North America

Blue Room - Session 4

10:30 to 11:30 a.m. Wednesday, June 14, 2017

Approach for "One-Shot Device" Reliability Analysis

Reliability analysis of one-shot devices pertaining to the medical industry presents a unique challenge for the analysts. In that, these devices are used only once and therefore there is no "life" associated with it. Establishing reliability goals and meeting them, hence becomes very critical for these devices. When approached in a methodical manner and with the aid of the right tools, the results usually yield a good estimate for the reliability of these devices. This presentation examines how some of the readily available tools such as sample size determination with Reliability Demonstration Test, Failure Modes Effects Analysis, Fault Tree Analysis and Accelerated Degradation Analysis can be utilized to form a robust reliability case.

Key Words: One-Shot Device, Sample Size Determination, Attribute vs. Variable Sampling, Accelerated Degradation Analysis

Rahul Patil

Eli Lilly and Company

Indianapolis, Indiana