Created as a new design in a little over six weeks and praised by a panel including ministers, clinicians and the Medicines and Healthcare products Regulatory Agency (MHRA), Veloci-Vent is an achievement to rank alongside any in Cambridge Consultants’ 60-year history.
Cambridge Consultants received the UK Government’s call on March 13 2020. Faced with the biggest crisis in decades, and the risk that the UK’s ventilator capacity would be overwhelmed, the company was proud to assist in the rapid development and manufacture of ventilators to meet the unprecedented challenge faced by NHS hospitals dealing with the coronavirus pandemic. This ‘Ventilator Challenge’ involved multiple concurrent streams, with leading technology and engineering firms engaged to build existing, modified or newly designed ventilators at speed.
Despite our long track record in pioneering medical device development, the team knew they’d taken on the challenge of their professional lives: to design and build a completely new ventilator, from a blank sheet of paper to manufactured units, in just six weeks. In addition, the team needed to base their 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 that sits at the core of the company’s quality system. A team was convened within hours, bringing together a range of disciplines including mechanical engineers, electronic engineers, software engineers, regulatory affairs specialists, physicists, mathematicians, human factors, design and more.
This team, that quickly grew to 185 people, began a programme of work that would run day and night without pause, despite the working constraints of a national lockdown, for a further 46 days.
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the early days of the Ventilator Challenge, when the clinical understanding of COVID-19 was less developed, and urgency superseded all else, the team was guided to design and build an ultra-minimalist device.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, so 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 tailored to the reality of the COVID-19 patient journey. While this evolution caused fundamental difficulties to some ‘minimum viable product’ type approaches within the broader programme, a highly flexible underlying architecture and massively parallel work streams meant that the Cambridge Consultants team could respond to changing needs and timescales while never stepping outside of the normal regulatory framework.
Veloci-Vent is based on the design of established ICU pressure-controlled ventilators. 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 well 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 (suction) 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.
To the relief of the whole country, 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. However, Cambridge Consultants is currently responding to interest to use Veloci-Vent outside of the United Kingdom in nations where ventilator capacity is limited.
Honouring the huge achievement of the Cambridge Consultants team, the Rt Hon Michael Gove MP, Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office, 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.”
Eric Wilkinson, Cambridge Consultants’ Chief Executive Officer, added: “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."