Medical devices companies use modelling and simulation in the design phase but it’s now possible in principle to produce evidences of safety and/or efficacy using computer models, something called In Silico Trials.

FDA has produced guidelines, and there is also a technical standard to assess the credibility of these models (ASME VV-40-2018).

In Europe it is all more confused by the introduction of the new MDR makes such new approach appealing for many products.

My questions:

• Is the use of In Silico Trials being discussed in your company?

• How high are the chances for adoption?

• What are the main barriers that are slowing down the adoption in your company?

Editor’s note: Image sourced from change.org/p/guido-rasi-foster-adoption-of-in-silico-trials-through-ema-s-strategy-on-regulatory-science-to-2025