Determining Reliability Requirements and Testing Costs in the Early Stages of Single Use Medical Product Design

Abstract

ABSTRACTThe production of single use medical devices, particularly for home use by patients, continues to grow, and the reliability of these devices is a primary concern for manufacturers and end‐users. The systems engineer tasked with the device development needs methods and tools to establish reliability requirements and provide cost estimates for the testing necessary to show compliance with those requirements. This paper examines methods for determining reliability requirements, the cost of reliability testing for single use medical devices in the design input phase of product development, and how the costs of testing and potential errors can be used to perform trade‐off analysis between reliability tolerance and confidence level.