Mechanical testing continues to play a strategic role in the constant effort to improve performance and compatibility of new biomaterials and improved medical devices. Laboratory test machines are commonly applied to perform biomedical research and for medical device development and product validation.
Modular static and all electric fatigue test equipment produced by TestResources has enabled improvements in implant design in vitro without putting patients at risk. With our equipment, biomedical test engineers can critically evaluate ever increasingly complex designs in a controlled and repeatable manner. Modularity ensures that our test machines can be configured to meet both immediate and future needs.
TestResources innovative electrodynamic test machines are uniquely suited for biomedical research applications because of versatility:
- They are very stable in slower speed monotonic and yet can perform fatigue tests as needed for regulatory compliance. They are used in simple tensile testing of biological tissues as well as complex cyclical biaxial fatigue applications with little or no tuning adjustments;
- They are modular. For example, it is easy to add a torsional channel to a customers' existing test machine which has an axial channel – thus creating a bi-axial axial-torsional test machine;
- They can be equipped with a wide variety of different specimen fixtures. TestResources recognizes the importance of serving our customers and so we build fixtures to application requirements.
Bringing a new medical device product to market often involves 3 phases of mechanical testing:
- Initial research and proof-of-concept testing;
- Design verification testing to confirm the product meets its engineering specifications; and
- Formal Design Validation Testing to be included for the formal 510k submission to the FDA.
Medical device product development engineers face many challenges in successful 510k submissions. Rigorous laboratory testing is often required to confirm substantial equivalency to the predicate device. Both the new product and the predicate product must be tested. Both tests require several test specimens to ensure high statistical confidence levels. Furthermore, the product and its packaging must be validated and tested as such. If submitted test results are not rigorous, the FDA will often request additional testing. If this testing is not planned and initiated early enough, it can significantly impede a product development schedule.
TestResources has been active in supplying static and dynamic fatigue test systems to the biomedical research and production industry since 1998. We have specialized in serving the biomedical community since our inception. Take a look at our select list of medical customers from around the world. TestResources offers testing solutions that are engineered to application requirements, and so are a good and natural fit to the needs of the biomedical industry.