Medical Design Briefs - June 2021 - 38

Coping with the Pandemic
Automated reel-to-reel machines precisely align and laminate treated materials. (Credit: Web Industries)
strip; a collection swab; positive and negative
control swabs; and a tube filled with
reagent fluid that also works as dropper.
During use, the sample swab is inserted
into the tube and mixed with the reagent
solution. Fluid from the tube is then dispensed
into a designated well on the test
device. The fluid flows across the device's
treated sample pad, prompting a chemical
response to the specimen. Trained clinicians
then insert the test into a portable
test-reading device to obtain the results.
The initial development phase was
mainly a batch process involving separate
manual operations. During this phase,
the lateral flow strips were cut using off -
line cutting machines. Multiple layers of
material were aligned and laminated
together. Assembly technicians then manually
inserted the laminated strips into
the test cassettes. It was a labor-intensive
process, but over the next few weeks Web
steadily increased its test kit output, and
within just 12 weeks, Web produced
12,000 devices, meeting its OEM's time to
market. This was confirmation to Web
and its OEM partner that the project was
viable and could be successfully scaled to
high-volume production.
Taking Precautions
A challenge to scaling from an initial
volume of 12,000 to a million per week
38
Cov
was ensuring the safety of all employees.
Preventing COVID-19 infections among
on site-based employees was critical.
Workers' health was paramount. From
the pandemic's start, a team of 14 Web
Industries' employees met every day,
seven days a week, via Zoom to develop
an infection-prevention strategy. Relying
on guidance from the Centers for
Disease Control and Prevention, the
team identified and implemented best
practices at all company locations.
Social distancing and masking were
mandated, and temperature checks were
required whenever an employee or visitor
entered a Web facility. The team also developed
procedures for necessary actions in
case of an infection, including rules on
quarantining workers and cleaning affected
areas. The group continues to meet regularly
to review prevention practices.
Phase Two: Full Automation
After the initial market push, Web
scaled to full production. This entailed
not just incremental changes, but a total
transformation of operations and processes.
It meant producing millions of antigen
tests per week, rather than thousands.
To accommodate full automation,
Web repurposed and added thousands
of square feet at its Holliston facility.
This included more space for dry rooms
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ToC
needed to maintain the right test production
humidity. The company also
obtained additional offsite warehousing
to store test materials and components
and installed a new enterprise resource
planning (ERP) software suite, which
consolidated many business functions
including production, distribution, finance,
and supply chain. The ERP system
keeps close track of data needed to
meet FDA record-keeping requirements.
Web acquired capabilities that facilitated
conversion from manual operations
to completely automated production.
These included pick-and-place machines,
machine vision cameras, and checkweigher
systems. The equipment is now
linked together and integrated seamlessly
on the factory floor. The company automated
each production step, including
reagent deposition, lamination, test strip
cutting and placement, and packaging.
In simplified form, the production
process works as follows: After large
batches of reagent and conjugate are
made according to the test recipe, they
are deposited onto test strip materials
via precision spraying or coating. Auto -
mated reel-to-reel machines precisely
align and laminate the treated materials.
Cutting machines, formerly offline, were
brought online and integrated with pickand-place
machines. These lightly grasp
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Medical Design Briefs - June 2021

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