Context: Computational modeling is successfully used to address safety-critical issues and to provide evidence in the regulatory approval process in the aerospace, automotive, and nuclear industries for quite some time. The healthcare industry is also moving towards this in silico approach, which can be used in all phases of R&D, from the design of the product, over development to the regulatory approval and post-marketing stage. Besides a clear definition of the context of use and a rigorous verification and validation process (as provided by ASME V&V40), the quality of the model input has a great influence on the model credibility. Therefore, the accurate representation of the involved biological tissues is identified as a significant barrier for in silico medicine to truly impact the healthcare industry and become an accepted method for evidence generation in the regulatory approval process.
Problem statement: Although the scientific literature abounds with articles experimentally characterizing biological tissues, the reported parameters often show a high variability, partially due to the absence of widely recognized testing standards for biological tissue.
Aim: The aim of the C4Bio challenge is to achieve community consensus regarding the testing protocols for material characterization of biological tissue and disseminate this consensus to the relevant standards bodies (i.a. ISO & ASME). The physical properties of interest can be thermal, mechanical or electrophysiological. In the first stage, this challenge will focus on mechanical tissue properties collected through in vitro experiments.
In vitro mechanical characterization of biological material entails many aspects, including tissue collection, preservation, preparation, experimental set-up, protocol development, execution and post processing. A wide variety of testing methods exist which are often specific to the tissue, the material parameters of interest and the clinical situation of interest. Standardization in this broad field is non-trivial. The challenge will therefore be organized in different test campaigns, each time focusing on a single aspect. The first campaign focusses on the uniaxial tensile testing of soft biological tissues.
In this video our Executive Director Liesbet Geris and the C4Bio chair Nele Famaey explain the purpose of C4bio: