A newfound need for ventilators has made interesting partners out of medical device makers and car manufacturers. The two industries have recently combined forces to rapidly mass produce ventilators and fill any shortages that may arise due to the coronavirus pandemic. On April 8, after weeks of dithering, the Trump administration ordered 30,000 ventilators from General Motors (GM) under the Defense Production Act (DPA) for the Strategic National Stockpile, which would quadruple its existing supply. The same day, reports emerged that some doctors were questioning using ventilators on some coronavirus patients at all.
The country’s ventilator shortage has quickly become a complex and nuanced debate. Some fear that the herculean effort by automakers won’t put enough ventilators in hospitals in time. Others point out that increasing the ventilator supply only saves lives if there are enough beds, medication, and health professionals to treat patients who need them. The FDA has temporarily loosened restrictions on who can make critical care ventilators and which devices can be used for critically ill coronavirus patients, which has made them easier to produce. But that doesn’t completely solve the problem — and it may even create other problems. It doesn’t help that President Trump is now using ventilators as a form of political patronage.
The Institute for Health Metrics and Evaluation (IHME) estimates that the concurrent need for ventilators in the United States will peak at about 17,000 on April 14, though the actual number could fall anywhere within a range of about 8,000 to 35,500. It’s estimated that we have about 170,000 ventilators in the country, but that doesn’t mean there will be enough wherever they’re most needed. The Strategic National Stockpile has a ventilator supply that’s meant to fill any shortages, but the tens of thousands of ventilators now being manufactured to address that shortage won’t be ready for months.
The delay isn’t for lack of trying. The medical device industry just wasn’t built to make this many machines this quickly. It’s never had to before: This is the first time we’ve needed to use any of the stockpile’s ventilators.
“If you’re a ventilator manufacturer right now and somebody wants to make 50,000 of your ventilators, that’s more than you would typically sell in five or six years,” Rich Branson, a registered respiratory therapist and professor at the University of Cincinnati, told Recode.
While GM’s efforts are perhaps the more widely known thanks to Trump’s recent Twitter tirade criticizing them, he’s also mentioned Ford, telling the company to “get going on ventilators.” Tesla has also expressed an interest in producing ventilators, as have car companies in other countries, such as Rolls Royce and Jaguar in the United Kingdom. These have drawn comparisons to wartime efforts by car companies — including Ford and GM — to produce tanks and airplanes out of their car factories during WWII. It’s so far unclear whether the results of these efforts will have the same sort of world-changing effects.
GM’s portable ventilators don’t reinvent the wheel
Car companies have large factories, mass production experience, and connections to supply chains needed for the hundreds of parts that go into a ventilator. But repurposing a car factory to make a medical device as complex as a ventilator isn’t easy.
GM is taking a streamlined approach by making Ventec’s existing VOCSN ventilator model, which is cleared by the FDA to fill the critical care needs like those faced by coronavirus patients. Initially, a stripped-down version of the VOCSN, called the V+Pro, will be produced that uses fewer parts and can be done sooner. Ventec’s ventilators are small and portable. They include the features needed for critically ill patients but are cheaper, easier to use, and faster to build than typical ICU ventilators.
“Rather than recreating the wheel and trying to build something from the ground up, let’s take what we know works, and find a partner who can help us scale that more quickly,” Chris Brooks, chief strategy officer of Ventec Life Systems, told Recode.
GM’s Kokomo, Indiana, factory was chosen for the effort because it already does advanced electronic work that lends itself well to producing these ventilators. The plant only has about 300 employees, so the company will also be making new hires for the effort, for which it ultimately hopes to have 1,000 people. If nothing else, the effort will provide work for several hundred people during a time of unprecedented mass unemployment.
A process that would normally take “many, many months or even years,” Brooks said, has been compressed into a few weeks. Ventec and GM have been working “flat-out” since their talks began in mid-March, but it takes time to secure a supply chain, create new molds and tools, and train workers. GM anticipates it will build a few hundred ventilators by the end of April, and the company is set to deliver its first batch of about 6,000 ventilators to the stockpile by June 1. The rest will arrive by the end of August.
The order for the stockpile will also cost the federal government nearly $490 million. But that’s not even the biggest ventilator contract in the works: The HHS also announced on April 8 that it will pay Phillips $647 million for 2,500 ventilators for the stockpile by the end of May and 43,000 by the end of the year. You might remember Phillips as the company the government once contracted to build 10,000 ventilators for the stockpile at a cost of $13.8 million. Those ventilators never arrived. The Department of Defense’s Defense Logistics Agency has also purchased 8,000 ventilators from four different companies for $84 million. And Trump has asked the HHS to use the DPA to procure ventilators from Hill-Rom, Medtronic, ResMed, Vyaire, and General Electric (GE), though contracts with those companies have not yet been announced.
Ford teams up with GE Healthcare to make even simpler ventilators
Though it doesn’t have an order from the government yet, GE Healthcare has already teamed up with Ford to lay the foundations of a plan to produce 50,000 ventilators by July. The partnership will produce ventilators licensed from Airon, a small company that used to sell 50 ventilators a month at best.
Typically used in transport situations, the Model A is FDA-cleared and has an Emergency Use Authorization from the agency for use on coronavirus patients. It’s a simple device, down to its power source: gas, rather than electricity or battery. Whereas your typical $50,000 ICU ventilator will have a large touchscreen and a computer that controls, monitors, and records all aspects of a patient’s breathing, the Airon ventilator is controlled by switches and dials and has an analog meter in lieu of a digital display.
The benefit of such simplicity is that many of these ventilators can be made quickly, as they require fewer parts. While the most complicated critical care ventilators have well over 1,000 parts, the Airon has between 250 and 300, according to the Washington Post. The stripped-down Ventec model that GM is producing, by comparison, has just over 400. GE Healthcare told the Post that it consulted with experts and clinicians who have treated coronavirus patients who said the Airon model meets the needs of patients who only require a “simplified, more basic ventilator.” But some experts disagree.
“I give Ford credit,” Branson, the respiratory therapist, said. “They went in, and they realized this thing’s really not very expensive, it doesn’t have very many parts, and the parts that are in it are pretty simple, so probably easy to scale up in a hurry. But if you’re going to have to distribute it with a disclaimer that says, ‘Don’t use on the really sick people,’ that is going to be a real problem.”
Branson was part of the Task Force on Mass Critical Care, which created guidelines more than a decade ago for stockpile ventilators in the case of a pandemic. The Airon model does not fill all of that criteria, Branson said. (Branson is also a member of Ventec’s Clinical Board and worked with Ventec to develop the VOCSN.)
Ford will initially produce the ventilators in Airon’s Florida plant, which can currently make as many as three ventilators per day. By April 20, Ford says it will have started production out of one of its own plants in Ypsilanti, Michigan. The company hopes this will allow 500 workers to make as many as 30,000 per month. Earlier, Ford and GE announced they would collaborate to produce a simplified GE ventilator, but the companies haven’t released details about that venture yet.
With thousands of them scheduled to arrive by the summer, the Airon ventilators could prove useful as the peak of the pandemic hits certain parts of the United States — not to mention other countries that will likely also need ventilators once America’s surge has passed. As is the case with GM, however, the Ford and GE Healthcare partnership will only produce several hundred ventilators by the end of April, missing the expected mid-April peak in places like New York, Louisiana, and California.
Tesla plans to repurpose its car parts as the DIY crowd gets creative
Outside of Detroit, there are myriad efforts to produce ventilators through even less-traditional avenues. In late March, the FDA loosened some restrictions on ventilators, saying it wouldn’t enforce certain regulations for the duration of the pandemic, paving the way for ventilator prototypes built by anyone from large companies to medical residents. While it’s possible some of these headline-grabbing efforts could be used to treat coronavirus patients, that seems unlikely.
Elon Musk made a much-publicized jump into the ventilator fray with a March 18 tweet that Tesla would “make ventilators” in the case of a shortage. He later said Tesla’s Buffalo, New York, factory would produce Medtronic machines. But it has yet to do so, and when Medtronic was asked about the status of the project, a spokesperson would only say that another Musk company, SpaceX, was making a subcomponent valve used in its ventilators. Tesla did not respond to request for comment.
Tesla is also designing its own model. The company recently released a video of a prototype made largely out of Tesla car parts, the idea there being that it wouldn’t take any parts away from actual ventilator manufacturers. Even the monitor is Tesla: a touchscreen powered by the car’s infotainment system. As intriguing as the design seems, Tesla has not said when, if ever, it expects this model to go into production.
Tesla’s homegrown ventilator is similar to the cottage industry of DIY efforts that has cropped up over the last several weeks. Some come from engineers and doctors who want to build entirely new devices, like this open source design from Vanderbilt University or MIT’s “E-Vent” project. Others aim to adapt existing ventilators to be more effective during the pandemic. Engineers from the University of South Carolina and Prisma Health’s VESper, for instance, are sharing plans for a 3D-printed device that can allow one ventilator to be used on two patients. Massachusetts General Hospital anesthesia residents are also hosting the CoVent-19 Challenge, a contest for “rapidly deployable ventilator” designs.
Over in the United Kingdom, there’s vacuum cleaner and fan company Dyson. Like Tesla, it designed its own ventilator prototype. The British government has already ordered 10,000 of them, but the design does not yet have regulatory approval despite the process being fast-tracked. It also appears that Dyson’s ventilators will miss the UK’s peak week, assuming they are ever produced at all. There’s even an effort to bring back the iron lung.
“I hear people say about the devices that people are trying to make in their garage: ‘well, it’s better than nothing,’” Branson says. “Well, not really. And people say, ‘well, it can be used on people who aren’t so sick.’ The patients who aren’t so sick aren’t going on a ventilator.”
Ventilators alone will never be enough
Some may see these options as better than nothing. Others don’t.
“I think the reality is, with Covid patients, they need a true critical care ventilator that’s powerful and precise,” Brooks, the Ventec executive, said. “If you don’t have the right ventilator for these patients, they’re just not going to survive.”
Dr. Ken Lyn-Kew, a pulmonologist at National Jewish Health in Denver, Colorado, was even more blunt, telling Time magazine that the prospect of treating patients with ventilators that weren’t up to critical care standards was “terrifying.”
There’s also a growing backlash against ventilators of any kind. Recent articles in Stat, NPR, and the Associated Press say that some medical professionals are starting to think that ventilators are overused for coronavirus patients, with some people being put on them before all other, less-invasive options have been exhausted. A higher-than-average mortality rate for coronavirus patients put on ventilators may also show that they can make things worse in certain cases. The AP reported a mortality rate of 40 to 50 percent for non-coronavirus patients in severe respiratory distress versus a rate of 80 percent for coronavirus patients in New York City hospitals. Put simply: Even a top-of-the-line, full-featured, critical care ventilator doesn’t guarantee that a patient will recover from coronavirus — far from it.
None of these challenges even begin to address the need for medical professionals to run these machines and care for the patients on them. That’s a round-the-clock job that requires specific expertise, from inserting the tube to managing and monitoring oxygen flow to removing lung secretions (the mucus you’d cough up in a normal situation, basically). It also requires drugs to keep the patient sedated while intubated, and those are now in short supply as well.
Again, recent projections put the peak concurrent ventilator usage at 17,000 on April 14. Experts also predict coronavirus patients will need about 20,000 ICU beds that day — and that we will be 9,000 ICU beds short. So it won’t matter how many ventilators we have if we also don’t have enough of everything else.
“All the ventilators in the world aren’t sufficient if you don’t have beds for the patients to be in, nurses to care for them, respiratory therapists to run the ventilator, and doctors to determine the best path of care,” Branson — who literally wrote the book on respiratory care equipment — said. “If, somehow, Elon Musk did invent the greatest ventilator in the world, and he could make them all by Friday afternoon, and he sent a million of them to New York, that wouldn’t solve this problem ... I understand we focused on the ventilator, but we focused on it too much.”
Whatever their drawbacks, ventilators do save lives. It would be a moral failing if we didn’t address this shortage, even in the face of discouraging odds. That in mind, it’s laudable that companies like Ford and GM are taking wartime-like measures to manufacture ventilators as fast as they possibly can. In any case, these ventilators are a stop-gap measure. But they aren’t a cure.
“Social distancing is the most important part in all of this,” Branson added. “And, of course, either a drug or a vaccine is really the solution.”