Complications from preterm birth and during childbirth are among the top three killers of children under-five. Many newborns require immediate medical attention in the neonatal intensive care units (NICU) where they are subjected to medical procedures that require specialized medical devices. Despite the advances in research and development of novel medical devices, the efforts directed to produce neonatal-specific devices are limited. Equipment and instruments used in the NICU are miniaturized adaptations of those used for older patients and are not optimized for safety and efficiency as it applies to newborns. In addition, design, development, testing, and fabrication of neonatal specific devices are not attractive for large medical device manufacturers due to the small market size for such products. Therefore, it is crucial to establish new fast, reliable, and cost-effective ways to manufacture innovative devices that are safe and effective for infants and neonates who have need of routine, as well as intensive care, treatments. Additive Manufacturing allows for the production of complex components and devices without the need for specialized tools or molds, which permits rapid design changes and implementation on a small number of units. Currently, polymer/printer combination that would allow the manufacturing of neonatal specific devices does not exist.
The National Institute of Health is strongly emphasizing the urgent need for research and development to design novel devices as well as improve existing devices and instruments used in neonatal intensive care units and outpatient settings. The limitation of currently used equipment is highlighted by the absence of thorough performance and safety research and testing of these devices as it applies to the neonatal patient population. Positive pressure ventilation, insertion of a feeding tube, and peritoneal dialysis due to one or more congenital defects (e.g. atrioventricular septal defect, tetralogy of fallot, gastroschisis) are common procedures performed on newborn infants. Currently, available medical devices for these procedures come with their inherent limitations when applied to infants, making it challenging to care for sick newborns. Thus, there is a need for advances in the manufacturing of medical devices specifically designed for the neonatal population.
Expenditures required for design, development, testing and IP development of new and unique neonatal specific medical devices are considerable. Furthermore, the market size for these devices is very small (in 2015, preterm birth affected <400,000 babies), limiting large medical device manufacturers from offering a solution to this critical problem. Moreover, extremely small and variable body sizes of premature and newborn babies make it difficult to develop and manufacture the devices with appropriate dimensions, especially for this patient population. Consequently, an alternate, yet commercially viable manufacturing process must be established to produce medical devices in appropriate sizes and configurations to aid neonatal patients.
AM is an alternative solution for the production of neonatal devices. AM has become an accepted manufacturing process in cases of customized, low-cost, and low-volume production of parts and objects. Flexibility in customization and on-demand manufacturing are the greatest strengths of this technology. AM has been used to produce patient-specific medical devices such as dental braces, surgical implants, and hearing aids. The process is capable of building complex 3D objects designed in CAD software or converted from a CT or MRI scan, thus making it a perfect candidate for the manufacturing of small quantities of medical devices in shapes and sizes that are patient-specific and not currently available.
This effort was specifically designed to address the above challenges. The project was focused on the development of NEOSAFE – 3D printable polymer formulations for the manufacturing of neonatal-specific devices using the PolyJet process. The appeal of using PolyJet in its ability to process multiple materials simultaneously, which allows the fabrication of objects with rigid, plastic-like, or rubber-like parts. Furthermore, PolyJet is a fast process that creates parts with a very smooth finish. Commonly used materials for PolyJet are acrylic-based polymers, which have high cytotoxicity due to residual unreacted acrylate groups. The NEOSAFE formulations developed in this project would have excellent biocompatibility and satisfactory mechanical performance to manufacture neonatal specific devices.