Original Date: 08/14/2000
Revision Date: 01/18/2007

Howmedica Osteonics’ Technical Services Group, Materials Science Laboratory is responsible for implant device evaluations such as risk analysis; verification of safety and functionality; specification, characterization, and testing of materials; establishment of device performance criteria; verification of performance criteria through fatigue and wear testing; and technical advisory support. The group also routinely uses computer aided engineering, computer aided design, finite element analysis, and mechanical systems simulation. For evaluating devices, these tools have considerably shortened the design-realization cycle for implant devices.

Howmedica Osteonics’ Technical Services Group, Materials Science Laboratory in Rutherford, New Jersey is part of the Advanced Technology organization. The group is responsible for implant device evaluations such as risk analysis; verification of safety and functionality; specification, characterization, and testing of materials; establishment of device performance criteria; verification of performance criteria through fatigue and wear testing; and technical advisory support. The facility houses possibly the world’s largest collection of instruments for tribological testing of medical implants and related devices. In addition, there are numerous specialized mechanical test systems including 34 uniaxial, four multi-axial, five electromechanical, and nine high-cycle fatigue test systems for tensile, flexure and fatigue tests. Many of these systems were designed in-house to meet special test needs.

The Technical Services Group routinely uses Computer Aided Engineering (CAE) as a basic and applied research tool. CAE tools include computer aided design (CAD), finite element analysis (FEA), and mechanical systems simulation (MSS). For evaluating devices, these tools have considerably shortened the design-realization cycle for implant devices. Prior to CAE tools, components were defined as continuous surfaces of complex geometry and described by complex differential equations that were not readily solvable on available computer equipment. Computer modeling was impractical and the design cycle consisted of an iterative process of make-it-and-break-it. Once a conceptual component was designed, a prototype was built and tested to failure. The process was repeated until an acceptable product was developed. The request for regulatory approval was not made until sufficient laboratory test data had been accumulated on production parts to demonstrate product performance. The entire design cycle was time-consuming and expensive.

CAE tools have also been used to reduce product development cycle times and costs, and improve product quality and performance. Mechanical design and testing now employs a single-pass process rather than an iterative process. The computer quickly generates and tests virtual prototypes repeatedly until a usable design is achieved. The virtual prototype can also be enhanced and optimized prior to undergoing physical testing. In some instances, FEA and MSS results can be submitted, instead of laboratory test data, during the regulatory approval process.

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