Objective 1

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

Objective 2

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

Objective 3

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

Objective 4

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

Objective 5

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

Objective 6

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

Objective 7

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

Objective 8

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