“There could be a great advantage in having a centralized coordinator for these various efforts that are important to maintain the device industry as a worldwide leader,” says Scott Danzis, a partner in the law firm Covington & Burling who specializes in working with device companies dealing with the FDA.
The industry’s competitiveness has been a topic of recent congressional hearings as medical technology groups have reported that smaller companies are finding it more difficult to obtain venture funding and public and private payers are adopting new technologies at a slower rate. Lawmakers have also fielded criticism that the FDA’s fast-track approval for many devices has endangered patients.
“If you look at our industry, we’re so intertwined with government in terms of our success,” said David Nexon, senior executive vice president at AdvaMed. “All our products are regulated by the FDA. A very large proportion of our products in the U.S. are sold to beneficiaries of public programs.” Nexon said that while it’s “awfully early” to determine the Obama administration’s stance on the medical innovation office, AdvaMed recently met with several economic councils within the White House to discuss the agenda.
Even as the industry is poised to address two job-creating, economy-boosting issues—an aging population in the U.S. and the growth of a middle class worldwide—inconsistent approval processes have triggered concern among devicemakers.
“The tolerance for problems with products, side effects or complications, is relatively low,” said Ben Andrew, a medical technology analyst with William Blair & Co. “Ten years ago, the tolerance was somewhat higher and it is, in many ways, a reflection of the political environment.”