#142 | Predictive Analytics Saves Lives

ATTENTION:  Below is a machine-generated transcription of the podcast. Yes, here at Rapport International we talk a lot about how machine translation lacks quality. Here you see an example of what a machine can do in your own language. This transcription is provided as a gist and to give time indicators to find a topic of interest. 

 

Wendy: Welcome back listeners to another episode of The Global Marketing Show. We're here at RESI, the conference that Life Science Nation sponsors to introduce investors and med device and life sciences, biotech companies around the world. So just to remind you, we're brought to you by Rapport International and they bring you high quality translation in over 200 languages. 

And today's tidbit is another one about gestures. And that if you do the cheek screw motion in Italy, it's praise and, Ooh, what a pretty girl or handsome guy. Whereas in Germany, it means crazy. 

 So my guest here, I'm guessing he's from Germany. I'm from Germany, that is correct, yes. His name is Thorsten Waloschek, and he's from NeoPrediX. Yes. So Thorsten tell me, what [00:01:00] does that mean?  

Thorsten Waloschek: Well, it's crazy. It's more like there's something, I don't trust you, I don't believe what you're saying, are you kidding me? 

 That's what it actually means.  

Wendy: Okay. 

Thorsten Waloschek: If you go further up with the gesture to your skull, that means you're crazy. But it's quite insulting. This is more like, you know, I'm not sure if I believe what you're saying. Is that maybe a story? The one up there, that really means I think you're crazy. 

Wendy: Well, so tell me about your company and what you're doing.  

Thorsten Waloschek: NeoPrediX is a digital health startup. We are spin-out, spin-off. Actually, not in Germany, but in Switzerland. I'm German, but the company is based in Switzerland. We are a spin-off from the University of Basel in Switzerland founded by two clinicians, a pediatrician and a neonatologist. 

And we are focusing on predictive analytics. We are developing predictive analytics for neonatal and maternal applications. We [00:02:00] can predict the dynamic progression of certain biomarkers in the newborn as well as in the pregnant woman to help clinicians to identify women patients, newborns, or pregnant women today that will be in a critical situation tomorrow, before they show symptoms. 

So, enabling clinicians to be more proactive and avoid complications in the long run.  

Wendy: So, what kind of situations?  

Thorsten Waloschek: For example, our first product that we have on the market is neonatal jaundice bilirubin prediction. Bilirubin is the biomarker for neonatal jaundice. Neonatal jaundice is when the skin turns yellow right after birth. 

We can predict the dynamic progression of this biomarker at the time of initial discharge from the hospital for the next two and a half days. So we can help clinicians to identify those babies at the time of discharge that will need treatment within the next two days and that will come back to the hospital. 

So we can tell clinicians [00:03:00] basically. Well, we don't tell clinicians what to do, but we can highlight to clinicians, well, maybe reconsider sending this patient home because he or she will come back.  

Wendy: So then the baby can stay there and not have the jaundice get the treatment for it. And, wow! And not cause the panic when the parents see it.  

Thorsten Waloschek: Exactly, and I don't know if you have children. 

Wendy: I have two children, yes. 

Thorsten Waloschek: Maybe you remember those times when you got home the first time? The very last thing you want to do is within two days, rush back to the hospital.  

Wendy: Absolutely not.  

Thorsten Waloschek: I mean, that is interrupting parental bonding, that is interrupting lactation. It's important for the baby to develop well. 

And again, bringing it back to the hospital interrupts this whole process. So, maybe it is better and easier for the patient to stay another 24 hours in the hospital, be treated, and be sent home healthy, and good to go.  

Wendy: Oh, that's fantastic. 

Thorsten Waloschek: So [00:04:00] that's what we have on the market in Europe as well as in the United States. 

We have MDR CE certification. We are FDA registered here in the United States. We have first users. We just recently signed up a commercial partner that helps us with the go to market strategy. And we now are developing a new product which is a maternal. Side of things because we believe a healthy start into life, the best thing we can do is to enable a healthy pregnancy, right? 

So that's why we are now focusing a little bit more on maternal health and we are developing a preeclampsia prediction. Oh. Globally more than half a million babies, unborn babies die because of preeclampsia as a consequence of preeclampsia. And about 70,000 women die every year because of preeclampsia. 

Wendy: I had no idea. 

Thorsten Waloschek: So it's not a rare condition. It happens. Just recently, last year, unfortunately, Tori Bowie, who was a gold medalist of the US [00:05:00] summer Olympics team, died because of preeclampsia. So it's happening right here in this country. And so we are developing and we participated in the Mayo Clinic Accelerate program. 

And based on that wonderful collaboration with the Mayo Clinic, we are developing an easy early prediction of preeclampsia that will help OBGYNs to identify pregnant women as early as at the end of the first trimester, after 12 weeks of gestation. Some women don't even know that they're pregnant at that time. 

Right. At that time we can identify women that have a very high risk of developing preeclampsia during the onset of their pregnancy. And again, enabling clinicians, we cannot prevent anything, but we can help clinicians to identify these patients on an individual basis, not statistically, on an individual basis that will run into complications. 

Wendy: That's amazing. [00:06:00] That's fantastic. Let's go back to your first device on the jaundice predictor. So you're a Swiss company.  

Thorsten Waloschek: We are Swiss company with subsidiaries in Germany and in the United States.  

Wendy: Okay. So talk to me about going global. It's The Global Marketing Show. Yeah. So at what point did the company go global? When it started doing clinical trials or after that?  

Thorsten Waloschek: Yeah, the company was founded in 2020. So pretty much four years ago, and we started our US affiliate one year later. So very early on. So in 2021, we already prepared the market launch here in the United States.  

Wendy: And why the US? 

Thorsten Waloschek: Why the US? 

Because it's still the single, unified, biggest medical device market in the world. I mean, my background, I was born and raised in Germany, but I'm a dual citizen. I'm German American. So for me, I feel very comfortable here. It's my [00:07:00] second home. Doing business in the United States is maybe a little less complicated than for Europeans that are not that closely affiliated with the United States. 

Wendy: Okay, so you had an innate familiarity with it. It was easier to come here, which I hear often times with how people pick countries.  

Thorsten Waloschek: My whole life was very international. My father was Polish. I was born in Germany. I studied in the UK and the Netherlands. I lived and worked in Germany and France, Denmark, and in the United States. I spent extended periods of times in Southeast Asia. So for me it's the world. And whether it's American or German or Swedish babies, doesn't matter. It's a baby and we want to make sure, I want to make sure that every baby has the best possible start in their life. 

Wendy: Right. Yeah. It's so interesting. That's why I started The Global Marketing Show is because there are so many people that have lived in one country and they only think [00:08:00] about that country and they're scared of other countries. And so it's always amazing to me that people who have had early experiences being a global citizen or more apt to do global business. 

Thorsten Waloschek: Yeah and I mean I moved to a different country when I was 19. The first time on my own, not like with my parents and then from there on I always went back to Germany. I like Germany a lot. But I always want to experience the world and I cannot imagine just being in one country or culture. 

Wendy: One country. So you automatically think the world. So you start, the first market you enter is the United States and then where do you think about the next?  

Thorsten Waloschek: So actually, we entered the United States, then we went back into Europe, launched in Europe. It was the second step because of regulatory challenges, quite honestly. 

And now we are also looking at the Asian market. So we are connected to Japan quite [00:09:00] strongly, actually. But in the end, it's global. We are not saying, well, we want to be in the United States or we want to be in Japan. We really want to help every newborn baby, every young family, every pregnant woman. 

Sometimes there's financial, commercial situations that make one country a little bit more easy to go to than other countries, especially as a small startup company. But in the end, as any health issue, I think it's a global market and, we always say, because we are so focused on maternal and neonatal, we want to serve and support the most underserved patient population globally. 

And it's always pregnant women and newborn babies. So it's not that here healthcare disparities, maternal health, and sometimes racial discrimination. It happens [00:10:00] everywhere in the world. Pregnant women and newborn babies are always the least taken care of population, no matter where. 

Wendy: That's crazy to me.  

Thorsten Waloschek: For us as a company, it's natural to go global.  

Wendy: Right. Now you mentioned regulatory challenges, and I always like to get into mistakes and challenges, because I think that's where the real learning opportunity is for our listeners. What regulatory issues and challenges did you have, and what did you learn from that? 

Thorsten Waloschek: So challenges is a big word. I mean the idea of predictive analytics is software as a medical device or clinical decision support systems. It's all the same thing. It's so new that regulatory bodies, authorities, don't yet really understand how to handle it. 

Because the whole quality management system [00:11:00] idea, the regulatory environment, whether it's here in the United States, whether it is in Europe or in any other country, comes from hardware. Because for the last 50, 60 years ventilators, anesthesia devices, this, that, it's all hardware. And suddenly, not suddenly, but for the last 10, 15, 20 years, there's more and more software coming. 

And now it's predictive software, which is the next step. And the regulatory systems can't keep up with the development. And that makes it challenging for both sides. For the regulatory body as well as for the industry. Right. So it's much easier to bring a medical device hardware to market. 

And just the terminology. Software as a medical device already tells you there's something we're trying to match something which wasn't meant to be matched.  

Wendy: Oh, okay. So just getting them to understand what it is and how it's using it and how it needs to be authorized. 

Thorsten Waloschek: Exactly. So that's a challenge not only for [00:12:00] our company, but for any company in that field.  

Wendy: And that's globally then.  

Thorsten Waloschek: And that's global. I mean, I've been between Europe and the United States for the last 20 years, going back and forth, up until 5, 6, 7 years ago, everybody said, well, Europe first because the CE certification is a little bit more straightforward than the FDA process. 

That completely flipped around. Now it's a one way street from Europe to the United States because for me, the FDA was never anything that I didn't want to deal with. And again, maybe that's my little bit American background, but I think the FDA is easier to work with as a startup company, especially then regulatory bodies in Europe. 

So that really changed. And you see that because there's a one way street from Europe to the United States.  

Wendy: Okay. And now you mentioned Japan earlier in the conversation. And so what are you [00:13:00] finding with the Japanese regulatory?  

Thorsten Waloschek: It's very well established. It certainly is. Also as a startup, especially as a startup company, it's always difficult to really understand regulatory systems when you're not local or if you have no local presence, right? 

We don't have a Japanese presence, but I personally have a longstanding relationship with companies in Japan, so that will help us to get into that market because we have basically friendly companies that will support us and help us understand. It's always also the culture behind it. 

It's not only the system itself, but it's much easier to work within a regulatory system when you understand the culture behind it.  

Wendy: Oh, do say more on that.  

Thorsten Waloschek: Yeah, so I'm not a legal expert, but the legal system in [00:14:00] Europe, excluding the UK, and the United States is very, very different from a cultural point of view. 

I'm not talking about the individual laws. It's just the cultural approach to legal environments. It's different in the Anglo Saxon world, Canada, United States, UK, etc., and the rest of Europe. And that also plays into the regulatory system. So here in the United States, it's much easier to negotiate. 

Many things are negotiable. In the end, there's a law, and there's a judge, and there's a jury. But many things are negotiable. And that's why you rarely, I'm not aware of any TV show or series or something that is happening in a European courtroom. Because there is no negotiation possible. 

That's the law you  

Wendy: You follow the law. 

Thorsten Waloschek: Well, and if you don't follow, that's how it's applied, and done deal. Not that simple, but here in the United States ...  

Wendy: That [00:15:00] it's more black and white, and here everything's gray. Interpretation.  

Thorsten Waloschek: Yes, it's a lot of interpretation. And now of course the FDA has very strict rules and regulations. 

Yeah. No doubt. But in order to understand how to maneuver in that environment, actually, there's more wiggle room. There's more ways to find the right path to market. Yes. Than in Europe, because it's black and white in Europe. Okay. And if it's black and you're on the white side and it doesn't really work, then it  

doesn't work, then start over. And here you can negotiate.  

Wendy: So you said you have connections in Japan, you have friends that can help you with the culture. Are they in the same maternal health and young industry?  

Thorsten Waloschek: Yeah, I worked for the most of my life in the neonatal environment. And so it's the neonatal environment where I have that network. 

And jaundice is something that is also in Japan, [00:16:00] a health care challenge. So that's why that is good.  

Wendy: Yeah, so it goes back again and again. I'm hearing that in medical devices, it's less about your company culture, but build your networks on your specialty in the global environment to help you think global from the start. 

Thorsten Waloschek: Exactly, and especially as a small startup company. I mean, we don't have the resources, we don't have the knowledge, we don't have the experience to be here, there, anywhere. Right. So I'm a very big supporter of building not only networks, but partnerships, collaborations around the world. Also with what might be seen as a competitor. 

I mean, competition is not bad, right? Competition is a good thing, I think. And sometimes competitors can actually also work together and help each other to be more successful together. And that doesn't mean joining forces right away. But in the startup world, it's all about collaboration. And [00:17:00] so to enter a market where we don't have the cultural, legal experience, I would never try it on my own. 

I would always look for a partner that helps us as a company to enter that market.  

Wendy: Yeah, that's excellent advice that I don't think is brought up in the podcast episodes enough about how you form partnerships and you don't have to go fully in together, but how do you work together and establish that relationship and trust over time? 

Thorsten Waloschek: And then I think really it's a cultural aspect.  

Wendy: Yes.  

Thorsten Waloschek: I mean, yes, the disease pattern most likely is the same whether it's a German or American baby, but for example in Germany where I was born. It's still not possible to market prescriptive drugs directly to consumers, to patients. 

It's illegal. It's unheard of.  

Wendy: Yeah.  

Thorsten Waloschek: So it's a cultural aspect.  

Whereas here in the United States, for as long [00:18:00] as I can think, there was always direct to consumer marketing.  

Wendy: Yeah, that was actually, that was new in like the 80s. Yeah. Before then it wasn't allowed.  

Thorsten Waloschek: But for many, many years. 

Yeah. So with that, and of course there's pros and cons, but with that comes an educational piece to the consumer, to the patient. Yes. We don't have that in Germany. And again, I don't want to judge what's better or worse, but it's a different culture. And if you, now we are in the medical device business, not in pharmaceutical business, although that's where I started my career. 

If you understand the cultural difference, then you can tailor your marketing according to it.  

Wendy: Towards that, yes.  

Thorsten Waloschek: But if you don't understand the cultural difference, that's not a good starting point.  

Wendy: Now, how about language? You're multilingual, but you don't speak all the languages of the world. 

How have you handled or your company's handled the translation or interpretation aspects?  

Thorsten Waloschek: Yeah. So, I mean, that's also a legal aspect. You need a formal translation office. And then you [00:19:00] need to validate the translations. But to your point, we are always trying to find a local partner that speaks that language. 

 And it doesn't have to be a, necessarily a native speaker. I mean, that's the best thing. But I did a lot of business in Brazil. If you want to go into Brazil, well, find somebody who speaks Portuguese and don't work with an interpreter. Work with somebody who speaks the local language. 

And it doesn't have to be an employee, I mean, it can be an outside consultant that helps you for a couple of months, but I always make sure that we're targeting the country in the local language because it's a cultural aspect.  

Wendy: Interesting. So you would hire somebody there. Well okay, so you're going back to the partnership of this person's coming in as a partner with you as a country representative, country manager as opposed to using an interpreter to help facilitate the conversation because you're also getting the cultural benefit and the knowledge from it.[00:20:00]  

Thorsten Waloschek: And it's that cross culture experience that can make you much more successful. Or it actually can lead to failure.  

Wendy: Yes. A professional interpreter is also trained to be that cultural conduit, but you're pulling them in to more details.  

Thorsten Waloschek: What I want to make sure is that person also, doesn't have to be a subject matter expert in what we're doing, but at least should come from the medical industry somehow. 

Because all of these interpreters, I mean, you find also specialists, but in general, they are generalists. They can work for politicians, they can work for the medtech industry, they can work for I don't know what. But again in medicine, in medical devices, in healthcare, I think, It's not just language, but it's also, again, the cultural aspect of the language that plays a major role. 

And [00:21:00] translating an instruction for use, for example, that is a legal necessity. Yes, it can be translated correctly, but it's still not reflecting the culture of the language. So, the translation offices that we are working with, they do the grammatically correct translation. And then we run it by a local native speaking subject matter expert who then changes individual words to make sure that the culture is also reflected. 

Wendy: Yes. Okay. That's what we certainly see at Rapport International when people are having us do a translation. Get your local people to review it, but bring the changes back to develop the lexicon with the person who is doing it. That's the best way to do it.  

Thorsten Waloschek: Absolutely. And so it's always fun and I love to travel. 

I love to work in foreign countries or new countries where I haven't been to, but doing business is another story in such a country. And yes, it takes time. And [00:22:00] then time is money, of course.  

Wendy: Very American saying, yes. 

Thorsten Waloschek: I would rather limit the exposure in the beginning and make sure that you understand this culture. 

And so for us it was, for me especially, natural to come here to the United States. Because, yes, I have a very strong European background, but I think I have an understanding of American culture. So it was for me a natural fit.  

Wendy: So I can see somebody listening to this that says, okay, I'm coming out of one of these academic institutions here in the United States. 

This is what I know. I'm in this field. How would you recommend they go about developing the partnerships in their field globally rather than just in the US?  

Thorsten Waloschek: Well, attend such conferences in Europe, for example. That's one way.  

Wendy: Oh, like go to RESI in Barcelona, RESI in London. 

Thorsten Waloschek: Exactly. And as well as you find here, when you come to the United States there's at least I know a few [00:23:00] cultural coaches, trainers, that give you a first introduction into American business culture. It's not necessarily about the language. Pretty much everybody coming from Europe speaks English. 

But American business culture is a different thing. Yes. And there's trainers here in the United States, coaches that help you to understand how to maneuver that business culture. The same thing is available in pretty much every country. Now it's a different story when I'm from the United States. 

If I want to go to Europe, Europe is not one country. It's not as harmonized as one might think or as I would wish. There is no United States of Europe. So we have so so many countries even more languages because some countries have more than one language and you need to pick a country. I suggest to pick a country where to start. 

It doesn't have to be Germany. It's the largest population. It's the biggest economy, but it doesn't have to be Germany pick a country where you want to [00:24:00] get your foot in, where you have your anchor point and go from there and learn in that country. Learn about the European culture and then pick the next country, but don't go into Europe. 

That doesn't mean anything. Go into one country in Europe.  

Wendy: Yes. Yes. So maybe you're doing all the regulatory for Europe at once. Maybe you're doing the translation on your packaging and your instructions for work for use. But focus on launching in one so you can grow from there. Well, I do have to say it was interesting that you are in the neonatal and the guest right before you was John Konsin who is also in the baby industry and the two of you greeted each other with a great big hug and you're from completely different parts of the world so I was like well that right there is playing out before my face about how to build partnerships and relationships in the field. 

Thorsten Waloschek: Absolutely, and the neonatal industry, the neonatal community, also from a [00:25:00] healthcare perspective is very not closed, but close. It's family. I think we know each other, whether we are competitors or friendly competitors, or just in that business. Neonatology - taking care of babies is just something very special. And I more than 20 years ago, dedicated my professional life to making sure that babies have the best possible start to life. And anybody working in that part of the industry is not signing up to my vision, but can share that.  

Wendy: Can definitely can share that. 

Thorsten Waloschek: Absolutely share that. And so it was wonderful to see John here. I didn't expect that.  

Wendy: Yeah. Well I was chuckling because I didn't realize that you two were placed next to each other. And were going to know each other, but it's wonderful. So, you know, this question is coming. 

What is your favorite foreign word?  

Thorsten Waloschek: There are many. I lived and worked in Denmark, learned the language. I'm not fluent [00:26:00] anymore, it's many years ago, but there's a word called hygge.  

Wendy: Hygge.  

Thorsten Waloschek: You heard about it?  

Wendy: I have, but go ahead. 

Thorsten Waloschek: You have heard about it. So there's not one translation. 

It's to be comfortable. It's feeling pleasant. It's a nice environment. It's a safe environment. It's a relaxing environment. That means hygge, and it can be used in various forms. As a description of a place, of a house, of a spot. It can be a verb. It can be a whole environment. And the Danish culture is very good at creating this hygge culture which just makes you comfortable and relaxed and makes you feel safe and welcome. And I think it's a wonderful world and it's a wonderful concept.  

Wendy: Yes, I love it and I like the way that you explained it too. That was very good and [00:27:00] clear and it captures it. And there is no direct translation for that. 

Thorsten Waloschek: No, there's no direct translation. So I like words that don't have a direct translation.  

Wendy: Oh, I do too. Those are the fun ones if you're working for a translation agency specifically. Where can people reach you if they'd like to know more, get in touch with you?  

Thorsten Waloschek: Well, so there is the neopredix. com website. 

There is my contact details.  

Wendy: And can you spell that?  

Thorsten Waloschek: N E O P R E D I X. com. You'll find me on LinkedIn. My name is very unusual. Thorsten Waloschek on LinkedIn. There's only one, you'll find me there. So there are various ways of contacting me.  

Wendy: Oh, good. Well, thank you so much. Thank you. 

This has been such an interesting conversation. I particularly liked the partnerships forming that and how you do that around the globe and I have a feeling that you're very good at keeping up those relationships.  

Thorsten Waloschek: I try my best.  

Wendy: [00:28:00] Good. Well certainly keep a relationship with me and let me know if there's anything I can do. 

And as a thank you I'd like to give you a copy of the book that I wrote on global marketing. Thank you, thank you so much. The Language of Global Marketing.  

Thorsten Waloschek: Awesome.  

Wendy: And please let me know if I can do anything for you.  

Thorsten Waloschek: Okay. You're going to send out information when the podcast goes out? 

Wendy: Yes, we will send out the information. Listeners will let you know on social media where you can find him. We'll give you more information about his company. And we really appreciate you tuning in for this episode that we're recording live at the RESI conference. If you liked it, send it on, rank it a five, and certainly come back. 

And if you've got a good guest, send them over to The Global Marketing Show where you can apply to be a guest. Thanks so much and we'll see you the next time.