Medical Device Daily Executive Editor

Russell Windsor, MD, has an interesting vantage point from which to view the changes occurring in the orthopedics sector, some of them driven by the landmark U.S. Department of Justice (DoJ) probe into relationships between physicians and companies developing products for that sector.

For one thing, he's an orthopedic surgeon at the Hospital for Special Surgery (New York), the busiest center for orthopedic implant procedures in the U.S.

For another, he until recently was a longtime contributor to the development process at first one, then another of the big players in the orthopedic products sector.

Windsor addressed a variety of questions last week during a "Fireside Chat" webcast sponsored by BMO Capital Markets (New York) and hosted by BMO's med-tech analyst, Joanne Wuensch.

Windsor, who specializes in total knee and hip replacements, touched on the new technologies that are making their way into the orthopedics marketplace, as well as policy issues that either already are or soon will be affecting both patients and surgeons.

He noted, for example, that many physicians who were displaced from previous development contracts as a result of the DoJ settlement efforts of companies with which they previously were associated now are "free agents" looking for opportunities to work on development teams.

Windsor himself is among that group, having been terminated from such a contract by industry leader Zimmer (Warsaw, Indiana) in December after being part of that company's development efforts since 1999.

He also said that pricing is more of an issue for hospitals than ever before, with such institutions negotiating hard with suppliers to reduce the cost of implants.

The termination by Zimmer was part of that company's response to the DoJ investigation and settlement, Windsor said. He had been part of development efforts that included that company's much-ballyhooed "Gender Knee."

But the termination has not precluded his continued use of Zimmer implants at least for the time being. "I still use Zimmer knees and hips, save for when I use a ceramic-on-ceramic hip, when I go with Stryker [Mahwah, New Jersey]."

His rationale is simple: "I feel comfortable with the Zimmer systems [and] my team knows I have worked with them."

However, since he's also hoping to land a development contract with some other company, that could change.

So, asked Wuensch, "What does it take for a surgeon to start implanting other products?"

Noting that orthopedists are conservative in nature and "like to hang onto what is tried and true, where you know what the results are going to be," Windsor said switching to an entirely new set of implants from a different manufacturer is a hard thing to do.

But if it comes to that, he said, "It has to be a system that's very intuitive in terms of instruments."

Wuensch noted that "Zimmer has said it is losing docs" who use its systems.

"To be on a development team," Windsor said, "you pretty much need to implant [that company's] systems," which could be part of the "losing docs" equation.

The discussion turned to how the country's economic crisis may be causing a slowdown in so-called "elective" procedures, a description many would apply to hip and knee replacements.

"Just how elective are hip and knee replacements?" asked Wuensch.

"Well, the Medicare population is not waiting around," Windsor said. "They aren't affected by the economy." As for those covered by private insurance, well, "Others may wait if the economic situation warrants it, or they may choose to go in-network to do the procedure, rather than out-of-network" to a more prestigious center such as the Hospital for Special Surgery.

However, he added, "If you're having pain, you're going to want surgery."

Wuensch asked Windsor to characterize the knee and hip replacement market.

"Well, they're definitely transitioning younger," he said, adding that "because of the new materials and techniques available now, we have the ability to 'go younger' say five years or so younger."

But the same applies to the other end of the age spectrum as well. "I just operated on a 95-year-old a few weeks ago," he said.

Wuensch asked Windsor for his appraisal of this year's American Academy of Orthopaedic Surgeons (AAOS; Rosemont, Illinois) annual meeting, which took place in late-February in Las Vegas.

"The basic science was good," he said. "The new hip systems seem to be taking hold." He also was interested in new disposable instrument systems for knee replacement procedures, including those from Biomet (Warsaw, Indiana), saying, "They're very interesting. They may make those procedures easier."

Windsor said his impression of the company exhibits at AAOS was that "the tenor was very controlled, with a clear feeling of 'Less' in the technical exhibits."

Asked about advances in cartilage implants, he said: "For small defects, cartilage implants are getting close. That's going to develop [as a viable sector] over the next five to 10 years."

But as to whether such implants might eventually supplant either total or partial knee replacement, "It might be 20 to 25 years before it might replace the current standard of TKR," according to Windsor.

Responding to a question posed by Medical Device Daily as to the real impact of a much-touted trend toward minimally invasive surgical procedures, he said, "Everyone is now using smaller incisions, but patients aren't verbalizing about it as much."

The key point, Windsor said, is that "you still need to get the implant into the knee."

Wuensch asked about the push toward gender-specific knees, an effort spearheaded by Zimmer.

"It's still popular," Windsor said, "but people have to realize that it's just a different size implant." Zimmer, for example, just added five different, smaller femoral sizes to appeal to those who like the gender-size concept.

One of the problems with the marketing push on gender knees, he said, is that the product is priced "differently" i.e., higher.

"In the past, you could ask [the hospital] for a specific system and they would okay it." Today, Windsor said, such approvals are all but a thing of the past.

In fact, the degree to which hospitals are negotiating price cuts on everything orthopedic implants among them is one of the new facts of healthcare life, he said.

"I was part of the development of the Gender Knee from Zimmer," he said, "so I went to the hospital and said, 'Hey, I'd like to be able to implant this knee it's embarrassing to have been part of its development and not be able to implant it at my own hospital.'"

But, given that the list price of the Gender Knee was some $1,500 more than a comparable "non-gender-specific" system, "they [the hospital administration] said 'No way'," Windsor said. "It took a year of price negotiating [with Zimmer] to get it approved in our hospital."

He said hospitals are "pretty aggressive" in such negotiations. HSP, for instance, uses the fact that some 7,000 procedures are done there annually to try to drive prices down.

"This is going to be pervasive," Windsor said. "As much as I might want [a particular system], there has to be a cost benefit to it."

Asked by MDD about the future of robotics in the orthopedic operating room, he said that two of the 18 orthopedic surgeons at his hospital are working with robotics systems to evaluate their potential. "For more difficult deformities, it [robotics] will be more valuable," Windsor said.

The surgeon, however, still needs to "control the information given to the computer, otherwise he will have surgical error" in the outcome.

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