Exovent: an accelerated innovation journey in 2020
2020 was an exceptional year for the Exovent team. It has been an unusual year
for everyone with a global pandemic disrupting life, while putting enormous
strain on the NHS. This backdrop created an environment and an imperative
for innovation that is unique within the 21st Century, leading to extraordinary
achievements in the areas of vaccines and ventilators at a time when much of
the world’s population and businesses have been adapting to online interaction.
We describe the innovation journey for Exovent, a negative pressure ventilation
support device developed in record time by a UK charity with a small volunteer
team of clinicians and engineers, working alongside the UK’s largest privately
owned aerospace & defence company, Marshall ADG.
How did it start – the power of Facebook
The original idea came from Dave McKeown, a civil engineer
in Cornwall working for the Environment Agency on flood
defences. As the pandemic gathered momentum in March 2020,
Dave asked himself what he could do to protect his family if the
NHS was overwhelmed. After discarding several possibilities, he
came up with a modern lightweight version of an iron lung using
a wooden enclosure over the chest. He realised it could be built
in large numbers quickly and cheaply, so on the 19 March he
wrote to the Cabinet Office asking for support to turn the idea
into reality. Although there was no reply to his letter, that same
day an unknown person shared it on a Facebook post that was
circulated widely amongst doctors and beyond. Suddenly Dave
found himself being contacted by anaesthetists, critical care
specialists, surgeons and engineers, all keen to turn his idea into
reality. The Exovent team was born and had its first call the very
next day.
Rapid proof of concept
Driven by the urgent potential need for the device, the pace of
work was intense, often with multiple daily calls, working late
into the evening and weekends. Within days, several of the team
had built working prototypes at home based on plywood boxes,
drysuit neck seals, vacuum cleaners and simple control systems,
proving that a powerful system could be produced easily. All the
time the Exovent network was expanding, broadening the team’s
strengths and capabilities; everyone was working with other disciplines with no hierarchy. Most fitted the activity around their
day jobs, including NHS clinicians who would join meetings after
long days working in hospital. Early on the team moved from
phone calls to Zoom meetings.
Developing a professional system
The team needed partners to help turn the Exovent system
into reality. Progress came at the end of March when Warwick
University High Value Manufacturing Catapult was introduced
to Exovent who, in turn, introduced Marshall ADG. Using
specifications provided by the Exovent team, Marshall ADG
set about creating a system. With accelerated design control
processes allowing parallel engineering and development
activity, they produced the first system within three weeks, and
a week later a fully working second iteration incorporating
design improvements from Exovent clinicians. On the 29 April Professor Anil Patel, a consultant anaesthetist at the Royal
National Throat Nose and Ear Hospital, UCLH became the first
Exovent team member to test the unit.
Ups and downs
Early on it became clear that the UK Ventilator Challenge
covered only positive pressure ventilators, so fast track support
was unavailable. The team continued undeterred because they
believed that the benefits of negative pressure ventilation are
not limited to COVID-19, but may be indicated for patients with a
variety of acute and chronic respiratory diseases. By reducing the work of breathing, increasing the surface area for gas exchange,
and preserving right ventricular output, negative pressure can
not only help the deteriorating patient but recovering patients
too, with potential benefits to weaning and recruitment,
although much work needs to be done to substantiate these
aspirations [1]. The focus, therefore, moved to full medical
device approval and it was clear that we lacked the specific skills
necessary to navigate the medical device approval process.
Coincidentally, Michael Rose, a product management specialist
in the medical device industry filled the gap at just the right
moment.
Above: Figure 1. Professor Anil Patel in an Exovent
Above: Figure 2. The Marshall-Exovent
Medical device approval and clinical trials
Under normal circumstances it takes over three years for a
medical device to gain approval. Exovent plan to achieve this
in half that time, producing an approved device by September
this year. In 2020 there were additional complications, Brexit
uncertainty and replacement of the Medical Devices Directive
with the more complicated and challenging Medical Device
Regulations. After much analysis of the regulations and
examination of all the predicate negative pressure devices, we
now believe that approval can be achieved without the need
for a clinical trial, albeit with extensive documentation. We
also needed a manufacturer on board for submission, and are
delighted that this will be Portsmouth Aviation.
Once the system has achieved regulatory approval, Exovent will
conduct clinical trials as part of our post-market clinical follow-up
plan. This should provide data to extend the use of the system
to patients with a wider range of respiratory disorders. Much
of the planning for these trials has already been completed
by clinicians at the University of Southampton Hospital under
the leadership of Professor Mike Grocott. This is a major
undertaking, and Exovent will be applying for grants from a
number of funding sources.
Summary
It took six weeks from concept to a fully functioning negative
pressure ventilator that could have been produced in large
quantities had the UK faced a major shortage of ventilators
during the COVID-19 peak. Ultimately that was not needed,
but the work highlighted the benefits of negative pressure
ventilation; it is more physiological than positive pressure
ventilation and allows the patient to remain conscious
throughout, making it ideal for low-income countries where
access to sophisticated medical care is difficult. The Exovent
team are committed to delivering an approved
UK-manufactured system in record time, and are working
with teams around the world to help them develop their own
versions. We want everyone that needs breathing support to
have access to it.
Ian R. Joesbury
Exovent CEO and professional engineer
Professor David Howard
Consultant and Professor of Head and Neck Oncology
Imperial College NHS Hospitals, London
Jim Roberts
Consultant Anaesthetist and Clinical Lead,
Royal National ENT and Eastman Dental Hospitals, UCLH, London
and the Exovent Team
Twitter: @IanJoesbury; @ExoventNPV
References
- Coulthard MG, Ackerley D, Downie NA, et al. Exovent: a study of a
new negative-pressure ventilatory support device in healthy adults.
Anaesthesia 2021; 76: doi:10.1111/anae.15350.