Safety by Design in SCHERDEL Parts for Medical Devices with Design of Experiments

This whitepaper outlines how SCHERDEL Medtec applies the safety by design principle in the development of power springs for pen injectors. A key enabler of this work is the use of Cornerstone, an advanced data analysis software that provides the Design of Experiments (DoE) framework. Within Cornerstone, experimental designs were evaluated and factor interactions affecting torque and robustness were revealed.

The study demonstrates how DoE uncovers insights into system performance that would otherwise remain hidden among numerous interacting factors. This enables a suitable process setup and defines corrective actions for process control, providing a structured way to stabilize production and achieve consistent results in medical device component manufacturing.

Key Insights:

• Safety as a Design Principle: SCHERDEL integrates safety considerations from the beginning of development, ensuring correct and reliable functionality in medical device components.
• Systematic Evaluation with DoE: Using Cornerstone’s DoE framework, a D-optimal design with 32 runs was applied to analyze process factors and their interactions, providing a statistically reliable basis for understanding torque performance.
• Robust and Reproducible Outcomes: The DoE analysis revealed factor interactions that improve robustness, such as the influence of coil thickness, and delivered a statistical model that supports corrective actions and optimized process settings for consistent production results.