Hmmm.... The regulations on the medical device industry are just as harsh, if not more, than the pharma industry - and it was definitely interesting to hear this "side" of the issue. I guess to provide "my" side of the story:

• A lot of my product managers have to spend time making those presentations for our "thought-leaders," and I know for a fact that they wish they didn't have to - and generally the physicians themselves have their own presentations (for physician conventions, like AAOS, etc). However, the FDA is so stringent on off-label promotion that the orthopedic company legal teams mandate that the company makes the presentations. I am close friends with one of our corporate lawyers, and seriously - every single piece of labeling/marketing/periphery material has to go through her for approval. This always seemed like a practice that was for the best interests of the patient, and knowing everyone involved in my company, I can say that they feel this way also - interesting how it was spun otherwise in this video, though.

• While we are on the topic of "thought leaders".... I have always been on the fence about this, at least in some scenarios. On one hand, we bring physicians on as developing surgeons, and over the course of the project they provide a lot of great value to the project. As the project nears completion, we also bring on evaluating surgeons - physicians that have zero vested interest in the project (after a certain point, developing surgeons are too biased to call their baby ugly), and these doctors also bring a lot of value to the project - all in ways that directly benefit the patient. These developing and evaluating surgeons are the guys we bring on as "thought leaders" to help train other physicians after launch. There are two obvious reason for this: 1) They had a great deal of input into the design of the devices, and 2) These guys are the Crème de la Crème of the ortho industry - so of course we want them as thought leaders? Why would we get some moron straight out of med school that only skimmed by because he was able to memorize massive amounts of information to help design our devices, instead of the guys that do hundreds of procedures a year, can visualize concepts in three dimensions while they are performing in the OR, and independently lead and publish their own clinical and technical literature articles? I'm sure it is different in the pharma world since I doubt physicians are involved in the chemical engineering aspects of that industry, but in the medical device world the thought leaders generally are leaders among their colleagues....... But on the other hand, there are some projects where the engineers do all the work, and then the physician is tacked on at the end to give the thumbs up. There was one project I finished about a year ago where I was asked to write a design rationale for all the various decisions that went into my system design... So I wrote 20 pages, single spaced, summarizing all the clinical literature, biomechanical literature, theoretical analyses, and mechanical tests I performed that drove the final system design. This design rationale was then given to three surgeons I had never even met before, they essentially said "yeah, I agree with that," and now there is a whole new "movement" with these three surgeons leading the way. These surgeons are thought leaders in their own right, but within this context the ideas they are pushing were not originally their own, if that makes sense...
• I guess lastly I just wanted to mention that I have never in my career met a single person that tried to break the rules. My experience so far is everyone takes our responsibility to our patients very seriously. I haven't interacted tons with a multitude of sales reps, so maybe it is different in that environment, and same thing with closed-door executive meetings, but everyone else has always had the best intentions, and been more than willing to put their foot down and stone-wall projects until they are done right.