The European Parliament has recommended that the European Medical Agency (EMA) develops a framework for the regulatory acceptance of alternative models and new concepts based on human-relevant computer or cellular models, aiming at providing more predictive tools for advancing new medical devices and therapy applications.
In the US, the FDA as identified an important role for computer modelling and simulation to “stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes”, which involves the development of computational models of cells, organs, and systems, such as Virtual Patient Models, to better predict product safety and efficacy and performance of medical products and therapies.
Computer modelling and simulation (CM&S), is still practically inexistent at the (pre)clinical/ clinical evaluation, contrary to its widespread use in other areas.
The introduction of CM&S can:
i) enable the reduction of the number of trial-and-error cycles in medical devices design and manufacturing, dramatically reducing time and cost efforts;
ii) combined with conventional clinical trials, can help to predict the outcome of new surgical interventions, reducing the risk of complications, emerging only after MD launch;
iii) allow the selection of the best available treatment for each specific patient, taking into account their own characteristics and preferences (particularly relevant in the context of the emerging trend of Personalized Medicine).
To attain these aims an increasing level of rigour in the verification and validation (V&V) of these computer models is needed.