Medical and Pharmaceutical Engineering

Development of new technologies for use in biomedical engineering

© Fraunhofer ITEM, Ulrich Froriep

The development of innovative inhalation technologies has always been a priority at Fraunhofer ITEM. The current focus of research is on the development of novel technologies for administration of therapeutic aerosols towards smart drug/device combination products. In addition, Fraunhofer ITEM researchers explore the field of additive manufacturing of individualized implants, for example from medical-grade silicone rubber. In order to allow the long-term durability of such implants to be evaluated, they develop novel test methods tailored to specific requirements. Besides testing of the osseointegration of orthopedic implants, this includes the testing of active implants in particular, such as evaluation of the long-term performance of neural implants. Another research topic are in-vitro and in-vivo systems for toxicity and biocompatibility testing as well as test systems for functional implants, including ones with anti-infective or anti-fibrotic effects.

Next Generation Risk Assessment

For the assessment of medical device safety, the researchers use the new concept of next-generation risk assessment. With this approach, they use modeling parameters that allow them to avoid laboratory experiments and animal testing in particular. They employ methods that are used primarily for risk assessment of industrial chemicals, such as TTC, read-across and QSAR. This approach is all the more relevant in view of the current regulatory requirements for medical devices: The earlier the regulatory strategy is established, the less problematic the performance of the necessary conformity assessment and the shorter the time to market. A comprehensive database of requirements and materials for optimized (re)certification of medical devices is being set up.

Medical device development: recent projects and highlights

 

REMEDIA project

The REMEDIA project is aimed at determining how and to what extent the exposome influences the severity and morbidity of pulmonary diseases throughout the course of these diseases.

 

Center for Medical and Pharmaceutical Engineering

The High-Performance Center launched in March 2021 provides a platform for research and transfer of innovations into patient care.

 

RealWorld4Clinic

The collection of cardiorespiratory data in real-life clinical practice by means of a multi-sensor system is aimed at achieving a substantial improvement in drug development and patient care.

Publications

  • Abdul Nabi Ali, A., Alam, M., Klein, S. C., Behmann, N., Krauss, J. K., Doll, T., Blume, H., Schwabe, K. (2022). Predictive accuracy of CNN for cortical oscillatory activity in an acute rat model of parkinsonism. Neural Netw 146: 334-340. doi: 10.1016/j.neunet.2021.11.025 https://www.sciencedirect.com/science/article/abs/pii/S0893608021004664?via%3Dihub
  • Baron, Y., Sens, J., Lange, L., Nassauer, L., Klatt, D., Hoffmann, D., Kleppa, M.-J., Barbosa, P. V., Keisker, M., Steinberg, V., Suerth, J. D., Vondran, F. W. R., Meyer, J., Morgan, M., Schambach, A., Galla, M. (2022). Improved alpharetrovirus-based Gag.MS2 particles for efficient and transient delivery of CRISPR-Cas9 into target cells. Molecular Therapy - Nucleic Acids 27: 810-823. doi: 10.1016/j.omtn.2021.12.033 https://www.sciencedirect.com/science/article/pii/S216225312100336X?via%3Dihub  - Open Access
  • Meumann, N., Schmithals, C., Elenschneider, L., Hansen, T., Balakrishnan, A., Hu, Q., Hook, S., Schmitz, J., Brasen, J. H., Franke, A. C., Olarewaju, O., Brandenberger, C., Talbot, S. R., Fangmann, J., Hacker, U. T., Odenthal, M., Ott, M., Piiper, A., Buning, H. (2022). Hepatocellular Carcinoma Is a Natural Target for Adeno-Associated Virus (AAV) 2 Vectors. Cancers 14(2). doi: 10.3390/cancers14020427 https://www.mdpi.com/2072-6694/14/2/427  - Open Access
  • Wienhold, S.-M., Brack, M. C., Nouailles, G., Krishnamoorthy, G., Korf, I. H. E., Seitz, C., Wienecke, S., Dietert, K., Gurtner, C., Kershaw, O., Gruber, A. D., Ross, A., Ziehr, H., Rohde, M., Neudecker, J., Lienau, J., Suttorp, N., Hippenstiel, S., Hocke, A. C., Rohde, C., Witzenrath, M. (2022). Preclinical Assessment of Bacteriophage Therapy against Experimental Acinetobacter baumannii Lung Infection. Viruses 14(1): 33. doi: 10.3390/v14010033 https://www.mdpi.com/1999-4915/14/1/33  - Open Access