MassDevice New Year’s Special

MassDevice co-founders Brian Johnson and Brad Perriello

Predictions are easy if you don’t take any risks — we proved that last year with our forecast for 2010. So rather than aiming for another perfect (and perfectly dull) year’s prognostication in 2011, we asked a panel of experts in a variety of spheres for their takes on 2010 and what they’re expecting next year.

First, though, it’s only fair to review where we thought 2010 would take us.

Checking our work

Last year we said the biggest factor affecting medical device makers, excluding the economy, would be "rampant uncertainty over looming regulatory and legislative changes." Well, duh. But it’s still true: It seems all but certain that the Food & Drug Administration will make significant changes to the 510(k) clearance process. As Paul LaViolette tells us, the uncertainty around the regulatory environment is having a chilling effect on medical device investment (not that LaViolette sees all downside).

We also tapped healthcare reform as a looming concern back in late 2009:

“Medical device makers can expect healthcare reform to deliver two things: An influx of new customers and a much tighter, more competitive business environment. On the regulatory front it’s much the same story. Reforms to the device clearance process will make the regulatory environment much more stringent."

OK, so we were half-right on this one. Device makers don’t need to be told that their business climate is tighter and more competitive every day. But that influx of new customers has yet to appear and, should it transpire one day, may not deliver enough volume to counter-balance the effects of a 2.3 percent tax on revenues mandated by the Patient Protection and Affordable Care Act in 2014.

As for next year, many of the same issues are shaping up to dominate 2011. As you’ll see from our panel of experts, changes at the FDA, the healthcare reform rollout and the economy all loom large in their thoughts.