FDA Seeks Virtual Heart to Test Medical Devices

The Food and Drug Administration is looking for computational software and services modeling the whole human heart to incorporate in a project that aims to evaluate new medical devices and therapies, according to a recently released request for information.

Through an ongoing collaborative project with French software company Dassault Systèmes, the agency hopes to demonstrate how involving computer modeling and simulation, digital evidence and a virtual patient population could potentially speed up the regulatory evaluation and approval processes through which innovative medical solutions go to market. 

“We will need a physics-based computational model of a whole human heart, one that includes all critical functions of the heart: electrophysiology, solid mechanics, and fluid dynamics, including all relevant anatomical features (such as ventricles, atria and vessels),” the agency said in the program’s project brief. “The FDA intends to develop a generic medical device that will be virtually implanted in the whole human heart computational model.”

In 2014, FDA initiated its collaboration with Dassault around the company’s simulated 3D heart model, which the duo used to test pacemakers and other cardiovascular devices. Through the new project, researchers will incorporate virtual patients and testing to quicken the pace in which devices are tested and adopted. 

“Integration of [virtual patient] data within the clinical trial simplification framework has the power to revolutionize how device companies conduct clinical trials, sustain this paradigm shift, and satisfy patient and provider demands for safety, efficacy and improved access,” the agency said. 

Through the trial, researchers will design, manufacture and physically and virtually test a generic medical device on virtual populations and new methods will be created to combine digital evidence from the simulations to physical evidence from real patients. The objective is to receive FDA concurrence on the simulated approach, not to actually obtain approval of the device. 

Ultimately, the agency aims to use digital evidence and computer modeling to tackle the delays and costs that hinder patients from trying new treatments.

“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.

Interested vendors that can offer the capability to perform whole human heart computations with virtually implanted devices using high-performance cloud-computing should submit capability statements to the FDA by Aug. 12.