Can Computer Simulations Provide Trustworthy Regulatory Evidence?

This episode asks: Can computer simulations provide credible regulatory evidence?

Learn about the hierarchical framework that ensures the trustworthiness of virtual trials, using a Lego analogy to break down complex processes into manageable pieces. Understand how virtual devices, patients, and even surgeons are modelled to reflect real-world scenarios.

We also discuss the broader implications of this innovative framework and how it could lead to faster, more personalized, and more inclusive medical device development. Tune in to uncover the future of medicine and the role you can play in shaping it.

 

Aycock KI, Battisti T, Peterson A, Yao J, Kreuzer S, Capelli C, Pant S, Pathmanathan P, Hoganson DM, Levine SM, Craven BA. Toward trustworthy medical device in silico clinical trials: a hierarchical framework for establishing credibility and strategies for overcoming key challenges. Front Med (Lausanne). 2024 Aug 12;11:1433372.