Editorial: Obama's chance to unlock innovation

President Obama's Minnesota visit last month was a missed opportunity.

While the picturesque Goodhue County town of Cannon Falls epitomized heartland values, a president battling grim unemployment numbers should have paid a visit to an industry vital to the future of Minnesota and the nation: medical-device manufacturing.

Tonight, Obama has a chance to rectify that oversight by briefly highlighting the industry's value and challenges in his nationally televised economic address to Congress.

After a summer hijacked by the manufactured debt-ceiling crisis, lawmakers are returning from their August recess and finally are focusing on the nation's most-pressing problem: joblessness.

Obama is expected to call for an economic plan centered on payroll tax relief for workers and employers. He's also expected to propose a several-hundred-billion-dollar federal investment in roads, bridges and other infrastructure.

The speech's time constraints mean Obama will have to outline his jobs package in broad brush strokes.

But providing a few timely details about the medical-device industry -- in particular, recognizing that an improved regulatory environment is a key factor in its success -- could help steady an industry facing unprecedented uncertainty and potentially spur investment and hiring.

The debate over the U.S. Food and Drug Administration's medical-device regulation has been simmering for years in Minnesota and elsewhere. The state is home to industry giants such as Medtronic and to many small- and medium-sized companies. Medical-technology firms employ about 27,000 Minnesotans.

The industry has long been frustrated by the unpredictability and expense of the FDA's device-approval process. Many believe the FDA stifles innovation, and studies indicate that device development is moving offshore.

But activist groups, citing a small number of high-profile device recalls, accuse the agency of approving devices too quickly.

The debate reached new heights this summer when a long-awaited report from the Institute of Medicine punted on key reform questions and instead called for a harsh, unrealistic prescription: scrapping the 510(k) route to market for many lower- to moderate-risk devices.

It's too soon to say what substantive changes, if any, the FDA will make as a result of the IOM report. To its credit, the agency has said the 510(k) process shouldn't be eliminated, but regulatory unknowns are still reality.

One speech from Obama won't fix that festering problem.

But a few, well-chosen words would strongly signal that his administration is listening to this important industry and is committed to reforms that would safeguard patients and foster innovation.

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