In just 3 short weeks we have:
Designed, fabricated, and tested prototype 1.0 in the UC Med Simulation center and confirmed performance on an instrumented respiration dummy
Reviewed and demonstrated the unit to 36 UC Med doctors, respiratory therapists, and trauma nurses to receive and incorporate feedback on fitness for use.
Submitted to the FDA an initial description, incorporated FDA feedback, and submitted a full package this week for level II device clearance
Created an FDA submittal package that includes performance data, specifications, photos, blueprints, schematics, operating instructions, cleaning instructions, etc….
Designed, fabricated, and tested a sensor module that mitigates the risk the FDA identified with alarms to medical personnel should a BVM bag break
Evaluated multiple supply paths and have selected our initial company to fabricate, assemble, test, document, package and ship the first 50 units
Evaluated companies capable of joining the supply stream; some of which produce FDA Level II products today.
Organized a broad team of experts into sub-teams for; Design/Engineering, FDA, Medical review, Manufacturing, Supply chain, Legal, Funding, and Communications
Engaged directly with the Covid 19 teams in Ohio, New York, and the White House.
Requested and received a $100,000 grant from P&G to move forward with prototypes and preordering components for our first batch of units.