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Message to Device Industry: You're Next

"The medical device industry is no longer under the radar screen," assessed AdvaMed's president and CEO, Stephen Ubl during a conference at Harvard University (Cambridge, MA). Many experts agree with this statement, as it was a clear theme during much of the Medical Device Regulatory, Reimbursement, and Compliance Congress this week. Device companies should take notice of the government's enforcement actions against drug companies, because the device industry is most likely next.

It's anticipated that increased enforcement will be seen in areas from off-label promotion of devices to improper payments given to doctors. Companies also need to be aware of the new tactics that the government is using to find evidence. "The government has stepped it up a notch in terms of investigative techniques," said John Bentivoglio, partner at King & Spaulding (Washington, DC). If your company is looking at past settlements --which generally involve conduct that happened a long time ago -- as a model for assessing risk areas, then you're essentially looking in the rearview mirror, said Bentivoglio. As more government offices and prosecutors become involved in investigations, more tactics are being used than in the past. Some examples include taping promotional events, creating a paper trail within a company when dealing with human resource issues, and doctors serving as cooperating witnesses. The government has also been focusing on internal financial documents of a company of interest, because these records (which also detail audits, incentives, etc) can serve as powerful evidence of a company's intent.

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