Performing biological assessments of medical devices, involved in the development of innovative methods and devices for identifying pathological biomarkers
The Medical Device Biology and Biological Assessment Department has been set up to carry out safety assessment studies, coordinate all regulatory studies relative to biocompatibility and develop innovative technology for diagnosing and treating pathologies.
To achieve this, it has the following equipment and resources
- Morphological histology: immunohistochemistry and molecular markers on frozen paraffin-embedded tissue
- Mass spectrometry (MALDI-TOF), quantitative proteomics using isotope-coded protein labels
- High-speed profiling technology used to identify the minority proteome
- Genomics: Digital PCR and Next-Generation Sequencing (Ion Torrent)
- Cellular Biology (fluorescence microscopy)
- Expert assessment of human biological samples for optimized detection of pathological biomarkers
The Medical Device Biology and Biological Assessment Department carries out biocompatibility studies. One of the first stages in this activity involves tests, ranging from initial filtering of new materials to local tolerance tests on animals (for implanted devices) in order to identify the presence of toxic residues and any potentially harmful effects of a device. The second stage involves developing new tools and methodologies for bio-assessing medical devices developed from micro- and nanotechnologies, using a poly-omic approach.
The department develops pioneering approaches for the early detection of pathological biomarkers. Thanks to the extremely close collaboration between biologists and clinical practitioners, it is possible to identify specific medical needs and contribute to drawing up device specifications.
The department develops original primo-culture models, in close liaison with activities in the operating suite. Primo-cultures are collected by surgical excision and all the incubators and isolators are available for developing cell cultures in variable oxymetry conditions.