To overcome these issues, the company implemented a Design for Reliability (DfR) program from Hottinger Bru?el & Kjær’s (HBK) ReliaSoft suite (XFMEA, Weibull++, BlockSim) to proactively analyse risk, predict shelf life and model system-level performance.

The software provided deep, data-driven insights into device reliability, enabling targeted design enhancements, ensuring consistent drug delivery, and providing robust, objective evidence to support successful and efficient regulatory compliance submissions.

By leveraging HBK ReliaSoft DfR suite’s predictive and analytical power, the company was able to move beyond traditional testing to a proactive, science-based approach, which allowed them to build a deep, quantitative understanding of their device, engineer robustness into the device - and ultimately deliver on their mission to provide groundbreaking medicines that patients and physicians can trust.

The full case study is available on HBK’s website: Enhancing Patient Safety and Drug Delivery System Reliability with ReliaSoft