While the US Food and Drug Administration has chiseled away pharmaceutical review times over the years to speed innovative drugs to market, the opposite seems to have occurred in the agency’s approval of medical devices.
Instead of speeding innovative first-mover products to market, devices such as implantable defibrillators or transcatheter heart valves, the FDA’s regulatory approval process appears to delay those approvals, which in turn adds to development costs borne by device manufacturers, according to Innovation under Regulatory Uncertainty: Evidence from Medical Technology, a new working paper by Ariel Dora Stern, an assistant professor at Harvard Business School.
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