Former FDA Head Calls for More Integration in Medtech Community

On April 8, Andrew von Eschenbach, M.D., former head of the U.S. Food and Drug Administration (FDA), said that medical device and diagnostic companies must start working together better to face the new, complex problems facing the community.

Eschenbach, who served as FDA director from 2005 to 2009, described several broad changes needed in the regulatory and financial sectors of the medical device industry as keynote speaker at the Lahey Hospital and Medical Center in Burlington, Mass. He noted that because of the rapid pace in recent innovation on understanding how cells and cell nuclei work, the medical industry as a whole is at a turning point. As the types of medical conditions and diseases targeted become more complex, the solutions need to follow suit, going beyond a basic drug or device treatment. What that means, Eschenbach said, is that companies need to work together much more than current intellectual property (IP) law allows.

“You need to be collaborating and sharing intellectual property at the very outset,” he said. “Today, there are huge barriers to doing that.”

Among the changes, he said, are changes to the funding model to support teams of scientists and companies, not just individuals.

“There is no company that can ever get as big as it needs to be to do everything on this,” he said.

He also said that massive changes are needed in the FDA to allow more of what he called market-driven regulation instead of government-mandated regulation.

“We need the ability for people to hold each other accountable,” he said. “It makes the whole system better.”

While von Eschenbach acknowledged that for small biotech startups, intellectual property is often the most valuable asset, he said that the need to protect it must be balanced. He said that Europe and China are already working to create regulatory and financing systems that are more favorable to the changes in medical innovation.

“Do we have the right legal framework that allows for sharing of IP? I don’t know,” he said. “There’s going to be winners and losers here. Those countries that create the right legal systems to encourage that are going to be the winners. The game has begun.”