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The ventilator challenge will test ingenuity to the limit

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Via Financial Times

From inventors to academics, carmakers and aerospace companies, a race is under way to build hundreds of thousands of ventilators: the machines that help severely ill coronavirus patients breathe that are in desperately short supply worldwide.

The numbers required dwarf the normal industry output — New York State alone has said it will need 30,000 extra machines — so big names of industry such as General Motors, Airbus, McLaren and Dyson have offered their engineering expertise or factory lines, which in many cases have slowed or halted because of the pandemic. 

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Yet for all their technical expertise, the question is whether manufacturers inexperienced in the field can overcome the technical, logistical and regulatory hurdles in time to deliver an enormous number of life-saving machines. 

“The actual scaling up to manufacture at a great level isn’t the tricky part — it’s having the supplies and components,” said an employee at a ventilator maker. 

In some of the areas worst hit by the pandemic, crisis has sparked ingenuity. An Italian 3D printing start-up, Isinnova, has converted a snorkelling mask from the Decathlon sportswear chain into an emergency mask for hospital ventilators, based on an idea from a doctor.

To cope with the peak of infections expected in weeks, there will need to be an enormous push by industry. UK authorities are looking at ways to boost production of two existing models made domestically as well as new ones drawn up in response to the emergency. However, many of the ventilators used in Britain are imported.

UK engineering company Dyson this week said it had received a government order, subject to regulatory clearances, for 10,000 ventilators it designed from scratch in 10 days with The Technology Partnership (TTP), a consultancy with experience in medical devices. The company’s billionaire owner Sir James Dyson has said he will pay for another 5,000. 

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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 plants have come to a standstill, said it had a task force working to see if it could use its 125 industrial 3D printers, which can rapidly make components and complex shapes, to make parts. Skoda, a VW brand, has printed test parts in co-operation with local universities.

However, many manufacturing experts and medical device makers are sceptical about whether companies new to this specialised and heavily regulated sector can easily repurpose shop floors, and cast doubt on how quickly new ventilators can be made. 

“Just ordering the tools, for example for the plastic moulding, for assembly, the test equipment, will take three to six months,” said Bernhard Langefeld, a manufacturing expert at consultancy 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 responsive to a patient’s breathing, ensuring “synchronisation” so that excessive pressure and gas is not delivered. 

These highly specialised machines apart, a range of other options could be deployed depending on the stage of the disease, according to medical devices engineer Paul Dixon. These include transport ventilators, 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 some additional oxygen can be very simple,” said Mr Dixon. “You could fill that gap quite rapidly 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 airway pressure (CPAP) machines given to patients with sleep apnoea, a condition where breathing stops and starts when a person is not awake. 

There is a wide variation in critical care infrastructure

Mr Dixon estimates more basic CPAP devices will be needed at a rate of two or three for every advanced ICU ventilator. This opens the door to industries with advanced pneumatics expertise, such as aerospace and automotive. 

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

Mick Farrell, chief executive of ResMed, a large ventilator maker that is increasing production up to three-fold, said he would rather other manufacturers helped boost their production, rather than becoming competition for scarce resources. 

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

One of the top three ventilator manufacturers, Hamilton Medical in Switzerland, is doubling production to about 500 a week. Among the components it sources from overseas 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 up,” said Jens Hallek, chief executive. 

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

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

Ford, meanwhile, is working with GE Healthcare on a simplified ventilator that could be made at one of its plants, if the federal government gives the go-ahead. 

As the number of ventilators in use expands, an equally important consideration will be the supply of “consumables” — attachments such as masks, rubber tubing and sensors that must be regularly replaced. 

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Then there are the safety regulations. Approval for medical devices normally takes months or years, although the US and Britain have said they will relax the rules. Standards to be met include component traceability, final testing and even the manufacturing premises. 

Equipment that comes into direct contact with patients must be made in clean rooms, which are common in the aerospace sector. The Medicines and Healthcare products Regulatory Agency is working with companies that have facilities already used for other regulated industries to ensure they meet quality and safety standards.

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

“We could supervise the parts they’ve bought, how it’s assembled and all the technical work — essentially [they] borrow our processes and apply it to their facilities,” he added.

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

Additional reporting by Peggy Hollinger and Richard Waters

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