Experts Remain Hopeful for the Future of Interventional Innovation

SAN FRANCISCO, CALIF.—The field of Interventional Cardiology has seen negative trends in innovation – defined as novelty that creates value - despite decreases in CV-related mortality over the last 40 years. In a Scientific Symposia session held Monday morning, Martin B. Leon, MD, and Elazer R. Edelman, MD, PhD, debated the issue and discussed whether this trend should or should not be deemed a “crisis.”

Edelman, director of the Harvard-MIT Biomedical Engineering Center, Boston, argued against the “crisis,” citing barriers to development as the problem.

“In the last 2 years we’ve changed the way we operate in the clinic. We’ve provided new technologies, new materials and convergent technologies; we are fundamentally dramatically different, and all of this is by virtue of the extraordinary pace of innovation in and outside of the United States,” he said during his discussion.

According to Edelman, development barriers – not a crisis of innovation – are the culprits. The barrier to implementation is engineering, the barrier to envisioning is conceptual science and the barrier to profit is entrepreneurship, he explained. To remedy these issues, Edelman argued the need for an “era of cultural change” at several levels, including regulatory agency-industry interchange.

“Industry is going to have to provide more information, and the FDA is going to have to use that information for purposes other than regulatory approval,” he said.

Additionally, academia needs to shift its behavior, Edelman said. “It has to advance the discipline and extend the use of its models but it has to acknowledge that sometimes development transcends discovery,” he said. “It has to collaborate better and share more; it has to educate, not just publish; and it has to realize that sometimes you don’t promise the world, you just have to fess up to the limitations of academia and go back and say there is a responsibility – even in the ivory tower – in improving peoples’ lives.”

Furthermore, constituency agencies should define public policy need, prioritize areas of concern and help standardize techniques; funding agencies should help foster discipline and encourage collaboration; and lastly, the public should accept and appreciate risk.

“Innovation is not dead, in fact, I’d say it’s flourishing,” he said. “Engineering is flourishing; entrepreneurship is a problem, but none of these things are elements unto their own.”

Remedying a crisis

Leon, TCT Course Director and of Columbia University Medical Center, New York, took the opposite stance and argued that several factors, deemed “forces of change,” have led to current troubling trends in medical innovation.

“When we think of innovation, it’s not an iconic genius; progress and technology results less from that individual genius and much more from a collective effort and social, political and economic forces that come together to create an ecosystem, which fosters innovation,” Leon said. “Unless you have these things working in concert – social, political and economic forces – creating an ecosystem, then innovation goes wrong.”

Currently, Leon said, there are many “forces of change” influencing efforts to create new technology. These include “flat” interventional coronary procedures; a cost- and price-sensitive marketplace; the United States’ loss of global leadership in both interventional therapeutics and world patents; an increase in the media’s effect on medicine; health care reform; and rapidly evolving conflicts of interest regulations.

To remedy these issues and reinvigorate innovation, Leon suggests using lessons learned; accepting the fact that the innovation ecosystem he described has changed forever in the United States and adapt accordingly; emphasizing multidisciplinary activities, better communication and increased society leadership in the physician-scientist community; and the need for government and regulatory reform, among others.

“We need some positive case examples to prove that medical innovation in the U.S. can be restored – that we can be ‘alive and well’ again,” he said.