Projects will incorporate data on as many of the material properties as possible, allowing for the development of standardised protocols for the determination and measurement of the efficacy and safety of new biomaterials, taking into account the specificities due to sex, race and age, whether they be single or combination entities. Processing of data should be done in accordance with GDPR provisions.
A label of biocompatibility should be established so as to define the suitability of a biomaterial for eventual use in a Medical Device or Advanced Therapy that the biomaterial becomes a part of, so as to assist companies, especially SMEs, in choosing and facilitating market access for their products.
This database should also contain comparative analyses of the results of biological testing of biomaterials from the scientific literature (and clinical trials, where possible) so as to incorporate data on as many of the material properties as possible, incl. taking into account the specificities defined by sex, race, age. Based upon this, it should be possible to formulate, as necessary, standardised protocols for the determination and measurement of the efficacy and safety of new biomaterials, facilitating as it will, the need to establish high throughput test platforms in the future for biomaterials, that comprise standardised testing protocols for ex vivo, in vivo, pre-clinical and clinical testing.
Proposals must also address all the areas below:
- Develop a user-friendly platform for making all relevant data easily and readily accessible for the assessment and decision-making processes in appropriate formats to ensure interoperability. To ensure that the data are processed in accordance with the GDPR provisions;
- Facilitate extracting, analysing and re-using of the data with advanced data processing technologies e.g. Artificial Intelligence;
- Provide innovative trainings and manuals for the use of the database and its documentation;
- Develop a business model for the maintenance of the database demonstrating its sustainability beyond the funding period. A contribution of SSH expertise in the field of economics and marketing would be beneficial for the achievement of this goal.
Proposals submitted under this topic should include actions designed to facilitate cooperation with other projects, including; relevant ongoing Open Innovation Test Beds[[Cooperation with projects funded in DT-NMBP-02-2018: OITBs for Safety Testing of Medical Technologies for Health]], to enhance user involvement, and to ensure the accessibility and reusability of data produced in the course of the project by agreeing on metadata for the description of the materials databases.