Beyond Snapshot Diagnostics: The Future of Continuous Health Monitoring
Shownotes
In this episode, we discuss:
– Why today’s healthcare system still relies too heavily on “snapshot diagnostics” – How smart patches could enable continuous monitoring of biochemical signals – The difference between sweat, interstitial fluid, and capillary blood as data sources – Biomarkers such as sodium, potassium, lactate, troponin, and hormones – Why continuous real-world data could change prevention and personalized medicine – The challenge of translating sensor research into practical, wearable products – pheal’s platform approach to smart patches and reusable electronics – Wellness products vs. certified medical devices – Why startups often enter the wellness market before medical certification – Regulatory hurdles under MDR and the need for smarter innovation pathways – Germany’s funding gap between research and product development – Why early collaboration with patients matters – The risk of overpromising in digital health and biohacking – Accessibility, responsibility, and avoiding a future where only the wealthy benefit from preventive technologies – Agnes’ experience as a female founder in a tech-driven healthcare space – Why visibility matters, even for introverted founders
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00:00:00: if we are honest, in the future healthcare system will not take care of us.
00:00:04: We need to take care ourselves a little and consumer health is part of that.
00:00:11: there's so much discussion always about monitoring tools for health.
00:00:15: I'm not clinically validated And i am sure this would be huge problem.
00:00:21: If they help people maybe start being healthier.
00:00:29: Welcome everyone to our second episode here at the Beyond Outcomes podcast and today with me I have Agnes Musial-Agnès.
00:00:38: I've known you for several years, whenever we bump into each other it's quite a pleasure so i really enjoy the opportunity to sit down with about feel, what it's like to be a founder in an industry where you have overcome a lot of different challenges.
00:01:00: Talk about those today as well and get your insights out for the viewers there!
00:01:08: Yeah thank you very much.
00:01:09: I'm happy to share everything that you want to know.
00:01:12: Lovely so why don't we start with you first?
00:01:15: For people who do not know you this might be less because you are so active on social media and conferences, at least everyone in the industry or a large proportion of industries should know your already.
00:01:28: But for everybody else out there what they need to understand where we're at right now is pushing our healthcare forward?
00:01:44: What do I have to say about Agnes as a person?
00:01:47: about Agnes as a person, they need to know that I actually never thought of being founder.
00:01:55: my journey when I was young at school, um...I remember very well that i got very interested in research.
00:02:02: So we had biology classes human biology and I was so obsessed with all that stuff getting to know more about the body and the molecular biology.
00:02:12: really what's happening inside our body?
00:02:14: What makes diseases work?
00:02:16: how do we stay
00:02:16: healthy?".
00:02:17: And I thought wow!
00:02:18: That is more about the body and I do not want to learn only from books, but i want to be the one that actually does research on it.
00:02:29: And then got pretty excited in school being a big researcher or professor at university for health care when i read University.
00:02:39: It was falling into reality like okay this is not all what we were expecting... and its all about papers publishing and wrong stuff.
00:02:49: so.. at all what I imagined.
00:02:52: And so, i did my PhD but left pretty quickly and went into clinical research because i thought okay that will be the field where can do actually that and to all the innovations and push them in the market and do great stuff for their health?
00:03:10: To be honest it was a second time when i fell onto also was different.
00:03:18: During my time I saw a lot that our healthcare system is going downwards, everyone knows about it and at the same time we have a lot of innovators in great ideas but no one really gives them a hand and pushes.
00:03:41: When I was very frustrated with all that, i met my co-founder and thought like okay if don't like what's happening out there... ...I have to change it on my own.
00:03:51: And this is how I got to be a founder!
00:03:55: That really found me passion.
00:03:57: I would never think of being the founder one day.. ..and do all those innovations because they always start thinking about people doing things.
00:04:06: How are these great ideas?
00:04:09: Where do they get the energy from to actually do that?
00:04:13: Now I'm doing it on my own, so its really crazy.
00:04:16: So where DO YOU GET THE ENERGY FROM?
00:04:19: Understanding that you always questioned whether this was for you or if didn't occur to you... What made you push through that resistance thing like oh my god!
00:04:29: It's gonna be so difficult for me have ideas execute them pushing all of their energies Or did just feel no This is right.
00:04:37: The problem is big enough for me.
00:04:39: Actually didn't really think about it.
00:04:41: I mean, It was a lot that as i said i Was very frustrated also in clinical research at That point because its so A lot About bureaucracy So alot of just Documenting stuff and Sticking to the regulations which is Very important but you don't Really have time for This stuff that is important, which is the patience in the end.
00:05:04: We want to improve health care and That's when the opportunity came.
00:05:10: I met my co-founder, actually.
00:05:14: He...I offered him my help back then because i always knew that for founders it is really hard to tackle the whole clinical research part and regulations part And he said you can't do this with me.
00:05:32: I didn't think about it a second.
00:05:35: I didn' t think of any challenges or thinking that i have secure job, good job and just stop doing something very risky.
00:05:47: That wasn´t the problem for me at all because I thought this is absolutely something to do now And jumped into it.
00:05:56: It's courageous but sometimes you... Well, not probably even sometimes.
00:06:01: It feels like that's what you have to do because if you think about all the things That could go wrong You will never start and it is great that you found The courage To just say like nah Screwed I would jump head first.
00:06:14: And here we are!
00:06:17: You're a founder.
00:06:19: You've inspired.
00:06:22: I'm sure you have inspired many people already through your journey and just moving forward.
00:06:28: I am happy to connect all of these points today as well, but let me jump in once before because he mentioned that your interest has started at school And i was wondering whether it was... You feel from YOUR point?
00:06:42: That YOU had THAT interest or WAS IT also driven by a teacher that you had that was particularly good in evoking an interest in that field?
00:06:52: Finally, not at all by the teacher because a teacher was Really?
00:06:57: Not a good teacher none of them biology teachers sorry for that but they weren't all not interested in Giving you this park to be interested in the field.
00:07:07: So it was actually.
00:07:10: It was actually more me Because I was simply interested in human biology part and maybe also so from my father's side of the family.
00:07:19: there are some people that had jobs in the medical field and my father always said he's also wanted to do this, but is an engineer.
00:07:33: So here maybe some things come together now?
00:07:36: But yeah so it was simply my interest... It wasn't nothing too cool unfortunately because I think if we have the spark for especially things like biology or chemistry already in school, that would help a lot.
00:07:52: That also more women move to the field.
00:07:56: Absolutely!
00:07:58: Sad to hear you didn't have good teacher because I think they can always have a very nice influence.
00:08:02: but it's great to here and we had passion to still push through it so fast forwarding.
00:08:08: now where are today?
00:08:10: Can you give us of a rundown, let's say the inception.
00:08:18: How did you meet your co-founder?
00:08:20: What was the initial idea or problem that proposed to you and said I have to jump in head first take it on make my own.
00:08:31: how does this come
00:08:32: about?
00:08:33: So I come from Osnabrück and there we have the Osnambrück Healthcare Accelerator.
00:08:39: It's an accelerator for startups in a healthcare field, when it started at Osnimbrück was pretty interested of course because i always wanted to help start-ups really make it into health care.
00:08:54: so got into contact very early.
00:08:57: my co-founder actually wasn't second batch this head cake accelerator with the idea of you and I went to an event where there was a pitching contest, he pitched the idea.
00:09:11: And while it's really such great ideas could move so much in healthcare.
00:09:18: that is when we said how can i help?
00:09:24: And it's really, like we always say by chance.
00:09:28: But maybe in the end was destiny because he brings all that technical knowledge and everything around development of device itself about technology I bring to everything else from medical side regulation side together for this journey.
00:09:47: its a great team.
00:09:51: Sometimes you need to be lucky.
00:09:54: Well, I mean both of you sought out an opportunity for this to happen.
00:09:59: You know because you need To be brave and pitch well anywhere?
00:10:02: You have to be as a startup.
00:10:03: That's that what it's all about.
00:10:05: And at the same time you look For an opportunity to help and you went to an event where there was A possibility for it happens.
00:10:13: It's lovely when There are local events which are organized around The startup scene.
00:10:18: I guess is hard enough, so it's great if there is a supporting network that makes the first steps easier because we need that innovation.
00:10:26: So talking about fear can you give us and especially also to the audience a rundown of what exactly your device is intended to do?
00:10:36: And what sort of like... ...the journey you've been on with it?
00:10:40: Like What was the inception idea?
00:10:45: Yeah,
00:10:47: so the main idea is our health care today based on snapshots we always say.
00:10:53: So it's snapshot diagnostics.
00:10:55: There are always like a picture of yourself when you go to the doctor.
00:10:58: So there is for example lab values that this just moment Of your self.
00:11:04: but thats actually absurd because biology Is dynamic.
00:11:09: So there is always happening something in our body, so only to have these snapshots all over health care system which are very often also not even connected just crazy.
00:11:20: And my co-founder saw the opportunity that he was developing sensors actually in a beginning and another field, an automotive.
00:11:28: He said okay, an automotive makes sense but how much sense would it make if we use sensors on the body?
00:11:33: That really like when you get into a car... You have big dashboard which shows everything about the car.
00:11:39: so why don't we have them for ourselves?
00:11:46: do only snapshots diagnosed, like if we don't feel well for example because then it's already too late.
00:11:52: But to have technology that supports us and directly detects something is going wrong in your body from happening.
00:11:59: even so main driver of the whole story.
00:12:05: And so we developed these devices that from the principle many know, from the CGM continues glucose monitors.
00:12:14: they continuously monitor the glucose levels which is great but doesn't really help healthy persons even if there are a lot people claiming that I would be very cautious with What we do is to use more than one parameter, many parameters combined in one device.
00:12:35: To do different monitoring opportunities.
00:12:37: for example if someone's already chronically ill there was other persons that have the most need so they get a supporter who tracks their parameters all of the time.
00:12:50: supporter that says, oh now you need to be cautious and talk to a doctor for example because something is starting to be wrong in your body.
00:12:58: And that device can not only tell you that but also directly get in touch with your doctor say here are the values let's start something.
00:13:06: it doesn't get worse.
00:13:09: so how does this work on technical level?
00:13:14: too detailed, because it might be too complex.
00:13:17: But at the end of the day in a car I think intuitively you can understand that we are talking about like sure you have sensors everywhere but its an electric signal gets transferred and moves into dashboard...but You cant really put five different sensors like tire pressure sensor..you cant put them to your arm or maybe you don't.
00:13:37: so what's?
00:13:38: What's the level of information your device can access?
00:13:42: And how do you translate this into something that... ...your device actually pick up and then make useful for the person who is wearing a badge.
00:13:51: I always say we translate molecular language in our bodies, so we measure.
00:13:56: parameters like sodium or potassium are also a troponin which is very important for people that are prone to heart attack or something, lactate levels.
00:14:10: So really molecular language of the body.
00:14:12: we do this either in the sweat so being non-invasive um or in the interstitial fluid.
00:14:19: that's what also the continuous glucose monitors do even in the capillary blood.
00:14:24: And yeah, there we have different kind of biochemical sensors really.
00:14:29: So sensing systems that have a biological component on top catcher systems for example that catch the specific molecules from the blood and then we can translate it into a concentration.
00:14:43: Of course we already know concentrations are healthy.
00:14:47: We also know the concentrations which aren't healthy.
00:14:50: What we actually don't know today and what our device helps with is how do these parameters really develop over time?
00:14:58: So, what are their dynamics?
00:15:00: so that's something completely new.
00:15:02: That information we don't have right now in our healthcare system And we're very sure it will open up many different possibilities of knowledge to us.
00:15:12: where you can see things maybe at the moment cannot even imagine because we already see it from the CGM, that you can translate a lot of things just simply for this glucose levels.
00:15:22: So what can you translate if you see other parameters as well all the time?
00:15:28: And did you come to let's say conclusion?
00:15:33: these are key parameters which should be measured based on established technology and ease-of measurement or... Because he said those were key parameters where let's say a scientific link between changes over time and certain health statuses coming.
00:15:48: So was the medicine there or technology, first piece?
00:15:53: Yeah that is an interesting question.
00:15:55: I have to say it depends on our system.
00:15:59: we call ourselves architects of smart patches because we've built like house.
00:16:05: that is always the same for these technologies.
00:16:08: The inside, it's always different and there are sensors.
00:16:11: so the heart of this sensor can be exchanged depending on what you want to monitor.
00:16:18: For example, chronically ill patients with heart failure need certain parameters like there.
00:16:23: it is important to have potassium because It's very important for the heart and the probian piece Like a marker or heart failure.
00:16:30: we have lactate There so these are very specific for this use case.
00:16:35: But then you can have for example early detection of sepsis in hospital.
00:16:39: Then lactate is also very important parameter.
00:16:43: Or You just have look at your metabolism.
00:16:46: Of course, very different parameters are there.
00:16:49: And so we don't have specific parameters that we say everyone needs right now but it's really specific for every individual what their need is just right now and the parameters of course.
00:17:07: a lot of research already What, of course is very much in the focus right now are hormones and especially female hormone monitoring.
00:17:20: Of course, hormones I would say everyone wants to measure because they're so dynamic And Right Now we don't have a possibility To measure them continuously into really see how do They develop?
00:17:32: How it's my personal level So might be different between one another what Is normal and actually something that We need to act on.
00:17:43: So in the end, I have to be honest that we have to learn from all of our data first before making real insights possible for everyone.
00:17:53: Yeah it's going to be challenging because at the end of day this is a very long-term shot.
00:17:59: also you need to measure and then say well having measured all these now there are events but if no event occurs like what differentiates person who has an event?
00:18:11: versus a person that does not have an event.
00:18:13: I mean, at the end of day where you create foundation for future lessons being learned or preventive measures are being had so it do you see with that in mind your device as something that lays a foundation a certain level of research, medical research to be done on it or already as preventive device.
00:18:40: Or is this just the future evolution that your devices would undergo?
00:18:45: It's both.
00:18:46: so I think research will have a lot interest in and should have lots of interests because Actually, the first time that we can have this real-world data... ...that everyone is talking about nowadays.
00:18:59: About real world data collection and there's no possibility to collect them really!
00:19:03: And I think it will have a huge impact on what we know about the body.. ..and also change our health care in that way.
00:19:11: so at the moment everybody has handled like everyone else.
00:19:16: So there are no individualities And with our device, it will be possible that you have a personalized level about everything.
00:19:24: Then we'll really see what is the real difference between females and males.
00:19:27: because of course big thing yeah?
00:19:30: We will also see the difference between people!
00:19:34: You won't only get for example... how you handle your health, how do sports.
00:19:46: You will not get just very general advice but your advise would be personal and directly fit to yourself.
00:19:55: that will change a lot I think.
00:20:00: So it seems for me... And i'd love to get your perspective because its stuck between a desire to use your data, to advance the science and also at the same time developing product.
00:20:16: How do you balance those two?
00:20:18: Yeah that's
00:20:19: just
00:20:19: hard!
00:20:20: Especially because as a founder you also need, of course investors for example.
00:20:24: You cannot catch an investor with that... ...you want to do something good to the world.
00:20:30: we have to be honest.
00:20:31: it just simply doesn't work.
00:20:32: so We also have had to generate money and But we still try to do this With cases where really support people.
00:20:43: And its not about making money Because For example we can easily go To the biohacker scene all the parameters that we have right now to track, but it doesn't make sense.
00:20:54: So... But you could have a lot of money from there!
00:20:58: Yeah?
00:20:58: We start with cases where We can help the people.
00:21:02: For example, we have a combination of sensors that you use for hydration and that is something important to health so as not to excess at the moment really but also helps people with money in an early stage of their company which will help them grow.
00:21:25: So if... At your position where are you now?
00:21:32: What is the influx of data that you get?
00:21:36: Because at the end of day, I mean i'm sure and are using your product or device.
00:21:44: Other friends and family together like some information and whoever's willing to and there plenty of them.
00:21:49: but At The End Of The Day how do you And Do You Get Like A Stream Of Information To Form The Basis Of Well Assessing what Your device where it's currently at and also to lay the data foundation for further research.
00:22:08: What is your approach?
00:22:10: Yeah, that's what we're doing right now.
00:22:12: so We do some corporations with university clinics For example.
00:22:18: Also too start some studies especially in sweat monitoring because sweat monitoring something That this really starting to appear right now Because until now, we didn't really have a possibility once again to measure things from sweats.
00:22:30: We had the possibility do lab testing with bloods then you don't use the sweat.
00:22:35: why should you?
00:22:35: You sweat when you can do blood test.
00:22:38: but now I need to continuous measurements.
00:22:39: of course it's a lot easier for just put something on the body and don't have our go inside.
00:22:44: And there is also a lot of health information that we can access.
00:22:48: There and, of course university clinics are interested to learn from.
00:22:53: that's good thing for us because they're eager work with us do some testing on their patients.
00:22:59: often this isn't invasive.
00:23:02: now going into regulation We have the opportunity say okay it just something you add hospital stays, because it's not invasive.
00:23:15: It doesn't do them any harm and its a lot easier than anything that starts with needles or going inside the body.
00:23:21: so thats where we get some information then we do alot of self testing to be honest.
00:23:27: So put things on ourselves.
00:23:30: Test our sensors directly in the lab.
00:23:32: We don´t only test continuously but also do some validation studies at university clinics Where they do sampling for patients And there's always blood remaining, and that can be tested with our sensors to see how accurate are they?
00:23:47: How well do they fit the lab testing.
00:23:51: So we take everything that we can put them together.
00:23:54: To be honest of course AI is helping us now a lot to do analysis on that because I think before AI it was harder for startup.
00:24:04: have people who work in all the analyses.
00:24:10: That's good.
00:24:12: Yeah, I mean it's great that you have those collaborations.
00:24:16: Did You start?
00:24:19: Well i'm sure you Have to Start Somewhere in the Lab In Assessing Let's Say Reference Ranges.
00:24:25: Is It Even Measuring Accordingly?
00:24:27: And Then You Basically Move That To let's say Real-Life Sampling From Maybe Leftover Samples.
00:24:35: and then In Patience did You See Any Difference There?
00:24:38: Also Because Your patch sort of creates a micro-environment at the end of day, do you feel like that has an influence in the way that you sample on the sample itself?
00:24:49: Is this something that you need to recalibrate your device too.
00:24:53: Let's say if you're sweating and have a patch here or if you draw interstitial fluid does it change the composition of the interstital fluid?
00:25:06: Was this a harder transition for you, moving from the lab to real world?
00:25:11: It's always hard transition.
00:25:13: But in the end it is not shocking because of course when your develop you have think about the real-world use and then know that its hard to sample sweat as people sweat very differently.
00:25:29: so to have a method that induces the sweat, but if you induce the sweat it's level of the parameter then still right.
00:25:37: And this is definitely not something when we get into real-world testing where there are some things from beginning and develop whole device.
00:25:46: so theres alot technology inside for sweat microfluidics and everything.
00:25:54: The challenge doesn't come with patients in terms of the technology, because you see a lot of issues that you were expecting and maybe need to change a little bit.
00:26:08: But bigger challenges are often when we think about how the patient uses this device but then they use it very differently.
00:26:16: so mostly something like that makes them harder afterwards!
00:26:21: Since we talked so much about the device, you have a sample device with you.
00:26:26: Could We Have A Look At It and You Run This Down A Little Bit And Also How To Use it?
00:26:30: Yeah!
00:26:31: Maybe I can just click here in the camera because I'm wearing one.
00:26:35: that's always the best.
00:26:36: Now i am taking out the microphone but Here You Can See That Is The Current Model And I have some other device with me, because we are more focused on research and everything here.
00:26:49: Because also doing something very different... So i already said that were working in a platform system.
00:26:58: In the heart of it, there is always sensors and if you exchange a sensor.
00:27:02: You can have very different product but everything else stays the same.
00:27:07: And problem with sensors.
00:27:08: at this moment we have so many sensors in research that work well But where are our products?
00:27:15: So I want to ask what's happening?
00:27:16: A lot is the problem that optimizing for wearing on your body takes time.
00:27:21: We're taking them away.
00:27:23: What also take a long time is getting the sensor running.
00:27:28: So a lot of sensors work, but only for a few hours because then maybe the sensor is saturated.
00:27:35: There's no we call it refreshing system where the catcher system that catches the analyte also releases again.
00:27:41: so these are challenges that We worked on a lot But then takes a lot time to reach market.
00:27:50: And we have a platform system here, so generally in our device.
00:27:53: We have reusable electronics because of course.
00:27:56: We also need to have less waste In Our medical systems.
00:28:00: So the reusable which is demonstrated Here that's the electronics can be recharged and reused?
00:28:06: This is this our research System as A system where you Can Also measure either in The sweat interstitial fluid or in capillary blood Which Is put on the body and the sensors are Actually integrated On the card.
00:28:20: It's like an SD card that you can take out when the sensors are saturated.
00:28:24: it is still on the body and Can take a new one, put in.
00:28:28: And thats how we bridge this problem.
00:28:30: That the sensors have to be optimized but they still do clinical studies.
00:28:37: That is why we also want to have this really CE mark, the real system that you can do it as a research system.
00:28:43: That brings these technology quicker to the body because problem with sensors is... You don't know if he has chosen right parameters for things like disease or monitor might be completely wrong once but how will find out?
00:28:56: You need measure them on your own and then use this device which takes away some of the risk from developing devices that you simply chose the wrong parameters.
00:29:09: Then it looks like this one is a little bulky, we always say but because its for research use and other ones look different also have another version for sweat monitoring here.
00:29:24: That also shows the electronics that is reusable.
00:29:29: And then we have a magnetic system, which puts it into the patch and looks like this in a product.
00:29:34: so you see... It's not that bulky but very flexible!
00:29:40: It feels good because of course it's important to feel good on your body as no one will wear it if they are too bulky or don't feel well.
00:29:49: Okay, and basically from a content perspective these two are similar.
00:29:53: So where is the SD card piece of this?
00:29:58: Where do you exchange the sensors?
00:30:00: Is it all integrated into the magnetic cap?
00:30:03: Yeah!
00:30:03: It's just in this disposable part.
00:30:05: so for sweat monitoring here we see another thing that we do with sensors in a sticker form.
00:30:15: That goes very deep into the problems of development and so on, but that sensor is actually a part you can take off an on which it's great for prototyping everything.
00:30:27: But here the sensors are directly.
00:30:29: here It isn't much difficult about microfluidics because its easy to do testing device And this part everything is integrated.
00:30:43: That's
00:30:44: very nice.
00:30:45: It is great to hear that you designed it in a way that acknowledges both, let us say product limitations but also then integrates the solution anyway which is feasible actually from patient perspective as well because it looks easy enough.
00:31:03: if I can do this at home Then becomes useful If need go doctor or have something exchanged than loses its purpose
00:31:11: Absolutely.
00:31:17: Yeah, it's very important to think about these things from the beginning because also another thing that we talk a lot is design-to-costs.
00:31:26: Because there are lots of research institutes with fancy great things which can never be translated into real world as they're simply too expensive.
00:31:35: so... It's very important to think about these things from the beginning.
00:31:40: We can do great things and very accurate monitoring everything, but you never use it because its simply too expensive.
00:31:49: I think this touches on a very interesting topic The balance that you have to strike also between speed of innovation, but then the need to really have reliable and robust information at end-of-the day.
00:32:03: You know...you have to weigh both against one another And already highlighted how many branches of development you tackle yourself.
00:32:11: How do approach their topic?
00:32:14: Where having developed so many different products or product types How did you decide in terms of where do you need to collect evidence first, and push it
00:32:25: forward?
00:32:27: That's a really difficult question.
00:32:31: Yeah, you do it on the go a lot.
00:32:34: And I have to be honest that is also sometimes changing quickly according how the developments are in the market internationally if there was money available or not.
00:32:46: so as startup everyone knows we have to adjust quickly always and yeah things can change alot.
00:32:54: but what i learned?
00:32:58: You get a lot of feedback from investors or users, which is very important.
00:33:07: to your own aim and be true yourself, what is your opinion?
00:33:12: And what you want to do?
00:33:14: because the best founders in the biggest companies that we know.
00:33:18: We know the stories that there was always someone at the beginning telling them You will never make it Because That's simply either something no one wants or too difficult Something every founder I think more motivated by.
00:33:34: if someone tells you that's difficult to do then say, yeah.
00:33:36: I will show you this.
00:33:37: it's possible.
00:33:39: and so the most important part is always There are a lot of hurdles If it's about money or technology Or whatever.
00:33:47: but we shouldn't think about their hurdles.
00:33:49: We should think about the chances That's It gives us an how we can tackle them And not be focused too much on what is NOT possible.
00:33:58: because Daniel never make
00:34:01: I mean you're venturing into a sort of unexplored or not fully unexplore.
00:34:07: You know, your highlighted already continuous glucose monitoring before but in the width of biomarkers that we want to collect and level off insights from them.
00:34:20: What's the market pressure there for you?
00:34:22: Because at the end of day, that is one thing where you catalyze a lot startups when it says we need to find our niche and plant our foot.
00:34:29: But if its an open space how are other companies developing products in this space?
00:34:38: sometimes sway your offer certain paths because they say ok well we're more advanced than these spaces so we should focus
00:34:45: on them.
00:34:47: good thing, because I always say there are no competitors in this field.
00:34:52: Because we all working on a field that is just appearing.
00:34:57: it's very new and from everything that i told you right now...I think you can imagine..that the field is so big!
00:35:03: That they can be a lot of people working on it And The important part Is that We finally bring It to the market.
00:35:10: That´s the goal for everyone And we Can have rather help each other or stand Ineach others way.
00:35:16: If we stand in each other's way, then... Everyone will need a lot more time to reach the market.
00:35:23: If we help each other, We'll be quicker and there is enough space for everyone on this market And There are big players of course Interested in that field I wouldn't say Working so much On it themselves also working on It but not with That much energy.
00:35:40: people sometimes imagine Because they're so big players You want to compete With Abbott?
00:35:47: but because I don't think Abbott is doing the same that we are doing, so it's not competition.
00:35:52: It's good if they're doing something there also several startups and a little bit all over the world i would say That working on continuous monitoring solutions.
00:36:06: But none of the companies do exactly the same.
00:36:11: enough space for everyone, and I'm actually happy if someone reaches the market before us because you need to build a market.
00:36:18: And that will be hard enough too.
00:36:20: also convince people.
00:36:21: technology can be so great but still People need to be convinced use it.
00:36:28: Yeah So there is competition But that's absolutely nothing i am afraid of Because Enough Space For Everyone.
00:36:36: At The end Of The Day What You and what We all need is to translate the data that you're gathering into actions and into health outcomes.
00:36:48: And if you have more players exploring that space, it means that advancements in understanding what these biomarkers even mean will benefit you also because it means their knowledge gained from your device leads to better, more actionable outcome for patients that use it?
00:37:06: Yeah I hope so!
00:37:08: kind of a problem that I see, because there's so valuable data generated here.
00:37:16: And companies know this and would benefit in my view humanity a lot.
00:37:21: but these data will be kept by certain companies.
00:37:25: imagine if they just put all the data together to learn from it.
00:37:28: That'd be great.
00:37:29: But we know...that'll rather difficult.
00:37:32: unfortunately
00:37:34: Too many commercial interests compete with them In the development of different types of devices that you have here, what was or the general development journey?
00:37:46: What from your perspective is the most difficult and complex piece.
00:37:49: Or it's really hard to say because always changes from week-to-week?
00:37:54: It has been very hard for me to say every part in itself is complex but of course the developments somehow are complex.
00:38:03: For example, if you just look at the sensors what comes together is biology chemistry physics electronics.
00:38:11: The data algorithms.
00:38:14: so many people need to actually sit together and talk about the issues that we have in development because only one person cannot find out What.
00:38:22: this?
00:38:22: What does the problem?
00:38:23: it's always said We are sitting together in a group of something doesn't work And That Is complex.
00:38:30: But I don't see It as A Problem.
00:38:32: Still, it's a huge hurdle is financing things like that because we still have very big value of death where you'll have lot research funding.
00:38:43: So much money going into this basic research and then when its starts to be product there was no finding at all.
00:38:51: the way to final products are so long funding, especially in Europe.
00:39:01: Especially in Germany it is very hard because the risk is too high and risky things on Germany are
00:39:10: a
00:39:12: very hot topic.
00:39:13: so I think for me still that's the finding simply stopping us from moving quicker.
00:39:21: So we decided long time ago we would be quicker with the funding, but it takes so much time away from us and actually also nerves away maybe.
00:39:39: That reset okay?
00:39:40: We will not that quick.
00:39:42: if you do it on our own or bigger technology partners... ...we'll go step by step But in the end its a strategy feels lot better.
00:39:53: So when you talk especially about the risk and along development cycles You touched upon it earlier in your clinical research days.
00:40:01: one of the elements that you really disliked or struggled with Of course, I think we all can acknowledge.
00:40:08: The importance.
00:40:10: But regulations really make our life sometimes a little bit difficult to know Europe.
00:40:14: We had a lot of changes on the last five six years.
00:40:18: How did you perceive the regulatory landscape now?
00:40:21: from a founder perspective compared to your clinical research experience before?
00:40:28: Were there big differences or other things that annoy you more now, what's the perception and is this at the end of the day if we look at the picture.
00:40:41: The important piece still patient health should be ensured in trials outside The right.
00:40:49: is a balance at the moment?
00:40:52: I don't
00:40:52: think so.
00:40:54: Sometimes it's also, again... ...a german problem i think.
00:40:58: German angst because we talk about patient safety but we are taking away the patient safety by stopping all this innovation from moving forward.
00:41:10: That what no one thinks of It's too short-sighted often in the regulations also when you talk to BFARM and so on.
00:41:20: But we need patients who keep their patience safe, but not because they are stopping this very important technology from moving forward.
00:41:30: That is a little bit what changed my view And I always struggle with that To talk to patients and work with patients as early on as possible.
00:41:44: And regulations are now currently kind of stopping that because you always need the whole documentation, everything ready to really go into trials?
00:41:53: That is difficult.
00:41:54: so there should be a possibility if we can show that everything at least safe for the patient... ...that we can work with clinics to start some testing going deeper in research Even for me, coming from research sometimes so complicated to really find a smart way.
00:42:12: how do this.
00:42:14: That is too difficult and I think there should also be more... ...coming from the regulation side offering hand-to those technologies because everyone we all want to keep our health system running And we shouldn't have so much look on that.
00:42:35: keep all the regulations in line, but maybe be smart.
00:42:38: and how can we do this?
00:42:40: that benefits both sides.
00:42:43: And you stuck with Germany?
00:42:46: We are very happy about it.
00:42:47: I think its great for our startup community or ecosystem development is generally good.
00:42:57: Was there at any point a consideration of saying Maybe we should take this somewhere else because environments are easier from a regulatory and funding perspective.
00:43:07: Why you're still here?
00:43:08: Yeah, absolutely there was... A lot of times when we went to the US in San Francisco or Silicon Valley.
00:43:21: You definitely don't want come back!
00:43:24: Because it's so different and a similar feeling when we went to Qatar, actually.
00:43:31: Which is not the country I would go just because of other things.
00:43:37: but from their mindset they were so crazy!
00:43:40: They think so quickly that are so innovative And also look at positive science... They see problems absolutely.
00:43:50: They show them to you directly, but they also offer a perspective how we can work to circumvent that.
00:43:59: They are always looking at the aim and in Germany, that's still a big problem.
00:44:03: And we were definitely because of that thinking to go somewhere else.
00:44:08: but also from the beginning We wanted have our business in Germany.
00:44:12: so we want it to make Germany strong again Because In Germany A lot of ideas originate From here.
00:44:18: So we Still Have Our Engineers World Class.
00:44:23: Everyone Says That But they Are Leaving With Their Ideas Because We're Making It So Hard.
00:44:28: But running away is not always the right way.
00:44:32: So sometimes you need to push your country.
00:44:34: that's maybe just the art of thinking changes, and that's what we try to do.
00:44:39: so there could be a lot easier way to do this but We really want to show Germany can do that too.
00:44:47: now You are very public an outspoken person.
00:44:50: you appear on a lot of conferences and about panels.
00:44:54: Did you already feel like?
00:44:55: There was some resonance of the messages that you spread over the difficulty, like are there regulators that feel really willing to discuss and if so what do think is biggest hurdle?
00:45:08: That it seems need be overcome first for actual change in positive let's say expedition off research.
00:45:18: Yes, so absolutely a field change especially in the last half year.
00:45:22: I wouldn't just say Germany but so in Europe at all.
00:45:27: First of all and they health care system that we had a lot off.
00:45:30: talk about it that it needs to change when you tomorrow have more digitalization.
00:45:35: we need to move from this snapshot diagnostics and Now I feel that the talk is really going into action.
00:45:44: When you go to conferences, there was a health tech conference in Basel where we talked about preventive health and all of our speakers didn't talk before on this topic but everything went exactly in the same direction.
00:46:04: The four speakers were so different, So it was a speaker from Roche.
00:46:08: there was something.
00:46:10: someone from the Netherlands who has focus on innovation and what is really possible proves that scientifically.
00:46:19: Really, each and every talk was exactly the same from the story which showed okay people are thinking in the same direction.
00:46:26: And also people start to talk to each other not stand on each others way because every company wants to be first... ...and now it starts more like we have a big problem with healthcare and need to solve that kind of together.
00:46:39: And that's really starting to change, and I think regulators are always also starting to catch up.
00:46:47: Also in the
00:46:49: U.S.,
00:46:49: it works a lot better.
00:46:51: so the FDA is doing good job of having open eyes for everything as well.
00:46:56: seeing consumer healthcare isn't beast or enemy But it's something that we actually need, because if you are honest in the future health care system will not take care of us.
00:47:09: We need to take care off ourselves a little and consumer health is part of that.
00:47:15: there so much discussion always that monitoring tools for health are not clinically validated.
00:47:22: I'm sure this is huge problem.
00:47:25: they help people start being healthier.
00:47:29: If not, everything is very exact.
00:47:32: but just giving a general overview of your health can already be enough if you go to party and drink Very, very bad on the next day.
00:47:43: I mean everyone knows this but when you see it yourself It can have a very different effect.
00:47:49: So um i think we need to be open not always To be that strict about.
00:47:54: everything needs to be so regulated and validated And everything.
00:47:57: But We need things That help people Be healthier and Not only real Tools from healthcare Can do that.
00:48:08: So I think that brings us into sort of like an edge case off medicine, which is the consumer wellness products.
00:48:17: Which are at times really bordering medical devices?
00:48:21: Where do you see the distinction between two and what's your perspective on the regulatory opinion?
00:48:30: because it feels this being sharpened a bit more shadow.
00:48:37: medical devices, I think seen a little bit more critically and pursued more proactively now by regulators.
00:48:45: So how do you see that space from your perspective?
00:48:55: closer together, it's a good thing.
00:48:57: It's not a bad thing.
00:48:58: and once again that lot of people have they fear these devices.
00:49:03: so I've been recently to a conference where someone who does lots research on sleep
00:49:13: i
00:49:14: think felt intimidated by those devices and explained why they are not as good at the sleep lab?
00:49:20: That is obvious!
00:49:21: And he doesn't want to be asleep.
00:49:26: it is a tool that should help people be healthier.
00:49:29: So there's a lot about fear of the old medical devices, they think okay we are pushed out off the market and thats why you need to say its not good enough.
00:49:41: It´s always the fear that is driving us.
00:49:44: do those negative opinions?
00:49:46: Of course still I think also these device overpromise.
00:49:51: We know that especially in the US, there is a thing.
00:49:54: In Germany we are not over-promising but in the
00:49:57: U.S.,
00:49:58: it's a thing of startups to be biggest and newest.
00:50:03: That is problem.
00:50:04: I also don't like that.
00:50:07: for example CEO of Aura was talking everything.
00:50:11: he said absolutely right But made an impression This is a lot bigger than he's telling because you could understand the words two ways.
00:50:21: For example, the aura.
00:50:23: of course it can say there's this symptom detection when you get sick.
00:50:27: I have an aura myself so i know that works.
00:50:30: So it sees if your already ill and tells okay maybe slow down And you will not be sick for long When we are having infection.
00:50:38: That isn't real prevention to be honest.
00:50:41: but they sell as a big preventive thing, yeah?
00:50:45: But that helps the lot still.
00:50:47: What we are doing is of course then detect something in your molecular language very early and stop it from happening.
00:50:54: so this over-promising is hard.
00:50:57: but unfortunately sometimes as startup you need to be over promising otherwise you will not make your way.
00:51:03: And I would really love to change.
00:51:08: It's
00:51:10: it's difficult and I mean, I get that also have a ring.
00:51:13: That tracks all things.
00:51:14: And then it tells me like yeah six out of eight of your vital parameters are fine.
00:51:17: so slow down a little bit.
00:51:20: Okay, you know what?
00:51:21: The first indication this is not a medical device This is just the wellness product.
00:51:26: and drawing a line there in saying that well You know when does it become a recommendation to go to doctor because you know two out of Eight off your vital parent has only one.
00:51:35: this is this is a question needs to be addressed.
00:51:41: We need to have a clear structure here because otherwise you blow the lines and people always pushing for the easiest pathway is not regulated medical device, wellness product but make sort of like give the promises off a medical device, off actionable.
00:51:58: And as a consumer it gets really difficult.
00:52:01: you get an I don't know.
00:52:02: I mean Apple Watch is maybe not the right because they have certified a lot of medical devices but you'll get to watch and get a lot from us.
00:52:11: how do you know that one has a certified medical device?
00:52:14: The other one has an e-certificate which also needs European declaration.
00:52:23: This gets really tricky, really fast.
00:52:26: Yeah that is true.
00:52:27: but also I think the problem was once again financing because as a startup you are actually pushed to enter the wellness market Because when you can they want to see there's some money and push towards doing this.
00:52:43: It's reality we face too.
00:52:45: We would love start with medical device if it takes time But reality isn't able.
00:52:53: All the devices that we see if it's a woop and aura or something they try to really build health infrastructure for people, not healthcare systems.
00:53:05: We have to be honest – It takes time also to learn from this data because how should these companies tell you what does mean?
00:53:14: These are also data.
00:53:16: we need at least half of our time to learn from them, to do the studies.
00:53:20: They are also all doing clinical studies for different parts so we need to let them.
00:53:25: it's not that they don't want too but they also needs time to do this
00:53:33: and I mean its faster.
00:53:35: you're to market.
00:53:36: more innovation can push out better of course.
00:53:38: a company perspective financial perspectives Yeah, and then the question is how reliable are they new features?
00:53:45: Especially if we talk about big brands.
00:53:47: If a big brand that has some certified validated features pushes out in your more experimental feature but this is more on there.
00:53:54: you know wellness space.
00:53:56: They don't make it big declaration as he said promise.
00:53:58: you promised a lot because And that's easy to get.
00:54:01: I mean, it depends if...I only have experience with the Aura ring but there is an aura lapse so when there is a new feature especially in the aura lapse you can use it.
00:54:11: You don't know.
00:54:12: how do we have to do a mark where they say okay i want to be a tester and they tested before They really said now its official.
00:54:21: So yeah, of course it depends.
00:54:24: But I think these companies they are doing a good job still there overpromising that's
00:54:31: Yeah That's an erection and so if you look at it from the patient perspective Do you feel like?
00:54:43: Like I Think their two facades to your position in the positioning or for other let's say has care, wellness let's say medical devices that measure a lot of your biomarkers and make them available to you.
00:54:55: And on one side it sort like empowers you as a person because you learn more about your body also more continuously and That gives you more power over controlling your own life and maybe also more incentives.
00:55:08: On the other site I sometimes It can feel like puts a lot pressure in you Because now technically You Can Measure ten, fifteen, twenty whatever parameters.
00:55:19: You have six parameters probably on your sleep.
00:55:22: how deep was it?
00:55:22: What's the ram?
00:55:23: How often did you wake up or not?
00:55:24: this and that which all could lead to one in one form another To advice on what you could do better Which puts a lot of pressure on you like biohacking and optimization entire biohacking, you know biosensing longevity sphere.
00:55:50: Is it where is the line?
00:55:54: It's a more philosophical question but...
00:55:56: Yeah yeah it's a difficult question.
00:55:59: so what I see also a lot is that people start using for example the ring or whoop whatever and get a little bit too crazy about it starts self-optimizing.
00:56:13: I'm a lot happier, but they have also learned a lot over the time.
00:56:17: Of course you shouldn't forget that maybe they changed some things and of course now what?
00:56:21: They can also be better.
00:56:24: It's difficult.
00:56:24: i think we should not over-optimize.
00:56:26: it is problem.
00:56:27: A lot people try to optimize everything in their life And when you have possibility To see feedback from your health You might over optimise.
00:56:35: But most important thing are still more about Not those parameters and everything but about Having a good life Talking a lot to other people not being lonely.
00:56:50: so we should never forget that Those are actually the most important things.
00:56:54: That's A lot what we forgot when we start over optimize ourselves.
00:56:59: But yeah, it's very individual.
00:57:02: So I myself i love The tool because It slows me down When i tend To Yeah, to overwork myself or when I get sick too also slow down.
00:57:16: So for me it's a help.
00:57:18: It's always the way you treat those tools.
00:57:20: that's like everything in life.
00:57:23: And do you think?
00:57:26: That The tools that we now have and that can lead to potential better optimization and at the end of today Also better health insights.
00:57:33: I mean that that's what we ideally would want but invariably they come with a cost and that could lead to widening of let's say, a gap also in society between those more affluent.
00:57:47: And those who might not have an opportunity to watch a ring or earpiece on our patch... To measure fifty biomarkers for themselves.
00:57:57: They will need healthier lives so we can get more preventive treatment or personalized treatment.
00:58:02: compared someone who cannot have all the support in a society, we might be the same way.
00:58:09: that doesn't let's say publicly cover all of it.
00:58:15: Do you see concerns as this develops?
00:58:20: Is this really positively going to impact everyone or more?
00:58:25: like smaller group people
00:58:27: I really hope at least it will have a positive impact on everyone.
00:58:31: For example, that something we've been thinking about from the beginning because of this platform... We think you'll get an opportunity to develop devices.
00:58:44: if there was no platform would not be possible for patient groups where only very few patients especially for diseases where we still have no data.
00:58:54: We need a lot of data to do some research, so that would be very
00:58:57: helpful.".
00:58:58: So we're also already thinking about having like the second company – that is Gigi Mbihar– where based on the platform development exactly those devices... That's maybe our intention.
00:59:17: at least give it to people who wouldn't get a device like that in any other way when there's only people looking for the money out of such a device.
00:59:26: So I think as a company you always have this responsibility also, That is... When you get money out something Like for example Out Of The Longevity Bubble Then You Have The Opportunity To Also Give Back
00:59:41: Right?
00:59:41: so maybe thats one thing but still it´s always the case if they are.
00:59:47: just look at cars.
00:59:48: They are extremely safe because they have so much technology in it, but there more for the people that has money to use them.
00:59:58: So I think its absolutely same.
01:00:00: That shouldn't stop us of course from developing these things But also as i say with every founder or company should be part that you think about responsibility to give back.
01:00:15: But yeah, you cannot make the people do that.
01:00:18: I always hope.
01:00:19: especially in health care You meet a lot of founders That have good intentions so i always Hope if The company gets big but the intention stays and then they may maybe try To also give back And with that way we can Also help those thats Maybe don't Have their opportunity.
01:00:39: Otherwise
01:00:41: I mean, at the end of day that also strongly depends on who has ownership because during startup phase you need to live.
01:00:53: It's not only for some it is more comfortable than others but there needs money put into development testing research and much.
01:01:02: Where does that money come from?
01:01:04: Well, eventually it's traded against equity and then really depends who is on the board.
01:01:08: So do you see that with your taking an intentionally slower we-do more of a sales route You will also preserve more opportunity to really follow Your North Star And keep it accessible?
01:01:20: Yeah, that's what we hope.
01:01:22: So of course it is also one of the things why we go slower because now we can work on our aim and there is no-one telling you about your need to do this or that.
01:01:36: but yeah... We are also slow but I really want to keep that North Star to help people.
01:01:43: so our aim was helping people stay healthy not only helped the rich.
01:01:50: So that's also why we are not so much jumping absolutely on this longevity field because We heard it a lot.
01:01:57: You should just go to longevity will have all the money and everything which is true.
01:02:01: But I don't want to be a longevity company Um, but i want to Be a company That supports people.
01:02:10: Yeah, I bet It's very nice And it's lovely you push for.
01:02:15: However, unlikely it is as a startup to say we would take all the way on our own but its lovely that you try and push.
01:02:25: So let's maybe jump into future like what does the future hold for you?
01:02:33: or feel?
01:02:33: Like where are currently at in your development stage?
01:02:37: Yeah, so where
01:02:42: we are at is that?
01:02:44: We want to have our first product ready.
01:02:46: At the end of the year it will be a wellness device Of course.
01:02:52: But then also I have to say came a lot from from talks with different kind of doctors That came to us on fairs and we talked all that through And they said do you want to be a medical device?
01:03:05: and he said yes and they said but really You don't need two.
01:03:08: just develop the device, give it to me and I will give it my patients if that works.
01:03:12: So i don't care about this certification.
01:03:15: And yeah That's also why we start in wellness section now To be on the market a lot earlier to gain insights On The Market.
01:03:26: It Will Be A Sweat Monitoring Product.
01:03:29: In Next Stage We Will Work On Getting The Sweat monitoring Certified For Medical Use running from two research projects that go into the medical field for sweat monitoring.
01:03:43: One is really early detection of infections and also sepsis detection in that area where we work together with research institutes, university clinics to see if the FemTech section where we do a home monitoring system for certain indication that is also based on sweat monitoring.
01:04:12: And so, we are already looking at the medical device market because of course this our main aim and can reach more people than... So step by step, I hope in the next three years there might actually already be something almost ready for medical device certification even ready maybe.
01:04:37: The first test things will be done then.
01:04:39: That's a great goal and to put this into perspective with current discussions we have here in Germany.
01:04:47: So there is lots of discussion around healthcare reform, which has been pushed through I think as a lot of backlash to it and obviously especially if you look into moving onto medical device that's one the key elements he will have to tackle how do get reimbursed so patients can actually properly use that?
01:05:14: with discussions as we are currently leading them and the direction our government is taking, there will be space for more preventive healthcare.
01:05:25: Do you see it's a direction in Germany but also in the wider space?
01:05:30: Or do we continue to say let's wait until people get sick because they feel like this is where we're at
01:05:37: now?".
01:05:38: I really hope so!
01:05:42: Cots will explode.
01:05:44: I mean... It's not hard to do the math that if we wait for symptoms and people get sick, then you cannot handle it.
01:05:53: We definitely need this switch urgently.
01:05:56: If I see that in government right now... To be honest i don't but also dont know what real plans are.
01:06:05: You never know which direction they're going with current situation But in the global direction, I see that there is a shift.
01:06:19: That everyone in this area is pushing towards it.
01:06:23: so they must be this change otherwise everything will fail!
01:06:32: It's clear if all charts you look at just say we have more and more health care spending our general populations get older.
01:06:43: Yes, so and that's quite clear.
01:06:46: And I'm with you there.
01:06:48: of course we can spend hundreds billions annually in healthcare spending to treat symptoms which is sometimes the only thing you could do or try to prevent patients from ever developing them.
01:07:04: Yeah We can see it at a cost in Germany.
01:07:06: So we have very expensive health care system but do really healthy people?
01:07:12: I'm not sure about that.
01:07:14: Chronic diseases are spreading fast, so of course we advance in medicine.
01:07:19: a lot of people survive their cancer diagnosis for example but what you don't really think is they're healthy after that often have chronic illness and the treatments for cancer affect your heart.
01:07:33: then people get heart failure strongly rising heart failure numbers.
01:07:39: And these people are very sick and really need support, a lot of support from the healthcare system.
01:07:44: at the moment we're not able to tackle that.
01:07:47: so We really need To start the prevention also have systems That can support The doctors in treating those patients and exactly the systems that we Have because then you have this help for the person itself.
01:08:02: Also direct contact with the doctor get in touch if something goes wrong.
01:08:07: And what always a lot of people don't think about is that then you also focus on the people that need to help because, there are also a lot chronically ill patients who live well and have no problems but at this moment we're focusing all over them with our systems which can be focused by those who really need their
01:08:27: support.
01:08:28: You mentioned individualized treatment already?
01:08:30: That's not only true for us like day-to-day But also, of course once you have a disease that you struggle with and you have symptoms as highlighted they can be quite different from patient to patient.
01:08:44: Figuring out the differences is still... I mean that's the key differentiator.
01:08:50: if you're looking at also especially clinical trials these days there was so complex because we have such an narrow patient population Because We Have More And More Markers To Identify Or Predict try to predict who is really going to benefit from it.
01:09:04: And the more widespread markers are, The better we can leverage them to predict positive outcomes of treatment and they're more tailored rather than just in Germany's case.
01:09:13: So if you spread out all over here... We'll give everything and see what sticks?
01:09:19: Let us see how much speed we get there because one key element that we have touched upon several times today was research.
01:09:28: How do we leverage biomarkers to actually give us proper predictions.
01:09:32: And if we are very early still in the field, is there from your perspective other right research initiatives already ongoing?
01:09:40: To start using more of that data that's now available or it so earlier than you don't have enough and needs to be standardized?
01:09:50: It absolutely depends.
01:09:51: So I definitely see a change right now also when we look at the different funding opportunities that We, of course do a lot of research projects at feel.
01:10:06: And so we see how the research project is also evolving and nowadays it's really focused on actually getting in touch early-on with The Bee Farm for example to have scientific advice.
01:10:19: that everything set up for disease e-certification, because a lot of research projects unfortunately in Germany still will be stuck after that.
01:10:34: Because at the end there is... it's not advanced enough to really go into clinical study and so a lot money goes to waste.
01:10:44: And the change in this research projects also see that their opportunities are seen.
01:10:50: For example, now there was a call really for disruptive medical sensors and That is something that gives me the sign.
01:10:59: okay Germany Now sees Those are very important technologies and we need to tackle them if they explicitly say disruptive because then any incremental innovation will not be accepted in this call.
01:11:17: And so I really hope that there were some signs that show me things starting to advance in a certain region.
01:11:27: Now, you mentioned the scientific advice with the Bayfarm.
01:11:31: Are you yourself also looking for structured dialogue?
01:11:34: So an opportunity for communication with notified bodies who eventually approve of medical device which is I want to say more of a novel idea unfortunately in Europe after MDR.
01:11:48: so this i'm assuming out on the future.
01:11:53: Yeah, absolutely.
01:11:54: So we are of course trying to get in touch also with the authorities as early as possible and it's not that easy because they have other things to do.
01:12:09: but I would actually if someone was open then talk through how you can make this work in Germany.
01:12:20: And as always, it is hard to find the persons that you can even for me come from clinical research.
01:12:27: So they are already certain contact but still hard what I use a lot.
01:12:31: of course i'm still active in German Association for Pharmaceutical Medicine where have my contacts too also authorities and take part in conferences.
01:12:46: so on health working group there.
01:12:53: And this is where I try to find the right people with whom, too get this further on some people from the regulatory world and so on... ...and find smart strategies how we can bring this forward also when looking at the regulatory side.
01:13:12: And if you could do have like a regulatory change in mind that would enact to really benefit the biosensing space.
01:13:27: Would you have one thing which would say this will make the biggest impact for us and therefore also future generations with better access to data, more tailored treatments?
01:13:39: Yeah just opportunity too.
01:13:42: Test together with patients.
01:13:44: I would not say on patient because something we say it like that.
01:13:46: but to gather was patience as early is possible.
01:13:50: First of all, of course get the data to see if the whole thing works But also they get a feedback from the patients That day.
01:13:56: once so working closer with Patience and Not stopping this by bureaucracy By having who will documentation ready?
01:14:05: There's also already for when you need when you have developed the whole product.
01:14:11: But we have, of course shown safety.
01:14:13: that is... That's the most important part.
01:14:16: The thing is safe for use and I mean You see no patient can die if i put this on him.
01:14:21: There are not enough electronics And so why shouldn't it be able?
01:14:25: If we show that its biocompatible then there is No risk For general safety.
01:14:30: Why shouldnt'we start to use it more.
01:14:34: And that is at the moment, I think far too difficult and should be made easier.
01:14:38: so some kind of innovation fast track which has already discussed would be great.
01:14:43: That's
01:14:46: a lovely idea!
01:14:48: It is underestimated how many patients out there are willing but even beyond that be part of research, donate their time and the knowledge that can be gained from running tests with them to furtherment of research.
01:15:09: And I think picking it up giving them an opportunity – everyone has a chance at making things easier while respecting boundaries and ensuring everything is done as they could.
01:15:21: there must be way for us Before we sort of close out the conversation, I would be remiss having you here if i didn't touch upon a point which it sticks with me a lot in your presentation last year's DGFarmade where also pointed towards your role and being female founder especially in tech driven space.
01:15:48: It is something that need to talk about more.
01:15:54: As a startup, founder irrespective of gender you face enough headwind challenges and everything.
01:16:02: But then female found out in the tech driven space quite a lot different.
01:16:07: what if he were to summarize your experience?
01:16:11: What would you say is like how can you know an inspired young female venture into this journey?
01:16:22: What do they need to prepare for?
01:16:23: unfortunately
01:16:26: I have to be honest that i didn't.
01:16:28: Have so many problems like that, um...I think one thing is That I have a male co-founder?
01:16:36: That does a lot yeah.
01:16:38: So if you are only female team it's a lot harder.
01:16:42: I
01:16:43: don't see the struggle so much because at least I think It's The Thing that makes it easier.
01:16:52: Then of course I am a doctor.
01:16:57: That also changes a lot, i know that.
01:17:01: and yeah what-what...I do a lot is..i'm actually more an introverted person.
01:17:08: no one really when they say it always says you're introverted but I AM.
01:17:13: It takes for me doesn't give energy to be on stage But it take's alot of energy.
01:17:24: There is one young girl coming to me saying, you inspired me a lot.
01:17:29: Thank you so much for that!
01:17:30: I will also now try to pursue career in the direction especially when i get on stage and say... ...I'm not the one who loves to be up here.. ..i am more introverted because we need do this and it inspires alot of people happily And yeah.
01:17:50: So always just do it.
01:17:54: Despite all the things that everyone says about female founders, I always try to just focus on a positive also.
01:18:01: And maybe that's why i simply don't see negative comments and everything.
01:18:05: so there were some definitely especially in clinical research when I was very young... ...I already started to be at conferences at tables with harsh comments unnecessary harsh comment.
01:18:19: of course it is always male.
01:18:22: That did those, but maybe I don't care so much.
01:18:26: I simply ignore that and focus more on the positive And then of course it's also a lot easier.
01:18:33: Okay So you can encourage every young inspiring entrepreneur to say yes do embark into in it.
01:18:43: Maybe sometimes we will find headwinds But all-in-all It is manageable with changed enough already or it's moving in the right direction?
01:18:53: Well, yeah.
01:18:54: We've changed enough already.
01:18:55: I think we just saw on the media with The German Congress for Dr.
01:19:00: Erze Kongres that there were five young women saying which problems they encountered and i'm very happy they decided to do this, go on stage and address this because it is still a problem.
01:19:18: So I've also faced this a lot.
01:19:21: so... Also sexism?
01:19:26: Yeah the comments but yeah i think i simply tend to ignore it.
01:19:31: But there's still A whole lot that needs to change.
01:19:35: definitely There's still community where men push other man to come forward and I also hear a lot when there are panels.
01:19:45: Very often, if they're female that does the moderation but the panel is full of male founders or whatever.
01:19:55: And I always say, okay where are the females?
01:19:57: Why didn't you take a female?
01:19:58: and they'll?
01:19:58: we're saying no one wanted to do it too.
01:20:00: I'm pretty sure if you ever looked little bit deeper you would have found someone.
01:20:05: because still very often that's like other women don't want be on stage then push them.
01:20:11: So it is often that they also in the beginning don't want to.
01:20:14: But when they see which effect it has on other women, then maybe would do more.
01:20:19: and I also see for example in German Association for Pharmaceutical Medicine.
01:20:26: a lot of females told me i'd never go one stage here.
01:20:31: because why are you doing this?
01:20:33: Because we have to encourage women.
01:20:39: keep in the background, actually.
01:20:40: But if we always keep on the back ground nothing will change.
01:20:44: and now I see the first ones also taking stage despite having this fear or don't not wanting to be there but they still do it And that's really great.
01:20:53: so We have to push them.
01:20:54: There is still a long way to go because It's simply In The Minds.
01:21:01: I think they are very open.
01:21:09: Sometimes when i talk to them, They say things that Oh at the conference!
01:21:13: That's a very good... I was at the Conference.
01:21:17: That is a story where I was pretty annoyed because there were researchers talking about some research in quantum physics.
01:21:26: that's associated with diamond structures.
01:21:29: And the only thing he had to say about women, how great and shiny his daughter or his woman find their topic.
01:21:36: so they're really disappointed when found out it wasn't real diamonds.
01:21:41: I went to him directly after that because i was really annoyed or angry and he said, He only wanted be nice.
01:21:48: But it's not nice at all if the only thing you have say about women on stage is they find things are great when they're shiny.
01:21:59: So stories like this get me angry.
01:22:03: Back on stage should change And it's lovely that you do.
01:22:08: I mean, i'm always inspired when you are on stage and get to see it... Thank You!
01:22:12: ...and its lovely hearing also getting feedback from other people saying yes this pushes us forward and thats exactly what we need.
01:22:23: We will always need more of that More encouragement Hopefully not only females leading the way, but it's a very effective way of doing so.
01:22:34: And thank you for doing that despite the fact that you don't really enjoy it as much!
01:22:40: I enjoy it now and i think it gets better... ...but it was a long way to be that confident early But yeah.. Now It is a lot nicer Yeah ..I am happy there are more female taking the same route.
01:22:56: So That´s great And thank you for the opportunity to talk about that.
01:23:02: Always.
01:23:03: Agnes, anything else?
01:23:06: That we should talk about but haven't touched yet and do think this is important.
01:23:10: I know there's a big field...
01:23:12: About continuous monitoring fields or about life Lots of life.
01:23:19: One thing I always like to say that in Germany we need more courage, there are so many smart people here and stop ourselves on the track really have the courage to start something.
01:23:40: We only see how Germany is going down, we could be going up... ...we just need to push ourselves a little bit more or be a little but more bold and especially positive.
01:23:50: not the negative thinker nor the Reichsbedenkträger as in German words But it's really be open and positive.
01:23:56: focus on the positive things And then this situation can look a lot different.
01:24:02: That fits perfectly too.
01:24:04: my very last question What gives you hope?
01:24:08: What gives me hope?
01:24:09: I think, yeah.
01:24:12: In the world that we are facing right now what give me hope is... That people still stick together and especially in crisis, people start sticking together again and can also change.
01:24:26: So I've seen a lot of people that were pretty negative... ...that started to focus on the positives and got really optimistic and positive people.. ..that also starts giving the spark for everyone else because when you're this kind of positive person.... You have the spark to do it with another person.
01:24:46: So that gives me hope, people can change and the world is not a bad place to be.
01:24:52: but we all have changed.
01:24:56: Thank you Agnes for being here.
01:24:57: thank-you for sharing your journey telling us more about field And all of bests in future.
01:25:02: I know there's going to be lots of roadblocks
01:25:10: ahead.
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