FIBEr, towards a reference center for standardized mechanical validation of soft tissue prostheses

Soft tissue prostheses use any combination of synthetic, biological or tissue-engineered materials to manufacture structures that can be implanted in the body to improve or replace biological functions. The mechanical biocompatibility of a soft tissue prosthesis is essential for successful long-term integration in the recipient. However, detailed quality standards to which these products must comply are lacking and test procedures require specialized infrastructure and expertise. Product developers currently require (a) clarity and advice on the type of tests their product(s) must withstand (b) facilities to perform required mechanical testing (c) support in analysing and interpreting the resulting data.Therefore, the goal of this C3 project is to establish FIBEr as a preferred partner for the mechanical testing and validation of soft tissue prostheses, with an initial focus on (a) tissue engineered blood vessels and (b) synthetic meshes, later expanding to a broad range of implants. FIBEr will achieve this goal by capitalizing on its unique collection of infrastructure and expertise, while driving the formulation and establishment of scientifically founded standards for mechanical testing of soft tissue prostheses. Specifically in the current project, the complete workflow for the mechanical validation of a tissue engineered blood vessel (WP3) and a synthetic mesh (WP4) will be optimized. Generic aspects of these workflows will be identified and combined with standardized sample cryopreservation (WP1) and trustworthy data management (WP2), to create a standardized procedure for future customers.

Keywords:synthetic meshes, standardization, mechanical testing, soft tissue prostheses, tissue engineering

Disciplines:Biomaterials, Tissue engineering