Biomedical Device Simulations & In-silico Trials
Higher quality & shorter to-market times via simulations
The journey of a medical device is a long one. Medividia helps its customers by offering efficient routes to evaluate medical devices throughout the development funnel. From early design stages to detailed design level and to animal/clinical trials, controlled simulations of medical devices help reduce the ‘to-market time’ and improve the efficiency of animal and clinical trials, as well as increase the overall design quality.
While simpler, isolated simulations of a medical devices are common for early design stages (e.g. an LVAD without considering the deployment), more complex environments such as full heart simulations are used to understand the effectiveness of the treatment in relevant impairments (e.g. a digital heart with mitral valve deficiency used as a base model to evaluate a mitral valve regurgitation treatment).
Physiologically relevant in-silico environments for advanced evaluation
In advanced design evaluation stages, Medividia will help with building a specific in-silico environment, mimicking the impairment/deficiency with the necessary complexity. The proposed treatment/device can be applied in this environment. This can guide the designers to optimize the deployment location, to evaluate the correspondence of the device to anatomical variations, to understand optimum sizing etc.
Relying on standards
As a medical simulation provider, Medividia relies on existing standards for the computer modeling and simulation of the medical devices. Examples to these are, ASTM F2079, ASTM F3067, ISO 25539-1, ISO 25539-2, ISO 5840-1, ISO 5840-2, ISO 5840-3.
All CFD, FEA and FSI simulations conducted by Medividia meet the requirements dictated by ASME V&V 10, ASME V&V 20, ASME V&V 40
Full integration: In-silico, in-vitro, in-vivo testing & clinical trials
Often the intention of advanced medical device simulations is to minimize the physical testing as well as increasing the efficiency of them. To this end, tight interaction between the simulation and physical/animal testing teams is a must. Through its partners, Medividia offers a completely integrated solution for a medical device evaluation, which is especially important for newly developed solutions.
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