I have developed medical devices in a university setting and I have developed developed medical devices in industry. And not like bone screws, either. Atrial defibrillators. Artificial skin. Surgical ultrasound. More than that, I'm at the surgical supply store a few times a year. And outside of specialized, investigational devices, the proliferation of instrumentation and specialized fixtures is driven by the device industry. Full stop. Obviously you want all the best tools available. But at the end of the day Medtronic's recommended set of forceps isn't likely to radically alter the outcome from the surgeon's chosen set of forceps. Of course, if Medtronic says that the only way to do the procedure is with their chosen set of forceps and the doctor deviates, well of course that's going to come up in court. Even if this one goes well, 300 procedures from now when the lawsuits start flying Medtronic will hang that surgeon out to dry for using the wrong forceps "against advice" and the jury won't feel comfortable disbelieving a medical expert. And the doctor and the rep both know it. Reps need to stay the fuck out of the operating room because they aren't responsible for patient care. If a medical device is so complicated that a rep needs to be there, the FDA will never approve it anyway. It's been a while but I could tell you two or three ways to insert a pacemaker lead into a human heart but we both know I shouldn't pretend I have any expertise. And I helped design the damn thing. Reps just sell shit."I can't keep my socks together through the dryer. You can imagine trying to get 100 pans or 300 pans of instruments all set up correctly," says orthopedic surgeon Michael Christie of Nashville, who specializes in new hips.
If a medical device is so complicated that a rep needs to be there, the FDA will never approve it anyway
what? Nope. That’s not how the fda works in regard to devices and their application. There are plenty of devices MANY that require a physician be trained on their use. There are also many instances when the same device finds new applications. I’ve SEEN with my own two eyes a rep show a doctor how to use a new endoscope with a small saw attached and a hydration system to cut out polyps. I’ve seen the same rep show a doctor new techniques using the same device to help treat bronchioplasty. I also saw the same rep attempt to sell in their ancillary products at the same time. Reps don’t “just sell shit,” they train docs on how to use the equipment. They see hundreds of procedures using the same device from dozens of doctors and pick up on best practices. They then share these. You could argue that the company should have heads of product that sell nothing but just show doctors daily how to use the device and new emerging approaches. But you can’t ague that the reps don’t assist in the surgeons getting knowledge. Talk to a surgeon, they’ll tell you the reps are helpful. Even in my work with Forever Labs I see the Arthrex reps we work with assisting doctors in improving outcomes. I didn’t help develop a pacemaker but I have been in a lot of OR’s. Med reps are helpful. You can change their title to med advisors and remove the selling component. But their role as educator is needed.
"training" is very different from "sales rep needs to be in the OR" and you know it. More than that, I had to explain how antibiotics worked to a medical sales rep once - they're not the people I would choose to do training. The fact that that's been added to their roles is a perversion of the system, not a feature of capitalist enterprise. I worked at one firm that had an explicit policy preventing doctors from interacting with the engineers. Any questions a doctor may have had about our device had to be written down poorly by the reps and then mistranslated to the engineering department through a terrible game of telephone. There's no "training" there, there's a deliberate obfuscation of knowledge to make sure that the doctor doesn't start devaluing his rep. It's a bad system. It needs to stop.
The term med rep is like “chef.” There’s a guy at any Denny’s that calls himself Chef and then there is the Chef’s at the French Laundry. The Denny’s guy has never heard of a truffle or likely antibiotics :) (any present Denny’s chefs excluded). The reps I’m referencing are highly trained people that often have degrees in biology. They know what antibiotics are."training" is very different from "sales rep needs to be in the OR" and you know it
You are right, and I acknowledged as much. Still, someone needs to be in the OR as much as possible with these doctors because in doing so, the reps gather best practices and share them. This sort of consortium of ideas on how to use a specific product wouldn’t occur otherwise. It requires boots on the ground.
You're missing the big picture - medical device companies are sending out sales reps instead of instructors and you're insisting that if the reps weren't there there'd be no instruction! Imagine if any other industry operated like this. You can't fire the gun unless Colt has a sales rep sitting over the soldier's shoulder. You can't operate the bulldozer unless Caterpillar has a sales rep standing on the sideboard. You can't run the software unless Microsoft has a guy next to you saying "looks like you're trying to make a spreadsheet, would you like help with that?" And great. You've been hanging out with the Michael Jordan of surgical reps. That doesn't change the fact that the guys I interacted with are three-martini-lunch pharma bros with a business degree from Bumblefuck State whose principle business skill is getting a good table at Spago. And I, the 23-year-old kid working on his undergrad mechanical engineering degree, got to give the rundown to the guys who called doctors "bad carpenters" because everyone else in engineering was instructed not to talk to them. Sure. The term is like "chef." It's an unprotected term that anyone with any level of education can use. That means that yes, some b-school dropout wearing Hugo Boss is off showing a thoracic surgeon how to implant a fixation helix in an atrium. And you know what? The surgeon has done it before. Fixation helices are not new technology. But this one has a 90/10 cut instead of a 85/15! So obviously he needs to be there to show the guy exactly how it works or something bad will happen. And when something bad happens everybody wants to make sure that their Is are dotted and their Ts are crossed because the last person left holding the bag when the depositions stop gets to pay the class-action lawsuit. I tell you what: you require "medreps" to have a doctorate in medicine, you require them to register like lobbyists and you require them to be able to educate any surgeon in one (1) training and I'll agree with you - they have every reason to be in the theater. Until then? no. They're business majors. Their ability to convince a person to go Guidant over Medtronic does not qualify them to stand over a surgeon's shoulder, no matter how many times they've been through the deck.