MedAcuity Software (Westford, Mass.) announced today that it has volunteered to provide technical software assessment for The Ventilator Project, a non-profit working on developing a low-cost ventilator specifically for COVID-19 patients.
Founded in March 2020 by entrepreneur Tyler Mantel of Watertower Robotics, The Ventilator Project has built a team of more than 250 volunteers from diverse backgrounds, including The White House, Cornell University, Google and the San Francisco 49ers.
Their efforts have resulted in AIRA, designed as a scalable ventilator that uses materials sourced from outside the medical supply chain. MedAcuity will provide a gap analysis of the work completed by project’s engineers to offer guidance around hardening software and system-level requirements, deploying necessary process and best practices, documentation and supporting artifacts that will be needed to successfully clear a 510k submission. The group is also seeking an FDA emergency use authorization to speed its availability for COVID-19 patients.
The Ventilator Project recently concluded a rigorous three-week testing phase to ensure that the ventilator meets all the required safety specifications, according to MedAcuity.
“Seeing the devastation that hospital teams around the world were facing as the number of critical COVID patients began to exceed available ventilators, we recognized that something needed to be done quickly,” Mantel said in a news release. “We’re working under greatly expedited conditions, so it’s particularly essential to patient safety that everything is done right from a compliance perspective the first time around — and that’s where MedAcuity’s expertise will be invaluable.”
“When we heard what The Ventilator Project was aiming to do, we knew immediately that we wanted to get involved,” added Susan Jones, engineering manager at MedAcuity. “In the cases of hospitalized COVID-19 patients, timely access to a ventilator can mean the difference between death or full recovery. By applying MedAcuity’s expertise, we can help accelerate the process of ensuring AIRA’s software will be highly effective and FDA compliant.”