SimInSitu will develop a first-time in-silico method capable of predicting short- and long-term safety & performance of in-situ TEHV in a patient-specific virtual environment. This can potentially be used to complement or substitute clinical trials, but can also be used during earlier development phases

SimInSitu will combine proven state-of-the-art FSI simulation technology with the latest advancements in numerical modelling of scaffold degradation and simultaneous tissue regeneration & growth to predict the transformation of synthetic valve scaffold into a fully functional native tissue

SimInSitu will procure libraries of retrospective anonymized patient anatomies and prospective physiological variability for re-use in pre- and post-competitive testing of aortic medical devices

SimInSitu will verify and validate the developed simulation process at all system-levels to the most relevant extend, considering established standards / guidelines from the MedTech community but also established standards / guidelines from other industries

SimInSitu will conduct an extensive uncertainty quantification assessment to evaluate the propagation of input uncertainty through the simulation process towards output uncertainty at each system-level and the entire system

SimInSitu will also include the quantification of uncertainty originating from associated experimental methods used to characterise for instance selected materials (e.g. scaffold)

SimInSitu will demonstrate the capability of the validated process to predict device failure for representative scenarios

SimInSitu will share experiences & learnings, generated during the development & VVUQ into the ongoing discussion and activities of working groups within VPHi & Avicenna Alliance to contribute actively to the development of an in-silico regulatory framework