SMP Case Histories
SMP’s client Medical Designs, LLC
received clearance from the Food and Drug Administration (FDA)
and announces their national marketing launch of the FDA-approved
SAMBA™ Screw System. The SAMBA™ Screw System is
for the minimally invasive treatment of SI-Joint dysfunction.
The SAMBA™ Screw and associated
surgical instruments were developed for Medical Designs, LLC
by SMP Tech, Inc. under the direction of Dr. Wilson Asfora.
Life
Measurement, Inc. launched the
PEA POD® Infant Body Composition System at the Pediatric
Academic Societies’ (PAS) Annual Meeting held in San Francisco,
California May 1 through May 4, 2004.
The PEA POD provides vital information for optimal infant growth
and nutrition for infants. The system uses air displacement plethysmography
to assess body composition in infants. The accurate assessment of
infant body fat and fat free mass provides important data to assist
in addressing several infant situations, including optimizing individual
nutritional and pharmacological requirements. SMP Tech, Inc. was
responsible for the industrial design and packaging of the PEA POD
system. The enclosure system is composed of a combination of sheet
metal and pressure formed parts.
Integrated Biosystems, Inc. (IBI) Aubagne, France - the world's leading
supplier of controlled freeze-thaw technology to the biopharmaceutical
industry, and STEDIM, the world's leading designer and manufacturer
of single-use, sterile plastic bag systems today announced that
two new patents have been issued relating to the new Celsius product
line. Celsius, which is currently being launched in the US and
Europe, (by IBI) offers IBI's proprietary controlled freeze-thaw
technology in disposable containers. SMP Tech, Inc. designed and
built the production version of the Celsius S3 Freeze-Thaw System.
The Celsius S3 Freeze-Thaw System provides the capability to model
the IBI 100 liter system with as little as 15 ml of product. The
Celsius S3 is used for simulation in Scale Up, Scale Down and
Stability studies. Sartorius Stedim North America, Inc. purchased
IBI and the products are sold under the Sartorius Stedim North
America, Inc. name.