Testing and test methods in translational biomedical engineering

Conformity assessment of novel medical devices with the existing standard test methods is often not possible. This is why the relevant standards leave scope for action. ISO 20072, for example, does not stipulate the test method to be used for testing of inhalation devices. Quite the contrary, for novel inhalation systems in many cases it is necessary to follow a risk-based approach and adapt existing or develop new test methods.

We use standard methods as well, but our focus is on testing novel devices and especially devices used in inhalation circuits for adults and neonates. This includes not only measurements of device performance, but also investigation of any impact the delivered substance may have on the whole ventilator circuit. This might be, for example, blockage of filters or other air-conducting pathways, such as nasal prongs of neonates.

Development of customized test benches

• Enhancement of standard test methods or development of new methods according to a risk-based approach and taking into account specific project requirements
• Verification of device performance with the above methods during the development phase
• Identification of potential unwanted effects of medicinal aerosols on the inhalation circuit

In addition to personalized implants, which are produced by additive manufacturing from medical silicone, we are conducting research into durability testing for implants. In order to be able to evaluate the long-term durability of implants, we develop new testing methods depending on specific requirements. These include methods for testing the osseointegration of orthopedic implants and, in particular, the testing of active implants. We are for example developing standardized methods for long-term functional tests of chronic neuroimplants in vivo and for objective evaluation.