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Sleepless Nights: Compliance Challenges Facing Today's Medical Device Executives

May 3, 2013

By: Ronald H. Levine

In an article in the May 3, 2013 issue of Pharmaceutical Compliance Monitor, White Collar Chair Ronald H. Levine examines the list of compliance challenges that medical device executives need to consider as they risk analyze to allocate compliance resources.

Mr. Levine notes that,

"One can hardly scan the headlines and remain unaware of the continuing, intense regulatory focus on the medical device industry and the corresponding pressure which this places on the compliance programs and quality systems of medical device manufacturers. 2012 was proclaimed yet another record-breaking year in federal False Claims Act (FCA) enforcement. The Department of Justice (DOJ) opened over 1,100 new criminal and 885 new civil health care fraud investigations. Of the $4.9 billion in total FCA recoveries in 2012, $3.3 billion was recovered due to whistleblower or qui tam suits, and over $3 billion was recovered in health care fraud actions. 826 defendants were convicted of health care fraud-related crimes."

"By staying in front of the regulatory curve and appropriately allocating resources, medical device executives can limit their compliance risk while saving themselves some sleepless nights."