Once again, the media has stirred the pot on how device companies are paying doctors (and the fact that doctors are accepting compensation). This time, it’s the Wall Street Journal. The company in the line of fire is Medtronic, and the controversy is surrounding royalties related to spinal devices. The WSJ also names names, revealing five surgeons who have received more than $7 million from Medtronic for their role in designing one of these devices (Medtronic’s Web site houses a list of physicians to whom it compensates more than $5000 a year).

The issue begins at Norton Hospital (Louisville, KY), a center that ranks third in the number of spinal fusions performed in the United States, according to the WSJ. The story contends that overusing certain devices contributes to rising Medicare costs and taxes the healthcare system as a whole. Although this certainly is true in some instances, there is a deeper and much more complicated issue that orthopaedic manufacturers face—when is a payment in fact a kickback and when are doctors being paid for their contribution in creating a device? A gift as simple as a canvas tote bag can be considered a conflict of interest, depending on whom you ask.

There are several efforts within industry to promote (and monitor) ethical behavior. For example, the Institute of Medicine established the Committee on Conflict of Interest in Medical Research, Education, and Practice. The committee recommends that medical institutions establish conflict-of-interest policies that involve disclosing financial ties to the industry. AdvaMed’s Code of Ethics has been a major force in helping device manufacturers better understand their role in maintaining compliant relationships with doctors.

Under the Physician Payments Sunshine Act, medical device and drug companies must begin recording payments that exceed $10 in 2012 and begin reporting them on March 31, 2013. Consequently, a searchable database of this information will be available on September 30, 2013. However, medical device manufacturers haven’t been given sufficient guidance regarding payment data and time periods. In November, Senators Charles Grassley (R–IA) and Herb Kohl (D–WI) wrote a letter to HHS secretary Kathleen Sebelius, urging for federal guidance on the kind of information that must be disclosed. They also asked that Sebelius designate an agency to oversee the process of creating and operating the database.

During the next few years, manufacturers will probably continue to struggle with the balance between compensating doctors for their part in designing devices and engaging in ethical business practices. And they will no doubt be scrutinized for their behavior, even in the face of good intentions. This criticism may never end, but I hope that the collaboration between doctors and manufacturers doesn’t either. It’s not cliché to say that these relationships are indeed the lifeblood of the industry. They are where innovation is born, and the device industry cannot evolve without them.

—Maria Fontanazza