Efficient Design Framework for Developing and Demonstrating Auto Injector Reliability

The purpose of this paper is to provide an overview of the impact design frameworks and their associated methods have in developing products that are required to be highly reliable. Preliminary product development results are shown for two U.S.-based companies whose design teams are using the Improved Product Reliability Development Framework (IPRDF) to quickly design high levels of reliability into their emergency-use injectors. Both design teams achieved the FDA requirements for device reliability, reaching 99.9999% system-level reliability with a 95% confidence level after optimizing their designs.