SBIR-STTR Award

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project includes improved performance and minimized complications of manual ventilation through the development of a cost-efficient and user-friendly medical device. The bag valve mask (BVM) is used during first-response and emergencies to manually deliver air to patients unable to breathe on their own. Approximately 13.1 million BVMs are used annually in the United States. Due to a lack of feedback mechanisms, providers are unable to judge their compliance with ventilation recommendations, resulting in a high incidence of life-threatening complications. In the intensive care unit, mechanical ventilators are used for safe and precise air delivery, but the quality is different. This project prevents complications of unsafe manual ventilation, thereby improving the quality of care and providing cost savings for the health system. The project will help bridge the gap between manual and mechanical ventilation, aiding first responders in the COVID-19 pandemic. This Small Business Innovation Research (SBIR) Phase I project will advance the science of emergency airway management. This technology will fit into the existing treatment workflow and supply-chain while addressing the need for safer ventilation during COVID-19. Improper manual ventilation due to delivery of unsafe pressures, volume, or frequency is common and occurs regardless of a provider's training or experience. The prevalence and severity of the problem have been studied extensively, establishing the need for the device. The research and development goal is to develop a device that can achieve performance and safety closer to a ventilator. Studies include characterizing usability, performance, efficacy, and biocompatibility.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.

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project will be to reduce the risk of complications and associated costs caused by standard bag valve mask (BVM) resuscitators, which are widely used in emergency resuscitation and airway management. In the United States, about 13.1 million BVMs are used annually. Medical providers frequently deliver unsafe manual ventilation with BVMs, regardless of the qualifications and experience of the provider. Dangerously high pressures, flow rates, and volumes of air flow can result in complications such as gastric insufflation, and less frequently, aspiration pneumonia, acute lung injury, acute respiratory distress syndrome, barotrauma, volutrauma, and pneumothorax. There is an urgent need for an intervention to improve patient safety during manual ventilation with the resuscitator bag. This project involves the development of a safety device to be used with all standard BVMs on the market to regulate air flow and pressure. The device that will offer safe, affordable, and optimized ventilation while minimizing gastric insufflation. The technology should have broad applications across the entire care continuum, but especially in emergency and battlefield medicine.This Small Business Technology Transfer (STTR) Phase II project seeks to further develop and optimize the BVM safety. This effort optimizes the haptic and auditory feedback the provider receives when using the device and optimizes the design and manufacturability of the product. In addition, biocompatibility studies and animal studies of the device in anesthetized pigs and in pigs undergoing cardiac arrest will provide data necessary for FDA clearance. This Phase II work will ensure that patients will receive the most optimal evidence-based treatment and will help establish the safety device as the standard of care.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.