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MEDICAL
The distribution of
minicapsules, as seen in a
MRI scan (not pictured) can
provide objective evidence
of gut transit in patients
complaining of constipation
(72 in total), and then ask them to
come in for an MRI scan on the fourth day.
“The challenge was to produce
something small, workable, llable, and
safe to use,” states Marciani. He tasked
design consultancy Renfrew to nd a
solution.
PRODUCTION TECHNOLOGY
Renfrew design development director
Michael Phillips recalls that it could nd
no technology to make capsules of that
small size (8mm by 4mm, about the size
of a Tic Tac breath mint), so it considered
novel small-capsule lling methods, and
explored other ways of containing the
imaging medium, such as encapsulating
the emulsion within a polymer gel.
The innovative idea that the Renfrew
team ultimately chose was to ll a
medical-grade tube with the emulsion, and
then use a welding process to cut and
seal the lled tube using heat and
novel tooling. It developed tools and
iterated the process with a number
of materials and tube bore and
diameters. Experimentation helped
reduce the ashing and get
a smoother edge radius. The
team patented the method.
It also developed a semiautomatic
automatic injection moulding
production method.
As it is not a
manufacturer, Renfrew
passed the design to JEB
Technologies, a diversi ed
manufacturing subcontractor
and design engineering company
based in Suffolk that originally met
Marciani at the Med-Tech exhibition.
“The work that had been
done was very good,” recalls JEB
business development manager
Sean Licence, himself a quali ed
toolmaker. “And what we had to
do was use that as a springboard
to develop reliable volume
manufacturing.”
Although Licence
credits the Renfrew team
with a ‘superb’ idea for the
minicapsules, it had trouble
using the process to produce
the capsules at a suf cient level
of quality. And there were time
pressures; it had only three months
to set up production, validate it and
include it in the technical documentation
to send to the UK medical council for
clinical trial permissions.
Instead, JEB came up with an
alternative production concept “in an
afternoon, out of a ash of inspiration”.
Licence recalls working the heat-sealing
jig by hand, with another engineer. After
one particular run, he recalls: “We looked
at each other, and said, ‘that’s going to
work’”. Starting with tube, they closed
one end, injected the emulsion into the
other, and then sealed it thermally. After
making some prototype tooling, they sent
samples to Marciani for approval. His okay
led them to develop low-volume, manual,
single-cavity tooling, producing about
1,000 capsules per day using a revised
design that uses plastic injection-moulded
blank rather than tube.
The manufacturing process, however,
was only part of the work required for
medical sign-off. Process validation
included materials investigation to make
sure it would not put patients at risk, as
well as sterilization validation,
packaging validation, shelf-life
testing and transport.
The team in Nottingham
carried out a rst feasibility
clinical study, which was
successful. It involved giving
each of 42 test subjects a
72-microcapsule dose, all of
which were produced by JEB.
In July, Nottingham hospital started
gearing up for a second clinical
investigation to prove the capsule’s safety
and performance, following a £1.2m
funding award from NIHR. This will be a
larger trial of 436 children and teenagers
in clinics. After that, the team is possibly
going for the NHS’s Accelerated Adoption
Programme, which short-circuits the yearslong
process of testing new treatments in
special cases.
Having produced the initial batch, JEB’s
next focus is on CE marking. Research
results, clinically evaluated, are added
to the technical le and to be submitted.
Licence hopes to achieve that next year.
Part of that resubmission involved
up-scaling the manufacturing process by
automating parts of the operation. That
is a step toward the ultimate production
capacity of up to 500 parts/minute that
Licence estimates will be needed once
worldwide demand ramps up. This is
because JEB’s ultimate stake in the
project was not a share of the project
cost, but the contract to manufacture
and distribute the goods, worldwide, a
model that proved very successful for
the rm in a recent defence contract. Its
hope for future income is what supports
its £320,000 investment that Licence
estimates that JEB has spent on its
minicapsule development work so far.
Pentland Medical is lined up as the UK
distributor.
Concludes Licence: “It’s an amazing
project. We are so proud of this device,
and we know it’s going to change
people’s lives because of what it will be
able to do, once it’s approved for use.
That’s a great feeling.”
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