In a little over a month, a team of physicists and engineers from around the world took a simplified ventilator design from concept all the way through approval by the U.S. Food and Drug Administration. This major milestone marks the ventilator as safe for use in the United States under the FDA’s Emergency Use Authorization, which helps support public health during a crisis.
The Mechanical Ventilator Milano, or MVM, is the brainchild of physicist Cristiano Galbiati. The Gran Sasso Science Institute and Princeton University professor, who normally leads a dark matter experiment in Italy called DarkSide-20k, found himself in lockdown in Milan, a city hit hard by COVID-19. Hearing reports of ventilator shortages and wanting to help, Galbiati reached out to fellow researchers to develop a ventilator with minimal components that could be quickly produced using commonly available parts.
Word spread quickly, with engineers and physicists in nine countries – especially Italy, the United States and Canada – joining in to help. At the U.S. Department of Energy’s Fermilab, the researchers who typically spend their days building and running delicate detectors quickly applied their skills and volunteered their time to build a device for delicate lungs.
The MVM is inspired by the Manley ventilator built in the 1960s. The design is simple, inexpensive, compact and requires only compressed oxygen (or medical air) and a source of electrical power to run. The modern twist comes from the electronics and the control system.
And volunteers have jumped in with a wide range of skills. Fermilab technical editor Anne Heavey joined to work on documentation and the user manual, repurposing the formatting of the recently published Technical Design Report for DUNE. Elena Gramellini, an Italian neutrino physicist working at Fermilab, liaised with doctors on the front lines in Italy. Jen Raaf, a neutrino physicist who works on liquid-argon experiments, worked with the medical device manufacturer Elemaster and led the effort to bring together all the elements needed for FDA approval.
The project has not been limited to the researchers. While working through the prototypes, the team made sure to engage doctors, medical device manufacturers and regulators to ensure they were making something useful for hospitals, creating something with a robust supply chain that could be quickly produced and building the ventilator to the right specifications.
Experts from industry and medicine made themselves readily available for consults; doctors tested the MVM prototypes on breathing simulators. Underlying all the long extra hours and stress of the intense project was a sense of urgency and motivation for all involved.
With collaborators spread across 10 different time zones, work on various systems was able to proceed nearly around the clock, allowing MVM to progress from posting a preprint paper on March 23 to FDA approval on May 1.
By early April, completed prototype MVM units in temporary 3-D-printed cases were making their way through rigorous tests in Italy and with collaborators around the world – and they worked. Eric Dahl, a Fermilab and Northwestern University scientist, was able to use a breathing simulator at Northwestern Simulation (a clinical training center part of Feinberg School of Medicine) to test one of the first prototypes and provide input on the way to the approved design. The MVM now works properly in two modes: full ventilation of a patient and breathing support.
The end result is an open-source ventilator with off-the-shelf parts that the MVM team hopes will close the gap between supply and demand on a short timescale. The hardware and software designs will be made publicly accessible, so in principle, anyone in the world could make their own version. Galbiati is now working with Elemaster and other manufacturers on the first bulk production and getting ventilators to where they are needed most.