Cambridge Consultants develops emergency ventilator in six weeks – Med-Tech Innovation | Latest news for the medical device industry

Cambridge Consultants has unveils Veloci-Vent, a sophisticated emergency ventilator designed and built at the request of the UK government for use in the treatment of COVID-19.

It was created as a new design in a little over six weeks and has been praised by a panel including ministers, clinicians and the Medicines and Healthcare products Regulatory Agency (MHRA).

Cambridge Consultants received the UK government’s call on 13 March 2020 to assist in the rapid development and manufacture of ventilators to meet the challenge faced by NHS hospitals dealing with the Coronavirus pandemic. The Ventilator Challenge involved multiple concurrent streams, with leading technology and engineering firms engaged to build existing, modified or newly designed ventilators at speed.

The team needed to base its design around components available at scale in the UK, due to supply chain disruption. As a safety-critical medical device, it would normally take five or six years to develop a system to the levels of safety and clinical utility that are necessary for patient deployment. High volume supply and extremely rapid manufacture were key objectives, while remaining subject to testing and approval from the MHRA and without compromising the integrity and focus on patient safety. The team brought together a range of disciplines including mechanical engineers, electronic engineers, software engineers, regulatory affairs specialists, physicists, mathematicians, human factors, design and more.

The team, which grew to 185 people, began a programme of work that would run day and night without pause for a further 46 days.

Eric Wilkinson, Cambridge Consultants’ chief executive officer, said: “When the country necessarily went into lockdown, our team went to work and I, and all our staff, feel an immense sense of pride in their achievement. I thank the project team and the wider group of colleagues that supported their work, enabling them to focus solely on project delivery. Right from the start, the team used their considerable medical technology skills to fill in gaps in the evolving specification, meaning that many of the later, high-performance requirements were already designed in. As well as producing a fully-working, production-ready ventilator in just 46 days, the team followed all of the necessary quality management systems and microbiological standards required for a safety critical device. Veloci-Vent is not just a working ventilator, but a robust system, built without compromise to safety and all achieved in an almost unbelievable timeframe.”

In the early days of the Ventilator Challenge, when the clinical understanding of COVID-19 was less developed, and urgency superseded all else, the team was guided to design and build an ultra-minimalist device. But with an improved clinical understanding of the disease, the need and direction from government was refined. Working with an advisory team that included front line clinicians, the guidance was to develop a robust device fit for as many patients as possible – COVID-19 has no one specific phenotype – aiming for maximum versatility.

Veloci-Vent was designed from the outset as a fully-featured ventilator, capable of a range of sophisticated and technically challenging functions.

The ventilator is based on the design of established ICU pressure-controlled devices. It is suitable for long term use, has a familiar user interface and allows standard clinical workflows. The device enables the ‘basic’ mandatory ventilation originally envisioned and expands beyond that, providing a system that responds to patients as they begin to recover and breathe for themselves. Patient-triggered ventilation is capable of assisting through various spontaneous breathing modes, supports aspiration and, ultimately, weaning. These more advanced modes provide a system suitable for the longer period of intubation described by both the UK government’s specification and the team’s discussions with clinicians.

Social distancing measures put in place during March flattened the peak COVID-19 infection rate. The result is that the NHS retained spare critical bed and ventilator capacity, and the UK government now expects to meet demand using existing ventilator designs. Cambridge Consultants is currently responding to interest to use Veloci-Vent outside of the United Kingdom in nations where ventilator capacity is limited. 

Michael Gove MP, chancellor of the Duchy of Lancaster, said: “Thank you for the extraordinary efforts that Cambridge Consultants made to address the increased need for ventilators as a result of COVID-19. The ingenuity and commitment that your team and suppliers have demonstrated is incredible. You brought pace, collaboration and innovation to this challenge, and that is recognised and appreciated across government. The commitment that you have shown has been truly inspirational.”