Simon Karger, commercial director at Cambridge Consultants, reveals the story – and the learnings – behind Veloci-Vent and looks ahead to ventilator innovation beyond COVID-19.
It is a day indelibly marked on my memory. Friday the 13th of March 2020. Late in the afternoon, we took an urgent call here at Cambridge Consultants from Her Majesty’s Government. The request was polite but stark. With the deadly COVID-19 pandemic threatening to overwhelm the NHS, please would we assist in the rapid development and manufacture of lifesaving ventilators.
A few months on, as the UK inches tentatively out of lockdown, I am able to not just reflect on a rollercoaster period of activity but share a little future-focused perspective. Within hours of the call, it dawned on my colleagues and I that we were facing the challenge of our professional lives. It would normally take five to six years to develop a system to the levels of safety and clinical utility needed for patient deployment. We were given six weeks.
Of course, as we all now know (but didn’t know then) the government’s social distancing efforts mean that the need for emergency ventilators to supplement NHS capacity thankfully hasn’t materialised. But that in no way undermines our pride in Veloci-Vent, the sophisticated emergency ventilator we designed and built from scratch. It has earned praise from government ministers, clinicians and the Medicines and Healthcare products Regulatory Agency (MHRA). Encouragingly, it is now attracting interest from other nations with limited ventilator capacity. But just as valuable for me are several key project learnings that will undoubtably underpin our future developments.
The first is this: delivering complex innovation rapidly while managing risk isn’t impossible, but it is necessary to be set up for success. Your team will be instrumental in this, so they need to be empowered with the autonomy needed for rapid and sure decision making. The Veloci-Vent team at Cambridge Consultants, convened within hours, comprised a range of disciplines including mechanical engineers, electronic engineers, software engineers, regulatory affairs specialists, clinical specialists, physicists, mathematicians, human factors, design and more.
It quickly grew to no fewer than 185 people, driving a programme of work that ran day and night without pause. These were febrile days remember, when the country was gripped by the growing pandemic and my colleagues were working to unfamiliar social distancing guidelines while under intense pressure. But it was a group of people strengthened by collective experience in the development of safety critical processing. They were backed by robust processes and powerful tools to aid efficiency – everything from requirements tracking software to hardware-in-the-loop modelling capabilities.
The challenge of change
The transparent, fully integrated approach also had to be flexible enough to withstand the challenge of change. Early on, when the clinical understanding of COVID-19 was less developed, urgency prevailed, and we were guided to build an ultra-minimalist device. With improved insight, government direction switched to the development of a robust ventilator fit for as many patients as possible. With COVID-19 having no one specific phenotype, maximum versatility was demanded.
Veloci-Vent is a near fully featured ventilator, capable of a range of sophisticated and technically challenging functions tailored to the reality of the COVID-19 patient journey. For me it is proof that rapid medical device development needn’t conflict with the risk-managing requirements of ISO 13485 if the approach is well structured. While the evolving brief might have caused real problems for minimum viable product type approaches, the highly flexible underlying architecture and massively parallel work streams meant that we could respond to changing needs and timescales.
Crucially, these factors also prevented us from transgressing the normal regulatory framework of the MHRA, while meeting its evolving demand for increasingly sophisticated, fully featured devices. Veloci-Vent is based on the design principles used in 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 supports aspiration (suction) and responds to patients as they begin to recover and breathe for themselves.
Patient-triggered ventilation is capable of assisting spontaneous breathing modes 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 our conversations with clinicians. Such exchanges were a key contributor to the successful project outcome. We have a hard-earned familiarity at Cambridge Consultants with clinical context, physiology and regulations. This was a vital asset during the almost daily discussions with frontline clinical specialists and MHRA regulatory experts as we deep dived into a host of clinical, technical and usability issues.
‘Collaboration and innovation’
I think it’s fair to say we all felt a heady mix of pride, relief and exhaustion when Veloci-Vent was unveiled. Michael Gove, chancellor of the Duchy of Lancaster and minister for the Cabinet Office, was kind enough to say this: “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.” But like all innovators, our thoughts soon started to settle on the future.
Colleagues have been exploring the challenges and opportunities for a new generation of ventilators and ventilation. Automated ventilation, for example, has been on the market for a number of years but has yet to be adopted widely. Watch this space. The demographics of developed economies and the rising cost of healthcare will increase the demand for technologies that increase staff efficiency.
Healthcare professionals are reticent about handing over control to an algorithm, concerned about dumbed down care where staff no longer trust, or even make, their own judgements. To rise to the challenge, manufacturers must create interfaces that clearly communicate the status of the system, allowing seamless transfer back to human control. An understandable model of why current settings have been selected is also imperative to support understanding rather than blind acceptance of automation. It would be no surprise if automated ventilation gained an early foothold in emerging markets. There is a huge shortfall in skilled ICU staff and a documented willingness to embrace technology that leapfrogs developed markets.
But for the moment, our immediate day-to-day attention still rests on Veloci-Vent, discussions with representatives of countries eager to explore its potential for deployment and lessons we can bring to help all our clients bring speed and adaptability to all their complex developments. It was created at lightning speed yes, but it’s a robust working ventilator built by a team that followed all the necessary quality management systems and microbiological standards required for a safety critical device. Like I said at the start, it’s memorable indeed.