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What you do when disaster hits: Build an army of volunteers and get to work

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.

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