Medical Device Link.

Originally Published MDDI August 2002

EDITOR'S PAGE

The nascent biodefense industry may not prosper if its funding comes wrapped in red tape.

Can the device industry avoid crippling entanglements with the defense bureaucracy?

Since last September, the U.S. medical device industry has had thrust upon it a whole new role as a bastion of national defense. Overall, this is a good development for the industry and the nation. In an age of bioterrorism, medical device manufacturers have much of value to contribute to homeland security. Likewise, biodefense applications are likely to become a significant growth area for the device industry.

Both leading industry associations, AdvaMed and MDMA, have embraced this new role, not only as a duty, but also as a boon to business. But while there may be no downside to this trend, we believe the industry should proceed with caution. The defense industry, so intimately entangled with military and federal bureaucracies, is not exactly known for its efficiency, flexibility, or speed of development. In taking on a similar role, the device industry must be careful not to take on the same traits.

Some in industry have recently taken note of this danger. As quoted last July in the San Francisco Chronicle, David Gollaher, the president of the California Healthcare Institute, said bioterrorism funding brings with it both good and bad news. "It is clear we are going to have a U.S. biodefense industry," he said. "What is not clear," he added, "is to what extent that industry will thrive" if government funding comes wrapped in red tape.

The device industry, of course, is well accustomed to bureaucracy. But is trading the healthcare bureaucracy for that of the proposed Department of Homeland Security (DHS) a good bargain? The health research community doesn't think so. As originally drafted, the bill creating the department would have given the DHS control of the nearly $2 billion in funding for biodefense R&D conducted at National Institutes for Health and the Centers for Disease Control and Prevention. Thanks in part to a protest by the research community, the bill was amended in late July to allow for budgetary control by HHS. Final disposition of the bill will not take place until September, however, so this resolution is not yet certain.

For researchers, the critical issue is control of their work. If funding were controlled by a department unfamiliar with their type of research, they reason, the direction and success of that research might well be adversely influenced.

Such concerns hearken back to President Dwight D. Eisenhower's famous farewell speech, in which he warned of the dangers of the "military-industrial complex." Though speaking at the height of the Cold War and as a former army general, he cautioned against giving too much power to those in charge of "the huge industrial and military machinery of defense."

Commenting on the centrality of scientific research to this machinery, he noted with concern that "a steadily increasing share" of research "is conducted for, by, or at the direction of, the federal government." As the "solitary inventor" gives way to "task forces of scientists in laboratories and testing fields," he said, "a government contract becomes virtually a substitute for intellectual curiosity."

As the device industry prepares for an influx of biodefense money, it should keep President Eisenhower's warning in mind. This industry is characterized by innovation, flexibility, and rapid product development. Only by steadfastly maintaining an arm's-length relationship with the military-industrial complex can it preserve these distinctions.

The Editors

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