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Proof of Concept is
the first step in many projects.
Before
a project manager or engineer contacts Omnica, they usually have a good
idea what they need or they have a specific list of requirements.
Sometimes, however, the proposed project lacks one or more critical
elements. That missing element could require a new process, an unproven
technology, or the need to modify an existing system to fit the
application. That part of the development process, often referred to
as feasibility, proof of concept, or R and D, is addressed by Brad
Sargent, Ph.D. and the other members of our “Advanced Technical Services
Group.” Read more about
Brad.
Here
is a scenario that often occurs when we are introduced to a fresh
challenge by a prospect or a new client.
After
the facility tour and during brainstorming session, the Omnica team offers
a number of possible solutions and asks some key questions the customer
may not have considered. The meeting evolves into a thought provoking
experience for everyone. The usual result is renewed excitement and a more
well defined project direction. We can’t take too much credit. Synergy
often develops when professionals see a challenge from a different
point-of-view.
Our
client faced a challenge. Could we solve it?
As
an example, a long-standing client came to us with an established product
that needed some revisions. Elements of the technology used in their
medical device had become outmoded, and many of the existing components
were too large for the next-generation product. We looked closely at the
assignment, and considered searching for answers outside the medical
industry.
Brad
designed the accelerated testing device (right) to collect data. It
would serve to establish the reliability of critical infusion pump
components.
Accelerated
life-testing
One
of the possibilities involved the use of a force sensitivity sensor,
a “switch” commonly found in devices like keyboards and touch pads. It
was certainly small enough
to be considered, and initial evaluation for use in this
application was encouraging. Brad Sargent Ph.D., our Director of Systems
Integration, headed the testing and qualification protocol. For more than
a decade he has written instrument control and data acquisition software
for custom-designed
equipment.
Brad’s
first challenge was to prove that the component would perform as
anticipated over a period of time. He used a combination of digital and
analog technology (and our CNC machine shop) to build an accelerated
testing apparatus. Since the keyboard sensor was to be used in a Class
II medical device, our client needed performance statistics which
exceeded the manufacturer’s certifications. It was critical that after
thousands of cycles, its function would be stable, repeatable and
accurate. Over a period of weeks Brad’s specially designed computer
program collected all data for later analysis and the design control
documentation.
The
experiment and the development program were successful. Accelerated
life-testing validated use of the sensor when combined with the specified
motor, seals, and several other custom-made parts to be used in the final
product. The FDA submission would reference those tests,
procedures, and results.
The
sensor was eventually incorporated into the Paradigm™ insulin pump
marketed by Medtronic MiniMed. Omnica contributed to the broadly worded
patents. In the years to come they would protect our client’s future
exclusive use of the sensor for similar applications.
Read
more about our Advanced Technical Services Group.
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