Developing safe devices for neonatal care

Abstract

Currently, the majority of medical devices are designed for adults; some are then miniaturized for use in neonates. This process neglects population-specific testing that would ensure that the medical devices used for neonates are actually safe and effective for that group. Incorporating human-centered design principles and utilizing methods to evaluate devices that include simulation and clinical testing can improve the safety of devices used in caring for neonates. However, significant regulatory, financial, social and ethical barriers to development remain. In order to overcome these barriers and create a pipeline of safe and effective neonatal medical devices, specific incentives are required.

Keywords: Human factors testing; Neonatal medical devices; Pediatric medical devices; Regulatory pathway.