It is an simple and robust emergency use ventilator design that is based on a pneumatic pump compressing a resuscitator bag; the device costs under $400 to build. It is designed to meet the standards for emergency use resuscitator systems (i.e., the AAMI/CR503:2020 specification) and includes calibration, control, monitoring and alarm systems.
Why would someone want to license it? (what is the critical solution and what is it’s competitive advantage)
While there are a large number of emergency use ventilator designs, this one stands out for three reasons:
1) it was designed and is being testing against the AAMI/CR503:2020 standard.; This will minimize the work and risk involved in getting FDA approval to manufacture and distribute the device;
2) the project has developed and will release a large codebase of sophisticated calibration, control and monitoring software that would take significant effort to produce;
3) it is almost entirely built from readily available parts and has a very simple and robust mechanical design; it can be built for under $400. Competing designs that provide the same level of performance typically cost several times as much to build.
Who would want to license it? (what specific companies or kinds of companies might be interested).
Any medical device company, and in particular medical device companies looking to provide an extremely simple and inexpensive ventilator that meets standards for extended emergency use.
What is the stage of development?
Several prototypes exist and the control software has been developed. We have collaborated with colleagues at VA Palo Alto Healthcare System to test the final design using a simulated patient and a set of testing scenarios that demonstrates that the device meets all of the AAMI/CR503:2020 performance specifications.
We are also reviewing the AAMI/CR503:2020 and underlying IEC:60601-1 standards to ensure that the design can meet all of the hazard mitigation, safe use, labeling and documentation standards.
Do you have a publication available?
The paper should be on the MedArXiv in ~1 week. This will document both the design and the testing that we are doing to demonstrate that the device meets the AAMI/CR503:2020 performance specifications.