Physician-Industry Collaboration: How to Maintain Compliance

Throughout the medical device industry, physicians are used to teach and train fellow physicians and company sales reps on new products and surgical procedures. But with increased scrutiny on physician-industry interactions and the advent of Sunshine Act reporting, the industry faces a potential compliance minefield with this collaboration. While every company wants to find known, peer-respected faculty, a company’s faculty selection must not be related to volume of business. So how do we compliantly identify and select a physician who is credible and qualified to teach for a device company?

1. Involve the Sales Force, But Only to a Point

One of the inherit difficulties in maintaining compliance lies with the sales force. Field reps typically know physicians best. They call on doctors daily and know who is deemed a key opinion leader. Reps also see the physician using the device and can assess who excels at its use. But—there is an inherit conflict: The sales force has an incentive to get their physician involved with a company. At its worst, this can represent a quid pro quo situation that violates accepted corporate compliance rules.

Marketing and medical education professionals still need to use the info sales provides; let them be the eyes and ears to fill the potential faculty funnel. They can recommend a physician and provide introduction to a corporate representative. But at this point, to minimize conflict of interest and create a compliant physician-industry collaboration environment, sales must—crucially—have no further involvement in faculty evaluation.

2. Use Objective Criteria

Once nominated for a possible faculty role, the physician needs to be assessed using a set of clear, objective criteria. Why? While a physician needs to have experience with a device or procedure, the decision to include them as faculty—and remain compliant and credible—cannot depend on volume of use. A framework of objective criteria based on qualifications and unrelated to sales volume is essential. Objective criteria can include: Years in practice, number of peer-reviewed journal publications, number of society meeting podium presentations, etc. This allows for comparisons on an apples-to-apples basis and eliminates sales volume considerations.

3. Use Non-sales Decision Makers

Review nominations with a group of non-sales decision makers—typically a compliance committee whose members come from legal, marketing, medical education, etc. They should assess a physician’s teaching qualifications using the objective criteria.

After a physician is added to the company’s approved faculty list, the job of ensuring compliance is still not done. Requests for using physician faculty must still meet reasonable guidelines. Develop a set of objective criteria and ask probing questions to determine which faculty member to use. Ask: Who is making the request?; What is the educational/clinical value of the request?; What qualifications must the requested faculty member meet?; and why is this specific physician being requested? The answers will allow the compliance committee to make an informed decision on faculty selection.

As med device innovation expands, companies will continue to benefit from using physicians to teach and train. Developing a robust corporate compliance program and employing a few simple steps to identify and select physician faculty will prove to be a win-win.


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