In this episode of The Global Marketing Show, Wendy Pease sits down with John Konsin, Co-Founder and CEO of Prapela, to explore how a breakthrough medical device is addressing a largely overlooked challenge in neonatal care: irregular infant breathing and oxygen desaturation in the first months of life. Drawing on clinical research, including the widely cited CHIME study, Konsin explains that over 60% of otherwise healthy infants experience irregular breathing episodes—some severe enough to impact oxygen levels. For Life Sciences professionals working in neonatal care, medical devices, or clinical research, this conversation highlights an important gap in early-stage infant health that has historically lacked scalable, noninvasive solutions.
At the center of the discussion is Prapela’s novel infant mattress, a noninvasive medical device designed to improve respiratory stability through gentle, stochastic (random) vibration. This technology, originally discovered through neuroscience research on the brainstem’s control of breathing, has demonstrated the ability to reduce apnea events, improve oxygenation, and decrease reliance on pharmacological interventions such as supplemental oxygen or caffeine therapy in hospital settings. For clinical and regulatory teams, this represents a compelling example of how biomechanical innovation—grounded in neurological science—can translate into measurable clinical outcomes without introducing additional drug burden.
The episode also provides valuable insight into FDA regulatory strategy and medical device commercialization pathways. Prapela is currently pursuing clearance through the FDA’s De Novo pathway, reflecting the novelty of a device with no existing predicate on the market. The company has already received two FDA Breakthrough Device designations, underscoring both the clinical significance and innovation of the technology. For Life Sciences companies navigating regulatory submissions, clinical validation, and market access, Konsin outlines a pragmatic approach: build clinical credibility in hospital environments first, then expand into broader markets following regulatory approval.
From a go-to-market perspective, Prapela’s strategy is particularly relevant for MedTech and global commercialization leaders. Rather than launching directly to consumers, the company is pursuing a hospital-first model, partnering with manufacturers of bassinets and incubators to integrate its technology into existing neonatal care infrastructure. This “component branding” approach—akin to an “Intel Inside” model—enables faster adoption within clinical workflows while establishing trust among physicians and caregivers. It also creates a strong foundation for future expansion into the consumer market, where clinician endorsement and hospital exposure will play a critical role in adoption.
A key theme throughout the episode is the complexity of global expansion in Life Sciences, particularly across highly regulated and culturally diverse markets. Konsin outlines plans to expand beyond the U.S. following FDA clearance, with initial focus on Europe, India, and the Middle East—regions with strong demand for neonatal health innovation and varying regulatory requirements. He emphasizes that success in global markets requires more than regulatory approval; it demands local market adaptation, culturally aware communication, and collaboration with in-country experts. For teams managing IFU translation, labeling, and global product messaging, this reinforces the importance of balancing clinical consistency with cultural nuance.
Finally, the conversation underscores a broader lesson for Life Sciences organizations: innovation does not end at the lab or clinical trial. Bringing a medical device to market—especially one that impacts vulnerable populations like infants—requires alignment across clinical research, regulatory affairs, global marketing, and cross-cultural communication. Prapela’s journey illustrates how scientific discovery, when paired with thoughtful regulatory strategy and localized global execution, can drive meaningful advancements in patient care on a worldwide scale.