Dear OTW Reader:
Big theme this week…U.S. losing talent and innovation?
A concerned spine surgeon tells OTW, “We are losing our edge to foreign countries.
The Chinese in particular have a tremendous knowledge base and a great thirst for more education. It used to be that Chinese surgeons came here to learn, but in the next ten years we’ll be going over there to learn from them. They are a hard driving group…the type of surgeons I used to see here.”
FDA “moving” companies to Europe?
A reimbursement consultant tells OTW, “Startups are not going public anymore because of all the reimbursement and regulatory hurdles. One company I worked with was never was able get FDA approval to begin an IDE; they starting booming in Europe and have abandoned any thoughts of the U.S. market. My clients are leaving the country and that is a sad statement for the future of American innovation. Soon we will have to hop on a plane to access new technology.”
Pity for American orthopedists?
OTW hears from an engineer: “Korea, Japan, and China have got some sexy innovation going on—they are developing their own implants and designs, and are expanding on fusion devices. As for our friends just on the other side of the pond, a European surgeon recently said to me, ‘You guys are in the beginning of motion preservation implants. I feel sorry for you because by the time you get them cleared we’ve already figured out that they’re obsolete.’”
And on a somewhat less ominous note…
Christopher Bono, M.D., chief of spine at Brigham and Women’s Hospital, is the Deputy Editor of the Spine Journal. He tells OTW, “Medtronic’s decision to give Yale funding to examine its data is a step in the right direction.
What remains to be seen is how the conclusions of that investigation are going to match up with those from the Spine Journal. I would guess that this process is going to take approximately eight months to complete. Overall, I truly feel bad for all parties involved. It’s not good for patients if there was an increased risk of complications, and I know it must be upsetting for the researchers who thought they were in the right, and who are getting attacked.”
Too many trauma surgeons?
Jeffrey Anglen, M.D., Professor and Chairman of Orthopaedics at the University of Indiana University School of Medicine tells OTW, “There are so many people going into trauma now that there are not enough high level trauma cases for young surgeons to get good at it. Many believe that, due to several factors, they are coming out of fellowships less well trained and independent than in the past…coming into their first job not ready for prime time. Anecdotally, some of these surgeons have to start in a mentorship situation where they scrub in with the senior partner for a period of time, rather than being independent from day one. Also, in the past, high energy trauma patients were routinely transferred to level one centers, where experience could be accumulated and skills sharpened. Now, many believe they are staying in level two and three centers where young trauma surgeons have been hired, and trauma fellows at level one centers are doing fewer cases, as few as a half dozen or less pelvic fractures during their year…of course this affects their learning experience.”
Circle the wagons, says a sports medicine specialist…it’s Frontier Days.
This private practitioner tells OTW, “More than 50% of new surgeons are joining hospital systems now. Doctors are teased by the good economics of the first few years, but then realize how much they are beholden to the institution. And things are so uncertain with regard to hospital models and the accountable care organizations (ACOs) that are being tried out…three of the hospitals doing these on a trial basis actually pulled out because the model didn’t work. I do not see ACOs succeeding; good luck getting all the hospitals and private practices to agree on common goals. People in this country are still very independent, and have a frontier mentality. We are not Europeans, and are not accustomed to monarchies and dictatorships.”
An orthopedist dedicated to data collection tells OTW, “One of the problems with ACOs is that orthopedic surgeons themselves are bad at documenting results.
Medicare began making us do it then some of my orthopedist colleagues complained about how it was being done. The fact is that we dropped the ball; doctors are so fragmented that unless they are part of a hospital they are not going to keep data. Going forward hospitals will be paid by insurance companies…instead of orthopedists billing the insurance companies, the insurers will pay the hospitals then let the hospitals hire the doctors getting the best results for the least amount of money. But what do the hospitals use for outcomes? We’re not even sure of that.”
An industry watcher tells OTW, “Spine is overloaded…figuratively and literally. The field is beset by ankle biters;
in some cases it is Korean imports that are taking away market share from existing manufacturers. These offshore players are teaming up with local distributors who can negotiate better deals. Spine may be imploding because it is so diversified. The question is whether it makes any difference as far as patient outcomes. In 1994 the spine industry in the U.S. was $225 million (U.S. sales of spine devices sold to hospitals), by 2009 it was $7 billion, a 31-fold increase. In 1994, in the U.S., there were about 260, 000 fusions; in 2009 there were about 445, 000 fusions, a 1.7-fold increase. My feeling is that we’re trying to stuff more and more gizmos between those poor vertebrae.”
Elbowing out hips and knees…an orthopedic surgeon tells OTW, “Arthrex, which recently purchased Tardo Medical, is now going to expand into hip and knee replacement.
This has some of the larger companies concerned because Arthrex has a strong distribution network and a substantial network of sales reps with close ties to a plethora of doctors. The average community doctor may have a longstanding relationship with an Arthrex rep, who will now be showing up with a host of total joint products. The ‘Big Five’ hip and knee manufacturers are sweating.”
Peter J. Millett, M.D., M.Sc., Director of Shoulder Surgery at the Steadman Clinic, in Vail, Colorado tells OTW, “I am concerned about how cost containment will affect the process of innovation.
We saw big changes in pharma with the introduction of generic drugs—the same thing is going to happen with orthopedics. Products are becoming more commoditized and this could lead to less innovation. At this point, it is becoming harder to make improvements in procedures and devices as the orthopedic community has figured out what works well in so many cases. Thus, certain procedures and devices may be targeted for cost cutting. Physicians need to be involved—accountable care organizations and generic medical device manufacturers are two market-driven responses. Institutions such as ours—which are known for innovation—must be engaged in the process or we, as orthopedic surgeons and physicians, will lose our autonomy in decision-making.”
“We are at socialized medicine, ” says a worried spine surgeon.
He tells OTW, “Insurance companies are denying surgeries left, right, and center—and for NO reason. They are finding some excuse or another, i.e., ‘Things weren’t documented exactly right, ’ or ‘The request was not filed properly.’ In the end, only 30% of my patients who need surgery are approved. What a great way for the insurers to save money. And the patients, well, they are not being treated. This is no different than what happens in socialized medicine.”
MI surgery—challenging learning curve, says Bill Horton, M.D., Professor Emeritus of Orthopaedic Surgery at Emory University.
He tells OTW, “While certain minimally invasive (MI) surgeries may be less morbid for patients, the fact is that there is a very significant learning curve involved. And the outcomes of MI techniques are greatly affected by where the doctor is on that learning curve. We need to tease that out, and figure out what other measures can shorten the learning curve. How can we best disseminate these techniques while protecting patients? Ideally, we would engage in the robust development of meaningful simulation environments and virtual proctoring. Everybody knows this but we’re not doing as much about it as we might…in some ways, we’re still training surgeons like we did 50 years ago.”
“Insurance companies are killing our profession, ” says Mark Reiley, M.D., the inventor of kyphoplasty.
He tells OTW, “Though insurance companies always say they are trying to keep medical costs down, in fact, rates for patients keep rising and medical pay keeps falling.” ‘Find any article, anywhere, doesn’t matter if it’s in the Journal of Bulgarian Nursing, find some paper that reflects negatively on this surgical procedure the docs want to do, so we can deny it.’ Dr. Reiley says, “The above is an actual quote from an insurance employee, who is now quitting because after five years of dealing with people completely bereft of ethics, he decided he ‘couldn’t swim in the same sewer as these insurance companies.’ “Our biggest problem as physicians is not the competition down the street, it’s how to get out from under the insurance companies. There must be someone in the medical field with the leadership skills, and no personal ax to grind, that can pull the docs together to solve this issue. After all, if it weren’t for doctors the insurance companies would not exist.”
