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. 3D printing is a process of building parts layer upon layer from the digital model. It allows for production of complex components and devices without the need for specialized tools or molds, which allows for rapid design changes and implementation on a small number of units. Currently, polymer/printer combination that would allow manufacturing of neonatal specific devices does not exist. This proposed Phase I SBIR effort is specifically designed to address the above challenges. In this effort, Lynntech proposes to develop NEOSAFE - 3D printable polymer formulations for manufacturing of neonatal-specific devices using PolyJet processes. The appeal of using PolyJet is its ability to process multiple materials simultaneously, which allows 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 by Lynntech in Phase I will have excellent biocompatibility and satisfactory mechanical performance to manufacture neonatal specific catheters. During this Phase I project, we will demonstrate proof-of-concept by pursuing the following specific aims: (1) development of 3D printable materials for neonatal device manufacturing (NEOSAFE) and (2) assessment of printed materials for biocompatibility, mechanical performance, and sterilizability. Successful completion of these specific aims should demonstrate ample feasibility of using NEOSAFE as feedstock for 3D printing and allow Lynntech to plan more comprehensive technology development and commercialization avenues, in addition to exploration of applications of NEOSAFE for manufacturing of other neonatal specific devices.
Lynntech proposes to develop polymer/printer combination for 3D printing of neonatal specific devices. We will develop polymer formulations, validate their printability, and evaluate biocompatibility and mechanical performance of printed samples. This novel 3D Printable polymer will provide capability to manufacture medical devices specifically for newborns, thus reducing morbidity and mortality rates of these patients.
