We wouldn’t be writing about the showdown going on between Zimmer Holdings and its former star orthopedic surgeon if good Thought Leader development principles had been in place.
To recap: Dr. Richard A. Berger, who was a long-time consultant for Zimmer, is publicly biting the hand that formerly fed him, angry that the medical device company did not pay attention to data he had collected, showing a knee replacement device failed prematurely. In a statement that it gave to the New York Times, Zimmer said it had investigated Zimmer’s complaints, and said “he had disagreed with its findings.” According to the Times, Berger, of Rush University Medical Center in Chicago, presented his findings at two meetings of the American Association of Orthopedic Surgeons. Patient complaints started coming in four years ago, a year after he implanted this particular model, according to Berger.
There is the usual back and forth: Zimmer blames Berger’s technique, Berger counters with – I was a star, now I’m the problem? Zimmer says this particular model was a success – but doesn’t have “separate test data … because the F.D.A. had not required the company to study it in patients before selling it,” to quote the Times.
Should the situation have come to this? We suggest that had an active Thought Leader management process been in place, this issue could have been resolved and managed in a manner that could have had the same outcome, but without all the acrimony.And, for those of us who think having objective data showing a medical device works before it’s inserted into our bodies is a good idea, there is hope: the FDA is entertaining the notion of tightening the medical devices' approval standards. That will benefit patients.
Yes, these approval standards will mean more time spent on design and implementation -- which will increase the cost of bringing the product to market, which, overall, may not be a bad thing. At a recent town meeting between FDA officials and medical device professionals, the latter said current regulations lack clarity and are threatening the “survival of some venture-backed companies."
Wow. A win-win situation! Doesn’t happen too often, but it could with the right kind of management approach.