Durability testing for medical devices
Durability testing solutions with efficacy and patient safety in mind.
Also known as fatigue or stress testing, durability testing is used to validate device lifetimes by subjecting them to physiological loading. It can also be used to understand device failures and design margins using fatigue-to-fracture methods and hyper-physiologic loading levels. Most importantly, durability tests serve a critical purpose in helping prevent unintentional product failure, which can lead to severe consequences.
Durability testing includes physically and repetitively loading devices in a way that is very similar to the loading encountered in the human body over time. Testing typically includes applying both broad and targeted loading to devices or specific components by means of force, torque, rotation, strain, displacement, and pressure. This test loading is often repetitively applied through two test methodologies:
Testing to success
Testing to success methodologies helps assess that the devices do not fail under physiologically representative loading levels for the intended lifetime of the device. Testing to success methodologies has classically been one of the final safeguards that the device will be safe for its intended lifetime.
Fatigue to fracture
Fatigue to fracture (FtF) involves understanding where a device’s weakest component lies by pushing the device past its failure limits with a larger magnitude of loading. This approach is often used earlier during device development because the insights it provides contribute to the refinement of the device’s final design. With that in mind, these results provided through FtF can also be leveraged in regulatory submissions because of their ability to provide strong evidence of sufficient design margins.
Gain instant expert insight into the critical factors involved in medical device design, testing, and regulatory compliance.
Medical devices play an important role in the delivery of many health care services. However, before they can take their products to market, manufacturers must ensure that products meet specific quality, safety, and regulatory requirements.
Access our dedicated medical device testing webinar series to gain expert insight into the critical chemical and physical property testing considerations involved in meeting both performance and regulatory medical device requirements. Topics include chemical characterization, fatigue and durability testing, Rheology, and Thermal Characterization of medical devices.
Watch our on-demand medical devices testing webinar series to learn more about the critical nature of chemical characterization, mechanical testing, fatigue, and durability assessment, and rheological study of soft biomaterials.
Device innovation and approval is hard work, finding the right tools shouldn’t be. Contact us today to learn how we can help you accurately and efficiently gain insight into the chemical structure and physical property performance of your medical devices.