Working round the clock: Developing a ventilator to fight COVID-19

Ian Bolland spoke to Douglas Bradshaw from Cambridge-based technology and development company, TTP plc. The company developed the CoVent ventilator following a call from government to increase ventilator capacity as part of Ventilator Challenge UK, as part of the country’s efforts to battle COVID-19.

Bradshaw explained that whilst other organisations – such as in the aerospace and automotive sectors – were tasked with developing ventilators with modifications to existing design, TTP was given a brief to rapidly develop a ventilator from scratch.

For TTP, this was about creating a new prototype that responded to the specific COVID-19 challenge – this level of innovation is usually unheard of in such a tight time frame. TTP developed a ventilator ready for MHRA approval in six weeks, a project that would normally take between two to five years.

One of the main considerations, given this was a health emergency affecting other parts of the world, was TTP could only use parts readily available in the UK supply chain and ones that could easily be manufactured. The companies involved had to avoid conflict when selecting items. Bradshaw said it could have been a real challenge but was full of praise for the supply chain, describing the response as surprisingly easy and heart-warming. 

“It was a challenge that people were aware of right from the outset. It starts with the selection process, when we were thinking about technologies, parts, components, or indeed manufactured items.

“We had a team here at TTP who co-ordinated with the Cabinet Office to make sure what we were selecting was available in the UK, and available in volume.

“We had to ensure that the design, including the materials used in it, are intrinsically safe. You know that it’s safe because of what you’re selecting. It does restrict the number of materials or components you might use because you don’t have the access to testing to prove it.”

The three main aspects that informed the design of CoVent was to make sure the device was safe, clinically effective, and could be manufactured in high volumes.

Developing a ventilator during a national and international health emergency in the space of six weeks might be unheard of, in part helped by derogation in CE marking in order to bring the devices to the front line as quickly as possible, but in terms of its development Bradshaw suggested the company was able to take it in its stride.

Given the urgency of the impending national emergency within 24 hours a team of experts that quickly grew to 140 people came together and began to carry out all these tasks in parallel (Figure 1). By necessity, the pneumatics, mechanics, user interface and electronics of the ventilator were all designed simultaneously before the first MHRA device specification had been released.

The regulatory documentation plan was being put together without a clear idea of what the device would be. Prototype units were being designed and built at the same time the production line was being laid out. The instructions for use were being drafted prior to having a functioning prototype. All of this happened without a traditional line management structure but instead with highly distributed authority and responsibility. What surprised those at TTP is that they didn’t see all the mistakes and substantial knock-on consequences that would be expected when working in such a fashion. 

“At TTP, in a sense it’s what we do every day. People come to us to achieve the impossible or the seemingly impossible, and so for us in many ways it was quite routine to be faced with a seemingly insurmountable challenge.

“The fact that there was this goal of being able to potentially deliver safe and clinically effective ventilators into the NHS in volumes, the fact that we achieved that goal and we are ready and able to do that again if it’s needed - God forbid - it gives me a great sense of pride that we were able to do that.”

Developing a ventilator that was clinically safe and effective meant the company worked closely with the MHRA and NHS clinicians from the outset. As TTP employs clinicians and has an established network of medical experts including those from the, NHS getting real time information from the front line about the disease helped inform that aspect of the design.

“One of the challenges that countries have faced is that the disease is not particularly well understood, and this is true in the UK as it was abroad. The main involvement of the MHRA was helping to identify what the clinical requirements were as that understanding evolved through the early days and weeks of the crisis, and then how you translate that clinical insight into design requirements. As the clinical picture of the disease changed, we rapidly implemented additional functions for suction to remove lung secretions and support for spontaneous breathing.

“Ostensibly, TTP is right in the middle of helping translate that clinical requirement into a technical specification – one that the design teams can make sure that what we’re designing is a product that’s not only safe and been manufactured in volume, but also clinically effective.”

Bradshaw also shared some insight as to what it was like working so closely with government at a time of national emergency – saying the gravity of the situation was clear from the outset.

“It was quite evident that it was a crisis, there was very clear direction provided by ministers, the goal was set out pretty clearly.  

“They’ve also been very keen to make sure it’s consistent across the board. It was patently clear there was consistency and fairness in the way they’ve treated all parties in terms of information and the support that they’ve given.

“The combination of TTP, the relationship with government, the relationship with our suppliers and manufacturing partner, I don’t think you could ask for more.”