Health Innovation Case Studies

Safeguarding Preemies: The CareFold Journey

When a baby is born prematurely, their journey begins in the Neonatal Intensive Care Unit (NICU), where every detail of their care can determine their survival and long-term development. Among the most critical procedures in the NICU is managing invasive tubes for intubation and other essential treatments. However, these same procedures come with a significant risk: Unplanned Extubation (UE)—the accidental dislodgment of breathing tubes. UEs are the most common adverse events in the NICU, leading to complications like aspiration pneumonia, brain injury, or even death. Despite efforts to reduce UEs, fear of these events often prevents parents from engaging in life-saving skin-to-skin contact with their babies, creating a heartbreaking dilemma for families and caregivers alike.

The Problem

Each year, about 415,000 neonates require invasive ventilation, and nearly 20% will experience at least one UE during their NICU stay. Skin-to-skin contact—an internationally recommended practice known to improve neonatal outcomes—is often delayed or avoided altogether in intubated babies because of the risk associated with moving these fragile patients. The fear of UEs, especially during transfers for skin-to-skin contact, MRI scans, or repositioning, creates significant barriers to providing optimal care. In fact, 77% of NICU nurses in the U.S. cited UEs as a key reason they hesitated to encourage skin-to-skin contact for preterm infants.

Prototype

The CareFold project was born out of a biomedical design fellowship focused on solving high-impact healthcare challenges. The goal was to design a device that allowed easy, safe movement of intubated neonates while significantly reducing the risk of UEs. After extensive research, prototyping, and validation, the result was the CareFold, an innovative preterm carrier with integrated tube stabilizers that:

• Securely hold invasive tubes (endotracheal, catheter, and others) during transfers.

• Enable single-person lifting and handling, reducing the need for multiple caregivers.

• Allow for safe and comfortable skin-to-skin contact by creating a private, stable space for the baby and parent.

• Maintain thermal regulation with a special coating that reduces heat loss when the baby is outside the incubator.

The CareFold was designed to stay inside the incubator as part of the baby’s environment, ensuring a seamless transition to skin-to-skin or medical scans without compromising safety or disrupting tubes.

A Collaborative Effort

CareFold was brought to life through the efforts of me and my two cofounders, Maria Hvidberg Petersen and Kristine Kuni Buccoliero, who later took the startup forward after its spinoff from the Biomedical Design Fellowship. The development of CareFold was a truly multidisciplinary effort, combining the expertise of neonatologists, NICU nurses, engineers, public health researchers, and even parents. To ensure the device met the real-world needs of its users, we conducted interviews, co-creation workshops, and clinical observations across Denmark, the USA, and Pakistan. These interactions revealed a shared challenge across NICUs worldwide: the emotional and operational dilemmas faced by caregivers. When is a baby too critical to move, and when is it too critical not to?

To address these challenges, our team engaged experts in medical device design, business development, and health economics, ensuring that the solution wasn’t just innovative but also feasible and scalable. Prototypes were rigorously tested and refined based on feedback from clinicians and families, which helped shape a product that was both practical and safe. CareFold’s final design reflected its users’ real-world insights, delivering a solution that empowered caregivers while making NICU care safer and more effective.

Impact

The CareFold is projected to have profound benefits for NICUs and their patients:

1. 75% Reduction in UEs: Safer transfers reduce complications and improve outcomes.

2. Improved Parental Engagement: Enabling more frequent skin-to-skin contact promotes bonding and accelerates recovery.

3. Cost Savings: By decreasing UEs and shortening NICU stays by an average of 5 days, CareFold could save approximately $15,000 per patient.

4. Global Scalability: With patentable features and a well-defined business case, the CareFold is positioned to enter NICU markets worldwide.

Why it Matters

CareFold isn’t just a device—it’s a transformational solution for one of the most pressing challenges in neonatal care. Premature babies, some of the most vulnerable patients in any healthcare setting, require meticulous care to survive and thrive. Managing invasive ventilation tubes is a critical part of this care, yet it comes with a serious risk: unplanned extubations (UEs). These accidental dislodgements of breathing tubes are the most common adverse events in NICUs, leading to complications like aspiration pneumonia, oxygen deprivation, brain injury, and in severe cases, death. CareFold directly addresses this problem, reducing the risk of UEs and enabling safer, more effective care for neonates.

Beyond preventing harm, CareFold plays a pivotal role in facilitating skin-to-skin contact, an internationally recommended practice that is vital for preterm infants. Skin-to-skin bonding helps regulate a baby’s temperature, improve heart rate and breathing, boost immune function, and enhance emotional connections between parent and child. Despite its proven benefits, this practice is often avoided in intubated babies because of the fear of tube dislodgment during transfers. CareFold makes these transfers safer and easier, allowing parents to hold their babies without risking their safety. By enabling more frequent skin-to-skin contact, CareFold not only improves the baby’s health outcomes but also strengthens the emotional bond between families and their child.

For parents, the NICU can be a deeply overwhelming and isolating experience. Many feel powerless, unable to participate in their baby’s care because of the fragile medical situation. CareFold changes this dynamic, giving parents the confidence to engage in critical bonding moments. For caregivers, it alleviates the stress and anxiety of handling high-risk transfers, allowing them to focus on delivering exceptional care without the constant fear of causing unintentional harm.

The impact of CareFold extends beyond clinical care. Unplanned extubations not only put babies at risk but also significantly increase healthcare costs. These events often lead to prolonged NICU stays, additional treatments, and increased staffing needs, all of which burden already strained healthcare systems. By reducing UEs by an estimated 75%, CareFold can shorten hospital stays by up to 5 days per patient, saving an average of $15,000 per case. This not only improves resource allocation but also ensures that more families have access to the critical care they need.