Blog | 7/31/2025
Revolutionizing Infant Health: The Journey of Prapela and Their SVS Technology
By Matthew Feryo, Alena Petrella, and Darcy Krzynowek
Introduction
Health Advances, a healthcare strategy consulting firm, recently interviewed John Konsin (CEO) and David Morrill (CTO) of Prapela, a commercial-stage company focused on improving newborn health, particularly for infants exposed to opioids. Their flagship product, the Prapela SVS bassinet pad, created a new FDA medical device category as the first and only therapeutic vibrational mattress pad for neonates and infants. The interview explores Prapela’s journey, challenges, and their plans to support further development and commercialization of their platform technology.
The Importance of Addressing Neonatal Opioid Withdrawal Syndrome
The opioid crisis continues to have a profound impact on communities worldwide, with newborns among the most vulnerable. Infants exposed to opioids in utero often suffer from neonatal opioid withdrawal syndrome (NOWS), a condition marked by symptoms such as tremors, irritability, poor feeding, and respiratory distress. These challenges frequently require extended hospital stays and intensive care.
Addressing these health issues is crucial not only for the immediate well-being of these infants but also for their long-term development. Early interventions can significantly improve outcomes, reducing the risk of developmental delays and other complications. Prapela is at the forefront of this effort, offering an innovative, non-pharmacological, vibrating mattress pad, which uses Stochastic Vibrotactile Stimulation (SVS) technology. Pioneered by Dr. David Paydarfar, and improved at Harvard’s Wyss Institute for Biologically Inspired Engineering University, SVS delivers gentle, randomized vibrations that boost signals within the autonomic nervous system reducing episodes of irregular breathing and hear rates. This technology supports infants with NOWS, apnea of prematurity, and other cardiorespiratory instabilities.
Notably, Prapela’s product is the first medical device to receive FDA De Novo authorization specifically for treating opioid-exposed newborns. It complements standard of care practices—such as swaddling, rooming-in, and skin-to-skin contact—offering a comprehensive, non-drug-based approach to managing NOWS.
Prapela began with a scientific insight in the 1990s and evolved into a mission-driven startup focused on improving infant breathing through its FDA-authorized SVS technology. Initially targeting opioid-exposed newborns, the company has plans to expand into preterm infant care and developing a consumer device to support healthy sleep in all babies. Clinical use has shown reduced withdrawal severity, shorter hospital stays, and less reliance on medication—outcomes that not only enhance infant health but also ease the emotional and financial burden on families and healthcare systems.
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To explore Prapela’s journey, the challenges they’ve overcome, and their vision for the future, Health Advances interviewed co-founders John Konsin and David Morrill. The following Q&A captures their insights, the evolution of their technology, and guidance for fellow pediatric device innovators:
Matthew Feryo (MF): Can you tell us about the origins of Prapela and what inspired you to focus on infant health?
John Konsin (JK): The idea behind the technology began in 1995, when Drs. David Paydarfar and Daniel Buerkel hypothesized that precise random stimulation could improve infant breathing. Their 1997 study with a single infant showed it reduced apnea and improved respiration. Further development at Harvard’s Wyss Institute led to a device tested in small clinical trials, showing benefits for both preterm infants and those exposed to opioids.
This research continued through 2016. During that time, while I was consulting for the Wyss Institute, my stepson suffered an overdose, which I was fortunately able to reverse. Shortly after, Harvard introduced me to SVS technology. Recognizing its potential to help opioid-exposed newborns, I made the decision to abandon my efforts to lead another established company and instead create Prapela.
Darcy Krzynowek (DK): Can you tell us about the technology itself, how it works, and its intended primary clinical applications?
David Morrill (DM): Our technology uses Stochastic Vibro-tactile Stimulation (SVS)—a gentle, random vibration delivered through a mattress pad—to help stabilize newborns' breathing. These subtle vibrations, barely perceptible to the touch, have a significant impact on respiratory patterns. SVS is silent, non-habit-forming, and integrates seamlessly with hospital bassinets while adhering to the American Academy of Pediatrics' safe sleep guidelines.
JK: SVS introduces a precise, noisy signal that helps regulate infant breathing. For opioid-exposed newborns, it slows and stabilizes dysregulated breathing, offering a calming effect similar to rhythmic breathing in yoga. As a non-pharmacological option, SVS complements traditional treatments for conditions like neonatal opioid withdrawal syndrome (NOWS). In pre-term infants, it can enhance respiratory control, reducing apnea and improving oxygenation. Our consumer version can support healthier sleep in all babies by addressing irregular breathing.
MF: How did your past experiences help you get Prapela off the ground and running?
JK: I started my career as a marketing analyst at 3M Corporation, which helped me understand the factors that drive the success of a technology that eventually becomes a product. One of the first skills I applied from my background was that of a marketing analyst. There aren't many medical devices that have the potential to become consumer devices, but those that do and make the transition are fantastic organizations that achieve significant wealth and change people's lives. Knowing how to run a company and understanding what it takes to organize a company to answer appropriately to stockholders and investors was another skill that helped. Nothing prepared me for directly interacting with the FDA or writing grants, but we learned and adapted.
DM: Fiscal responsibility is something John and I both brought with us. I founded a startup, raised money, hired 30 people, and two years later, we were out of money. John and I are very sensitive to keeping the company small, which is just the two of us for now until we got regulatory approval. This means wearing a lot of hats and learning new things to accomplish our goals. Any startup should pay attention to the bottom line and not hire people until absolutely necessary.
MF: What was the biggest challenge during the development process, and what do you expect the greatest challenge to be moving forward?
JK: The first big challenge was reducing the electronics from the size of a shoebox to something that could fit in your hand. The second challenge was the FDA's concerns about the cytotoxicity and biocompatibility of the sleeping surface fabric. The FDA moved the goal post, requiring a new test standard, which we met through a lot of effort and testing. Looking ahead, we created a new device category with our de Novo, and now we need to learn how to do a 510K submission, which will be easier than the 4000-page de Novo.
One of the biggest takeaways from this process has been just how critical it is to maintain open, transparent communication with the FDA. Being proactive—really taking the time to prepare thoughtful, well-supported responses to their questions—makes a huge difference. And above all, we've learned the importance of backing every claim with solid data and statistical rigor. That level of evidence builds trust and helps move things forward more efficiently.
DM: The FDA is out there to protect us and does a great job. They don't budge on safety issues, and you have to prove your device is safe. Although the process was frustrating at times, it ultimately ensured that our device met the highest safety standards.
DK: How did the breakthrough designation impact how you go to market now and your future indications?
JK: We’re proud to hold two FDA breakthrough device designations—likely the only pediatric company to do so. The breakthrough device designation offers major advantages, including expedited regulatory review and frequent, collaborative communication with the FDA. For our current indication—opioid-exposed newborns—it enables rapid feedback on product modifications, treatment cycles, and different product sizing through sprint discussions. This expedited feedback is invaluable as it helps us refine our product and address any regulatory concerns promptly.
Commercially, the designation helps us bring our product to market faster and underscores its innovation and impact, which resonates with hospitals managing neonatal opioid withdrawal syndrome (NOWS). It also simplifies reimbursement by allowing us to sell as a hospital supply item, bypassing delays inherent that come with coding, coverage and payment decisions.
For future indications, the breakthrough designation continues to offer benefits. We can use the designation to seek expedited review for new applications of our technology, such as treating apnea of prematurity or other cardiorespiratory instabilities in newborns.
DM: Pursuing the de novo pathway alongside the breakthrough designation also strengthens our competitive position. It ties our indication to our intellectual property and requires clinical data for any similar products, making it harder for competitors to replicate our solution without rigorous testing.
MF: You are America’s most-awarded pediatric device startup - Congratulations. How have you used that funding so far? What has been your experience raising funding for this device in the pediatric space? What has been difficult? What (and who) has been helpful?
JK: Thank you. When I launched Prapela in 2016, I thought that with Harvard technology and early studies, I would quickly attract angel funding. But by late 2017, it was clear that raising equity wasn’t going to be fast or easy, so I pivoted to grants.
In 2018, we won a $10K NIH challenge grant and received coaching on grant writing. That experience was humbling but rewarding. Since then, we’ve secured multiple non-dilutive grants, which, while time-consuming, have allowed us to advance our technology without sacrificing equity.
Grant funding enabled us to run larger clinical studies, improve our product, and meet FDA requirements. For instance, after our initial de novo submission was rejected, we used grant support to redesign our fabric and conduct a more robust study—leading to eventual FDA marketing authorization.
Equity fundraising has remained challenging. Finding aligned investors takes time. We’ve now narrowed our focus to 30 serious prospects and, despite the tough climate, are optimistic about closing our Series A soon. In parallel, we’ve generated interest from several different companies in the infant care space. We’re excited to explore how these potential partners can accelerate adoption of our product.
DM: The biggest challenge has been finding investors who understand and share our vision. However, the support from the NIH and other grant programs has been incredibly helpful. The coaching and feedback we received from experts have been invaluable in refining our grant applications and securing funding.
Alena Petrella (AP): Given that your device is more advanced—and likely more expensive—than a standard NICU mattress, are there concerns about hospitals adopting it as a supply item, and are you conducting any economic studies to support its value proposition?
JK: We are the first and only FDA-authorized device to treat opioid-exposed newborns. Despite being more expensive than a standard foam mattress with a plastic cover on it, supporting studies show a real impact on length of stay and the amount of care required. We believe there's a huge pent-up demand for new solutions. This is a community of very active clinicians that are out there looking for new solutions. Time will tell, but I'd rather be the first in a product category than trying to be "just as good as".
DM: We estimated a three-month payback for hospitals based on reduced length of stay and reduced intervention by staff. The other advantage is that the product fits within their existing infrastructure, so it’s sized to fit a standard hospital bassinet. Implementation only requires the purchase of the pad and simple training.
For me, the strongest validation comes from clinical trials. After hospital testing, nurses have sometimes refused to return the device, and parents have asked to take it home. That kind of response shows our product isn’t just effective—it genuinely improves life for both infants and caregivers.
MF: How do you plan to expand past the initial patient population of opioid exposure to preterm newborns?
JK: The evidence generated by Harvard revealed that our technology could help preterm babies in addition to opioid-exposed newborns. My own investigation showed that most issues neonatologists face with newborns in hospitals are respiratory-related. As we get older, most of our issues are around our heart, but for babies, it's around breathing. We identified several conditions we could address beyond apnea and hypoxemia. The combination of David and myself also revealed a great consumer opportunity due to the prevalence of irregular breathing episodes in healthy newborns.
MF: Do you have any advice for early-stage innovators in the pediatric space?
DM: Stay lean, wear many hats, and create your own luck. By that, I mean hard work creates opportunities—and what often feels like luck is really the result of that effort. John and I had to find ways to make things happen. While some moments felt lucky, we often realized they were actually the payoff from work we’d already put in.
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Health Advances’ MedTech Practice supports medical device companies and investors in evaluating and executing commercial opportunities, both organically and through M&A.