this is our ambition.

00:54:30: And then I thought about this also a lot with the patients.

00:54:34: now see all the patient numbers and we want more because it's more impact.

00:54:38: But when?

00:54:41: so we're profitable?

00:54:42: When are there enough patients or enough insurances or enough happy reviews that it isn't enough?

00:54:49: So no No That its success Because you can always do more in this.

00:54:54: our ambition at least until we have served everyone.

00:54:59: Until this problem doesn't exist anymore, then that definitely would be a success.

00:55:03: but in between I think when the company... The next thing will be if it's break-even and from all of public funding and investment they came into In terms what do you make of revenue?

00:55:18: That also reached neutral point.

00:55:23: We received public funding.

00:55:26: Often I see people criticizing taxation and other things, but my ambition is also to repay in terms of taxes as a company.

00:55:34: Minimum everything that we have received rather more to appreciate the public dedication we got And give the public opportunity To found other projects.

00:55:47: Then i would say... I think then were there.

00:55:52: But probably than will invent more thing This and this, but then it's a success.

00:56:00: So very likely to happen And we can recall this conversation by that time.

00:56:05: I think like maybe you were can't recall Like year or two back when we had this conversation That this was gonna be your goal post and you moved it again.

00:56:14: But i really appreciate just the thought on character behind The consideration.

00:56:19: hey We got A chance Was given To us in the minimum?

00:56:22: Yeah, I know you are very active also in the scene and your supportive of new startups.

00:56:32: You're doing a lot to pay it forward beyond anything that can be measured in financial transactions.

00:56:39: so...I know without a doubt.

00:56:42: anyway leaving a mark this should from an external point-of-view not be your measure of success but i can understand how you got into Seeing sort of the point off getting a CE certificate and then beyond, where did you see for yourself as developing medical device?

00:57:08: For the European market.

00:57:09: Where do you see the biggest challenge?

00:57:10: running up to the CE certificate?

00:57:12: And how has that changed since?

00:57:14: because I'm sure it's almost incomparable before or after in terms Of focus of regulatory compliance and structure.

00:57:24: How would you say those two?

00:57:24: and were there hurtless before an

00:57:26: after?

00:57:27: Yeah, it's like a light switch.

00:57:28: It's so different because before you cannot do anything.

00:57:31: this is the one thing You need for so many other activities.

00:57:35: So um That was so fundamental.

00:57:38: and if that fails?

00:57:40: That's it Like same with the clinical trial.

00:57:43: If your early stage start on I Don't really have a second shot back.

00:57:49: i don't know if we could have had a second.

00:57:50: maybe Maybe i don' t know but there's.

00:57:54: It's so fundamental.

00:57:55: So this is really crucial.

00:57:57: and then the moment we got it suddenly now many things a limiting factor, that We get so many requests And I have so many opportunities.

00:58:10: But our person times limited.

00:58:12: they will need to scale their company but at the same time it takes time for training etc.. Now its rather weird becoming more of limitation.

00:58:20: Well before it was hard cut.

00:58:22: So now we're really free to do things.

00:58:26: And of course the regulatory journey is never over and you need a good quality management system, something that needs to be lived.

00:58:33: You always have training in place The risk analysis.

00:58:37: We do software every update needs to evaluated.

00:58:40: Then after supervision audits kind of find something, we have no non-conformities.

00:58:55: Of course there are some recommendations where they say like oh you can do better here and this time I recommend this but also cool!

00:59:03: And now as every device manufacturer should always take it serious But on the quality management side okay We know how it works.

00:59:13: Now let's rather see when we scale our organization that we don't compromise in quality can be shifted and the main focus on other fields.

00:59:25: And that is the main difference until we want to enter in another market, so I haven't talked about FDA always saying that probably again like you don't have the FDA mark?

00:59:36: Don't think about entering the US

00:59:39: exactly.

00:59:39: yeah That's gonna be its own challenge for sure.

00:59:42: So do you think there is a secret ingredient for you too having passed so well with the quality audits?

00:59:49: or Do you feel It is risk-appropriate that since it's, you know at the end of day.

00:59:55: Its a class to A device or there was only so much risks So they should only put like this scrutiny Is aligned with the risk classification?

01:00:05: Or do you feel like you simply Put yourself on exceedingly solid footings worth your quality and issuance?

01:00:13: I've made lots in Quality management and also MDR etc.

01:00:18: lot has just common sense But common sense it will work, then not understand.

01:00:24: Then reading to this like oh now we need do all these things just for documentation and then It's a circle you end up with ah well in the end is just common sense.

01:00:34: So um This was really interesting.

01:00:37: so that as point What were?

01:00:41: other edge of question?

01:00:43: For me whether I feel it scales with risk class or if there are certain regards to what you're doing because of your risk class or if this is simply an after like the complexity of your device which puts it in a lower-risk glass already means that, let's say more common sense.

01:01:03: To develop a quality management system that's compliant whereas when you have really high risk devices Of course we need to put a lot effort into them Which also makes things easier to find something that isn't aligned.

01:01:15: I think that's rather a question for you, because i have experience with an MDR to A product.

01:01:21: I know a lot of software startups who came with class one then realized they need class two-a and class one basically gave themselves the approval And then they struggled alot Because we're not complying anything but were already on market.

01:01:43: Then installing in Running process is really, really hard.

01:01:47: But I do not have experience in the very high-risk classes.

01:01:52: This is pretty interesting... ...I mean it gets stricter when you think of cooling management but at the end the importance of clinical data's even higher.

01:02:05: and then comes down to risk benefit evaluation which where we see this so common sense.

01:02:12: What is benefit, what's the risk?

01:02:14: Would a person with you know common sense say that benefits outweighs risks given data.

01:02:21: So I think this principle is true for every risk class.

01:02:24: but what do you think?

01:02:26: No i mean in general.

01:02:27: it' s true probably if we have ten year implantable device maybe has an energy source.

01:02:35: its also quite apparent.

01:02:36: he will have lot more boxes to take.

01:02:39: in terms of your risk management profile.

01:02:42: And even then, you're quality management like the effort put into the Quality Management System should be risk proportionate.

01:02:50: so if you already find a good avenue to say technically we have lamb which is not ours So it's just an energy source there.

01:02:56: and this how we technically control it.

01:02:59: The rest as software reduces.

01:03:01: Your software wouldn't be class-to-A because there are lamb purchase at two A. And so, I think innately what you're producing has a very low-risk footprint.

01:03:12: So i would also be surprised if there was a lot of scrutiny given it's disproportionate to how much impact that can have on

01:03:20: the patient.

01:03:21: In our case this just made sense from the very beginning because the risk is already like strict interpretation.

01:03:32: we go into with that risk class.

01:03:35: But for other things, especially if you go into drug development

01:03:38: etc.,

01:03:39: You don't really know the outcome.

01:03:45: I have big respect to all these stage one and two.

01:03:49: That's a real science!

01:03:51: Big respect for that.

01:03:53: And there it is far more difficult evaluation.

01:03:56: We work with therapy which already existed.

01:04:00: This isn´t easy.

01:04:02: Be respectful of the pros in here.

01:04:07: Our secret sauce was to not be fully by ourselves, but to learn from people who are doing it.

01:04:15: And then maybe talk with another person.

01:04:17: and do you also see like that?

01:04:18: Ah yeah okay!

01:04:20: And then drafting together... That's our secret choice To learn from others and have them kind of in the same journey.

01:04:30: Well congratulations on passing it so well.

01:04:34: So one thing is that you have been addressing is health insurances, how you've now partnered with nine of them.

01:04:45: But also I think and this was fun recently because we had those discussions at the moment in Germany And i think all the comment was well We have ninety two ninety three health insurance's in germany.

01:04:55: Maybe we should go back to ten.

01:04:57: it like what?

01:04:57: You realize when your at ninety why didn't you comment on This one?

01:05:00: you were at fifty.

01:05:02: Why do even need ten?

01:05:03: whats That number?

01:05:04: so for you this very practical implications because it means these are all individual discussions, or largely individually discussions I guess that you have to lead from a reimbursement point of view.

01:05:15: So i guess a lot of the post market journey for you resolved revolved around finding footing with health insurance companies.

01:05:26: how did?

01:05:28: Because also, I'm assuming you had no prior contact points.

01:05:31: You have no prior experience and didn't broker health insurance deals for ten years.

01:05:35: So how did you start approaching it?

01:05:36: And what do you feel in hindsight now is the key to starting that journey For other medical device companies out there That say hey this challenge will come up after you hit your CE mark.

01:05:48: Yeah, this is a good point.

01:05:50: And oh we didn't have.

01:05:51: like my co-founder Janina I used did an internship in insurance at least little bit and we had great connections to the chairs for public health and Thanks to that We got some contact or two local health insurances.

01:06:04: That was something but in a point where it wasn't about the scholarships after we had certification years F past What?

01:06:12: Let's some things that work first of all didn't work enough.

01:06:15: course defected.

01:06:16: there are ninety two.

01:06:18: Are we at ninety two?

01:06:18: It changes.

01:06:19: Now there are a lot of mergers, ninety something public health insurances doesn't make it easier Well is also not like everything or nothing situation.

01:06:30: At least ten would make it a lot A lot easier Especially because they have different market shares.

01:06:37: and if you ever doctor who wants to prescribe you third ninety options You have one hard for the doctor to have a high probability.

01:06:49: that is that specific assurance, if it's not one of the larger ones.

01:06:54: What did not work and there was frustrating?

01:06:56: Was like just writing email saying hey we've got great solution!

01:06:59: Take time let us send you through contact that didn't know us... It was so frustrating but still some insurances who never took the time to talk with or look at them.

01:07:17: But it's so good.

01:07:20: Let me talk to you why.

01:07:21: its' good, but there are also other things that work really well and generally in the state where we had literally no contacts I think going on pitch events was really good.

01:07:35: when they're awesome means You have to go on stage or will be also measured across other startups.

01:07:40: but There are pitch events.

01:07:41: were those innovation managers Are In The Jury Or In The Audience That Really Worked and then finding people who can do intros to the right people at the health insurances.

01:07:50: So these matchmakers, this was also really important for our mentorship but also for their investment journey that we saw.

01:08:02: maybe we could get business angels on board who know people in the health insurance world.

01:08:08: what they're doing is not so much it's just like hey have you considered taking half an hour to listen.

01:08:18: That's everything, two lines of text or so.

01:08:21: but then have the opportunity to talk with people and they might still decide not make sense for them.

01:08:29: that makes sense by everyone But I had the opportunity get in.

01:08:34: So people who do intros really important And pitching on stage Not being afraid going on stage talking about your idea

01:08:44: Well, you have definitely a lot of experience with that and a lot exposure to it.

01:08:49: There were I think Definitely more than one hundred pictures on the stage minimum More but But he becomes normal.

01:09:00: So what's installed for the future of skin-to-veeter?

01:09:03: then now?

01:09:03: That you have your C mark first health insurance is are in there.

01:09:07: Of course You know those about eighty still left, or maybe you're aiming for like mid-fifties and then say okay it's good enough now.

01:09:17: Never good

01:09:17: enough!

01:09:20: True true but sort of.

01:09:22: what is next?

01:09:24: I said that earlier.

01:09:25: so we have one specific problem for patients And even though there is some optimization in the software, you always update it.

01:09:36: You'll see how to improve and track your KPIs as good.

01:09:40: but generally majority of the problem solution fit is there.

01:09:44: Now at next stage we have the patient population.

01:09:49: We get requests from patients with all different kinds of severities.

01:09:51: So right now we also need a treatment that will be justified.

01:09:55: I'm happy for large range of treatments But what we will do next is to expand on this stage, so that we offer a suitable solution through the whole patient pathway from educating yourself how can you adapt your lifestyle and live a healthy life.

01:10:12: That would have positive impact in disease too getting quick prescription for topical cream that need without waiting four months but maybe could get within day by telemedicine.

01:10:22: Then if the cream doesn't work for the therapy, we already have that.

01:10:25: If you are in a really severe case and need injection You find all your documentation And assistance and guidance In there.

01:10:33: The digital ecosystem We've already developed.

01:10:36: There's so many other ideas That could do I don't know, B to C. Hey you want bath salts because bath salt is really good for getting rid of your plaques or maybe some supplements.

01:10:50: but so many ideas.

01:10:51: we need to structure it and i think on the medical side.

01:10:54: that's where we see... Because we have this certification now right?

01:10:57: This also kind of our competitive advantage That we now say We do not go in a broad thing with the right solution For every dermatologist Every disease nail fungus or the pimple is not our focus.

01:11:13: But for those diseases, we want to be very best and then just only in Germany but also

01:11:18: across borders.

01:11:20: Yeah that comes with new requirements New journeys into different regulatory spheres which again I'm sure The team has now sort of like settled in a German ecosphere will be happy Maybe to a certain extent that again, there's the journey to jump into.

01:11:37: but I mean they've managed this very well so far.

01:11:39: So it'll be great awesome.

01:11:42: and do you see That in Germany now since use sort of like opened for A lot of intensive purposes The let us say home care market in Germany especially For photo therapy?

01:11:54: i mean thats where he really pushed open the door.

01:11:58: At the same time, currently we have a lot of discussions around how can we restructure our health care system here in Germany?

01:12:03: How can we reduce costs?

01:12:05: a lot which means that a lot things are sort on the chopping block or going to be reconsidered.

01:12:17: the future of German healthcare, let's say not at large but maybe in terms of dematology.

01:12:25: You see that there is going to be significant shifts based on those discussions we have over the years.

01:12:29: it mostly gonna move around you.

01:12:32: Yeah There will big shift and they're already happening right now The situation are really bad And fundamental problems get worse.

01:12:41: One thing is demographics also.

01:12:45: a lot of dermatologists, more than thirty percent are about to retire within the next five years.

01:12:50: So that the density of specialists is reducing and at the same time we have this cost problem.

01:12:57: so um... And often this leads to higher costs.

01:13:01: if there's no access to certain treatment then The expensive drug is the only solution and it's you know the fast pathway where could go And this is a general topic, I think for the whole German healthcare system and most health care systems in the West.

01:13:19: How can you solve it?

01:13:20: Technology's main opportunity.

01:13:24: we have to see that you bring more effectiveness.

01:13:28: where all of AI tools are so important for early detection prevention will be increasingly Let's talk, for instance in mental health.

01:13:42: For instance if there is a waiting time four months before therapist... If you give someone at least something an app they can work with it doesn't replace the therapist but atleast have some thing like.

01:13:52: these kind of solutions are good and this also what we see.

01:13:56: And then when step further physical treatments There're also-if theres'an opportunity to do from home and save capacities which can be used for other really needed purposes that make sense.

01:14:11: I think the insurance company talked a lot about digital before ambulance, before stationary.

01:14:16: so they kind of set up certain structure where digital would be first thing.

01:14:23: then you will maybe go to doctor preferably via telemedicine.

01:14:27: and very last point is going to clinic or do something that requires lots resources necessary in time when resource are the main constraint.

01:14:38: You briefly touched upon the topic of artificial intelligence.

01:14:42: now you sort off and I really appreciated that consideration also from yourself.

01:14:46: If you didn't fall into this, a couple last years it would have been easy for your to say but we are an AI first company like many others have especially in startup sphere because This was associated with higher company valuations maybe more interest from investors.

01:15:04: What do you see in terms of your own development as well, especially since you mentioned that from the initial product and problem that we are solving?

01:15:12: if want to branch out.

01:15:13: And become more an ecosystem now it might make sense to sort-of reconsider exactly how will position yourself?

01:15:22: How much use software artificial intelligence or enhance that journey provide information I don't know, do image analysis and saying like this is the type of skin disease.

01:15:34: And you can use this or that treatment?

01:15:36: This how we would recommend it.

01:15:38: are there any considerations yet have in terms of how he will develop in their direction?

01:15:43: Yeah That's pretty interesting.

01:15:45: AI as one of biggest opportunities We have especially health care Especially when talk about big data and business massive.

01:15:53: really good Still, I think you should never lose the problem focus and that the center.

01:16:00: It's like a few decades ago.

01:16:02: we're an internet company in Internet-first Company Like it's at all And That's also how i see it is powerful massive tool that can bring effectiveness In so many productive in So many levels of every organization?

01:16:18: And then also on the medical side to improve.

01:16:21: And of course, for us image analysis and therapy projections will be a major role.

01:16:27: Also different kinds of analysis how treatment can be adapted or probability if the side effect will occur in three sessions after treatment plan has not changed.

01:16:41: Or giving patients like visual clue How probably their skin will look over the course of two weeks because in the first weeks usually you don't have a lot of therapy effect and then it really hits, so there's a lot things that can be done.

01:16:55: And this is wonderful.

01:16:56: we do it within the problem that we solve... The main problem with phototherapy is driving twenty-five times four times per week to a clinic needing to do it from home And that we achieve mostly with telemedicine and AI is the thing they can leverage to make it even better.

01:17:20: But, uh... The problem's always the main thing in movies-the center not technology solving a problem.

01:17:28: I love that because i think its very easy for you fall into an opportunity trap where Well, AI is a solution to everything.

01:17:38: So let's just slap it on everything.

01:17:40: but as long you are and its very clear and apparent from our conversation also You're so focused on ensuring that don't lose track of your problem.

01:17:51: That will make it easy for you see the opportunities of leveraging or not feel remorse over not leveraging because simply doesn't address core problems.

01:18:03: So maybe a couple of closing questions.

01:18:14: First one would be if you got the opportunity to act and act any policy, which policy would you like?

01:18:24: political in nature or for the way that our healthcare system is shaped?

01:18:29: Which one would you enact?

01:18:32: I guess in this case address your core problem.

01:18:36: or for you, yourself and other companies to have an EDA path.

01:18:39: Which one would you?

01:18:41: I think generally our society under the MATEC community a mandatory policy that between submission of for instance MDR application when notified body starts reading it We have a certain deadline.

01:19:02: and just that will not be the solution because if you don't have enough notified bodies, then it's impossible.

01:19:10: But this is the main problem.

01:19:12: It doesn't provide any value to anyone between submission And point in time when someone starts reading like its literally Just there nothing happens.

01:19:23: That needs to be shortened.

01:19:24: I think This Is so important Because it will boost innovation without Any harm of Anyone.

01:19:30: It should be a priority to speed that up.

01:19:32: And if the submission is bad and product is bad, it's okay.

01:19:35: but look at when this submitters start-ups die during waiting time... That doesn't make sense!

01:19:41: The one thing I would drive forward.

01:19:47: apart from that there are so many things but this dominates everything.

01:19:51: Okay i can feel then also key pain point wasted year, so to speak.

01:19:59: where like we are ready.

01:20:01: Let's have a conversation let's move things forward and you idle for four or twelve months yeah?

01:20:07: And you were early with reaching out to NodifyBuddy.

01:20:11: it is one of the thing that... We always say when we're engaging start-ups waiting time for your Nodified Buddy will be the rate limiting factor in vast majority cases.

01:20:22: So don't wait until Get in early, have those conversations early.

01:20:27: Involve them early get contracts ready with them.

01:20:30: don't wait with selecting a notified body until you're ready because it's just going to take a lot of time for them to respond.

01:20:37: and You were early And still there was a lot Of work-time and I know how hard you pushed and how persistent you had To be at the end of the day to try an and get things to work again.

01:20:45: We called

01:20:46: every day we vote as unless with three people in The end Was before Christmas?

01:20:51: Because they It was exactly one year ago, and we knew if Christmas happens that they would also disappear.

01:21:00: And they promised... They did promise but they announced us that which were already gone in the end.

01:21:08: We're so annoying!

01:21:10: That is what's needed.

01:21:12: because right?

01:21:15: I mean.. Like it's difficult music has you have to be something.

01:21:19: You don't like doing but It was pivotal for you as a company and was pivotal four for the success And for your survival frankly speaking.

01:21:27: so yeah, uh-huh?

01:21:28: We have to do what we have to go through or make that company survive.

01:21:33: Yeah give me one thing That gives you hope.

01:21:39: This is a very the enthusiasm of people I see around Me.

01:21:44: there are So many People who have so much enthusiasm seeing that While in the news you see wars and crisis, whatever.

01:21:57: But it's... The real thing I see.

01:22:00: that gives me a lot of hope.

01:22:01: There are so many people who want to create great things!

01:22:04: I love that answer!

01:22:05: I truly love that answers.

01:22:08: Anything else?

01:22:09: You wanna touch upon what we haven't touched on before we wrap up?

01:22:13: I would say thankyou.

01:22:15: This was really fun.

01:22:16: It is also our first episode.

01:22:19: So as guest this is a really fun podcast.

01:22:25: And yeah, thank you for the close partnership we have since so many years.

01:22:30: Thank you for friendship also and I'm looking forward to what comes in

01:22:37: future!