Ventec and GM, 2 months later: How a startup took on the ventilator shortage, and where it stands now

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Ventec CEO Chris Kiple, left, with Vice President Mike Pence and General Motors Chairman and CEO Mary Barra, right, on a tour the GM manufacturing facility in Kokomo, Indiana. (GM Photo / AJ Mast)

Two months after President Donald Trump tapped a little-known Seattle-area medical device startup called Ventec Life Systems and automotive giant General Motors to help solve the nation’s ventilator shortage, the manufacturing partnership forged by the companies almost overnight is poised to produce tens of thousands of devices at a breakneck pace.

Like many Americans, Ventec CEO Chris Kiple never could have predicted, at the outset of 2020, the position he would be in today. In January, Ventec’s business was on a predictable, albeit high-growth, path. The company had just secured more than $20 million in a Series E funding, which it planned to use to grow its 111-person team. Kiple estimates sales volumes were increasing about 100% each quarter, allowing the company to produce approximately 200 ventilators each month.

Ventec CEO Chris Kiple. (Ventec Photo / Nataworry Photography)

A few weeks later, everything changed. The first known cases of COVID-19 in the United States were reported in Ventec’s backyard. A nationwide shortage of ventilators quickly emerged as a key challenge. Ventec’s world turned upside down.

Today, Ventec is working with General Motors to produce 30,000 ventilators by August at the behest of the federal government, giving tours to senior Trump administration officials, receiving national media attention, and working round-the-clock to exponentially increase production.

“The team feels the weight of the world on our shoulders in terms of the obligations before us, the commitments we’ve made, both to the federal government and states, to countries around the world, to hospitals, to try to get the tools into the hands of the real heroes, the medical professionals battling this every single day,” Kiple said.

The goal is to produce 12,000 ventilators per month by July, 60 times the number Ventec was shipping before the pandemic struck, with only a slightly larger team. Ventec has 140 employees today. But the GM partnership is a game-changer for the Bothell, Wash. startup.

“We tend to think about producing in the thousands,” Kiple said. “General Motors tends to think about producing in the millions and together we’ve got our innovative product with their manufacturing know-how.”

Ventec and GM are increasing their ventilator production daily and are on target to deliver the 30,000 ventilators by the end of August, the companies say.

“It’s hard to find an hour of the day that we’re not working,” Kiple said. “Folks are working as much as they can around the clock. It’s tiring, but there’s a real mission here and people are motivated by the mission. We feel like we have a solution that can help medical professionals and help save lives.”

Overcoming early challenges

Ventec and GM are working together to solve supply chain and manufacturing challenges and dramatically increase production of Ventec’s portable life-support system called VOCSN. The device combines ventilation, oxygen, cough assistance, suction, and nebulization (medication delivery) services in one suitcase-sized ventilator.

Ventilators use pressure to deliver oxygen directly into patients’ lungs using a breathing tube. Though there is wide variance in the types and functions of the devices, physicians rely on critical care ventilators to treat the most serious cases of COVID-19.

Ventec and General Motors first started discussing a partnership in mid-March as the U.S. prepared for a surge of COVID-19 cases that could overwhelm hospitals and make resources scarce. At the time, Ventec faced what seemed like insurmountable supply chain hurdles. For example, the Indian factory that manufactured a key part needed for the ventilators was shuttered due to the pandemic. In that case, company representatives flew to India to assess the problem and worked with local officials to re-open the factory. But that was just one of many obstacles the companies faced.

Ventec is preparing to ship 12,000 of its VOCSN per month devices by July. A few weeks ago the startup produced 200 per month. (Ventec Photo)

The teams got creative, leveraging GM’s global supply chain to develop a plan that would source all of the necessary parts to ramp up production. By March 25, crews were in place to manufacture the ventilators at GM’s Kokomo, Indiana, factory.

Despite that progress, Trump took to Twitter on March 27 to call out General Motors and Ford for failing to make ventilators fast enough. That same day, the president signed a Defense Production Act memorandum, using a wartime law that allows the government to force companies to manufacture needed items.

In an interview with GeekWire, Kiple did not directly address the confusion in the early days of the partnership but instead said, “it’s been a very productive relationship with the administration and with GM and with Ventec to get this done.”

Ventilators are used to treat patients with extreme respiratory distress, one of the most severe possible symptoms of COVID-19. Critical care ventilators can cost $25,000-$50,000. Under the terms of their $489.4 million contract with the Department of Health and Human Services, Ventec and GM will sell VOCSN devices for about $16,000 each. Despite the low cost, Ventec is expecting to make a profit on the contract. “Exactly what that profit looks like we don’t know,” said Chris Brooks, Ventec’s chief strategy officer.

Ventec engineers work on an expanded production line. (Ventec Photo / Stuart Isett)

Much like COVID-19, the dynamics of ventilation are evolving rapidly. A handful of doctors are questioning whether intubation using a ventilator is the best approach for COVID-19 patients. The debate hinges on discrepancies between the symptoms of COVID-19 and a condition called acute respiratory distress syndrome (ARDS), in which patients are often intubated.

Questions about ventilators and COVID-19

Skeptics of ventilators say COVID-19 patients do not respond as well as typical ARDS patients to intubation. Even among that group, most doctors agree ventilators are necessary for the most severe cases of the virus but many say it should be used as a last resort after other measures, such as turning patients so that they are prone to improve breathing.

Cameron Kyle-Sidell, an emergency room doctor in New York City, published a YouTube video suggesting that responding to patients as if they have ARDS could be “treating the wrong disease.” In severe COVID-19 patients, he describes a condition more like oxygen deprivation at high altitude than viral pneumonia. A ventilator is used to treat respiratory stress in critical viral pneumonia patients, which Kyle-Sidell says could damage the lungs of COVID-19 patients. Instead, he believes ventilators should be programmed to treat oxygen deprivation, putting less pressure on the lungs.

“I don’t know the final answer to this disease,” Kyle-Sidell said in the video. “I do sense that we will have to use ventilators. We will have to use a great many ventilators … but I sense that we can use them in a much safer way.”

Only a small percentage of COVID-19 patients experience lung distress severe enough to warrant intubation with a ventilator. Among those that do, studies in New York and China estimate 66%-80% do not recover. But because only the most severe COVID-19 patients require ventilation, it’s difficult to determine what impact the devices have on mortality.

As the American Journal of Tropical Medicine and Hygiene explains in a recent study, “it is yet uncertain which of the histopathological pulmonary findings in fatal cases on ventilatory support are caused by the disease itself or are secondary to the injurious effects of invasive ventilation.”

The COVID-19 data also doesn’t exist in a vacuum. Many hospitals are overwhelmed with cases, and therefore aren’t able to dedicate highly trained lung specialists to operate the complicated machines in each case.

Kiple stressed the importance of using the right type of ventilator and enlisting a lung specialist to operate it, though that is not always an option in underresourced communities. What sets critical care ventilators apart, Kiple said, is the ability to precisely control airflow, monitor patient oxygen levels, and help patients eventually wean off of the devices.

“If you have COVID-19 and you’re fighting an infection, right now, in the absence of a vaccine, in the absence of a cure, the only option you have is to give your body time to fight the infection and a ventilator does that,” he said. “You have to have a true critical care ventilator to save a COVID-19 patient’s life.”

Because many doctors are only using ventilators as a last resort, demand for the devices is down, according to an analysis by the Associated Press. HHS is on track to have 100,000 new ventilators by mid-July and 200,000 by the end of the year.

Daniel Adelman, a healthcare analytics expert with the University of Chicago, told AP that the U.S. is now buying more than twice the number of ventilators it needs to deal with even the direst COVID-19 forecasts. The U.S. may export excess ventilators to other nations that need them, according to the report.

But Dr. Marcus Schultz — an author of the American Journal of Tropical Medicine study — does not expect demand for the devices to drop, at least not globally.

“The surge of patients is becoming such that, especially in low and middle-income countries, systems will get overwhelmed … also, this is not the first pandemic we are faced with, and it will certainly not be the last,” he said in an email. “And lastly, COVID-19 is not a disease that will just ‘disappear.’ ”

Ventec says the debate has not had any impact on demand for its devices.

“We’re building to demand,” Brooks said. “There will be a surplus of ventilators after this. I think that’s generally accepted at this point. But for us, we’re still building ventilators based on the demand and orders that we have, so it’s not something that particularly worried about.”

Like everyone, Ventec hopes a vaccine will allow for a return to some form of normalcy. Brooks expects the company to come out of the pandemic in a stronger financial position than before despite the “extreme costs that have gone into ramping up production.”

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