Food and Drug Administration Looks to Use Modelling and Simulation to Improve Clinical Trial Designs

Aug 7, 2019

by ASME.org

The Food and Drug Administration (FDA) is undertaking a new project to highlight how modelling and simulation can help with the development of medical devices and bring them to market in a more timely fashion. As part of this project, FDA is asking the public for assistance in identifying players in the bioengineering space familiar with Computation Human Heart Modeling Software and Services to conduct simulations and studies that can help move this project forward.

 “Modeling and simulation can help to inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study, and assess product safety. In some cases, in silico clinical trials have already been shown to produce similar results as human clinical trials,” Tina Morrison, deputy director of applied mechanics in the FDA’s Center for Devices and Radiological Health, said in a statement.

Through this new request for information (RFI) the FDA is seeking modelling and simulation software that can provide necessary information to develop and improve current medical devices used on the heart, such as pacemakers, without having to use more traditional trial methods. Acceptable modelling and simulation software should be capable of functions that include:
 
  • Incorporates the three fundamental physics represented in the heart-electrical, structural, fluid;
  • Spatially includes all four heart chambers as well as its peripheral vasculature
  • Provides a computational human heart model that allows for electrophysiology and electromechanics of the heart
The end goal of the current RFI is to receive FDA concurrence on the simulated approach, not actual approval of any medical devices at this time. The deadline to submit a capability statement for this request in August 12.

For further information and to submit a capability statement, click here: https://www.fbo.gov/index.php?s=opportunity&mode=form&id=fb56bc8127a061df7a37950ab185486d&tab=core&_cview=0