Overview of Program:

Paving the way for evaluation of 21st-century medical devices

The Computer Modeling and Simulation Project was developed to achieve the delivery of medical product solutions in a responsible, patient sparing way that balances the desire for certainty in the device performance while limiting the delay in patient access associated with increased certainty through the use of computer modeling and simulation as valid scientific evidence.

Based on stakeholder input, the steering committee formed working groups tackling issues in seven priority areas operated by member volunteers.

  • Combining simulations and experiments to inform clinical trials.
  • Simulation of the heart, vasculature, and related medical devices.
  • Neurostimulation electrochemical mechanisms of damage identification.
  • Magnetic resonance-induced heating.
  • Modeling and simulation in orthopedics.
  • Libraries for publicly sharing models, inputs, and validation data.
  • Simulation of blood damage, hemolysis and thrombosis.

Program Background

Computer modeling and simulation has the potential to revolutionize the field of medical devices. Gone are the days of building a physical prototype in a machine shop to test every new idea. Today, medical device developers can use computer models to eliminate many bad ideas before they leave the drawing board—and refine many good ones before they’re used on human patients. Tomorrow, simulations of virtual physiological patients may replace clinical trials.

Why aren’t we there yet?
What exactly do device developers and regulators need to know order to tell whether a computer model sufficient reflection of reality? The MDIC CM&S steering committee conducted a member survey to identify the barriers holding back the industry from more fully embracing modeling and simulation.

Current as of December 18, 2020
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