Switching from cars to fans is not that easy, however. Ventilators are complex machines that use sophisticated software and special parts, and companies who want to manufacture them face several hurdles – including intellectual property rights, the need for specially trained staff, regulatory approvals, and security issues.
But it’s a race against time.
Sick patients are already overwhelming hospitals in New York. The state fears that it is headed for a situation like the one in Italy, where the lack of ventilators has forced doctors to decide which patients can use the potentially life-saving devices.
Ford works with 3M and GE to manufacture breathing apparatus and ventilators “The number of ventilators we need is so astronomical,” New York governor Andrew Cuomo said Thursday, adding that hospitals have resorted to experimental solutions, such as putting two patients on one machine.
According to the Johns Hopkins Center for Health Security, there are approximately 160,000 ventilators in America, but up to 740,000 could be needed.
Fans can help some of the most seriously ill COVID-19 patients who are starting to lose the ability to breathe themselves. The devices provide gentle breathing support so that a person’s lungs can rest while fighting the virus.
The best way that automakers can help quickly
Not all ventilators are exactly the same. Some are more complex than others. The lungs of the sickest COVID-19 patients can stiffen and require high-end devices that cost up to $ 50,000. These machines can be precisely tailored to patients and must be operated by trained medical professionals.
According to Vafa Jamali, vice president of Medtronic, one of the few ventilator companies, the manufacturing and assembly of these high-end devices is best left to traditional ventilator manufacturers.
Key components are manufactured in-house by experienced employees. Medtronic said. Not only does it not want to outsource this production, the automakers are also unable to manufacture these high-end machines – at least not quickly.
“Because this is a life-saving device, it cannot be turned off. Practice and experience in making the parts are really, really important,” said Jamali.
Medtronic alone has increased the weekly production of ventilators by 40% since January, among other things through the 24-hour assembly of the assembly lines. And the company plans to increase production by another 200% over the next few weeks by doubling the number of employees in existing production lines.
The goal is to increase the performance of first-class ventilators to 500 per week, which is a quintuple.
Still, the company will only be able to manufacture hundreds of ventilators – and doctors need thousands of them.
For this reason, the company welcomes ideas from automakers to fill this gap.
Medtronic has spoken to Tesla, GM and Ford, although the companies have no formal plans to work with them yet, Medtronic told CNN Business.
General Motors (GM) said last Friday that it was working with another fan manufacturer, Ventec Life Systems, to increase Ventec’s production. The companies produce up to 10,000 units per month or more, it said in a later announcement. Some of the fans are built at the GM electronics assembly plant in Kokomo, Indiana. The first of these ventilators is expected to be delivered in April.
The New York Times reported late Thursday that the White House would announce the venture between GM and Ventec that would enable the production of up to 80,000 fans. However, the Federal Emergency Management Agency said it needed more time to assess whether the company was too expensive.
GM replied to the report in a statement, saying, “Efforts are underway to build production capacity at the GM Kokomo plant to manufacture Ventec’s intensive care ventilator.” It also said it had started hiring workers for the company.
For its part, Ford has announced that it will work with GE Healthcare to increase the production of GE ventilators.
Jim Baumbick is the Vice President responsible for all of Ford’s vehicle product lines. However, lately he has focused on driving the production of health technologies.
He said Ford, who introduced mass production to the auto industry, has seen efficiency gains in GE’s production processes that will increase production in the coming weeks. Ford has also been able to find additional suppliers for some of the parts that make up the fans, Baumbick said, so GE won’t face bottlenecks in its supply chain.
The automaker has even suggested changes to parts to make it easier for other suppliers to make them.
GE Healthcare declined to provide additional details about its work with Ford, but said it plans to double its production by the end of June.
Toyota also has “agreements to work with at least two companies that manufacture ventilators and respirators to increase their capacity,” the company said in a statement emailed Friday. Toyota has not said which medical device companies are involved.
A less complex machine
Medtronic also makes less complex ventilators for less seriously ill people, and the company is considering making “one or two” out of it his designs open source. This would enable external manufacturers to take over the production of fully functional machines.
Jamali said he was confident that automakers could do the job.
But he added: “The question is: what is the time frame in which you start and when do you start to bring ventilators to the market?” Jamali said.
As part of its partnership with GE Healthcare, Ford is helping to develop a new, simple ventilator that is relatively easy to manufacture, said Baumbick. For this purpose, the designers at Ford and GE start with an anesthesia machine. It is a machine that is essentially a kind of ventilator. Baumbick said the idea was to remove everything that is not needed for breathing.
“It’s about getting to the first principles,” said Baumbick.
Once this machine has been successfully designed, it could be manufactured in a facility outside of GE. It could even be made in a Ford factory, he added. However, the companies did not provide a schedule for starting this production.
According to the Food and Drug Administration, it has made drastic regulatory changes so that automakers and other non-medical manufacturers can quickly take on such tasks.
“The FDA message is clear,” the agency said in a statement on March 22. “If you want to help expand ventilator production to save American lives in this pandemic, we will work with you to remove all possible obstacles.”
For example, the agency said it does not enforce rules that require ventilator manufacturers to obtain FDA approval before making minor changes to their devices.
This approach “will help manufacturers who want to add production lines or want to produce at alternative locations [that] can have different production facilities, “according to FDA guidelines.
Intellectual property concerns threaten
However, some traditional manufacturers remain cautious when working with third parties.
If there is a manufacturing defect, “it would be a disaster if you brought out these devices in bulk,” said Jamali. “They could cause great harm to the most acute patients.”
Intellectual property rights can also be an obstacle. Ventilator designs, their software, or key components are often patented or contain trade secrets.
The medical device industry has “been extremely sensitive to the protection of its intellectual property in the past,” said Debbie Wang, a Morningstar analyst working on Medtronic. “And I can’t imagine that that would necessarily go away,” she added – even in the face of a pandemic.
Patrick Keane, an IP lawyer who works with hospitals and ventilator manufacturers, agreed that intellectual property concerns might make traditional manufacturers hesitate to work with third-party manufacturers.
The Defense Production Law is the most powerful tool the government must use to ensure that this does not happen. If you refer to it, the White House could run production. President Trump’s previous approach was encourage Car manufacturers help manufacture ventilators, but he does has stopped issuing guidelines within the data protection authority.
If Trump takes this step, it is up to the companies that have been given the ventilator manufacturer’s instructions to ensure that they are not liable for patent infringements after the crisis ends, Keane said.
The President is under increasing pressure to use his DPA powers to better coordinate the production and sale of much-needed ventilators. This could alleviate the concerns of governors like New York’s Cuomo, who are desperately looking for new ventilators.
However, the problem will continue to lead to a large supply gap and a race against the clock. Current ventilator production is lagging far behind demand – and setting up new production lines is no easy task.
“They don’t want people who make air conditioners for cars to suddenly produce whole fans,” he said.