Our entire Electronics and Advanced
Services departments were involved in the software development, circuitry
design, troubleshooting, and the problem-solving challenges that occurred
during development. For this article we interviewed Paul Gleason, a member
of that group.
Projects that are a technical challenge,
and solve real-world problems are a great fit for us. Do you recall the
news about illness arising because of eating undercooked hamburger, and
raw milk? E. coli 0157, a bacterium that normally lives in the intestines
of mammals is the microbe responsible for most of these recalls. In 2002 a
major U.S. supplier had to recall 19 million pounds of beef because of E.
coli contamination!
Companies that process food need a rapid and accurate method to test their
products before they are sold to the public. We have developed such a
testing device for Centrus International, a subsidiary of Eastman
Chemical. It is a desktop instrument and assay test cassette that uses
para-magnetic microparticles, which bind to the target microbes during the
test. The results are displayed and printed. Until now the food industry
has not had access to a system with this combination of accuracy, speed,
and sensitivity.
The system has its own built-in CPU
and printer, and calibrates itself each time it is turned on.
But how does it work? 1) The sample in question is mixed in enrichment
broth, a growth media for E. coli. 2) After an incubation period the broth
is filtered. Magnetic particles that later attach to the target bacteria
are added. 3) A small amount is placed in the assay cassette. 4) Capillary
action pulls the magnetic particles, with or without their E. coli
hitchhikers, along the assay membrane strip to a detection zone, and then
into a control zone. 5) A magnetic detector module reads the strip and
identifies minute concentrations of the magnetic-bound bacteria. Results
of the test are displayed on the instrument, and printed with its internal
printer.
Development
of the Envisio® instrument (shown at right)
was an example of an integrated team effort.
Paul Gleason, Omnica's Vice President,
was chosen to head the development team because the system requirements
were similar to those found in the clinical devices area, his field of
expertise. "There’s an assay consumable, a detection methodology,
software, user interface, and instrument hardware. It's a different
market, but it is laboratory instrumentation," explains Paul.
"Originally we worked for MagnaBioSciences® to develop the
technology of their assay cassette (shown below left) and the
magnetic detector module. Eastman® licensed the patented magnetic
detection technology, and we were hired to implement it in their new
instrument."
 The
Envisio device is aimed toward high-volume test sites, so it was designed
to be easy to operate. The assay results are interpreted in less than 30
seconds. There are only two buttons, one for the printer paper feed and
the other to cancel the process. "Basically the user opens the door
and inserts the cassette, and that's all they have to do," states
Paul.
The instrument incorporates the cutting
edge of electronics and software design. "There's a lot going on in
that box. In most lateral-flow assays, concentrations of the target
molecules are high, as is true with a pregnancy test." comments Paul,
"To achieve the sensitivity our client wanted, we had to develop
special algorithms to detect very low concentrations in test samples. This
part of the software and firmware development was particularly intense and
rigorous."
They said “develop the product, and
get the appropriate approvals for marketing on three continents.”
The Omnica team faced significant challenges combining just-perfected
technology from one company with reagent chemistries from another into an
innovative, sleek, and distinctive package. Our client made it clear that
the instrument development should not be a hold-up to production (not a
unique circumstance for us). Paul describes other unique requirements,
which could have slowed the process. "We had to develop a custom
miniature barcode reader, which may be the world's tiniest, and we had to
design, tool and mold the cassette. The production processes and
components we chose were tailored specifically to their projected
production volumes. From Eastman's point-of-view, the process was
turnkey. They said 'develop the product, and get the appropriate approvals
for marketing on three continents', and we did that." Transfer to the
contract manufacturer was another big part of the process. Paul clarifies
by saying, "Eastman chose the manufacturer, and we tailored elements
like the documentation, control drawings, preliminary release prints, and
inspection according to that manufacturer's quality system."
Near the end of the program, one ranking member of the client's
development team commented that the large medical OEM he previously worked
for could not have done this job in the short amount of time Omnica
completed it. Later, another member added that Omnica has successfully
pushed the envelope to the state-of-the-art limit for this parallel
project effort.
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