FDA Extends Collaboration on Living Heart Project with Dassault Systèmes

FDA Extends Collaboration on Living Heart Project with Dassault Systemes

FDA Extends Collaboration on Living Heart Project with Dassault Systèmes | DeviceDaily.com

What if a realistic computer simulation of your heart surgery was performed before it happened? What if your doctor could then use this digital twin to test the treatment plan and ensure there were no surprises? What if new medical devices and drugs were designed and perfected on these virtual patients before testing them on living beings?

Dassault Systèmes and the FDA are working together to make these ‘what ifs’ a reality and improve both medical care and clinical testing.

In 2014, Dassault Systèmes began a collaboration with the U.S. Food and Drug Administration (FDA) through the Living Heart Project. The project develops a 3D computer model of the human heart.

The goal is to enable physicians and surgeons with the ability to create digital twins of their patients, allowing them to analyze treatment plans for the best outcomes in advance.

These virtual patients could spur innovation of new medical devices and drugs that could be designed, tested and subject to regulatory review with minimum real-world consequences.

The Living Heart Project brought together experts from around the world.

The project unites the most advanced 3D modeling technology with leading cardiovascular research and clinical experience. The project also creates a singular environment where biomedical engineers, research scientists and practicing clinicians can combine their expertise.

Leading experts collaborate to revolutionize patient care, with an initial focus on transforming the development of new medical devices.

Over the past five years, Dassault Systèmes and the FDA, along with 130 member organizations and over 250 cardiovascular specialists, have worked systematically to develop the Living Heart model.

Now they can reproduce the natural beating of a human heart at rest or exercise. They can use it to simulate blood flow and disease conditions and even determine how drugs will affect important phenomena. These conditions include such issues as arrhythmias — the number one cause for new drugs to fail in clinical trials.

New digital tools aimed at increasing efficiency.

Recently, Dassault Systèmes and the FDA extended their collaboration for an additional five years, to develop a new digital tool aimed at increasing efficiency in the regulatory review process for medical devices.

This is the second phase, and that will support the 21st Century Cures Act. By creating virtual patients based on the Living Heart, an in-silico clinical trial for a new medical device can be started.

The goal is a “playbook” for the use of virtual patients to improve new device designs and minimize the number of human patients needed to assess product safety. The digital regulatory review could speed the approval process and lower overall cost without sacrificing safety.

This collaboration demonstrates the ultimate potential of the 3DEXPERIENCE twin to help speed medical innovation and is just the beginning.

The same technology is now being used for orthopedic devices and even new for treatments for the brain.

Organizations spanning 24 countries are involved in this project and include both medical device and pharmaceutical companies. The hope to pioneer new processes that increase innovation and pave the way for an efficient path. Paths moving towards accessing safe, effective new treatments for heart disease are critical.  Currently, heart disease is the world’s leading cause of death.

Image credit: Simon Matzinger/Pexels

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Steve Levine

Steve Levine is the Senior Director, Virtual Human Modeling and Founder, Living Heart Project at Dassault Systèmes, as well as Chief Strategy Officer for SIMULA.