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Just eight days ago, Andrew Farmery, a professor of anesthetics at the University of Oxford’s Nuffield Department of Clinical Neurosciences, was discussing with a colleague and some Ph.D. students the dire need to produce more ventilators in the U.K.
“My initial thought was that this just can’t be done,” Farmery said. “Ventilators are very complex devices, and upscaling them is extremely difficult.”
He joined forces with a small group of academics — engineers and medics — to brainstorm a prototype. After rejecting dozens of ideas, they settled on one, named OxVent.
“It has very few parts, no motors to burn, no cogs to rotate or snap or bend,” Farmery said. “But it works, and all we need right now is a basic product that keeps people breathing and stops people from dying.”
As the number of confirmed global cases of coronavirus has soared, doctors everywhere are searching for ventilators. In the U.K., the National Health Service has more than 8,000, but the government has said it needs at least 30,000 as it fights the pandemic.
To deal with the shortfall, the government plans to immediately buy several thousand ventilators from abroad, take spare capacity from private hospitals, and work with existing manufacturers to try to scale up production quickly.
“We have been inundated with offers of help and have teams of several hundreds working through this. To solve the immediate shortage, we are picking the low-hanging fruit by bringing in as many models as we can,” a government source said.
Prime Minister Boris Johnson has called on the U.K.’s biggest manufacturers to help produce vital medical equipment like ventilators as the coronavirus crisis worsens. The U.K. has ordered 10,000 ventilators from British appliance maker Dyson, best known for highly engineered vacuum cleaners and hand dryers. The custom-made ventilation devices are expected to be delivered to the NHS within weeks, subject to passing stringent medical tests.
The government has also taken another approach, issuing an open call for proposals for a quick-to-produce ventilator that could help fill the gap. Now hundreds of government employees are combing through more than 3,000 pitches from major manufacturers as well as smaller groups, including academics like Farmery and his team.
It is a daunting task. The designs must be based on rigorous criteria issued by the Department for Health and Social Care as specified by the Medicines and Healthcare Products Regulatory Agency, the U.K. body that approves medical equipment for use. Ventilators, for instance, have to connect to hospital gas supplies and need at least 20 minutes of backup battery in case of main power failures. Such necessarily stringent procedures inevitably slow down the procurement and development processes.
The simple design of OxVent meant Farmery and his team were able to take pressure off supply chains, already under immense pressure from the wider economic shutdown, by sourcing readily available components needed to make the medical device. This included finding 5,000 oxygen sensors from a supplier in the scuba-diving business that are critical to measuring the oxygen output of the ventilator.
“We have access to literally hundreds of offers of manufacturing help,” Farmery said, including companies willing to provide cut Perspex sheets and injection mould, as well as printing our PCBs (like Sony in Bridgend). “The beauty of our system is that it doesn’t involve many components or much manufacturing.” The parts are then assembled like a kit which only takes two hours to build.
For Farmery and his team, it has been a tense time, with their potential solution tangled up in a chaotic procurement procedure hastily arranged by a government under extreme stress.
Farmery says that he pitched the OxVent — essentially a small, squeezable bag inside a solid Perspex box, through which compressed air is injected, and which costs about £1,000 to make — on Monday to the Johnson cabinet and the MHRA.
Once the team is given the green light, Farmery thinks it will be able to make between 2,000 and 5,000 OxVent units a week. The plan is for a 10-unit trial at Guy’s Hospital in London and in Oxford within days.
Meanwhile, Farmery got in touch with PA Consulting — a management consulting firm that is running the government’s proposal process — which asked OxVent to submit forms outlining the specifications of their prototype by the Sunday evening deadline of 7 p.m. However, OxVent says PA only sent the team the specific forms required for the tender process 20 minutes ahead of the deadline.
Farmery was then left hanging for a few days. On Wednesday, though, the OxVent team was informed by PA that it is still in the running and that its ventilator will be independently tested.
OxVent’s proposal has been one of the over 3,000 offers received and was assessed by clinicians and the regulator within less than a week of the standing up of the program.
Farmery also said that one issue is the MHRA’s high specifications. “The government says that ventilators require this feature and that feature, but really they don’t need anything complicated. They just need something that saves lives, and they need it quickly, because every day that passes hundreds more people will die.”
The OxVent does meet all of the essential specifications required by the MHRA, as well as all essential safety features. It meets some of the optional/desirable features too, such as a “pressure support mode” that assists those who can breathe independently to some extent. “But to satisfy every optional feature exhaustively would simply delay the start of the build, and it being available to patients whose lives will depend on it,” Farmery said.
The MHRA said it is able to take swift action to allow medical devices without formal regulatory approval to be used in the U.K. in the interest of the protection of health.
“The MHRA will support the Government in drawing up appropriate specifications and will ensure that companies understand what standards they must be meeting in order for their products to be able to be used safely on U.K. patients,” a spokesperson told MarketWatch via email.
