The devices are a telehealth tool to track newborn development, a wearable phototherapy device, a portable oral aspirator, a novel endotracheal tube, and a one-step adrenal crisis management device.
Funded by the U.S. Food and Drug Administration and based at Children’s Hospital of Philadelphia (CHOP), the PPDC provides know-how and seed funding to help innovators translate promising ideas into commercialized medical devices for use in children. The PPDC is a collaboration involving CHOP, the McGowan Institute for Regenerative Medicine and sciVelo of the University of Pittsburgh, and the University of Pennsylvania.
“This round’s sponsored device projects represent a range of clinical disciplines and will provide novel solutions to unmet needs in pediatric healthcare,” said Robert J. Levy, MD, attending cardiologist in the Cardiac Center at CHOP, the William J. Rashkind Endowed Chair in Pediatric Cardiology at CHOP and the Consortium’s Principal Investigator.
Neoneur LLCof Pennington, NJ is creating the Neoneur, a telehealth-enabled device that provides objective measurements of infant oral feeding capability and developmental status. An infant’s feeding skills consist of patterns driven by the brain to enable adequate nutrient consumption and respiratory protection at the same time without hindering growth. All infants must have feeding skills to thrive, but currently clinical observation is the only means to assess them. The Neoneur will enable the ability to monitor feeding and skill development for at-risk infants both in the hospital and through telemedicine at home to enable earlier discharge, decrease readmissions, and aid in early identification of developmental issues.
TheraB Medical, a pediatric startup out of Michigan, is developing SnugLit, a wearable infant swaddle that treats neonatal jaundice with phototherapy. Neonatal jaundice affects 2.4 million infants in the United States and as many as 20 million globally. The most common treatment involves light therapy systems, which require constant monitoring by nursing staff and cause prolonged separation of mother and child. With SnugLit, babies no longer have to be separated from their parents during phototherapy, but instead can receive complete treatment in the arms of their caregivers.
Tychermont Products LLCof Philadelphia will receive support for the OrVac™, a portable oral aspirator to assist patients with pediatric dysphagia and other swallowing disorders. To date, these patients do not have a way to self-suction oral waste without assistance. The OrVac™ returns control and independence to the patient by providing a portable, non-invasive, and user-controlled device to evacuate oral liquids.
The University of Illinois at Chicago, in partnership with Olifant Medical Inc, will receive support for Dr. Girish Deshpande’s work on the SecureTube™, a new endotracheal tube with several features designed to mitigate various factors that lead to unplanned extubations in pediatric patients. Unplanned extubations can lead to significant complications, especially in young infants, who could suffer cardiac arrest requiring CPR and may need an emergency re-intubation. Unplanned extubations are also associated with increased respiratory tract infections, increased length of ICU and hospital stays, and an overall increase in healthcare cost. The unique two-port design of the SecureTube™ and its specially designed holder will standardize the way endotracheal tubes are secured to the patient. It will replace the currently used Y-adapter and bite-block and will eliminate the use of tape that will minimize, if not eliminate, the unplanned extubations and associated complications.
SOLUtion Medical LLCof Philadelphia is developing the TwistJect™, a device that enables caregivers to manage children during an adrenal crisis. Adrenal crisis is a life-threatening condition resulting from insufficient levels of the hormone cortisol. Children and adolescents experience some of the most severe morbidities of all patients who experience adrenal crisis due to the difficulties in managing adrenal insufficiency in younger populations and the difficulties in providing rescue injections. The TwistJect™ is a one-step delivery device that reconstitutes hydrocortisone sodium succinate and removes all entrapped air in one user step.
Applications for PPDC funding opportunities are accepted from throughout the U.S. The Consortium also accepts applications year-round for in-kind services and expert advice.
We are hosting The Pediatric Device Innovators Forum (PDIF), a new, quarterly collaborative educational experience from the FDA and the five Pediatric Device Consortia designed to connect and foster synergy among innovators across the technology development ecosystem who are interested in pediatric medical device development. From pediatric clinicians and surgeons, to academia, engineers, industry, entrepreneurs, investors, and more, this event is for you.
The Pennsylvania Pediatric Medical Device Consortium and its partners at the McGowan Institute for Regenerative Medicine, University of Pittsburgh, are hosting the first forum in the PDIF series as part of McGowan's Annual Scientific Retreat.
Biomaterial Challenges in Pediatric Prosthetic Heart Valve Development March 11, 2021 at 3-4:30pm EST Please register at: https://www.pdiforum.org
Somerville, MA, September 17, 2019 – Little Sparrows Technologies, a neonatal medical device startup committed to promoting the well-being of newborns, announced today it has received 510(k) clearance from the Food and Drug Administration (FDA) for the bili-hut™. The bili-hut is an innovative ultraportable neonatal phototherapy system that leverages a bassinet-like design to treat hyperbilirubinemia, commonly known as neonatal jaundice. The device features a unique curved light emitting diode (LED) illumination canopy that delivers high-intensity blue light phototherapy. This highly portable device allows newborns to effectively undergo jaundice treatment anywhere – at home or in a hospital setting.
“Neonatal jaundice is very common and is often diagnosed when a newborn is almost ready for discharge from the hospital or after the baby is home for a few days, requiring longer hospital stays or readmittance,” said Dr. Donna Brezinski, CEO and founder, Little Sparrow Technologies. “Phototherapy treatment typically occurs in NICUs, which separates newborns from their mothers who are bonding and establishing breast feeding. The bili-hut provides the best possible start for jaundiced babies by enabling treatment at the mother’s side, whether in the hospital or at home.”
Neonatal jaundice is a transitional phenomenon which affects three out of five newborns in their first weeks of life. Jaundice causes a yellow discoloration of the skin and eyes in newborns and typically subsides within a few days. In newborns with severe jaundice, blue light phototherapy is required to prevent irreversible neurologic injury.
Jaundice is also one of the most common diagnoses associated with infant readmission to a hospital in the first month of life. In the United States, it is estimated that 100,000 infants develop severe jaundice, costing the healthcare systems $500M annually for hospital-based care. Hospital phototherapy devices can be daunting for new parents and extended hospital stays are often stressful and expensive. Invented by Dr. Brezinski, a neonatal-perinatal specialist, the bili-hut is capable of delivering hospital intensity phototherapy at the parent’s bedside in either the postpartum room or at home, presenting a new, innovative and cost-effective approach to addressing the challenges of treating jaundice. With the bili-hut doctors can improve the quality of care for infants by maintaining a close relationship with parents while helping to reduce emergency room visits and readmissions.
The bili-hut will be on display at the Little Sparrows Technologies booth #133 at the 2019 American Academy of Pediatrics National Conference & Exhibition in New Orleans, October 26-28. For more information on the bili-hut, visit www.little-sparrows-tech.com.
About Little Sparrows Technologies:
Founded in 2013 by Harvard Medical School affiliated doctors, Little Sparrows Technologies offers an innovative approach for treating jaundice. The bili-hut™ is a cost-effective phototherapy device that uses blue LED lights in a reflective bassinet that is capable of operation on battery power. It is simple to use and collapsible for easy transport. Little Sparrows has received two phases of funding from the NIH’s Small Business Innovation Research (SBIR) program, and The World Health Organization included the bili-hut in its Compendium of Medical Devices for Global Health. Little Sparrows Technologies was the winner of a 2018 Patents for Humanity Award. The company offers solutions to support hospitals, US pediatrician offices and international implementations. For more information, visit www.little-sparrows-tech.com.
FDA Commissioner, Scott Gottlieb, recently announced plans to update the FDA's 510(k) pathway for approving new medical devices. The new plan emphasizes a need to be less reliant on older predicate technologies, and may publish when an applicant uses a predicate more than 10 years old.
"We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria."
A partner organization of the PPDC. NAMSA is a medical research organization providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers.
Provides information about the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, including opportunities to apply for federal funding to support small companies in research and development that has a strong potential for commercialization