Adequate testing of electrically active medical implants.

Development of universal test methods for the reliability of flexible microimplants and their encapsulation.

In the APreMedI project, standardized test methods for the validation of flexible active implants are to be developed. The primary focus here will be on a lifetime estimation of the function of active implants, as well as on the identification of typical causes of failure and the development of remedial measures.


Developments in microsystems technology are enabling ever smaller actuators and sensors for medical implants. Active microimplants can improve patients' lives in a variety of ways. Implantable sensors enable seamless monitoring of physiological parameters (e.g. blood pressure or blood flow in stents) and thus early diagnosis of diseases. On the other hand, various active implants are currently being developed for therapeutic purposes. Examples are invisible hearing aids and retinal implants for the therapy of severe hearing and visual impairments.

However, the number of active microimplants available on the market is far from reflecting the diversity of potential application fields. One reason for this is that encapsulation technology is a major hurdle to product introduction: Function and safety of the implant must be demonstrated over a lifetime of 10 years or more. While rigid titanium housings have become established for larger implants, for which there are proven and accepted test methods, product-specific encapsulation and test methods must be developed for microimplants. This entails a great deal of effort and an immense approval risk. The Apremedi project is intended to provide a solution here: By developing standardizable test methods, the developers of innovative medical devices are to be relieved of the validation work they have to perform themselves.

01.10.2018 - 01.09.2020