FDA approves ventilator designed by particle physics community

In just six weeks, from March 19 to May 1, an international team of physicists and engineers led by Princeton’s Christian Galbiati brought a fan from concept to FDA approval.

The US Food and Drug Administration announced on Sunday May 3 that the Milano Mechanical Ventilator (MVM) East safe for use in the United States under FDA Emergency Use Authorization, which helps support public health during a crisis.

A massive international team led by Princeton’s Cristian Galbiati worked to design, test and finalize the Milano Mechanical Ventilator (MVM), a low-cost ventilator designed to alleviate device shortages caused by COVID-19. With FDA approval secured, production has begun and the first 20 ventilators are already on their way to hospitals. Full production begins next week, with an initial planned manufacturing rate of 50 ventilators per day.

This the fan is an original idea de Galbiati, professor of physics at Princeton University who normally conducts a dark matter experiment called DarkSide-20k. While confined to Milan, a city hard hit by COVID-19, Galbiati heard of ventilator shortages and wanted to help.

“The sense of crisis was palpable,” Galbiati said. “It was clear that many patients would require respiratory support.

He contacted other DarkSide-20k researchers to develop a ventilator with minimal components that could be quickly produced using commonly available parts. Dark matter researchers have extensive experience design and use sophisticated gas handling systems and complex control systems, the same capabilities required in mechanical ventilators.

“Princeton has provided strong support for more than 15 years to the DarkSide project, which aims to discover dark matter with an argon-based detector,” Galbiati said. “To this end, we have faced unique challenges, such as the development of special techniques to extract isotope-depleted argon from mantle gas wells and the development of cryogenic distillation columns hundreds of meters in height to further purify the argon. None of this would have been possible without the support of Princeton. Our scientific collaboration has grown to encompass nearly 400 scientists from 100 institutions, including many talented researchers with strong technical gas expertise and know-how. When the time was right, we were ready to turn our attention to the problem of mechanical ventilator development and put the collective talents of the collaboration to good use in this context.”

Word spread quickly, with engineers and physicists from nine countries – particularly Italy, the United States and Canada – stepping in to help. Experts who typically spend their days building and operating delicate detectors quickly applied their skills and volunteered their time to build a device for delicate lungs.

“We’ve taken a huge benefit from the way particle physics collaborations work,” said Steve Brice, head of the neutrino division at the Fermi National Accelerator Laboratory. “The structure already in place includes large international and multidisciplinary groups. We can reallocate that structure to work on something different, and you can act much faster. »

The MVM is inspired by the Manley ventilator built in the 1960s. The design is simple, cheap, compact, and requires only compressed oxygen (or medical air) and an electrical power source to operate. Mojtaba “Moji” Safabakhsh, head of the manufacturing group at the Princeton Plasma Physics Laboratory, was part of the initial team working seven days a week on the design. A mechanical engineer, he offered his expertise in the design of several aspects of the device. Design variables include volume and pressure control for example, when the system supports patient breathing, what type of valve to have, how the power supply and software components work.

“We had to see what kind of parts were available through the supply chain, what hardware we could get, and I gave my expertise on how it might work,” Safabakhsh said. The design needed to be simple and use readily available parts.

The modern twist on the classic Manley design comes from the electronics and control system. “We focus on the software and keep the hardware as minimal as possible,” said Stephen Pordes, a DarkSide member based at CERN, the European Organization for Nuclear Research.

The project was not limited to dark matter researchers. While working on the prototypes, the team worked with doctors, medical device manufacturers and regulators to ensure they were making something valuable and easy to use for medical staff, with a chain of robust supply and which could be produced quickly.

Christian Galbiati

“One of the main issues was translating between what the machine does technically and how the operators would interact with the machine itself,” said Elena Gramellini, an Italian neutrino physicist who liaised with first-line doctors. line in Italy.

Industry and medical experts made themselves readily available for consultation; the doctors tested the MVM prototypes on sophisticated breathing simulators. Anesthesiologists from the COVID-19 wards in Lombardy, one of the districts hardest hit by the pandemic, played a special role in providing detailed advice for the design of the unit. With collaborators spread across 10 different time zones, work on various systems was able to occur almost around the clock, allowing MVM to go from publishing a preprinted paper March 23 at FDA approval May, the 1st.

“It’s in our DNA to collaborate across borders and in real time as particle physicists,” Galbiati said. “As borders increased and supply chains became more difficult, it remained a ray of hope for me to be able to collaborate internationally. It is important to see that as the virus spreads around the world at the speed of jets, research spreads at the speed of the internet. And if there’s a way to beat the virus, it’s if research can prevail.”

While physicists are used to collaborating remotely, telecommuting and social distancing have added new complications. Researchers working from home did not have access to their labs – or all the parts they needed to test. Instead, they connected various components through the Internet. So a microcontroller in Italy could connect and receive software written in the United States, then have someone test the interface on a touch screen in Canada.

In early April, completed prototype MVM units in temporary 3D-printed enclosures were making their way through rigorous testing in Italy and with collaborators around the world – and they worked.

“This effort is the demonstration that the particle physics community pays attention to the application of basic research to social needs,” said Fernando Ferroni, professor at the Institute of Sciences of Gran Sasso and former president of the INFN, the Italian National Institute of Nuclear Physics. Applying the efforts of hundreds of people in a very effective way was possible thanks to the level of organization and the shared vision of this community. This is an incredible result, indeed.

The end result is an open-source fan with ready-to-use parts that the MVM team hopes will close the gap between supply and demand in a short period of time. Both hardware and software designs will be made publicly available, so in principle anyone in the world could create their own version. The modular design can also be adapted to interchange parts depending on their availability in different regions of the world. Additionally, the MVM is specifically aimed at COVID-19 patients, offering two key modes – full ventilation and gentler respiratory support – available at the touch of a single button. Most traditional fans require pressing half a dozen buttons or switching between different operating modes to accomplish the same thing. Galbiati is now working with Elemaster and other manufacturers to produce fans and get them where they are needed most.

“It was great to work with such a skilled and highly motivated group of scientists and engineers,” noted Arthur McDonaldwinner of the 2015 Nobel Prize in Physics and head of Canada’s involvement in MVM, who taught at Princeton in the 1980s. “Everybody worked hard on this because they see it as a way to use their skills to help in this global crisis.We are very grateful for the contributions of our team members and all the external support we have received.

“MVM is a new paradigm, and it shows the incredible impact that basic research can have on society, thanks to its unique ability to generate new knowledge and technological innovation; it also highlights the importance of international and multidisciplinary collaboration to meet the great challenges of this new era,” said Galbiati. “Our Milan mechanical ventilator is now a reality, and we hope it will help save many lives.

Princeton collaborators on the MVM include Peter Elmera senior research physicist; Bert Harrop, senior technician in physics and at the Princeton Institute for the Science and Technology of Materials (PRISM); Andrea Ianni, Borexino General Engineer in the Department of Physics at Princeton; David Langea computational physicist; Xinran Lia graduate student in physics; Daniel Marlowprofessor of physics Evans Crawford 1911 from Princeton; Javier Romualdez, postdoctoral researcher in physics; Mojtaba Safabakhsh, Manufacturing Group Leader in Engineering and Technical Infrastructure at Princeton Plasma Physics Lab; and Jeff Thompsonassistant professor of electrical engineering who is an associate professor at PRISM.

[Editor’s note: You can hear more from Cristian Galbiati on the June 29 episode of the “We Roar” podcast, available as audio or video with closed captions.]

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