SBIR Phase II: A Novel Respiratory Bag-Valve-Mask Resuscitator

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel device which reduces injury to patients by emergency personnel when using a bag-valve-mask (BVM) manual resuscitator. BVMs are used in pre-hospital and hospital settings by emergency medical personnel on a daily basis to deliver air to critically ill patients. Their basic design has been in place for over 60 years and are often misused resulting in damage, complications, or occasionally fatal lung injury. This project will complete development of a novel BVM that precisely controls the volumes and pressures delivered, and aims to redefine the stagnant BVM market which is projected to surpass $750M annually by 2025. This Small Business Innovation Research (SBIR) Phase II project develops a novel, adjustable, universal bag-valve-mask resuscitator enabling emergency providers to deliver air volumes and pressures customized to patient body size. Current devices are commonly misused, even by highly trained medical personnel, resulting in hyperventilation, barotrauma, and occasional death. The project will complete remaining design and testing tasks, and a human factors proof of concept study to demonstrate users are able to quickly and properly utilize the device with minimal instruction will be performed. The second objective will address manufacturability and testing requirements within standards for US approval. Finally, the third objective is to establish the assembly processes and initial quality control testing to ensure consistent manufacturing at scale and in a cost effective and quality consistent manner. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.