At an FDA Town Hall Meeting at TCT last week, deputy director for science at FDA Bill Maisel proclaimed that a new paradigm is needed to ensure the safety of medical devices. The paradigm of benchtop testing followed by animal testing and later clinical testing is outdated, he said. And there is a need to think “a little bit more broadly.”
“[At FDA,] we’ve been looking at computational modeling as a fourth pillar of pre-market evaluation,” Maisel said. Computational modeling could be used in the cardiovascular space to, say, simulate the aorta, the peripheral vasculature, arterial trees, or even the heart itself. “If we have high quality models, we can help better devices to be developed more quickly.”
The agency has started working on a project called the virtual physiological patient, which can be applied to device design and testing. FDA is teaming up with academic centers and industry to catalog human variation and structure in both the normal state and the disease state. “The hope is to end up with libraries that industry could use or an academics could use to develop devices that are better,” he said. “Rather than having to go and put a number of aortic stents in, we have a computer model of thousands of patients that have healthy aortas and thousands of others that have diseased aortas.”
FDA can’t take on this project alone, Maisel stressed. The efforts to develop advanced computer modeling and the larger efforts of helping to foster innovative devices require partnership between FDA and industry. Everyone really needs to be “sitting at the table,” he said, including representatives from professional societies, academics, and legislature to help usher regulatory science into a new era.
Heart image from Solomon Eisenberg, Sc.D.