Tissue Characterization Task Force
Mission: Create a data base of biological tissue properties with Certificate of Birth
There is a strong, industry-driven need for a quality label for computer simulations in in silico medicine. Various agencies have formulated guidelines regarding model credibility, including rigorous verification and validation processes. However, clear guidelines on how to assess the quality of model input parameters are still lacking. Indeed, material properties of the involved tissues are often essential input parameters, but it is extremely difficult for numerical analysts to find appropriate and reliable values for their simulations. The scientific literature abounds with articles experimentally characterizing biological tissues, but widely recognized testing standards for these tissues are absent. This shortcoming leads to significant variability and hence (epistemic) uncertainty of test results, on top of the already high inherent variability exhibited by biological tissues.
To minimize the degree of uncertainty and error that propagates into computer simulations, the Tissue Characterization Task Force is driving efforts to:
- Identify the extent of variability in currently present in biological tissue characterization methods. The task force has launched the C4Bio initiative (Community Challenge towards Consensus on Biological Tissue Characterization), in which research groups from all over the world are invited to test the same tissue type using the same test method, each using their tried and tested methodology. A pilot study on uniaxial tensile testing of aortic tissue revealed a disconcerting amount of variability between groups, with coefficients of variation in the order of 100%, proving the urgent need for this kind of study.
- Reach community consensus on testing protocols. Again, under the C4Bio initiative, the task force brings the testing community together to find consensus protocols and quantify to what extent the use of these optimized protocols can reduce inter-research group variability. A consensus protocol for uniaxial tensile testing of aortic tissue is currently being formalized.
- Enable wide adoption of the obtained consensus. The task force connects stakeholders in the entire chain of tissue characterization and modeling, from test bench manufacturers, over experimentalists to medical device simulators and regulatory bodies.
- Ultimately, create a universal tissue properties database. The pinnacle of the task force’s efforts is to enable the creation of a tissue property database with regulatory grade material properties of various relevant biological tissues.
Goals
- Define a reliable protocol to characterize human tissues and create the certificate of birth.
- Define the modalities to create a “Certificate of Birth” acceptable to regulatory authorities.
- Populate a data base with material properties and their certificate of birth.
