Originally Published MX May/June 2004
EDITOR'S PAGE
Innovating a Critical Path
For medical device companies seeking to bring innovative products to market, maintaining the confidence of investors is an ongoing struggle. To do so, medtech executives must repeatedly demonstrate their preparedness to overcome whatever obstacles may stand in their way.
Such obstacles to innovation are the subject of a recent FDA white paper, Innovation, Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, issued in March. The report evaluates the slowing pace at which innovative medical therapies are reaching patients, and asserts that "If the costs and difficulties of medical product development continue to grow, innovation will continue to stagnate or decline, and the biomedical revolution may not deliver on its promise of better health."
In FDA's view, such obstacles can have a chilling effect on industry. "For very innovative and unproven technologies," says the report, "the probability of an individual product's success is highly uncertain, and risks are perceived as extremely high. Whole fields may stagnate as a result of the failure of early products."
But in written comments delivered to FDA at the end of April, Elizabeth D. Jacobson, PhD, executive vice president for technology and regulatory affairs at AdvaMed (Washington, DC), dismissed the agency's concerns. Observing that the report's conclusions about product slowdowns are "based on metrics for drugs and biological products," Jacobson noted that "there has been no similar decline in the number of medical device submissions."
Medtech start-ups may be less sanguine about this issue. For such companies, the more important metric is the unknown number of additional submissions that might result if investors had confidence that all possible obstacles to product development were being minimized.
Encouragingly, Jacobson's comments conveyed AdvaMed's willingness to work with FDA "to enhance the movement of innovative products to the patients who also need them." If such efforts help to improve investor confidence, a good first step will have been taken.
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