AUSTIN (KXAN) — As local and state leaders continue to talk about the importance of ventilators in helping patients with breathing complications due to COVID-19, employees at a company in Pflugerville have been pulling long hours to design and manufacture low-cost ventilators.
Project development company Sisu is striving to produce ventilators that will cost less than options on the market, while also performing the necessary functions medical staff need.
Since mid-March, Sisu has developed a prototype and three different models of ventilators by using feedback from several hospitals and health systems. Currently, they are running tests on the models they have made so far and are awaiting an Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).
Sisu is optimistic they will be able to obtain that approval in the coming days, once they do, they plan to produce thousands of these ventilators. While many ventilators currently can cost tens of thousands of dollars, AIR BOOST says the ventilators this effort has made will likely range between $1,000 and $2,000 depending on the features.
A call for ventilators
Sisu, which has around 40 employees, typically works on machine and robotics projects, including a cinema robot and a knife sharpening robot. But in mid-March, Sisu CEO Russell Aldridge got a call from Austinite Stephen Yacktman.
Yacktman had recently joined together with friends and colleagues to form a nonprofit called AIR BOOST. Collectively, they wanted to help avoid Austin area health systems to become strapped during COVID-19 in the same way that health systems in Italy and New York have. They pooled money together into this nonprofit in hopes of creating a ventilator that’s both more affordable and that meets the needs of medical staff treating COVID-19 patients.
“We basically donated insurance money to society to make sure that there could be ventilators to be produced and we wouldn’t have to watch people go without them,” Yacktman said.
“We are not trying to make a margin, we are not trying to capture [research and development] costs,” he said.
Sisu CEO Russell Aldridge remembers getting a call from Yacktman on March 16. Aldridge remembered that Yacktman was citing reports that New York hospitals were projected to run out of ventilators within a few weeks.
“He asked if Sisu could make a ventilator in two weeks,” Aldridge said. “And I said absolutely we can, what’s a ventilator?”
Aldridge explained that his team got to work, speaking with a group of pulmonologists and respiratory therapists from both Mr. Sinai Hosptial in New York and Baylor Scott & White Health in Texas.
Sisu’s starting point for these ventilators was based on an open-source “E Vent” project started at the Massachusetts Institute of Technology 10 years ago.
Alison Ang, a software engineer with Sisu, explained that after using the MIT design as a jumping off point, the company “really expanded on more features, in working with doctors closely to get feedback.”
“We discovered it’s good to have additional features like assisted breathing and also controlling for the volume that’s delivered to the patient in real-time to ensure that the volume delivered is actually accurate,” Ang said.
She explained that the team adapted its design based on the feedback from doctors, over-nighting ventilator models to Mt. Sinai hospital for doctors to test on manikins.
“These doctors are actually treating COVID-19 patients, we would have them test the ventilator, and based on their feedback we would actually redesign that day and then overnight another ventilator to them to test,” Ang continued. “And that brought us to where we are today with a ventilator that has actually incorporated the feedback of physicians who have treated COVID- 19 patients.”
Sisu explained that by March 20, they had built a prototype for their first model of the ventilator and by March 23 they had begun prototyping subsequent models. All employees put previous work on hold to focus their energy in this project, many explained they had clocked 70- to 100-hour weeks to work on the ventilators.
Ang described the model Sisu wound up with as “not quite as bare bones at the MIT design” but also “an extremely low-cost version that actually is going to have some of the features doctors are wanting in this kind of ventilator.”
Because Sisu was initially planning to respond to an expected ventilator shortage, they were able to create 100 ventilator units within two weeks in the event that New York hospitals needed those. All team members, even those who wouldn’t typically be involved in assembly, pitched in to make this initial batch of ventilators.
Aldridge explained that when this project started, Sisu was looking to produce about 100,000 ventilators. But as the projections for COVID-19 spread shifted, Sisu has also shifted its targets. Instead of aiming to make 100,000 ventilators over the course of several months for an anticipated surge, the company is now planning to produce several thousand to help respond to potential regional surges in cases.
The Austin P51
The ventilator Sisu is working on now is named the Austin P51. Its name gives a nod to the Austin area where it was built, and draws inspiration the quick design and production of the World War II P51 Mustang fighter plane.
The Austin P51 uses “fingers” created by a 3D printer to compress a bag and push out air which will flow into COVID-19 patients’ lungs, to assist them in breathing or to move air for patients who cannot breathe on their own. The latest model is carried in a protective case so that it can be transported.
Many of the parts can be made in house by Sisu’s machinists. The ventilators can also be entirely assembled by hand. When Sisu does gets authorization to begin producing these, they plan to use the space in a nearby office building to assemble them on a larger scale.
What happens next
Aldridge explained that Sisu has been actively talking with the FDA and is hoping to get the agency’s Emergency Use Authorization soon.
An FDA spokesperson told KXAN that they can’t provide specific information on EUA submissions because they are generally considered confidential, commercial information.
The spokesperson explained that during the pandemic, the FDA “is allowing for maximum regulatory flexibility for devices that are critical for the response to COVID-19.” This emergency flexibility includes ventilators.
“Our staff are reviewing applications rapidly,” the spokesperson said. “As long as data supports the application, we are authorizing these products quickly. “
Sisu is running stress tests on the ventilators they have to see how many cycles they can run continuously. The Sisu break room has been turned into a buzzing, humming testing ground for ventilators, complete with pressure gauges and manikins.
When Sisu gets FDA authorization, they already have orders to fill for more then 1,000 ventilators, which will go to Texas hospitals.
Aldridge explained of the ventilators his team has been working on, “there’s some local hospitals and local state governments that have been really interested in this device.”
“We’ve also been talking with the military, we’ve passed the Army’s first and second rounds of a contest, they could order thousands of devices, basically as an insurance policy in case the disease flares up again,” he added.
If the ventilators are not needed in the Austin area or in the U.S., Sisu explained that these units could also be sent internationally to locations which do not have many ventilators per capita.
“We hope that the small effort we’ve put forward here can make a difference in somebody’s life,” Aldridge said.
AIR BOOST says its founders are paying for the design, engineering and production of these ventilators. The ventilators will be sold for the cost of labor and cost to make them, the nonprofit said. Now that the supply chain for these ventilators is set up, people who would like to donate to the labor for future P51 ventilators can do so at this GoFundMe page.
The need for ventilators
The Texas Department of State Health Services told KXAN Wednesday that there are 6,615 ventilators available in Texas. A spokesperson explained that throughout the pandemic that Governor Greg Abbott’s Supply Chain Strike Force has been purchasing (and will continue to purchase) personal protective equipment and other equipment to “to be sure Texas has the necessary resources it needs to respond to COVID-19.”
Austin-Travis County reports having a total of 534 ventilators, which include 437 adult ventilators and 97 ventilators for children. A city spokesperson told KXAN that of those 534 ventilators, that 407 were available on May 6 (66 pediatric ventilators and 341 adult ventilators).
Austin Public Health says it has not seen any particular surges in the demand for local ventilators so far. However, hospitals continue to report their ventilator numbers to Austin Public Health and the department says it has “a cache of ventilators on local, regional, and state-level which can be quickly deployed as needed.”
Correction: A previous version of this story listed Sisu as a Round Rock company. The business has Round Rock mailing address but it is technically within Pflugerville city limits, the company says.