John Konsin is co-founder and CEO of Prapela, a company pioneering noninvasive stimulation to improve infant breathing and oxygenation. The company’s infant mattress technology has already received two Breakthrough Device designations from the US FDA, which expedites clearance for clinical usage. Prapela expects to debut an additional application based on the technology in 2025.
John and Wendy connected at the Redefining Early Stage of Investment (RESI) Conference in Boston, which Life Science Nation hosted. (Wendy recently interviewed Dennis Ford, founder and CEO of Life Science Nation, which specializes in fundraising for life sciences companies.) In this episode, John describes three clinical applications for Prapela’s technology and outlines the company’s global expansion strategy, focusing on providing valuable insight into navigating international markets, regulatory challenges, and cross-cultural communication.
The Science Behind Safer Sleep
At the heart of Prapela's innovation is that 62% of healthy infants experience irregular breathing patterns and oxygen desaturation in their first three months. The Collaborative Home Infant Monitoring Evaluation (CHIME) study monitored over 1,000 healthy infants at home using hospital-grade equipment to track their respiration, cardiac activity, movement, and oxygen saturation levels. Episodes varied in frequency, severity, and duration among babies—some experienced them once, while others showed multiple occurrences.
Most significantly, these breathing irregularities occurred not just in at-risk infants but in otherwise healthy babies, highlighting a previously unrecognized challenge in early infant development. (Ramanathan, R., et al. (2001). Cardiorespiratory events recorded on home monitors: Comparison of healthy infants with those at increased risk for SIDS. JAMA, 285(17), 2199-2207.)
Prapela's infant mattress helps to regulate babies' breathing through a gentle, barely perceptible vibration. The innovation grew out of research by Dr. David Paydarfar, who, in the 1990s, discovered that a specific type of random vibration, known scientifically as "stochastic" vibration, could improve the “pacemaker function,” the neurons in a baby's brain that controls automatic breathing. The vibration is so subtle that it moves less than half the diameter of a human hair, making it effective and non-disruptive to sleep patterns.
The Hospital-First Strategy
The company has secured over $8 million in funding through grants and awards, allowing them to maintain control while developing their technology. John says this will enable the company to seek equity investment from a position of strength, with FDA clearance on the horizon and a clear path to commercialization.
Their market strategy began in hospitals, aiming to directly and immediately impact infant care in critical settings. This approach is grounded in decades of successful medical device launches, which built a foundation of clinical credibility before venturing into the broader consumer landscape. The technology has already demonstrated its potential, reducing reliance on supplemental oxygen and minimizing the need for traditional breathing interventions.
John envisions a future where "Prapela Inside" becomes as recognizable in infant care as "Intel Inside" is in computers, starting with the 52 global manufacturers of hospital bassinets and incubators:
We can make this mattress fit any infant sleep device worldwide. So it doesn't matter if it's an incubator, bassinet, crib, or cot, as they use the term in international markets, right? We can make it fit those products. So, our strategy is similar to that of Intel with the microchip. You'll see a little badge when you buy a computer from Dell or another company. It says Intel inside.
By positioning their technology as a vital component that transforms standard infant care equipment into advanced breathing support systems, Prapela aims to revolutionize hospital infant care worldwide. Following FDA approval, Prapela plans to pursue regulatory clearance in other markets, initially focusing on Europe, India, and the Middle East. The sequential approach allows them to leverage their FDA clearance while adapting to local regulatory requirements in each new market.
Cultural Intelligence in Global Marketing
John offers valuable insight into cross-cultural communication and marketing. He emphasizes several key principles for successful global expansion:
- Language Simplification: English is widely spoken in international business, but vocabulary depth varies significantly. John advocates using simpler terms and friendly communication to bridge language gaps.
- Local Market Adaptation: Success in one market doesn't guarantee success in another. Companies must adapt messaging, pricing, and marketing approaches to local market conditions rather than forcing an American-centric approach.
- Brand Management: While maintaining global brand consistency is important, local managers should adapt messages to their markets flexibly. This is particularly critical when moving from clinical to consumer marketing, where terms like "calmness" might carry different cultural connotations across markets.
He underscores the importance of remaining open to and respectful of local customs and traditions in international business relationships with a memorable story from his early career in Mexico. The general managers of manufacturing operations presented him with a stuffed armadillo. Initially puzzled by the gift, he later learned it symbolized appreciation for his patience and understanding of their culture.
Brand Identity Across Borders
John explains that "Prapela" was carefully constructed from Latin roots to create a unique name that wouldn’t carry unintended meanings in other languages. This thoughtful approach helps avoid the pitfalls that some major companies have encountered, such as the famous case of Chevrolet's Nova in Latin American markets, where the name unfortunately translated to "doesn't go."
The company's branding strategy balances global consistency with local flexibility from the outset. They maintain core clinical messaging that resonates with medical professionals worldwide while recognizing the need for nuanced consumer-market approaches. John explains that exercise is particularly important when communicating concepts like infant calmness or comfort, as cultural interpretations can vary significantly.
Listen to the full episode to learn more about Prapela’s innovative approach to their technology and market entry strategy.
Links:
Website: https://www.prapela.com/
LinkedIn: https://www.linkedin.com/in/jkonsin/
Connect with Wendy: https://www.linkedin.com/in/wendypease/
Music: Fiddle-De-Dee by Shane Ivers - https://www.silvermansound.com
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 The Global Marketing Show. I'm glad to have you join us again. We are here for another episode at the RESI conference in Boston, and I'm very excited to bring you another good story. Before we get into that, I want to remind you that the podcast is sponsored by and brought to you by Rapport International, who connects you with anyone around the world in over 200 languages by providing high-quality translation.
And today's tidbit is about believing somebody. And did you know that hitting the palm of the left hand with the right fist in Argentina means I don't believe you or that's stupid. Well, I'm not going to use that gesture in this podcast episode because I'm going to believe John, we've run through his experience.
So John Konsin is the co-founder and CEO of Prapela.
John Konsin: Prapela.
Wendy: Prapela. Oh, I have a T here, not an L. [00:01:00] So I'm glad. Prapela. So John, tell me about Prapela and what you are doing.
John Konsin: Sure, Wendy. So we're introducing the world's first infant mattress that helps babies breathe. And by improving their breathing, it also improves oxygenation.
Wendy: Oh, that is fantastic. So we don't have to debate whether it's backs to sleep, fronts to sleep, or sides to sleep with the babies?
John Konsin: Well, to a certain extent, we want all babies to sleep on their back and follow safe sleep practices. That being said, though, there's no mattress in the world right now that takes care of irregular breathing rhythms that most newborns experience up to three months of age.
So that's the problem that we're addressing. And while they have these episodes where they're not breathing regularly their oxygen desaturation levels can drop, and this happens in babies in hospitals as well as healthy babies at home, again, up to three months of age.
Wendy: So, tell me more about that. I didn't even realize that was the thing across all babies, and how you got [00:02:00] interested in it, and where you are now.
John Konsin: Sure, thanks. So, there was a major study called the CHIME study, well over a decade and a half ago, and they monitored over a thousand healthy infants at home with hospital monitor grade equipment. And they were recording respiration, cardio activity, movement, as well as oxygen saturation levels.
And they found that sixty-two percent of these infants at home healthy, were experiencing episodes where their breathing patterns were irregular and their oxygen desaturation levels dropped. Now, some of them varied in terms of the frequency, how often it occurred. In some babies, it only occurred once. Other babies, it occurred many times.
These episodes, occurred in different levels of severity, meaning their oxygen levels dropped really, really low. Some babies, it didn't drop hardly at all. And then, there is also how long these [00:03:00] episodes lasted. And it was pretty revealing to the pediatric community at the time, so we know it exists.
However, what we're focusing on initially as a company is babies in hospitals. So, as adults, typically our health concerns become more focused on our heart as we age.
But, when we're newborn babies, most of the health concerns that pediatricians and neonatologists have, have to do with cardiorespiratory function. Are the babies breathing properly? So there's a number of different conditions that regular, healthy babies at birth as well as preterm babies experience in terms of breathing irregularities when they're at the hospital.
In fact, you may know that to have a baby discharged today, they have to pass a car seat test. And that's where they sit up in a car seat and they're actually monitoring, is the baby breathing properly? That's how important respiration is. So, we're putting our bassinet pad in hospital bassinets, those clear tubs that we're all familiar with, as well as incubators [00:04:00] for preterm babies.
And we're finding in studies that the hospital needs to use less oxygen to help these babies breathe, or maybe less caffeine, or maybe other types of pharmacotherapy that's not required. They can instead just lay on a naturally beautiful, simple mattress that helps them breathe.
Wendy: Okay, so tell me more about the technology behind the mattress and how it does that.
John Konsin: So, it was really an accidental discovery by Dr. David Paydarfar way back in the 1990s. And he first postulated on the idea of a simple vibration that was random in nature, called stochastic in scientific terms, could actually improve the pacemaker function, the neurons inside the baby's brain that control automatic breathing.
That was his hypothesis and in 1997, he published his first paper with one baby that proved his postulation. Since then, there have been multiple studies [00:05:00] with the vibration that shows indeed it reduces irregular breathing rates, it reduces oxygen desaturation events, it reduces apneic episodes, that's when babies stop breathing altogether for 20 seconds or more.
And more recently, a major study showed that it helped opioid-exposed babies, those are babies that are exposed to opioids before they're born, who have irregular breathing patterns and are also incredibly frantic. It helps them recover from withdrawal symptoms that they experience shortly after birth.
Wendy: I'm sitting here wondering, why would babies have such trouble breathing? Is that something they're really just trying to learn to do?
John Konsin: So it's a lot to do with the irregular breathing apparatuses that are in the brain. So, automatic control of breathing of the brain is controlled by the lower brain stem.
And, at that point in birth, and certainly with preterm babies, the lower brain stem is not fully mature. So, [00:06:00] as a result, it's not doing its job all the time to control breathing at a regular rate.
Wendy: So it is just that development that is still happening in those first three months.
John Konsin: Absolutely.
Wendy: And so you have a mattress, or is it a pad that goes over the mattress?
John Konsin: It's a mattress that replaces standard mattresses used in bassinets or incubators or in some day we hope, cribs used at home.
Wendy: Ok, and it vibrates then?
John Konsin: Right, it's a vibration you can hardly feel, you can hardly sense it. It's very specific. It moves up and down less than half the diameter of a human hair.
Yeah. So, it doesn't make any sound. It's non-habit forming. It doesn't disrupt sleep cycles when babies fall asleep. It's just a gentle, random vibration that they experience.
Wendy: So you wouldn't even realize it if you touch it.
John Konsin: If you touch it softly, you can kind of sense it.
Wendy: Okay.
John Konsin: But otherwise, you're right. It's very hard to discern.
Wendy: [00:07:00] Where are you in the stage of development?
John Konsin: Well, we've been working on it for quite some time. We recently filed an application with the FDA to get marketing clearance through what they call the De Novo regulatory pathway. And the reason I bring out De Novo is because De Novo means from the new, so there's no predicate or no other device on the market available today that does what it does.
Wendy: There's nothing that even focuses on that from what I know.
John Konsin: From what I know as well. So that has been submitted to the FDA and they've been terrific. We've been talking to them all along with the research that we've been doing and they've been giving us guidance. We've received two FDA breakthrough device designations from the FDA.
So they've acknowledged this is a breakthrough device and now they're just waiting for us to complete our submissions, provide the data. So one of them has been completed. We expect to hear from them with a decision in 2025. Hopefully the first half of the year, probably even as early as Q1. And then we'll [00:08:00] follow that with another submission, probably in 2026, for a different application, a different indication for preterm babies in 2026.
Wendy: Okay, and so where are you in your planning the go-to market then?
John Konsin: You asked, is it a pad, is it a mattress, right? Well, we can make this mattress fit basically any infant sleep device in the world. So it doesn't matter if it's an incubator or a bassinet or a crib or a cot as they use the term in international markets, right?
We can make it fit those products. So our strategy is similar to what Intel did with the microchip. When you buy a computer from Dell or from some other company, you'll see a little badge. It says Intel inside
Wendy: Right.
John Konsin: Well, what we want is no matter who you buy your bassinet from or your incubator, it will say Prapela inside.
So, they'll be [00:09:00] using our mattress inside their infant sleep products.
Wendy: Okay. So, you have talked about around the world.
John Konsin: Right.
Wendy: So, it's The Global Marketing Show. So, how are you thinking globally with this?
John Konsin: Yeah. So, we are going to go direct initially to the companies that sell and make hospital bassinets and incubators located in different countries around the world and form partnerships with them.
Say, look, we think you should be using our device. Here's our medical and clinical results. This will expand the claims that you can make for your device because you don't offer this right now in your bassinet or your incubator. And it will really help babies in hospitals.
Wendy: So it really is a direct to consumer.
John Konsin: It's direct to business, to hospital, to consumer, right?
Wendy: Oh, right because you're going after the hospitals first. So then the hospitals are doing it. [00:10:00] It's not like I'm thinking as a mom, I go out and I buy a bassinet and they're going to say, do you want the regular old mattress or do you want the Prapela?
And if I haven't heard about it and there's going to be a markup for Prapela because it's life saving.
John Konsin: Right?
Wendy: So, how would I make that decision, but you're starting with the hospital market.
John Konsin: What we've seen in the clinical trials that we've done, right, thus far, is that parents ask how can I find this?
How can I take this home? Can I take it home? Can I buy it when I'm at home? So, our strategy is to make it a very viable and important medical product where physicians support it, clinicians of all sorts support it, therapists support it, and parents see it in the hospitals, and then later introduce our consumer version of the product.
Wendy: Okay, and now you're going through the FDA process to sell that internationally. Are you going through any other regulatory bodies?
John Konsin: So we're first going with the FDA, which we believe is the [00:11:00] most difficult part to get through, and then once we have FDA De Novo, we'll be filing for regulatory clearance as a medical device in other markets around the world.
Initially focusing on Europe, however, a lot of interest we have, is from physicians and clinicians in India, so we'll be pursuing that. They have a lot of hospitals, a lot of babies are born in India every year so we're excited about those two markets in particular, soon after we get FDA clearance, but we'll be doing this again in concert with the manufacturers of incubators and bassinets in those countries.
There are about fifty-two incubator manufacturers around the world. There are a couple major companies that sell worldwide, but believe it or not, in some markets, there's a trusted brand that hospitals have used for years and years, and they want to continue to use that from a local incubator manufacturer or a local bassinet company.
Wendy: So you've got fifty-two companies that you test, so a very defined target market. [00:12:00] Yeah, and why did you pick Europe and India as your first markets?
John Konsin: Because, there is a huge huge appetite for healthy baby wellness products in Europe and has been there for a long, long time. In fact, one of our inspirations, one of our very first awards was in Finland.
We actually flew to Finland and participated in a competition, a global competition for the next gen baby box. In Finland, baby boxes are very, very popular and have been given away since before World War II. We actually won the competition. Our innovation was put our mattress in a baby box.
Wendy: Right, it makes logical sense.
John Konsin: Yeah, it was our first award actually, our first major award I should say.
Wendy: Wow, yeah, that's great.
John Konsin: We've also been learning more about other countries and other opportunities. For example, last year we were invited to present at the World Innovation Summit for Health in Doha, Qatar. And I [00:13:00] was able to meet with physicians and clinicians from all over Doha and parts of the Middle East.
And meet mothers as well, about our innovation, and it was absolutely exciting. And there's a lot of interest there. So, Europe and parts of the Middle East, because of the focus on healthy babies. In India, of course, it's the same. I mean, doesn't matter where we go worldwide, right? We want our babies to be healthy.
But India, of course, because there's a large number of hospitals that are treating a large number of births every year and we believe we can make a big impact in the market in India.
Wendy: Now you've had a very expansive global career across companies.
John Konsin: I've very fortunate.
Wendy: Yes. And very accomplished.
And so you've run into language and cultural issues. And so I'm kind of curious as the global marketing show, those are two key things. What issues have you seen with communicating across languages, and then we'll get into cultures?
John Konsin: I was fortunate [00:14:00] enough to work for Smith & Nephew, a UK-based company, for five years and had global responsibilities.
And there the joke was that when you hear someone from home office in England say, well, you could say that, what they're really telling you is, but I wouldn't. So we've heard those types of jokes. So language is really key, right? And the first thing you have to recognize, especially I believe as an American medical device manufacturer or consumer products manufacturer or even citizen is that while many people around the world know English, the depth of their vocabulary is much more limited than it is compared to an average American.
So limiting your use of an expansive vocabulary, speaking in simple terms. Right? And being friendly gets you a long, long way. So, the other lesson learned that I've had over my career is that just because it works in America doesn't mean [00:15:00] the same approach, the same ideas, the same benefits that you stress in America will work in certain countries.
Right? Every country is different to a certain extent, and there are subcultures within countries that are very different. So being sensitive to a posture where you're not bringing in an American message to a local market outside the United States is really, really important. So, I've learned to lean on the experts, the locals, right?
The many, many companies that are successful internationally have country managers or country operations. for their worldwide business located in the country and they can adapt messaging, they can adapt to pricing, they can adapt to the peculiarities of that market.
Wendy: Yeah, I've had some interesting conversations with people recently at a trade show last week that they went to do local marketing and now they've lost control of their global brand messaging, they're having Spanish translations done in [00:16:00] Columbia, and they're also having them done in Spain.
And so they feel like it's all mishmash. Talk to me about your experience with keeping a global brand, but wrapping in those local marketing people.
John Konsin: Yeah, you just reminded me of the famous General Motors story about Chevrolet's Nova, which was introduced to the Latin American market. And then they realized that Nova meant doesn't go, no go.
So I think that's where relationships and trust are really important. You want a brand to be successful, yes, with kind of an image if you will, but you have to let go to a certain extent of what the brand identity may equate to in certain countries. I think for my, and medical devices, it's a little bit easier because many physicians read the same journals worldwide.
And that really, really helps quite a bit. So, as it relates to at least the clinical benefit of your device, it's translatable no [00:17:00] matter where you are around the world.
Wendy: Right.
John Konsin: In terms of the consumer market though, I'm sure we'll have some really interesting challenges as we forge ahead into that area.
What does Prapela mean? I took it from two Latin roots and created the name. So, it's a for all intents and purposes, a unique name, that really doesn't mean anything in any specific language.
Wendy: Which is good. Which is good. And that you test it across all the languages too, which we've done for clients.
John Konsin: Right, so I think if you can get like one major theme to carry across all countries that you participate in, and that you decide to go commercial globally in, that's a good thing. But in terms of the sub messages behind your brand, maybe have some latitude there.
Wendy: Yeah. So in the companies that you worked with, you'd have it globally translated, then sent to the country managers for review to make sure that it's accurate.
John Konsin: Absolutely. And even give them discretion to [00:18:00] change. So we don't use this term, John, let's use this term. Instead, this is what it means in our country.
And this is a more important term.
Wendy: But they're not starting from scratch every time and making up their own messages.
John Konsin: Clinical terms are easy, right? But softer consumer terms, like will it calm my baby? Does calmness mean the same thing to a mother in the US as it does say, for example, in Brussels, or does it mean the same thing to a mother in Poland? Does the word translate or do they have a better word?
That means something more encompassing than calm.
Wendy: Yes, and that's all the stuff that you can't get from the automated translation. So if you're working with those consumer marketing, it's that cultural country expert that gets you in. Right. And how about cultural? You must have had some funny cultural stories from your international travel.
Can you share a good one with us?
John Konsin: Oh boy.
Wendy: What you didn't understand or something confusing happen? [00:19:00]
John Konsin: I remember my first trip to Mexico, right? Where I was working for a company with maquiladora operations in Mexico. In other words, they were actually taking raw goods and creating our finished product that we would then sell throughout the world. Well, I'll just get to it. At the end of two days, I was presented by the general manager of one large operation in Magdalena as well as actually the general manager in Armacillo. They presented me with a stuffed armadillo, and I wasn't quite sure why I was receiving a stuffed armadillo, but I took it graciously and I found out later that the tradition with them was that it was to represent thank you for understanding us.
Thank you for being patient with us. And so I came to name my armadillo Mondo and he proudly sat in my office for quite a few years.
Wendy: Oh, that is such a wonderful story. I don't think I've ever [00:20:00] seen a stuffed armadillo before so that is a unique gift. Oh, I love that story.
John Konsin: Thank you.
Wendy: So what are you hoping to accomplish here at RESI?
John Konsin: New relationships. So we're going to do our first equity raise with investors. We've been very fortunate. All of our funding, well, ninety-eight percent of our funding has come from non dilutive grants, awards.
Wendy: Oh, nice.
John Konsin: And it's over eight million dollars now that we've received in non dilutive funding. So we have not had to go to private investors to keep the company operational or get it going at this point.
We will, however, after we get our FDA clearance, we will then expand the company and we'll have a proven product from an investor standpoint that we can commercially sell. So we're very fortunate that we're going to have the FDA clearance before we take on any equity investment. So I hope to meet a few investors that are interested.
We are lucky we have several already interested, but you can never have enough. Right. [00:21:00] And then just to meet other entrepreneurs that are dealing with regulatory issues, with quality issues, manufacturing issues, marketing clinical trials, etc. You can never learn enough. Yes. And this is a great forum to learn from other entrepreneurs.
Wendy: Oh, that's great. Yeah, it certainly is. It's a good crowd here. Alright, you know this question's coming. What's your favorite foreign word?
John Konsin: Yes, I do know this question's coming, and I've thought quite a bit, and there's many, many different words, but I probably would have to go with prego.
Wendy: Prego.
Prego. That's such a good Italian word.
John Konsin: Yes, my friends in Italy of course use it often, and it always makes me smile. It's an easy word to say, and you just want to do this when you say prego.
Wendy: So where do you use it or what does it bring up for you? What's it mean?
John Konsin: Yeah, it means like, Hey, you're okay.
Yeah, this is all right. Like, way to go and kind of like an enthusiastic, keep it up. [00:22:00] Kind of is the way I take it. It's okay. It's all right.
Wendy: That's like a motto for an entrepreneur, isn't it? Well, where can people reach you if they'd like to know more?
John Konsin: Oh, thanks.
We do have a website. We're a small company. I created it myself with the help of a platform. So we're at www.prapela.com. We're located in Biddeford, Maine. But the easiest way to get in touch with us is through our website. The contact information is there. You can leave an email. I'm happy to respond and answer any questions.
Wendy: All right. Well, thank you so much. I really appreciate you taking the time out of your busy conference networking. And as a thanks, I'd like to gift you a copy of the book that I wrote. It's called The Language of Global Marketing. I'd love to hear what I forgot, because it sounds like you've got a lot of good experience in there so I appreciate you coming on and sharing your good stories.
John Konsin: Thank you. It's a real delight and [00:23:00] honored to be part of the podcast. So thank you.
Wendy: Listeners, thanks for tuning in. I hope you enjoyed this one. I had no idea that babies having sleep apnea in the first three months was such a thing, it's kind of scary.
I'm glad my kids are older now or I'd have one more thing to worry about when they're a newborn. So, if you enjoyed this episode, please share it with somebody else that you think might learn from it. And if you know of anybody that might be interested in funding it, pass John's company's name along.
And listen for us in our next episode. Thanks so much for tuning in.

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