Italy was one of the epicenters of infection after the outbreak in China.
He and research colleagues began to develop a simple ventilator that could be assembled quickly with minimal and easily found parts.
“The sense of crisis was palpable,” Galbiati said. “I knew the availability of ventilators was critical.”
Fermilab is a U.S. Department of Energy particle accelerator lab based outside Chicago, Illinois. With many Fermilab experiments on hold during the quarantine, engineers and physicists from nine countries collaborated on the ventilator project.
Volunteers broke into teams and met daily to identify obstacles and share results. Ultimately, more than 200 scientists, engineers, technicians, business representatives and doctors contributed to the project. The group even included a Nobel laureate, Canadian physicist Arthur McDonald.
Winning FDA approvals was a daunting prospect. The international standards were written in legalese that was as foreign to Raaf as particle physics equations are to most nonphysicists.
“I was working with a stack of virtual documents at least an inch thick — descriptions of how the device works, diagrams of what it does, flow charts of algorithms for ventilation,” Raaf said.
“It was pretty intense. I quickly learned I was in the deep end of the pool. I didn’t know what I was getting myself into,” she said.
She conferred with volunteers working on integration, hardware and software to make sure the ISO requirements were communicated in plain language.
“This requirement means we need to make sure the device must automatically switch to backup power if the cord gets unplugged,” she said. “In ISO language, it’s not so easy to understand.”
The FDA granted an emergency use authorization on May 1.