Medical Design Briefs - June 2021 - 37

Web's turn to the medical sector. Despite
the challenges, the company had a solid
foundation on which to build. It was one
of the few U.S.-based contract manufacturers
with a network of domestic factories
capable of processing the type of
flexible materials used in diagnostic
tests. Plus, its medical business featured
an LFI competency, established in 2014.
Web consulted first with potential supply
partners and identified a new opportunity
in the medical field: producing
rapid LFI antigen test devices. Antigen
tests are one of the two main diagnostic
tools used to detect COVID-19 infections,
along with molecular RT-PCR tests. Speed
and ease of use are LFI antigen test hallmarks.
The antigens recognize proteins
on the virus's surface by sampling a nasal
or throat swab. They can be administered
and read close to the point of care.
Results appear within 15-30 minutes. In
contrast, RT-PCR tests require specialized
laboratory processing and can take a few
hours up to an entire week for results.
As with vaccines, diagnostic tests usually
take years to design, develop, and
earn approval. But under
Emergency Use Authorizations
(EUA) from the U.S. Food and
Drug Administration (FDA), Web and its
partners were able to move forward much
quicker. The company faced a tight deadline
- 12 weeks - to complete the first
stage of test development.
" It is not the
strongest of the
species that
survives, nor the
most intelligent. It is
the one that is most
adaptable to change. "
- Charles Darwin
Phase One: Proof of Concept
Web invested millions in its Holliston,
MA, LFI facility to accommodate rapid
antigen test device production and reassigned
engineers and technical staff from
the aerospace division to Holliston. The
relocated employees brought with them
experience in converting flexible materials
and working in a regulated industry to
manufacture the critical components for
antigen test devices. At the same time, the
company began a massive recruiting
effort to hire hundreds of new employees
to fill manufacturing positions.
The ramp-up in test production
occurred in two phases. Phase one
entailed building capacity, mostly manual,
to scale to 1 million devices per week.
Phase two involved full automation of all
processes and high-volume production
to exceed 2 million test devices per
week. Web, with its supply partners and
strong support from its OEM partner,
built a solid supply chain and procured
the necessary automation to support this
volume's production of antigen test
devices. The production process also
adhered to exceptional quality standards
and took place in an FDAregulated
environment.
The COVID-19 antigen test kit contains
a plastic cartridge housing an LFI test
Web Industries converted from manual operations to completely automated production. The equipment
is now integrated seamlessly on the factory floor. Automated production steps include reagent deposition,
lamination, test strip cutting and placement, and packaging. (Credit: Web Industries)
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Medical Design Briefs - June 2021

Table of Contents for the Digital Edition of Medical Design Briefs - June 2021

Medical Design Briefs - June 2021 - Intro
Medical Design Briefs - June 2021 - Cov4
Medical Design Briefs - June 2021 - Cov1a
Medical Design Briefs - June 2021 - Cov1b
Medical Design Briefs - June 2021 - Cov1
Medical Design Briefs - June 2021 - Cov2
Medical Design Briefs - June 2021 - 1
Medical Design Briefs - June 2021 - 2
Medical Design Briefs - June 2021 - 3
Medical Design Briefs - June 2021 - 4
Medical Design Briefs - June 2021 - 5
Medical Design Briefs - June 2021 - 6
Medical Design Briefs - June 2021 - 7
Medical Design Briefs - June 2021 - 8
Medical Design Briefs - June 2021 - 9
Medical Design Briefs - June 2021 - 10
Medical Design Briefs - June 2021 - 11
Medical Design Briefs - June 2021 - 12
Medical Design Briefs - June 2021 - 13
Medical Design Briefs - June 2021 - 14
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Medical Design Briefs - June 2021 - 18
Medical Design Briefs - June 2021 - 19
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Medical Design Briefs - June 2021 - 21
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Medical Design Briefs - June 2021 - Cov3
Medical Design Briefs - June 2021 - CovIV
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