The ventilator challenge will test ingenuity to the limit

From inventors to academics, automakers, and aerospace companies, a race is underway to build hundreds of thousands of ventilators: the machines that help breathe the seriously ill coronavirus patients who are desperately rare in the world.

The figures required are below normal industry production – New York State alone has said it will need 30,000 more machines – big names in the industry such as General Motors, Airbus, McLaren and Dyson offered their engineering expertise or their plant lines, which in many cases slowed down or stopped because of the pandemic.

However, despite all their technical expertise, the question is whether manufacturers inexperienced in the field can overcome technical, logistical and regulatory obstacles in time to deliver a huge number of rescue machines.

“The actual scaling to manufacture at a high level is not the tricky part – it is to have the supplies and components,” said an employee of a fan manufacturer.

In some of the regions most affected by the pandemic, the crisis has sparked ingenuity. An Italian 3D printing start-up, Isinnova, transformed a snorkeling mask from the sportswear chain Decathlon into an emergency mask for hospital ventilators, based on an idea of doctor.

To cope with the peak of infections expected in a few weeks, it will take a huge push from the industry. British authorities are looking for ways to boost production of two existing domestically produced models as well as new models developed in response to the emergency. However, many fans used in Britain are imported.

British engineering company Dyson said this week that it had received a government order, subject to regulatory approvals, for 10,000 fans it had designed from scratch in 10 days with The Technology Partnership (TTP), a consulting firm with experience in medical devices. The billionaire owner of the company, Sir James Dyson, said he would pay 5,000 more.

A representation of a CoVent ventilator designed by Dyson and attached to a hospital bed

A representation of a CoVent ventilator designed by Dyson and attached to a hospital bed © via REUTERS

Meanwhile, Volkswagen, whose European factories are stalled, said a task force was working to see if it could use its 125 industrial 3D printers, which can quickly make complex components and shapes, to make pieces. Skoda, a VW brand, has printed test pieces in cooperation with local universities.

However, many manufacturing experts and medical device manufacturers are skeptical about whether new companies in this specialized and highly regulated sector can easily reuse workshops and cast doubt on the speed with which new ventilators can be manufactured.

“The simple ordering of tools, for example for plastic molding, for assembly, for test equipment, will take three to six months,” said Bernhard Langefeld, manufacturing expert at consulting firm Roland Berger. . “If you don’t take [the decision] now you will not have 100,000 devices in June. “

The most sophisticated ventilators used in intensive care units can cost more than £ 20,000 and are sensitive to the patient’s breathing, ensuring “synchronization” so that no excessive pressure and no gas is delivered.

These highly specialized machines aside, a range of other options could be deployed depending on the stage of the disease, according to medical device engineer Paul Dixon. These include transport fans, which are found in ambulances and often sell for less than £ 5,000.

“A device that produces some positive pressure [to keep airways open] and a little extra oxygen can be very simple, ”said Dixon. “You could close this gap fairly quickly with relatively high volume manufacturing with very little need for complex controls.”

This could take the form of a simple ventilator with a mask, similar to continuous positive pressure devices (CPAP) given to patients with sleep apnea, a condition where breathing stops and starts when a person does not is not awake.

There is a large variation in the critical care infrastructure

Dixon estimates that more basic CPAP machines will be needed, two or three for each advanced ICU ventilator. This opens the door to industries with advanced tire expertise, such as aerospace and automotive.

But some worry about the risks of these well-intentioned efforts to fill the supply gap.

Mick Farrell, CEO of ResMed, a large fan manufacturer that triples production, said he would prefer other manufacturers to help increase production, rather than competing for scarce resources.

“When we get offers of help from others like big electric car manufacturers, we say, ‘Fantastic, we don’t really need another final production line, we need, for example , a lithium-ion battery, or an aerospace manufacturer, we need a certain part, “he said.

One of the three major manufacturers of ventilators, Hamilton Medical in Switzerland, doubles its production to around 500 per week. Among the components he purchases abroad are non-complex metal fittings, computer screens, and electronic circuit boards.

“Raw materials will be a limiting factor. You don’t know if suddenly a supplier can keep pace, ”said Jens Hallek, Managing Director.

Instead of starting from scratch, some manufacturers have turned to existing designs. GM will build approved Ventec fans at its manufacturing site in Indiana, donating resources at cost. The first will be delivered next month and, together, the companies will have the capacity to increase production to 10,000 per month.

While all of the automaker’s North American factories are temporarily closed, 1,000 employees will return to assemble the devices.

Ford, meanwhile, is working with GE Healthcare on a simplified ventilator that could be made in one of its factories, if the federal government gives the green light.

As the number of fans used increases, an equally important consideration will be the supply of “consumables” – accessories such as masks, rubber tubes and sensors that need to be replaced regularly.

Then there are the safety rules. Approval of medical devices normally takes months or years, although the United States and Britain have said they will relax the rules. The standards to be respected include the traceability of components, final tests and even manufacturing premises.

Equipment that comes into direct contact with patients must be manufactured in clean rooms, which is common in the aerospace industry. The Medicines and Health Products Regulatory Agency works with companies that already have facilities used for other regulated industries to ensure they meet quality and safety standards.

Another option is for specialist manufacturers to lend their accreditation, said Tom Ackrill at ITL, which does outsourced design and production for medical device brands.

“We could supervise the parts they bought, how they are assembled and all the technical work – basically [they] borrow our processes and apply it to their facilities, ”he added.

As the emergency unfolds, stop holes like this may well become a necessity.

Additional reporting by Peggy Hollinger and Richard Waters

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