Reliability Prediction of Implantable Leads

Article

Myrum, S.; Sahni, A.   (1986, ASQC)   Medtronic, Inc., Minneapolis, MN

40th Annual Quality Congress, May 1986, Anaheim, CA    Vol. 40    No. 0
QICID: 3175    May 1986    pp. 162-167
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Article Abstract

One of the important steps of reliability engineering during the development of a product is to assess its reliability against predetermined goals. If the reliability predictions do not meet or exceed the predetermined goals, corrective action must be taken to enhance product reliability during the design or manufacturing process of the product development cycle. Once the predicted performance meets or exceeds the reliability goals, the product can be considered ready for market release.This paper demonstrates a) how the reliability estimates/predictions of a product (implantable leads) can be made before it is considered for release in the market, and b) how continuous monitoring of field performance can be used to revise/update the reliability estimates of existing as well as future products. In this particular case, we will model and predict the performance of lead model B,which is similar to lead model A (whose performance data is available). The estimate/prediction is performed utilizing two well known techniques, namely, the Time Series Principle and the Delphi Technique. The key assumption in a time series model is that patterns that occurred in the past will continue in the future.

Keywords

Biomedical


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