With the end of the year just around the corner, MassDevice is taking a look back at 2009 and the five biggest national stories of the year for the medical device industry. Here’s our list:
- Regime change at the FDA: New commissioner Margaret Hamburg (and the departure of Center for Devices and Radiological Health head Daniel Schultz) spelled big changes for the Food & Drug Administration this year. With a renewed focus on public health and the budget muscle to pull it off, the FDA instigated internal and external reviews of its 510(k) clearance process, with as-yet-unspecified consequences for the medical device industry. This may end up being an even bigger story for the industry than the economic crisis and healthcare reform, after everything shakes out.
- The economy puts the clamp on the first half of 2009: It was tough sledding for a while there in the early days of 2009, what with hospital spending freezes, a capital equipment market drier than the Sahara, zero credit and a non-existent IPO market. Medical device makers reliant on capital spending or elective procedures suffered, but others fared much better and the industry as a whole did better than the general economy during the worst climate in 70 years.
- Healthcare in the crosshairs: The Dept. of Justice is made from crackdowns on healthcare fraud, with about two-thirds of the $2.4 billion recovered from false claims prosecutions this year being healthcare-related. The department said it collected $1.6 billion from busts of Medicare and Medicaid fraud rings, off-label marketing and illegal promotion of drugs and devices during fiscal 2009. This year’s haul is the second-highest-grossing year ever, according to a DOJ press release.
- Healthcare reform and the medical device tax: If the original, $40 billion price tag was still on the table, this would be the industry’s biggest story of the year. But even at half the cost, and deferred until 2013, it will still have a huge impact on medical device makers. Stay tuned, as this story promises to have legs well into 2010 and beyond.
- Supreme Court’s Riegel v. Medtronic‘s preemption decision reverberates: The Supremes ruling that FDA approval trumps local and state regulations in product liability lawsuits reverberated throughout the medical device and legal worlds, and will continue to until and unless it’s overturned by new federal legislation.