A collaboration between Lawrence Livermore National Laboratory (LLNL) and medical device company BioMedInnovations LLC (BMI) resulted in an innovative mechanical ventilator for COVID-19 patients that was approved for emergency use just three months after the design work began.
As the COVID-19 pandemic surged and estimates predicted a critical nationwide shortage of ventilators, LLNL immediately began designing a durable, portable mechanical ventilator made from readily available parts to avoid burdening an already-strained supply chain.
On the other side of the country, BMI was also pivoting toward the pandemic from its traditional focus on devices used in organ and tissue perfusion. BMI is a North Carolina-based medical device startup that makes precision air and fluid flow devices.
LLNL and BMI came up with a promising design — tentatively dubbed NERVe (Novel Emergency Response Ventilator) — after only two weeks of late nights and extended hours of remote conferencing. Highly accurate pressure regulation technology was contributed by Equilibar LLC, a BMI partner. At five weeks, the team had the necessary ventilator test data and documentation to submit the design to the Food and Drug Administration (FDA) for approval.
The solution to the team’s manufacturing needs came from an unexpected source: professional race car engine shops, which were idle because of the postponement of all professional sports necessitated by the pandemic. The ventilator — renamed SuppleVent™ — is being manufactured by Roush Yates Manufacturing Solutions (RYMS), which builds engines for NASCAR teams as well as hardware for aerospace, defense and medical uses.
On June 8, SuppleVent was added to the FDA emergency use authorization (EUA) list. The device operates in continuous ventilation mode for late-stage COVID-19 patients but is adaptable to patients who eventually breathe independently while being treated. The machine is built from a minimal set of components to facilitate a rapid volume-build while keeping costs very low for global use.
This remarkable “all hands on deck” collaboration was largely remote, with many scientists, engineers and medical experts contributing from home offices due to shelter-in-place orders.
LLNL and BMI designed, produced and tested an easily reproducible ventilator design while partnering with manufacturing facilities and gaining authorization for the device’s emergency use. This remarkable “all hands on deck” collaboration was largely remote, with many scientists, engineers and medical experts contributing from home offices due to shelter-in-place orders.
The T2 mechanisms used to move SuppleVent from design to development so quickly included a Non-Disclosure Agreement among LLNL, BMI and Equilibar, executed March 30, and a Cooperative Research and Development Agreement (CRADA) for the NERVe innovation, between BMI and LLNL, executed May 6.
BMI and its partners are set to manufacture up to 1,000 SuppleVent machines per month. As of Oct. 30, the first round of devices was ready to ship, and 100 more devices were ready for assembly. The company is also addressing logistics to handle recent requests from multiple countries.
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