University of São Paulo-bred mechanical ventilator already in use at the institution’s general hospital

Ten units of the device developed at the university’s Engineering School (POLI-USP) began operating at Hospital das Clínicas in July.

By André Julião  |  Agência FAPESP – The first ten units of the INSPIRE low-cost mechanical ventilator developed in four months by 200 researchers at the University of São Paulo (USP) in Brazil were delivered on July 16 to the Heart Institute (INCOR) of Hospital das Clínicas (HC), the general and teaching hospital run by the university’s Medical School (FM-USP). HC is the largest hospital complex in Latin America. FM-USP partnered with the university’s Engineering School (POLI-USP) to develop the ventilator.

“It’s a great achievement, an important victory,” São Paulo State Governor João Dória said in a press conference held to announce the news on July 15.

“This feat was made possible not only by four months of hard work by 200 researchers but also by state government support and funding for São Paulo’s higher education and research institutions. It’s important to note that the participants in this project are researchers who have dedicated themselves to this topic and similar interests for decades. For this reason, when society needed it, we were happily able to make this equipment available in a very short period,” said Vahan Agopyan, Rector of USP.

The units just delivered are part of a pilot study involving 40 patients and authorized by the National Research Ethics Commission (CONEP). The team is now completing the last set of compliance requirements for the mass production of the ventilator to be licensed by ANVISA, Brazil’s national health surveillance authority.

“We’re preparing to produce 10 to 20 ventilators per day,” said Raul Gonzalez Lima, a professor at POLI-USP and principal investigator for the project. The ventilators are being assembled at a Brazilian Navy facility in São Paulo. Lima estimates that the process of complying with ANVISA’s requirements might be complete by mid-August.

Lima has been working for approximately 20 years to develop technologies to monitor and optimize mechanical ventilation in intensive care units (ICUs) with FAPESP support. Monitoring patients in intensive care can mitigate side effects, shorten the weaning process and minimize the duration of mechanical ventilation (read more at: agencia.fapesp.br/33249/).

“USP is a public university and research institution. One of its missions is technology and knowledge transfer,” Lima said. “The achievement we’re announcing is the result of 20 years of research in the pulmonary field combined with cooperation among several parts of the university.”

The specifications of a mechanical ventilator have to be very precise in order for it to provide effective lung support, Lima said, adding that this explains the importance of his team’s partnership with a group led by Carlos Carvalho, a professor at FM-USP and a member of the São Paulo State Coronavirus Contingency Center.

“In this epidemic, a well-organized ICU staffed by properly trained professionals is what can keep patients alive long enough to produce antibodies against the virus,” Carvalho said. “To treat respiratory insufficiency, the only option is mechanical ventilation. We have performed pilot tests and validated this ventilator. Tomorrow [July 16] we start a trial with 40 patients, which will last three to four weeks.”

“This is one more victory for academia and science, and it reinforces the commitment of the state of São Paulo to science and technology,” said Patrícia Ellen, economic development secretary in the state government. “Initiatives like this will genuinely make a difference and give São Paulo a welcome boost in the fight against coronavirus.”

Production cost

According to Lima, the unit cost of producing the device was initially estimated at 1,000 Brazilian Reais (BRL) but ended up being higher because of local currency depreciation and the addition of new components to comply with legislative changes. The cost is now estimated at BRL 5,000-10,000 (now approximately USD 1,000-2,000).

Gov. Dória added that if the ventilator is produced on a large scale, he will seek tax exemption for the manufacturers. “At present, it’s funded by donations and doesn’t pay either federal or state taxes. In the event of mass production, we’ll send the state assembly a bill to waive state tax for the producers. This isn’t a measure the executive branch can implement, but we expect it to come into force as soon as mass production starts,” Dória said.