Medical Devices Today

Device Makers Cite Special Concerns With Comparative Effectiveness

From the October 29, 2007, issue of "The Gray Sheet"

Comparative effectiveness research, where evidence supporting an established medical therapy is stacked up against that of up-and-coming approaches, is a small but growing element of the U.S. government's strategy for assessing health care.

It is likely to become much more significant in the coming years. There is substantial momentum in Congress to establish a new federal center for prioritizing and conducting comparative effectiveness reviews as a component of Medicare reform (¹"The Gray Sheet" Oct. 1, 2007, p. 12). Several presidential candidates have proposed similar measures.

The device industry is viewing these developments with substantial skepticism and is lobbying Capitol Hill accordingly.

Foreign Corrupt Practices Act: Device Industry Under Scrutiny

From the October 22, 2007, issue of "The Gray Sheet"

Federal prosecutors have begun targeting medical device companies in Foreign Corrupt Practices Act investigations.

Early this month, five firms - Stryker, Zimmer, Biomet, Smith & Nephew and Medtronic - announced that they were under investigation by the Securities and Exchange Commission for possible violations to FCPA, which prohibits bribery of foreign public officials by U.S. companies ("¹The Gray Sheet" Oct. 15, 2007, In Brief).

And in February, Michael Dormer, worldwide chairman of Johnson & Johnson's medical devices business, abruptly stepped down when J&J disclosed that foreign subsidiaries may have made improper payments in the course of marketing activities ("²The Gray Sheet" Feb. 19, 2007, p. 16).

CDRH Software Forensics Lab: Applying Rocket Science To Device Analysis

From the October 15, 2007, issue of "The Gray Sheet"

CDRH's recently upgraded "software forensics lab" marks a substantial financial and time investment by the center to get at the root cause of the most troubling postmarket device software failures, but the agency hopes manufacturers will pick up the tab in the future to prevent dangerous anomalies before their products hit the market.

In the past year or so, the forensics lab, housed within the Office of Science and Engineering Laboratories, has used high-power instruments and techniques to analyze "source code" in roughly a half dozen medical devices whose software was thought to be responsible for causing serious adverse events.

Japan's Device Payments Will Continue To Decline, Government Official Says

From the October 8, 2007, issue of "The Gray Sheet"

Pressures on reimbursement in Japan will not ease anytime soon and more payment cuts for medical devices are expected in 2008, according to a top Japanese health official.

The U.S. industry sees Japan as a mostly untapped market hindered by government barriers. U.S. device makers have long urged the Japanese health ministry to eliminate its controversial foreign average price rate-setting method, which generally reduces device treatment fees to be more in line with payment levels in lower cost countries.

Electronic Adverse Event Reporting Will Soon Be Mandatory, FDA Says

From the October 1, 2007, issue of "The Gray Sheet"

FDA is urging device manufacturers to voluntarily adopt the agency's electronic Medical Device Reporting (eMDR) process in anticipation of being required to do so as early as next spring.

The eMDR program is intended to help CDRH more easily identify patterns in adverse events.

The program is currently optional, but a draft rule mandating electronic reporting is being completed within CDRH and will likely be released for public comment by February, Don St. Pierre, head of FDA's Postmarket Transformation Management Group, said Sept. 25 at the Regulatory Affairs Professionals Society annual meeting in Boston.

"I can guarantee you the center will be done with those comments very quickly to move that final rule forward," St. Pierre said. "So you can do [electronic reporting] now or you can wait for it to be done to you."