Focuses of research in Translational Biomedical Engineering: from idea to safe medical device

Medical devices make a significant contribution towards improving patients’ quality of life. Numerous universities and research laboratories are continuously developing new and innovative solutions to further improve patient care.

However, these basic research developments are not easily brought to the clinical testing stage, as test series of medical devices and medical products must have undergone standard-compliant manufacturing, the regulatory requirements of which are difficult for research institutions to meet. Service providers offering manufacturing of medical devices are, however, often unable to implement highly innovative products containing new materials and involving related processing steps.

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This gap is closed by the Fraunhofer ITEM translation platform with trained scientists who are able to qualify these special – partially external – processes, supportively integrate them into medical device management and subsequently devise overall risk management strategies for the entire manufacturing chain.

The focus of the scientific support here is on so-called combination products involving the application of two or more components from biomedical engineering and other life science areas. This often means that a medical device is functionally integrated with a conventional medicinal product or with human products. As far as the Fraunhofer ITEM scientists are concerned, two thematic key areas form the starting point for this research, namely innovative inhalation systems and active implants.