A recent article from TCTmd noted that, “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.”
Citing to a recent Scientific Symposia session at the Transcatheter Cardiovascular Therapeutics (TCT) conference, Martin B. Leon, MD, and Elazer R. Edelman, MD, PhD, debated the issue and discussed whether this trend should be deemed a “crisis.” Both Drs. Leon and Edelman have extensive experience conducting research and consulting with numerous pharmaceutical and medical device companies.
Need for Innovation
Dr. Leon, who is director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center in New York City, 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.”
As an article from CardiovascularBusiness noted, “Compared with 2005, the U.S. medical technology market’s startup valuation has dropped 55 percent, healthcare funding has decreased 52 percent, venture capital investment has declined 25 percent and private equity funds have plummeted 65 percent.” Currently, Leon said, many “forces of change” have directly affected the interventional cardiology specialty. The several forces of change include:
- Interventional coronary procedures are “flat” and won’t demonstrate important growth in the next decade.
- Everywhere, the interventional marketplace is becoming remarkably cost and price sensitive.
- The U.S. has surrendered its position as the global revenue leader in interventional therapeutics.
- The regulatory climate for device approval has intensified and the gap between the U.S. and Europe has widened.
- The cost burden of investing in iterative “sustaining” medical technologies has skyrocketed.
- An increase in the media’s effect on medicine;
- Health care reform; and
- The U.S. contribution to world patents is steadily declining, due in part to new and rapidly evolving conflict of interest regulations, “restricting physician participation in industry-sponsored research, education and other entrepreneurial activities.”
Dr. Leon noted that several unintended consequences on innovation have already occurred, including:
- physician integration;
- reimbursement pressure, especially for procedures; and
- a changing interventional milieu which may restrict access for patients in the future.”
Dr. Leon also pointed out “that it took months for an approval to occur between 2003 to 2007, compared with 2010, jumping from three to five months for 510(k) devices and 15 to 30 months for pre-market approvals (PMAs)—representing a 100 percent increase for PMAs.”
Also, the current cost to clear and approve a medical device in the U.S. is $31 million on average to bring a 510(k) product from concept through clearance, with $24 million spent on FDA-dependent/related aspects. “Likewise, it costs $94 million on average to bring a PMA product from concept through approval, with $75 million spent on FDA-dependent/related aspects. Leon said that these figures do not include reimbursement approval and sales or marketing costs.”
He pointed to countries “such as Israel and India, as being friendlier to medical innovation, and therefore, those markets are growing. For instance, in Israel, government subsidies and encouragement foster technology transfer from universities and government agencies, especially military. Also, in Israel, physicians, scientists and engineers are not discouraged from working with industry, Leon said.”
To reinvigorate medical innovation, the U.S. is in “desperate need of governmental and regulatory reform” and “we need positive case examples to show that it still can be achieved in the U.S. Leon suggested
- Accept the fact that the innovation ecosystem in the U.S. has changed forever, and therefore adapt and evolve, embracing a more strategic approach based on hard-earned lessons.
- The physician scientist community must reorganize, emphasizing multidisciplinary (non-territorial) activities, better communication, and increased society leadership. “Sometimes, the enemy is us,” he added.
- Innovation will be a global phenomenon, including: idea creation, intellectual property, device development, clinical research, regulatory approvals, commercial revenue and financial investment.
- the need for government and regulatory reform, among others
“Most other nations still lack crucial elements of the innovation ecosystem, such as cultures of entrepreneurialism and commercialization, coherent reimbursement systems, IP protection, trained management or a comprehensive network of reliable suppliers and distributors,” Leon concluded
Problem in Innovation?
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. Edelman asserted that industry will need to:
- collaborate better and share more
- educate, not just publish; and
- 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.”
He also asserted that
- 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.”