Our
Product Design Team - Selected
Employee Profiles
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Brad
Sargent, Ph.D.: Systems Integration Director
Producing today’s medical and
industrial products is increasingly dependent on technologies from
traditionally separate fields. Omnica’s ability to successfully
integrate these technologies has been enhanced by our staff scientist,
Brad Sargent.
When
Brad worked on his Ph.D. in Biomedical Engineering from U.C. San Diego, he
was involved with building sensors for physiology research using
semiconductor processing techniques and studies with long-term implanted
glucose sensors. Following completion of the Ph.D program, Brad spent a
year developing silicon microchip sensors at
the Institute for Microtechnology in Switzerland. Read
about a recent project Brad headed.
Brad
has also worked as a senior scientist at UniFET Inc. (renamed
SenDx), a biosensor company in San Diego. He helped developed both
point-of-care blood gas analysis systems and techniques for monitoring
on-line dialysis patients. Brad is knowledgeable with current FDA design
control regulations. He has been involved with feasibility testing,
product safety, software verification and validation. Additionally, he
provides engineering support for clinical trials.
With
wide and varied experience in electronics, mechanics, fluidics and
software makes Brad an important contributor to Omnica’s Advanced
Technical Services Group.
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Paul
Gleason: Director of Laboratory Instrumentation
Paul has been in the product
development business for 20 years. In 1982, the Loyola and UICC alumnus
was working as a consultant and engineer (in high-end audio). That year,
he and a group of colleagues combined career interests to found Ocean
Scientific, a firm specializing in the design and manufacture of
medical diagnostic instrumentation. As the company evolved, Paul’s focus
became business development and project management for the now renamed Source
Scientific. 
Paul’s area of expertise is in optically-based,
point-of-care laboratory instrumentation. He worked on an automated
sample processor for the first FDA approved DNA probe test which directly
detects specific microbial agents. In addition, he has played a major role
in developing products for Merck, Roche, B-D, Sorin Biomedica and
others.
Some of the products Paul has been
involved with in his career include:
- Hybritech Photon I and II (4MU
fluorometer & polychromatic photometer, FIA and EIA
- Roche COBAS RESA (CEA by EIA)
- Merck EASY-ST - clinical chemistry
Point-of-Care & TDM's
- Vicam Series-4 Fluorometer -
Aflatoxins in food, etc.
- BD Biosciences Affirm VP - DNA probe
processor
- Qualigen FastPack Chemiluminescent
Immunoassay Point-of-Care System.
From diagnostic instruments to Class III
medical devices, Paul has seen a lot during his international career. He
has conducted business in Europe and Japan, speaks 3 languages, and is
familiar with the world-wide regulatory environment including FDA, GMP,
ISO-9000, TUV, and European CE marking.
The point-of-care products Paul is so
familiar with are playing an important role as medical devices of
the future. Integration of automation into diagnostic systems means faster
more accurate results, lower patient and professional costs, and better
patient management. Paul’s marketing and engineering background brings
competitive knowledge and a sense of product positioning that
significantly adds to the breadth of Omnica’s customer offerings.
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| Tom
Pacala Ph.D.: Director of Science and Technology
Tom, a Ph.D. in electrical engineering,
began his career in the mid-seventies with the JPL Institute of
Technology as a member of their technical staff where he worked on
developing electronic and magnetic pulse compression circuits for lasers.
Afterwards he worked with excimer lasers and the application and use of
lasers in various surgical procedures in the bio-tech field. He was also
in research and development as a staff scientist with U.S. Surgical
Corp. in the cardiovascular market, evaluating new technologies. Tom
has experience developing optical instruments (some with fiber optics), RF
devices, and diagnostic ophthalmic instruments employing optical coherent
tomography.
As you can see, Tom is both a practical
application and a science-oriented fellow, with management and
technical expertise in medical instrument development in cardiovascular
surgical devices, and others when they involve physics, optics,
electronics, firmware, and software conforming to FDA, CE, and ISO
requirements. His background and skills define the type of person who is
an excellent fit for the type of work we do when there are feasibility, R
& D, or complex technical concepts that need to be addressed or
developed.
From the above description, you may have
the impression that he is only at home in the lab, solving problems. In
fact, Tom is an excellent communicator, and very easy to converse with.
Indeed, he is a great addition to the Omnica Advanced Technical Services
team, and one who our customers will grow to appreciate.
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"the ability to make sense out of chaos". While we haven’t
yet had any truly chaotic situations (to test the full extent of her
abilities), she has demonstrated exceptional organizational skills and
an exemplary working knowledge of regulatory issues, documentation
processes, and evolving FDA requirements. Kathryn interfaces with our
customers by coordinating parts lists, the bill-of-materials, and edits
the weekly reports for all of our active projects.