† Past Consulting Projects
Evaluated premature failure modes and related device
process manufacturing problems for diaphragms a heart assist device.
Evaluated elastomer selection and device design followed
by specific testing on an inter-gastric balloon that was failing prematurely.
Evaluated claims of patent infringement on a vascular
Evaluated background and proposed biological safety
testing methodology on a new rubber.
Evaluated material and process problems encountered in
dip casting a latex biomedical product.
Evaluated premature failure by environmental stress
cracking of an artificial heart pump casing.
Evaluated process problems resulting in the separation
of layers of elastomeric tubing.
Pointed out potential materials availability problems
in the development of a long-term implant.
Determined the composition of a competitive product
(adhesive) and suggested modifications in a current formulation.
Product Development and Commercialization
spinal interbody fusion cages, I invented a new pseudorandom composite
structure, coordinated testing of a polymer never before used in the
biomedical area and refined cage and instrument designs.† The cages are now implanted in over
20,000 patients, approved in Europe and Japan, and in the USA.
(with surgeons) and oversaw implantation of worlds first polymer composite
spine plates, wrist wedges, ankle stabilization spool, skull plate,
intermedulary rod, vertebral bodies, and injection molded composite
screws.† Also first artificial
sacrum from titanium.
and directed development of first artificial spinal discs to be implanted
in USA. These discs were the subject of a Johnson & Johnson worldwide clinical trial and USA IDE.† Some initial custom spine discs implants now over 12 years
with surgeon to develop and have manufactured special spine ligaments that
have been implanted in patients above a fusion to reduce adjacent segment
Product DEVELOPMENT and research
and molded bilaminar compliance chamber diaphragms from butyl rubber and
Hexsyn for the Cleveland Clinic Foundation artificial heart programs for
required high fatigue life and low gas permeability.
the effect of flexing surfaces on clotting and platelet/white cell
deposition in artificial hearts.
a Ph.D. studentís dissertation on the fluid dynamics of artificial hearts
in conjunction with NASA Lewis Labs and the Cleveland Clinic.
permeability of silicone fluid and blood components through Biomer
diaphragms with the University of Utah.
a potential method of treatment of implant associated (slime layer)
and used an accelerated fatigue testing methodology for rubbers in the
artificial heart program.
mamographic examination of rubber components for determination of
various ultraclean carbon blacks for potential use in heart pump
and implemented synthesis techniques to yield higher molecular weight
alternate monomer systems to replace a monomer no longer available.
alternate curing systems to find one that developed proper mechanical
properties while reducing potential toxicity/carcinogenicity problems.
and analytical research
relative carcinogenicity of a number of chemical compounds where limited
data was available for direct comparison using the same test systems.
and validated by field testing wide spectrum passive and active monitors
for ppb levels of† airborne
carcinogens.† Passive dosimeter was
capable of detecting 1 ppb with one hour sampling.
a field soil tester for PCBs.
interlaboratory validations of several analytical methods using 20
research on environmental fate of chemicals in soil, development of blood
and urine tests for a rocket fuel, and establishment of a
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