NOVEMBER 2019
The call came on March
16, 2020 when the prime
minister Boris Johnson
urged manufacturers
to come forward in a
collective effort to make
ventilators for the NHS.
Around 5,000 ventilators were
estimated to be in circulation, but
the onset of Covid-19 prompted
government to call for thousands
more to help those expected to
be stricken with the respiratory
disease.
“We wanted to help but we
didn’t know what shape that help
would take,” said Victoria Howells,
Director of Engineering at Thales
Avionics.
Thales are members of
VentilatorChallengeUK, a
consortium of businesses
including the consultancy
Newton Europe, who worked
with low volume medical device
manufacturers Smiths Group
and Penlon to ramp up ventilator
production.
Newton were among those
pivotal in helping Penlon
modify and scale up production
of its Prima ES02 device. The
consortium worked also with
Smiths Group to deliver paraPAC
plus ventilators at three new
production sites.
Smiths and Penlon are more
used to producing a combined 50
and 60 ventilators per week. By
May 20, around 5,500 consortium
employees were working across
nine sites to produce between
100-200 of the combined units per
day to fulfil a government order for
15,000 ventilators.
Each unit had to be fit for
the Medicines and Healthcare
products Regulatory Agency
(MHRA)’s Specification for Rapidly
Manufactured Ventilator System, a
25-page document outlining what
each unit must, should and could
have.
Sprinting a
marathon
Engineers win the race to make Covid-19 ventilators
For Newton, key to the team’s
success was ‘identifying the fastest
route to regulatory sign-off’ and
working backwards from there.
“Central to this was codesigning
and agreeing on the
process for trialling and approving
machines with the regulatory
body, which then shaped the
demands on production,” said
Lorenzo Bassano, Business
Manager, Newton. “Thanks to
the hard work of the Penlon
Regulatory department and the
consortium’s support team, we
achieved regulatory approval for
Penlon’s adapted ESO 2 device in
just 22 days.”
Before rapid production could
go ahead it was necessary to
record and pass-on the specialist
knowledge of a few experts to
a much broader group, which
Bassano said involved sitting with
June 2020 / www.theengineer.co.uk 10
Penlon specialists and clearly
documenting the steps to take, so
that this information was easily
digestible for the new teams.
“Secondly, we needed a
process to link the right people
together quickly so we could
understand any constraints and
solve production issues. This
was done by forming a contacts
handbook,” he said. “Finally, we
needed to source more people with
transferable skills to help us rampup
production at pace.”
With its background in defence
training and simulation Thales
came on board to upskill over 100
engineers across multiple sites to
build the paraPAC plus, and deliver
ventilator operator training to NHS
staff digitally.
For Thales, helping an SME
to scale up presented less risk to
the project’s success, and did not
THANKS TO THE HARD WORK OF THE PENLON
REGULATORY DEPARTMENT WE ACHIEVED REGULATORY
APPROVAL IN JUST 22 DAYS
require the company to accrue a lot
of specific medical detail that the
company had no background in.
With GKN Aerospace stepping
in to assist Smiths with the
additional resource required
to scale up, Thales set about
producing the content required to
train people in what the devices
should look like and feel like.
Laura Shrieves, Head of
Systems Engineering at Thales
coordinated work streams with
Smiths. Howells said this could
involve between five to eight
meetings a day on different topics
working with international teams,
such as Microsoft and PTC in the
US, plus the team in the UK.
“To give a sense of intensity,
the team…had been running for
40 days, seven days a week…in an
effort to get the various strands
of training to a position where we
could support Smiths with what
they needed,” she said. “We’ve also
been working with Public Health
England to do clinician operator
training which is being distributed
by NHS E-Learning tools.”
Thales assessed the skill
level of those on the assembly
lines and introduced a ‘context
manufacturing’ approach to
making sure everyone understood
ventilator idiosyncrasies. When
it came to testing, Newton first
ensured that staff understood
requirements based on a ‘fit, form,
function and bio-compatibility’
model.
“Secondly, we needed to write
a well-defined process that testers
can pick-up quickly and perform
to a high standard,” said Bassano.
“At Ford, we broke the process up
to different steps so one person
performs a singular test. Other
parts of the testing process needed
to be undertaken at the same time
as the individual needs a broader
picture of what’s required to assess
the whole machine.” ”
News analysis
WRITTEN BY JASON FORD
/www.theengineer.co.uk