How a low-cost ventilator was created, FDA-approved, and made its way to New York hospitals in 30 days

• Scott Cohen, of technology hub New Lab, teamed up with engineers, medical experts, designers, and FDA regulators to rush a 10-year-old idea for a low-cost ventilator into New York hospitals.
• FDA approval for ventilators ordinarily takes at least a year, but amidst fears of a ventilator shortage, the Spiro Wave was approved in 30 days.
• The Spiro Wave is not a substitute for a traditional ventilator, but can help patients struggling to breathe on their own, acting as a bridge ventilator.
• $4.

Scott Cohen had chills, headaches, feelings of fatigue, and a fever, all the usual hallmarks of a mild case of COVID-19. Like many New York residents, he hadn't been diagnosed, but he and his wife had most of the symptoms.

The $4 was to stay hydrated and rest, but Cohen couldn't. It was mid-March and he was working on the Spiro Wave, a device which he hoped would help the city as it scrambled in the face of a significant ventilator shortage — a situation doctors in Italy had been warning about for weeks.

A typical ventilator costs around $30,000, consists of about $4, requires a lengthy training to use and is often complicated to produce. There are $4 a ventilator must be independently tested for before it can be used. According to an April Johns Hopkins report, the US only had $4 while some experts were predicting that at least $4 would soon need ventilators.

Companies like $4 announced they'd be producing $4 for hospitals. Production began the week of April 20, but it would be months before those ventilators made their way to hospitals.

Meanwhile, Cohen's $3,300 Spiro Wave ventilator, which was designed, manufactured, and received FDA "emergency use" approval within 30 days, is designed for immediate use.

How the Spiro Wave works compared to a standard ventilator

The Spiro Wave works as a bridge ventilator, not for the most severely ill patients, but for more stable patients who need help breathing but aren't at such a critical stage.

The device has robotic hands which compress an "ambu bag" — a respiratory bag found in many hospitals — regulating the volume of air and oxygen being pushed into a patient. What a typical care provider might have to do by hand for patients that need help breathing but may not require a ventilator yet, the Spiro Wave will do automatically.

This ensures traditional ventilators, which can also regulate oxygen and air, only get used on the most critically ill patients and makes the work of care providers a little easier.

"The Spiro Wave is not meant to replace ventilators completely, but it expands the functionality of a manual resuscitator bag," Albert Kwon, anesthesiologist at Westchester Medical Center, and member of the Spiro Wave effort, said in a Spiro Wave press conference.

"It helps free up human resources, increases quality control from where a human may be manually bagging a patient, and it helps hospital reallocate conventional ventilators for patients with more sophisticated life support needs."

It came to life after Cohen got an email from an Italian friend asking if his lab could build ventilators

The Spiro Wave was born when Cohen, the founder of $4 a members-only innovation lab based in a formerly abandoned Brooklyn Navy Yard building, received an email in March from Manuel Toscano, an Italian friend and New Lab member.

"He asked me if there's anything New Lab could do to help design and build ventilators quickly," Cohen told Business Insider. "My reaction was that I'm not sure we could actually do anything that would impact things in the near term."

After Toscano emailed him, Cohen had to Google exactly what a ventilator was and how to make one. His prior experience was in managing the over 80 tech businesses that rented space in New Lab, which served as a hub for new start-ups. He had no experience in medical technology, and neither did most of New Lab's member companies, like Honeybee Robotics, which made devices for NASA, and 3D-printing company Ultimaker.

After his phone call with Toscano, as bodegas and offices across the city began to close down, Cohen began to think about closing New Lab. But then he changed course.

"I thought, well, we do have all these engineers and mechatronic experts and sensor technology experts and we should be able to do something," he said.

He poked around online for cheap ventilator substitutes and found a prototype for a bridge ventilator created in 2010 in the MIT classroom of a mechanical engineer called Alex Slocum. It had been designed as a prototype for a low-cost ventilator to bring to developing countries, and the idea had sat dormant for a decade.

Alex Slocum quickly came on board, along with a few other big names in engineering.

They pitched it to New York government, and got an initial investment of $100,000 as a research grant at the $4 Bill de Blasio announced in an $4 that the city had signed a contract to pay almost 10 million dollars for 3,000 Spiro Wave ventilators.

A team of 100 people took turns sleeping under desks during the frenzied rush to create the device

There was a 30-hour sprint to make the first iteration of the Spiro Wave. For engineers, designers, and manufacturers, it felt like time was of the essence.

"It was like a fever pitch of talking to people," said Cohen, who worked from his SoHo living room to mobilize experts from around the world, while his wife sat next to him, taking notes on the phone calls.

The first version was driven straight up to MIT for their engineers to inspect, but it didn't make the grade. The garbage outside the offices piled up with versions of the Spiro Wave, each scrapped as the team refined their ideas.

Ten days into the project, some city officials brought in 20 critical care doctors to look at the device. "They said, 'Yes, we need this and we want it now and how soon can you get it for us?'" said Cohen.

"We were saying, we could deliver it to you if it's like an absolute critical emergency but we'd prefer not to because we still want to improve the software and add alarms and stuff," said Cohen.

The team of 100 engineers, clinical doctors, and other medical experts Cohen had assembled, took turns sleeping under desks in shifts as they rushed to get the machine ready.

After one nearly-sleepless month, the Spiro Wave received the emergency use FDA approval that would normally take at least a year to get.

The Spiro Wave is one of a few low-cost ventilators the FDA has rushed to approve

The Spiro Wave is one of a few low-cost ventilators in the process of being pushed to market in record time.

Medtronic has released the blueprint for its $4, freely available for other manufacturers to use. Tesla $4 it would be re-opening its New York factory to produce Medtronic ventilators, and one Minnesota hospital said the device meant hospital staff would have $4

The $4 created by a team of University of Minnesota researchers, will cost about $1,000 to produce. The researchers are working with $4 to figure where to deploy the ventilators.

But New York is no longer as in need of these ventilators as they were. "The curve flattened just early enough for us to not have to make those agonizing decisions," Shereef Elnahal, the CEO of University Hospital in Newark, told $4

But many experts have noted that there may be a need again soon, and the US government has invested $4 in producing 187,000 ventilators. "There is likely to be a second and third wave of coronavirus, and those waves could occur simultaneously with influenza," said Mitchell Katz, CEO of NYC Health and Hospitals, in a press conference. "We may well be using these Spiro Wave devices in our emergency rooms in the future."

Currently, Cohen is in talks with the health ministries of Malaysia, Ethiopia, Colombia, and South Africa.

The other day, Cohen heard from Toscano, his Italian friend whose email inspired the project. "He's really, really proud of the fact that we all rallied," he said. "He got me thinking about it ... it seems impossible. And then here we are."

Read the original article on $4