Experience: Mechanical Fatigue - S&V SIU Associates LLC

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DESIGN

Wireless Data Collection
Thermal Simulation and Modeling
Design for Manufacturing (DFM)

ANALYSIS AND TESTING

Mechanical Fatigue
Failure Analysis
Statistical Process Control

OPERATIONS

Design for Manufacturing (DFM)
Lean Manufacturing
Statistical Process Control

EXPERIENCE

MECHANICAL FATIGUE

S&V Siu Associates determined the fatigue lifetime of an implanted medical device; this analysis was used to support FDA filings for device approval.

ISSUE

Our client needed mechanical fatigue lifetime estimates to support their FDA filing for an implanted heart valve device, but they did not have experience with fatigue lifetime testing.

SOLUTION

The device was analyzed and modeled to determine the load points and areas of high stress. Strain gages were attached to the device and in-situ load measurements were made in a live animal. The collected load data was analyzed and used to calculate critical stresses and the corresponding device operational lifetime.

RESULTS

The fatigue lifetime range was found to be well within FDA lifetime requirements and this analysis was used to support FDA filings for device approval.