Category Archives: Med Dev Sales

Medical Device Executives Found Guilty

Go Directly to Jail (23/366)


Three of the four former Synthes executives who pled guilty to charges under the Park Doctrine were sentenced to jail time and large fines recently. The four men were charged for training and supplying doctors with bone cement to repair fractured vertebrae in spinal surgery, an indication that was off-label according to FDA. Continue reading

5 Things You Didn’t Know About Off-Label Sales Compliance

Originally published in PharmaPhorum


Off-label sales compliance is difficult. There is subtlety to staying on message. Pharma sales representatives are highly mobile and verbal. Compliance and regulatory departments love paper to convey messages because they can match them up to corresponding policies. This makes the marriage of the two functions challenging. Continue reading

4 Synthes Execs Indicted for Off-Label Promotion


Last Sunday’s Philadelphia Inquirer reported on the indictments of four high-level medical device executives for off-label marketing practices. The indictments mark a next step in the enforcement of off-label marketing practices in the US.

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3 Tips to Keep Your Reps On-Message vs. Off-Label


A medical device sales manager has plenty to worry about when it comes to what your sales reps are doing in the field to reach their sales goals. Are they making enough calls? Are they in surgery enough? Do they have the tools they need? Where are they when you try to call them? But in today’s current regulatory environment, a sales manager’s biggest worry is what they are saying when in front of customers. How do they convey the message when they are standing at the scrub sink or in the physician’s office? Continue reading

Perception vs. Reality of Industry Support


Last month we were discussing the changes to educational programs, something those of us in sales have long seen as a “safe harbor.” To learn the latest, review the recent White Paper (PDF) issued by the American Board of Medical Specialties which includes their discussion on commercial funding of medical education.  Thanks to our friends at Policy & Medicine for bringing this to my attention.

This is a discussion of CME programs, their future and where the line in the industry-physician support needs to be drawn. Please take a moment to review the document, and provide feedback to the ABMS committee before March 1. Continue reading