It was a call to arms of a generation. On March 15 the government issued a national challenge to UK manufacturing,
“We need more ventilators,” pleaded Minister of Health, Matt Hancock. The UK had access to around 5,000 ventilators, but with the NHS frantically preparing for the most challenging time in its history, it was calling for thousands more.
Ventilators are vital in treating the minority of seriously ill Covid-19 patients who have to be cared for in intensive care units.
UK manufacturing heeded his call. Within days a consortium had been set up of technology and engineering businesses from across the country’s aerospace, automotive and medical sectors.
More than 1,000 offers of help came forward. From the mighty Dyson, which sank around £20 million into ventilator development, to Banbury-based Prodrive which designed a ventilator using components from outside the medical supply chain so that it can be brought to market quicker and cheaper. Both are now destined for global markets.
There were many radical but overly simple ideas being aired across on social media too, including breathing bags being squeezed by windscreen motors. – and a collaboration between 3D printing engineers in Italy and sportswear company Decathlon to turn a snorkelling mask into a DIY ventilator (see left),
But ventilators are highly complex machines, with incredibly complicated software. You can’t just knock something up and expect it to work, never mind getting it through the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
However, one UK company already had considerable expertise in the design and manufacture of anaesthesia ventilators, intubation and oxygen therapy equipment. More importantly, Abingdon-based Penlon had a system already approved by the MHRA.
Craig Thompson is Penlon’s Head of Products and Marketing. “The idea that you can build an effective ventilator in a few weeks and guarantee that it will work in the way it’s intended is naïve. You have to prove it works, and that takes time – which we didn’t have.”
Compared to other members of the new ventilator consortium, such as Airbus, BAE Systems, Renishaw, Meggit, Ultra and STI; Penlon (which in normal times has just 45 people working in its manufacturing facility), was small. But the ventilation and regulatory expertise it had to meet this challenge was huge.
As soon as the call went out, Penlon’s CEO Guruswamy Krishnamoorthy and Head of R&D Cliff Kersey contacted Duncan McPherson, Clinical Director Medical Devices at the MHRA who responded immediately.
The next few days were a bit of a blur admits Craig. “There were numerous calls with the MHRA and PA Consulting, acting on behalf of the government.” Direct contact with the Cabinet Office came less than a week later.
Penlon makes anaesthesia machines. These are machines with a gas delivery system, mounts for drug delivery devices called vaporizers, a breathing circuit called an absorber, and a ventilator – which is where most of the technology is.
The company had to simplify the system to meet the particular demands of Covid-19.
“We concentrated on developing a prototype that would meet the Government’s ventilator specification,” continued Craig. “It was clear that the solution needed to be based on existing regulatory approved products in order to meet the short timescales and MHRA regulatory requirements. The first prototype for testing was completed on the 23rd March, and MHRA approval was given on 15 April.”
In the medical world, it doesn’t come faster than that.
The result is the Prima ES0 2 ventilator, a fully integrated mechanical ventilator designed to support critically-ill patients with functions including volume and pressure-controlled ventilation. Penlon has done away with the vaporizers, because the patient is intravenously sedated, and the absorber part of the breathing circuit isn’t needed because drugs from the vaporizers aren’t being used.
Scaling up production, with a little help from your friends
The exponential increase in production volume required a radical plan. Penlon didn’t have the manufacturing capability to meet the increase production targets, so Ford is manufacturing the ventilators, Airbus the breathing module and gas delivery, McLaren the trolleys and STI the final assembly. Many, many other companies are also providing parts and expertise. Penlon, assisted by GKN, is undertaking final test and product release. The company now has around 450 people testing the ventilators on the shop floor, having borrowed people from the other companies.
The challenges have been immense, especially as the main consortium manufacturers had no experience of medical devices. Integration of the different manufacturing processes and IT systems was a headache. Parts and assembly supply chain issues remain a challenge and the scale up from manufacturing ventilators by the hundreds a year to hundreds a day result in inevitable daily issues, all of which are being overcome.
Capturing all the work that Penlon (see the Penlon team right), and its fellow Consortium members has done in a few paragraphs doesn’t begin to pay tribute to the long hours the talented engineers from all companies put in to design, plan, build and test the new ventilator.
Craig is quick to pay tribute to the Penlon leadership team, in particular Guru, Penlon’s CEO, Mary Ryan, Head of Quality, Tim Rance, Head of Production, Paul Merrick, Head of Production Engineering, Darren Boyce, Head of Service, Tony Serratore, Head of IT, Mike Barlow, Materials Manager and Linda Moss, HR Director.
“I don’t think they’ve been home except to sleep in the last two months. They have worked hand in hand with the consortium and consultants and have devoted their lives to the success of the project,” said Craig.
He also pays tribute to the dynamic people employed by the consultancy companies involved. “They have a can-do attitude to problem solving and were prepared to work all hours. They are instrumental in making it happen.”
Today, the company’s UK factory in Abingdon is completely dedicated to the ESO2 project. It has been totally reconfigured for testing of the new ESO 2 emergency ventilator and its regular business of manufacturing anaesthesia systems, patient monitoring, laryngoscopes and suction and oxygen therapy will only begin again when all the ESO2 delivery objectives have been met.
Several thousand have been ordered for the UK NHS in case of re-occurring infection or for any future epidemic or pandemic treatment. Penlon and the Ventilator Consortium UK are well on their way to meet the government’s requirement and will be busy making the ESO2 for the UK until the end of June.
Dick Elsy, Chairman of VentilatorChallengeUK and CEO of High Value Manufacturing Catapult, said: “We have covered an incredible amount of ground in the two months since the Consortium was formed. The progress we have made is testament to the effort and energy brought to the challenge by every member of the VentilatorChallengeUK Consortium team. They have never wavered in their determination to make sure that our NHS always has the number of ventilators it needs to treat this virus.”
So what of the future? In times of adversity, great things can happen. For Penlon, which turned over under £20 million last year, normal manufacturing will begin again after June. Craig believes that a UK manufactured ICU ventilator would help in the planning for any future pandemics, and the company is currently investigating how the development of this product can be funded, alongside boosting its current position as a world-class manufacturer of anaesthesia and respiratory devices for the global market.
“With ventilator and other critical shortages, the world went from globalisation to localisation in the blink of an eye,” said Craig. “Now the UK has the evidence to back an industrial strategy to make more critical products in the UK.
“We are delighted to have been given the opportunity to dedicate our lives, 24/7, to the task of making the ESO2 for the UK NHS. We would also like to pay tribute to the dedication of NHS staff, the Penlon workforce, Ventilator Challenge UK members, and all key workers around the world.”