TCT: Regulatory process, costs drive medical innovation out of the U.S.

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SAN FRANCISCO—To reinvigorate medical innovation, the U.S. is in “desperate need of governmental and regulatory reform” and positive case examples to show that it still can be achieved, according to Martin B. Leon, MD, who gave a Nov. 7 lecture at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) conference.

Leon, who is director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center in New York City, defined innovation as a novelty that creates value, and medical innovation as “progress in technology usually resulting less from individual genius and more from collective effort and social, political and economic forces that come together to create an ecosystem which fosters innovation.” 

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.

There are several forces of change that have directly impacted the interventional cardiology specialty, he said, including:
  • 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.
  • The U.S. contribution to world patents is steadily declining, due in part to new regulations.
In fact, the U.S. regulatory timelines have been slipping, he said. He noted 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 exemplified 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.

Other factors that have impacted medical innovation, including the media and healthcare reform, the latter of which Leon said “has already resulted in several unintended consequences.”  Those include physician integration; reimbursement pressure, especially for procedures; and a changing interventional milieu which may restrict access for patients in the future.

Finally, he said that recent “conflict-of-interest regulations continue to rapidly evolve, restricting physician participation in industry-sponsored research, education and other entrepreneurial activities.”

In order to reinvigorate medical innovation, Leon provided three recommendations:
  • 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.
“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.