Colombian Engineers’ Ventilators to Be Tested in COVID Patients

At its core, a ventilator is a simple machine, blowing oxygen-rich air into a body and removing carbon dioxide–loaded exhalations.

But when the team of five got to work trying to reverse-engineer one of the hospital’s ventilators, they quickly realized that building a dependable replicate of the biomechanical instrument wasn’t a trivial task. The robots and vehicles that the group was used to making were easy enough to repair if they broke. But if a ventilator had even a minute imperfection, a patient’s lungs could rupture. “We had to change everything in our thought process because we knew that everything had to be extremely reliable,” Echeverry says. “People could die if we made mistakes. That was different from anything that we had done before.”

Fast forward three months, and the team had produced a working prototype that could ventilate a sedated pig. It costs less than $3,000 to make—a fraction of the usual price tag, which can reach into tens of thousands of dollars. But the researchers still have to clear the hurdle of demonstrating that the machines can keep real patients alive.

Echeverry’s group is one of dozens in low- and middle-income countries racing to build low-cost, emergency replacements for the standard-of-care ventilators that have been already bought up or given unattainable price tags thanks to bidding wars between wealthy nations. If projects such as Echeverry’s succeed, they could not only save lives, but also improve ventilator design more generally and empower local communities by proving that “you don’t need to be a Philips or some billion-dollar company to make them,” notes Daniel Kraft, a Silicon Valley–based biomedical entrepreneur and chair of Exponential Medicine, an annual medical conference.

At its core, a ventilator is a simple machine, blowing oxygen-rich air into a body and removing carbon dioxide–loaded exhalations. The challenge for engineers such as Echeverry is to ensure that it does that job consistently, and can precisely measure the volume, pressure, and timing of the breaths passing through a patient. If the air pressure entering a patient’s lungs is too low, her lungs could partially collapse and oxygen levels could drop dangerously, and if it’s too high, “you could literally blow a hole in the lung,” notes James Frank, who directs the pulmonary and critical care fellowship training program at the University of San Francisco, California. This need for precision in the parts of the ventilator that sense air volume, pressure, and other factors is in part what makes the machines so expensive.  

Echeverry and his colleagues decided to make their own mechanical sensor to measure the amount of air being passed into a patient—something that proved to be their biggest challenge, although eventually the researchers figured out a way to do it, Echeverry says.

Industrias Médicas Sampedro, a Colombia-based company that makes implants for trauma surgery, launched several of its own ventilator-building projects in March. Mauricio Toro, the CEO of TECHFIT Digital Surgery, a Florida-based branch of the company, says that he and his colleagues were able to cut costs by sourcing ventilator components locally. In a collaboration involving three different teams—one led by TECHFIT and its parent company, and two spearheaded by local universities—Toro and his colleagues have created three different prototypes designed to be built primarily with parts made by Colombian manufacturers, although some components, such as pressure-controlling, corrosion-resistant oxygen valves, which undergo extensive safety testing, still had to be imported.

Like University of La Sabana’s prototype, Toro’s three models have passed their first test: keeping a sedated pig alive for several hours while the animal couldn’t breathe on its own. Both teams aim to connect their ventilators to human patients in the coming weeks. Echeverry’s group, which just received the green light to start testing, plans on ventilating five human COVID-19 patients, alternating every four hours with a commercial ventilator that will be on standby the whole time should anything go wrong with the team’s prototype.

Toro is working with Colombia’s medical device regulatory body, INVIMA, to develop a trial for human testing. He says he already has 100 ventilators ready should the pandemic spiral out of control before Toro has a chance to properly test the devices—an emergency situation for which regulatory authorities would approve of the devices’ use. “We sincerely hope that we are not needed and that the health system of the country is able to cope with the pandemic,” he says. “But in case it gets overrun, we’re happy to be there.”

There are dozens of similar projects underway across Colombia.

Although the devices have yet to be tested in people, Frank says he’s impressed with all of the designs so far. Referring specifically to one of Toro’s models, he notes that, “compared to a modern ventilator that’s been tested and approved by our country’s FDA, I would be a little bit more worried about it, but its ingenuity, its low cost, and its attention to most of the key details that give clinicians concern make me think that it’s a pretty good design.”

However, the simplicity of some of these low-cost ventilators may come with some trade-offs, Frank notes. Standard-of-care ICU ventilators allow for patients’ own lungs to do some of the breathing as well, adjusting the amount of air they put into the patient accordingly. That kind of dynamic functionality is challenging for Echeverry’s ventilator, for example, which would require sedating patients so the machine could take full control over the breathing process. That, however, makes it harder for doctors to evaluate patients’ clinical progress.

Another point to remember is that ventilators alone aren’t enough to prepare an ICU ward for a pandemic, Kraft notes; that would require access to sufficient sedative medications, anesthesiologists, as well as personnel trained to operate the devices. To address part of this issue, Toro launched a training program for hospital staff learning to use his ventilator models.

The TECHFIT and University of La Sabana groups are the furthest along with their designs, but there are dozens of similar projects underway across Colombia, which gives Echeverry hope that the country will escape severe ventilator shortages. “Every single city in Colombia was able to develop a big project around [building] ventilators,” he says. “We are actually very proud of Colombian engineering.”

This story is part of a series by The Scientist on how researchers around the world are pitching in to aid the effort against COVID-19. 

Click through to find out about more projects that research teams in other countries are working on.