When it comes to healthcare reform and its impact on medical device industry, manufacturers should be prepared to “do more and spend more” on technology-oriented studies as all signs are pointing toward an evidence-based future. 

That message was delivered by Steve Halasey, vice president for programs at the Washington-based Institute for Health Technology Studies, during the Medical Silicone Conference keynote address in Anaheim.  Halasey told his audience that healthcare reform, especially when it comes to defining comparative effectiveness, and regulatory reform, as it pertains to the more than 60 proposed revisions to FDA’s 510(k) premarket notification, are contributing to unpredictability and uncertainty throughout the industry.

He also said that with healthcare leadership in place at agencies such as FDA and CMS (Centers for Medicare and Medicaid Services), the industry has an opportunity to make its voice heard when it comes to proposed changes. “Full engagement in building reform-initiated programs is industry’s best hedge against uncertainty.”

More of Halasey’s analysis can be found in his downloadable presentation.