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 revealed a nationwide shortage of ventilators, LLNL immediately began designing a durable, portable mechanical ventilator to help fill the gap. LLNL scientists set an additional goal of using readily available parts to avoid impacts to 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. 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. LLNL and BMI also pursued manufacturing assistance to scale production to a high volume, depending on how the disease spread.
The solution to the team’s manufacturing needs came from an unexpected source—the race-car engine shops of NASCAR and Indy Car, which were idle due to the postponement of all professional sports necessitated by the pandemic. The ventilators—renamed SuppleVent™—will be manufactured by North Carolina-based Roush Yates Manufacturing Solutions (RYMS), which builds engines for multiple NASCAR teams as well as hardware for aerospace, defense, and medical applications. The racing connection also led to testing and engineering advice from Indy Car engine designer Honda Performance Development.
The racing connection also led to testing and engineering advice from Indy Car engine designer Honda Performance Development.
On June 8, 2020, SuppleVent™ was added to the FDA Emergency Use Authorization (EUA) list, only three months after the project began. One LLNL researcher said that, for this life-saving project, the typical device development process of many years had been reduced to a few weeks.
LLNL and BMI designed, produced, and tested an easily reproducible design prototype while partnering with manufacturing facilities and gaining authorization for the device’s emergency use. This remarkable collaboration was largely remote, with scientists, engineers, and medical experts contributing from home offices, in many cases, due to shelter-in-place orders.
While industry partnerships forged in cooperative research and development agreements (CRADAs) often take years to deliver a commercial product, particularly a medical device, the LLNL/BMI CRADA produced the SuppleVent emergency ventilator—FDA-cleared for use and approved for sale—in just a few months.
BMI estimates the cost of the suitcase-sized SuppleVent™ units will be a small fraction of a traditional ventilator, making SuppleVent™ easy to deploy in a sudden resurgence of COVID-19. The device can also serve patients with Acute Respiratory Distress Syndrome (ARDS) and other breathing difficulties, particularly where ventilators are in short supply such as underdeveloped areas and rural medical services.
The rapid creation of SuppleVent™ in the midst of technical and public health challenges exemplifies the propulsive energy and productivity that LLNL and its industry partners can apply to complex problems. The engineers and scientists involved are proud to contribute to the saving of lives.
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