Fatigue and durability have been an engineering challenge because the human body is one of the most challenging environments in which to implant a device. Fatigue and durability testing may be needed during your product development process to assess the ability of your device to withstand these challenges. Durability testing may include pulsatile, flat plate, low- and high-cycle longitudinal, bending, axial, torsional, and custom-designed loading modes. The actual tests will depend on clinical boundary conditions, such as movement, strain, and force that are present when the device is implanted in the body. Our mastery of physical bench testing and iterative alignment of this testing with clinical performance are key elements provided as part of our services. We can couple the bench and clinical experience with finite element analysis (FEA) capabilities to deliver a complete durability evaluation package for risk mitigation.
Our first fatigue test of a medical device was in 1999. Since that time we have completed a trillion plus cycles of durability testing on medical devices (1,000,000,000,000). This experience is significant and available. Some of the questions we encounter are as follows:
Our lab is ISO/IEC 17025 accredited for fatigue and durability testing. We perform almost every type of boundary condition development activity needed for your device, and have experience with fatigue and durability evaluations in accordance with ASTM and ISO standards.
D. Choules, A. L. Lewis, B. G. Gulker, J. M. Metcalf, & J. D. Kelley (2019). Effect of Variable Amplitude Loading in Nitinol Fatigue. In M. Mitchell, B. Berg, T. Woods, & K. Jerina (Eds.), STP1616-EB Fourth Symposium on Fatigue and Fracture of Metallic Medical Materials and Devices(pp. 54-68).