Government Certainty

While not everyone is pleased with government and its role in healthcare, it’s safe to say that there is a little more certainty in Washington now that the U.S. Supreme Court has upheld President Obama’s Affordable Care Act. Healthcare providers and payors—and the medical device companies who do business with them—at least now have a firmer grasp on what lies in store for them in the years ahead as the new law gets implemented.

It remains to be seen, of course, whether the new potential customers that will be created by the influx of previously uninsured Americans will offset the new medical device tax that was included with the new law to help make it revenue neutral. Though the sentiment is appreciated by medical device manufacturers, it’s not likely that HR 436, the Protect Medical Innovation Act, which repeals the new tax and was recently passed by the House of Representatives, will become law anytime soon. However, we believe there might be potential for at least amending the tax in a way that’s less onerous to small device manufacturers if House leaders would compromise with the Senate and administration on healthcare reform, rather than pursue their scorched-earth strategy of making the new law the president’s Waterloo.

We were also somewhat encouraged to see more certainty coming out of the Center for Devices and Radiological Health. The FDA sent two representatives to the Neural Interfaces Conference this month in Salt Lake City [see conference report, p7] to advise attendees on strategies for getting device approvals. Kristin Bowsher from CDRH’s Office of Device Evaluation described a new “Innovation Pathway 2.0” that potentially streamlines early feasibility trials. Though the proof of principle program is not accessible to everyone at this point, it does at least open the door to the possibility of speeding up the approval process for some Class III devices.

Cristen Welle from CDRH’s Office of Science & Engineering Laboratories described some of her team’s efforts to refine regulatory science in an era of new materials, new forms of stimulation, and new types of interactions between implanted stimulation devices and living tissue. It was encouraging to see a regulator with an understanding of issues such as charge density per phase, excitotoxicity, and changes to ion channels. Indeed, her lab conducts its own experiments on long-term safety and reliability of neural interface devices. And while she stressed that the FDA approves devices and not materials, she advised that there is a master file by which the agency collects information that can be accessed when a new submission comes in.

Taken together, these events make us believe the regulatory waters are a little more navigable for neurotech device vendors these days.

James Cavuoto
Editor and Publisher