If a company were to develop a new biomaterial, there would need to be a significant amount of tests done to ensure that the device has a strong biological performance. Toxicity tests (from the toxicity chart attached with this week’s course material), as well as material characteristic tests, such as tensile and compressive stress/strain among others, would be a necessary minimum. If working with cell culture, tests can be done to see how well it promotes growth (if you want cells to grow on it) or if it is effective in killing toxic cells (such as cancerous cells). If the material is meant to be integrated with a device that is used for structural support, like a knee or hip implant, additional tests will need to be done, not only to test its mechanical strength, but also for its longevity. The quality and safety of the material will need to be tested, especially if this is going into a patient. Tests will need to done to determine if there will be any adverse responses in the host or any responses that will negatively affect the function of the biomaterial.

After these basic tests are done on just the biomaterial, there will need to be research trials, in which animals may be used. Pre-clinical and clinical trials should follow.

Ultimately, the more tests that are performed, the better. It can prevent you from having any liability issues.