Tarik Yousef runs TY Fine Furniture in Clintonville. But with his store shuttered, Yousef has devoted his time to building a ventilator he hopes can help meet the sudden demand caused by the coronavirus pandemic.
The ventilator is a broad flat box made of white plastic, a bit bigger than a briefcase.
“I’m here working on our COVID-19 ventilator project,” he says in one YouTube video. Walking around to one side, he zooms in on a touchscreen display. “Here is our working model, pumping away—we’re measuring our volume and our speed.”
There’s a small arm on one end rising and falling in rhythm to squeeze a plastic airbag.
As cases of COVID-19 rise, Ohioans are looking for all sorts of ways to help. Businesses are retooling and sharing their stores of gloves and other equipment. An army of residents are cranking up sewing machines to make masks for first responders.
Yousef decided to go in a different direction. Although he runs a furniture store now, his background is in mechanical engineering. In college he even participated in a project that built an artificial heart.
"Although, I've never been really a medical kind of guy in general," he says, "I found it pretty intriguing that we could essentially mimic a heart mechanically."
After school he went to work for Honda. In another of his YouTube videos, he points out one of the sensors on his ventilator is also in every new Honda on the road. He readily admits his background doesn’t scream "medical device manufacturer," but the same can be said of large factories trying to shift their production on the fly.
“I know that timeline, and it’s just not feasible,” Yousef says. “They’ll be cranking out ventilators after this whole thing is over with. So it doesn’t really solve a problem if you can’t do it essentially overnight.”
The plan, Yousef says, is to produce these units for less than $1,000 and to get them in the hands of physicians as quickly as safety allows. Once he’s cleared to go forward, Yousef believes he could ramp up to building 1,000 units a week.
“Early on, I kind of see-sawed between doing this and not doing this, and I realized that within weeks the country needs a million ventilators,” Yousef says.
With a bit of back-of-the-envelope math, he didn’t see a way for manufacturers to meet demand. And, Yousef explains, he couldn’t quite shake the sense that he had the skills to build a what physicians are going to need.
At its core, a ventilator is a fairly straightforward piece of technology. But it requires a highly-skilled medical professional like a respiratory therapist to oversee its use.
The stakes are incredibly high. When a patient is placed on a ventilator, doctors are putting that patient’s life in the hands of the machine. It’s a situation where it has to work.
Yousef says he understands those stakes. His team is working with physicians to test the model, and they’re preparing to get approval from the Food and Drug Administration, which regulates medical devices.
Biomedical engineer Jamie Williams explains that approval won’t happen quickly.
“Anywhere from a couple of months to a year a more,” Williams says of the process. “It really depends on the application and whether the application contains all of the data that the FDA is looking for.”
Williams works for Robson Forensics. She hasn’t seen Yousef’s ventilator, so she didn’t want to weigh in on the device itself.
She explained that devices with a long track record like ventilators typically follow a regulatory process where manufacturers demonstrate their product meets the same benchmarks as other, previously approved models.
While the FDA opened the door to using similar devices like anesthesia machines in the place of ventilators, it hasn’t taken steps to speed new products to market. Williams says that’s probably the right call.
“The failure of that assistive device could be catastrophic,” she says. “So I think there other ways of increasing availability of these products.”
She says increasing supply by directing manufacturers to build existing, approved designs is a safer bet. Last Thursday, the Trump administration announced it would do just that—invoking the Defense Production Act after resisting the move for weeks.
Under that order, six companies including GE and Medtronic will begin building ventilators.
Yousef’s team is cagey about exactly how they plan to secure FDA approval and what that would entail on their end. Although Williams is realistic about how long the process might take, she sees in Yousef a kindred spirit.
She says the widening crisis is likely inspiring innovations in all sorts of unexpected corners, and those effort should be encouraged. She hopes there are many more people out there, like Yousef, trying their hand at building life saving devices.
“We may not get products to market in time for helping with this particular event,” she says, “but the solutions that we come up with now may help humanity as we move forward, so I think everyone with a good idea should continue to look at it.”
