In an operating room, there's the surgeon, the anesthesiologist, a surgical tech and a scrub nurse. And in many procedures that involve an implanted medical device, there's often someone else standing quietly along the back wall — a sales representative working on commission for the maker of artificial joints or bone screws.
With the exponential growth of procedures like total hip and knee replacements, their presence is under new scrutiny.
Medical device reps are more often business majors than biology buffs, but they train on-the-job as if they might have to conduct surgery themselves. At an educational center in Colorado, future reps learn how to saw off a hip bone and replace it with an artificial hip.
The corporate training also frequently uses cadavers, helping them develop the steel stomach required for the unsettling sights and sounds of an orthopedic OR — like hammering a spike into a bone.
"Before we're allowed to sell our products to surgeons, we have to know the anatomy of the body, go through tests of why physicians use these types of products and how we can assist in surgery," says Chris Stewart, a former rep based in Nashville.
Stewart spent his sales career with Stryker, an industry behemoth that makes everything from surgical robots to artificial foot bones. Now, he helps manufacturers navigate relationships with hospitals at Ortho Sales Partners.
Reps are supposed to have explicit permission to observe surgeries. Big companies like Stryker have detailed policies about boundaries for their reps. But they don't have to be there. In fact, reps can't touch the patient or anything that's sterile.
Some use a laser pointer to guide surgical assistants who need help locating a little part or tool in the trays of parts and tools often delivered by the rep prior to the surgery. They want the procedure to run as smoothly as possible and turn a busy surgeon into a steady customer.
"Obviously, there's a patient on the table being operated on, so that's where the sense of urgency is," Stewart says. "You have to become an expert in understanding how to be efficient with helping everyone in the OR making sure your implants are being utilized correctly."
Keeping Up With New Devices
Stewart says it's become difficult for the hospital staff to keep pace with constant design changes for artificial joints or spinal rod systems, which are sold by many companies like Medtronic, DePuy Synthes, Zimmer Biomet or Smith & Nephew.
But the speed of innovation concerns some researchers, such as Adriane Fugh-Berman, a doctor who studies medical device sales at Georgetown University.
"What we need are skilled helpers in the operating room who are not making money off of the choices of the surgeons," she says.
Fugh-Berman has come to believe that reps should be banned from operating rooms. Her biggest concern is safety, and not the occasional violation of sterile protocol. As part of her research, she anonymously interviewed sales reps who said they're instructed to always push the latest, most expensive products, even when the old version is more proven.
"The newest device is not necessarily the best device," she says. "In fact, it may be the worst device."
Fugh-Berman is especially worried about the FDA's practice of granting fast-track approval to new designs that are fairly similar to existing products, a process known as 510(k), which was highlighted in a new Netflix documentary called "The Bleeding Edge."
The accelerated path to market has become the standard, and sometimes with disastrous outcomes, like an all-metal hip joint that seems to be disintegrating in dozens of patients. Even a joint replacement surgeon in Alaska was sold on the new technology and has since had to have his own hip replacement corrected.
And yet safety issues are not what has worn out the welcome for some reps. It's their potential cost to hospitals, which have a greater incentive now that insurance reimbursement formulas have changed. For example, Medicare has converted the way it pays for a joint replacement to a set amount, a so-called "bundled payment." Joint replacement is now one of the most common reasons for inpatient hospitalization for Medicare patients.
"They’re looking at costs and saying, 'I want to understand everything that drives cost in my OR,'" says Doug Jones, a former rep with DePuy who now works for Nashville-based HealthTrust. "I think they're becoming more aware that that rep is in there and saying, 'Is there a cost associated with it?'"
Brent Ford, a former rep who also works for HealthTrust, holds up a simple piece of hardware he once sold called a pedicle screw, often used in spine procedures. He says they cost anywhere from $50-$100 to manufacture but might cost a thousand dollars apiece to the hospital. And there could be several screws and rods used in a basic spine procedure, with the sales rep standing to make a 10- to 25-percent commission, according to HealthTrust's market research.
"They're starting to figure out what these reps make for a living," Ford says. "They feel like they're making too much money, and I think that's why they want them out."
Until recently, many hospital administrators have been unaware that salesmen work in operating rooms, according to HealthTrust. Some hospitals, including HCA's TriStar Centennial, have instituted new rules that ban selling in the OR and only allow reps to "support" a case.
But in many places, "up-selling" occurs in the room. Ford recalls seeing reps encouraging a surgeon preparing for a procedure to use a fancier device that hasn't been discounted for the hospital.
Some HealthTrust clients are piloting operating rooms without company-sponsored reps and buying equipment directly from smaller firms, which often have devices that are nearly identical to the brand names.
The problem is, getting rid of the rep has hidden costs too.
Joint replacements have become so commonplace that an experienced surgical team can nearly operate in silence. When the surgeon says "neck" and reaches out his hand, an assistant places the piece in his hand without a moment delay.
The tools and components are often in the right place because a device rep made sure of it. Logistics is a big part of the job — delivering trays of instruments in the pre-dawn hours to be sterilized by the hospital.
"It's the non-glorious side of being a rep," Ford says.
And it's a role that has essentially been filled by the manufacturers instead of hospitals in recent decades. And now surgeons may trust their reps more than anyone else in the room. They're often the first call when scheduling a case, to make sure the devices will be ready to go.
"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. "Because if that widget isn't there the next day when I'm doing a case and I need the widget, we're kind of at an impasse."
Many experienced joint replacement surgeons, like Christie, also have financial ties to manufacturers, collecting substantial royalties for helping design new implants. As of 2013, these payments are now disclosed publicly.
An industry trade group spokesman defends the close relationship as a way to improve their products and provide hands-on training to surgeons.
"Those are two areas where it's key to maintain a close, collaborative relationship, with the appropriate ethical limitations," says Terry Chang, associate general counsel for AdvaMed.
Filling A Personnel Gap
The overall result is that many clinicians are happy to have reps in the room.
"You say sales rep," says Marley Duff, an operating room manager at TriStar Centennial's joint replacement unit. "I look at them more being somebody that’s expertly trained in their field to provide support for the implants that they happen to sell."
Duff says reps can be especially helpful when a failing artificial joint needs to be removed and replaced. Often, a rep sees more so-called "revision" surgeries than a single surgeon ever will.
Hospitals are hesitant to remove reps, for fear of irritating surgeons, who could move their cases to another hospital. Those that are experimenting with going "repless" have done so quietly, and have had to hire additional staff to pick up the slack.
One of the first in the country to try, Loma Linda University Health, boasted in 2015 of reducing costs for total knee and hip replacements by more than 50 percent.
But, according to a hospital spokesperson, the medical center has since abandoned the effort.