Reliability Analysis for a Medical Device

Problem

A European manufacturer of implanted medical devices learned of premature failures of one of its products after implantation.

Procedure

After consulting with the FDA on the problem, the manufacturer's asked Analysis & Inference to analyze current failure rates and to project probabilities of device failure.

A+I used models of the data drawn from the product reliability of standard tools in industry tools, as well as survival analysis in medicine.

Result

The manufacturer was able to answer its distributors’ questions and to more accurately assess its legal position.