Medical device manufacturers are increasingly using predictive computer models during the product development process. These models are created for a specific context of use in order to simulate the device and relevant anatomy and physiology associated with predicting safety and efficacy outcomes. Since these models are created to predict the same endpoints that would be observed in clinical practice with the same population variability, we use the term virtual patient models to refer to these simulations. These virtual patient models can be incorporated into a study in way that is analogous to how some Bayesian clinical trials incorporate historical data as prior information.

To properly inform clinical evaluation, the virtual patient model must:

The construction of a virtual patient model will be different for each particular outcome and may involve a variety of disciplines. Applications that lend themselves to virtual patient models will involve local...

References

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