The FDA and French software company Dassault Systèmes expanded their partnership around the latter’s simulated 3D heart model. Having figured out how to test pacemakers and other heart devices using the model, the duo is now sizing it up as a source of digital evidence for new device approvals.
Dassault unveiled its Living Heart Project in May 2014 and joined forces with the FDA six months later to come up with a testing framework for the insertion, placement and performance of pacemaker leads and other devices used to treat heart disease. In a crowdsourcing approach, more than 100 cardiovascular specialists ranging from cardiologists and devicemakers to academic researchers had a hand in the project, testing the model in diagnostics and planning surgeries as well as in assessing devices.
The extension of the partnership will see Dassault use computational models to create virtual patients on which to test devices, the company said in a statement. This includes an in silico trial designed to cut down on animal testing and reduce the number of patients needed for a human trial while making sure the safety and efficacy of the device are still being shown.
“Enriching technology already well established in regulated industries such as aerospace and automotive, virtual patients support the complex development of therapies for the heart, brain and more by eliminating traditional cost and time bottlenecks,” said Claire Biot, Dassault’s vice president responsible for the life sciences industry, in the statement. “With this new review process, Dassault Systèmes and the FDA can be partners in the transformative impact of the virtual world on industrial innovation, new treatments and the patient experience."
The idea is that in silico studies can be done more quickly and efficiently than traditional clinical trials without sacrificing confidence in a device’s safety and efficacy.
“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,” said Tina Morrison, Ph.D., deputy director in the Division of Applied Mechanics of the Office of Science and Engineering Labs at the FDA’s Center for Devices and Radiological Health. “The FDA continues to encourage research to facilitate the introduction of safe and effective therapeutic solutions.”