The hospital ventilator sits at an intersection: It's complicated, expensive and scarce. The Spiro Wave ventilator from an ad hoc team of makers, inventors and health care experts seeks to address these logistical problems by moving ventilators to a different place.
Developed by New York based consortium Emergency Ventilator Response, the Spiro Wave is what it looks like: a robot that operates a balloon-style manual resuscitator by mounting it in a frame with software, sensors and actuators. That elevates a simple bag to one that automatically manages:
- How large a breath is pumped in.
- How often those breaths are pumped in.
- How much time to allow the patient to naturally exhale each breath.
- How much pressure to apply when doing all this.
And all without a human health care worker being impractically tethered to a patient's breathing device for long periods. About 30% of people who enter a hospital with COVID-19 need mechanical breathing assistance.
The Spiro Wave was inspired by initial work done at MIT on something called the E-Vent to demonstrate the core concept of automating a manual breathing bag. It was a direct response to the ventilator shortage in Italy.
The Spiro Wave isn't meant to replace full-scale hospital ventilators, but to support patients who don't need the most sophisticated machines, freeing up those top machines for the most critical patients. Spiro Wave can be used now under an FDA emergency authorization as the device works toward 510(k) review from the FDA that would speed its final approval.
The device costs about $3,300 as the first 3,000 units are about to be built in Long Island and prioritized for use in New York municipal hospitals. The initial $10 million to fund that run is being underwritten by the New York City Economic Development Council. As other companies come online to manufacture Spiro Waves under a free open source license, the cost is expected to drop to $2,500 or less, a far cry from the $30,000 price of full-featured ventilator.
Project lead Scott Cohen says the entire project could have collapsed for want of an $8 part called a pressure differential sensor. Sourcing those turned out to be difficult in an era when just-in-time manufacturing leaves little inventory on shelves, complicated by much of the world's supply chain being in shutdown.
The Emergency Ventilator Response consortium behind the Spiro Wave is mostly composed of New York firms that directly saw the need for its development: The Newlab tech incubator is located at Brooklyn Navy Yard, 10XBeta is a rapid product development company in Brooklyn, and Long Island's Boyce Technologies is better known for making assistance kiosks you see around subway stations. The name Spiro Wave, however, came from Austin, Texas, where design and innovation agency Frog Design based it on the Latin "respiro," which means "I can breathe."
There has been an easing of the ventilator crisis, and some suggestion that ventilators have been overused on COVID-19 patients, but the developers of the Spiro Wave say that is too narrow a perspective. "It's naive for us to think that something like this may not happen again, sooner or later," says Scott Cohen, co-founder of Newlab, "so why not be prudent and prepare at this time?" New York City Health and Hospitals CEO Dr. Mitchell Katz predicts "there's likely to be a second and third wave of coronavirus and those waves could occur with influenza. As bad as it was in New York, coronavirus did not emerge until the flu season was mostly over."
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