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Medical Devices
Projects
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Failure analysis of a line of stainless steel stents for a medical device
manufacturer. The project included review of the manufacturing process,
metallography, electron microscopy and finite element analysis.
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Fatigue analysis of a stent design for a medical device manufacturer. The
objective of the project was to determine if cracking in the stent could
occur from normal pulsating blood pressure after insertion. The project
included finite element analysis.
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Review of current tribological problems (wear and friction) in polymeric,
metallic and ceramic implantable devices and an assessment of the materials
and design approaches being utilized to solve these problems, for a
manufacturer of hip and knee implants. This program included review of the
literature and contacts/meetings with medical device industry organizations.
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Assessment of the market for a new, high temperature ceramic material and
coating process for an automotive component developer.
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Review of manufacturing and quality control testing operations,
particularly those related to mechanical reliability, for the manufacturer
of heart catheters.
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Analysis of manufacturing methods used to produce surgical staples of
various cross sections in support of a patent litigation for a law firm.
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Failure analysis of a fetal monitor spiral electrode for a medical device
manufacturer. The project included review of the design and manufacturing
process, metallography and scanning electron microscopy and finite element
analysis.
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Design analysis of a syringe component to reduce product cost
substantially for a manufacturer of medical products. This project included
substantial finite element analysis, durability assessment, and mechanical
testing of syringe and seal.
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Assessment of the structural integrity of a disposable blood separation
bowl for a medical product manufacturer. This project included finite
element analysis and validation testing using instrumented bowls.
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Modeling of a novel, polymer drug release device taken orally. Analytical
models were developed and an experimental study was carried out to determine
the stiffness, recovery and degradation properties of a set of degradable
polymers for a drug company.
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Development of a new metal forming process, including design of
manufacturing equipment, to reduce the cost of a stainless steel surgical
blade for a medical device manufacturer. The project included finite element
simulation, mechanical testing and failure modes and effects analysis.
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Determination of the mechanism of fatigue in methacrylate bone cement
used for knee and hip implants for an implant device manufacturer. Detailed
electron microscopy and mechanical testing were conducted.
Stent Deformation
Stents used for treating coronary artery disease are required to satisfy
numerous mechanical requirements. Deployment by balloon catheters must
result in relatively uniform expansion at modest pressures. Details must be
carefully designed to minimize the risk of cracking where individual
elements meet. Meeting these and other requirements, such as flexibility
during insertion and resistance to collapse from the arterial wall pressure,
can be accomplished with simulation and an understanding of the mechanical
behavior of the materials.

Unexpanded Stent Segment (4 mm OD)
 Stent Segment
Expanded to About 6 mm
 Strains in the
Corners Remain Well Below the Failure Value
 Shortening
During Expansion Is Relatively Low |
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