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AAOS Now

Published 10/1/2019
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Bruce H. Ziran, MD, FACS, Douglas W. Lundy, MD, MBA, FACS, Eeric Truumees, MD

Point/Counterpoint: Effective Implant Development

Orthopaedic Surgeons Are Integral to Effective Implant Development

U.S. orthopaedic surgeons have been behind many of the advances the industry has seen in the past 50 years through involvement with the medical device industry. Such relationships have created progress that has made the United States a preeminent leader in orthopaedic care, as evidenced by the following contributions:

  • closed-section, statically locked, titanium nails
  • uncemented hips and knees with low-wear debris liners
  • spinal instrumentation
  • suture anchors
  • demineralized bone matrix and bone morphogenetic proteins

The list of improvements is even more extensive. However, times have changed. Currently, innovation in orthopaedics is crippled.

There are many reasons, but one has to do with the onerous scrutiny on the surgeon-industry relationship. The question is, “Why is such scrutiny placed on these relationships that help create products which benefit patients?” A recent healthcare article opined, “It’s the [money] stupid!” Or maybe it’s the political optics of finding scapegoats for systemic issues in health care.

Consider the three following business relationships:

  1. “Hey Joe, my company really needs your help. If you can help us get more market share, we will take care of you now and in the future.”
  2. “Hey Joe, my company has a really good product. If you use it in your work, we will pay you in the form of some type of incentive.”
  3. “Hey Joe, my company needs your help developing a better product. If you help us out, we will give you a small portion of the sales.”

How are the above scenarios different, and which seems least ethical? Scenario No. 1 is a typical politician/lobbyist relationship. Scenario No. 2 is what you might get from a contractor who suggests using “company X.” Scenario No. 3 is the typical surgeon/consultant who helps develop medical devices. However, there are other differences. In scenario No. 1, large amounts of taxpayer money are affected, and the impact of lobbyists’ influence is obvious.

In scenario No. 2, company X wines and dines the contractor, spending lots of money to court business. Thus, the consumer is unwittingly impacted by the choice.

In scenario No. 3, however, when surgery is performed, the surgeon does not benefit from his or her own use of the product. And there will still be an expense for the product used whether it be product X, Y, or Z.

So, what is the issue? The surgeons involved also provide feedback about the products they are helping to develop; thus, innovation occurs.

Unfortunately, with new regulations, there are strict limits on surgeon compensation for such endeavors, with limits on travel, pay, and what is considered fair market value for services. But the costs of devices and pharmaceuticals have not decreased since the inception of such restrictions. In fact, they have continued to rise. The previous scenarios are different, and although one could find scenario No. 1 objectionable, scenario No. 3 is not unreasonable.

In an effort to reduce costs (maybe due to a perverse payment system), surgeon-industry relationships have suffered, resulting in the United States losing its grip on innovation. The patients (the consumers) need the surgeons (the contractors) to help the medical device industry (the makers) keep the United States at the forefront of orthopaedic innovation.

As a world leader in so many other domains, the United States shouldn’t backslide into the recesses of inferior care, having our successes be known only to our veiled memories as “once, we were great.”

Bruce H. Ziran, MD, FACS, was an engineer before becoming a physician. He holds several patents and works with industry in speaking and design/development capacities. Industry relationships can be found on the AAOS disclosure website and include Citieffe, Synthes, Acumed, and CarboFix.

Bruce H. Ziran, MD, FACS
Douglas W. Lundy, MD, MBA, FACS

Orthopaedic Surgeons Should Be Wary of Industry Involvement

It’s all about trust. We do it every day: We meet complete strangers, and within a matter of minutes, they consent to pay us (usually) to watch another physician place them into a state of complete unconsciousness so that we can cut into their bodies and permanently alter their bones and/or joints. They rarely check our credentials or look into our backgrounds. They just say “okay” and write a check to cover their deductibles and copays. As orthopaedic surgeons, we bear an amazing and massive responsibility to “do the right thing.” The blind trust our patients often place in us is beyond my understanding.

The trust between a patient and a surgeon is perhaps one of the most intimate relationships in the human experience. It is also one of the most imbalanced in terms of power. Patients essentially give up any control they have to nearly total strangers in the belief that we are worthy of that power. As a trauma surgeon, I understand that my broken patients are often in severe pain and will consent to nearly anything that could improve their lot in life. Nonetheless, it takes incredible arrogance to say that we always deserve this massive trust.

Why would we do anything to violate such a sacred bond? We are usually paid well for our labors, and we deserve to make an honest living. I am copresident of a very large orthopaedic group, and we have developed ancillary services to improve the care of our patients. We know that our imaging, surgery centers, and rehabilitation far exceed anything in our market in terms of quality, efficiency, and convenience. It is true that we receive a return on the investments we have made into those services, we fully disclose this fact to patients, and they are better off that we own the products.

With all of this in mind, we should be incredibly careful about perceptions that we are profiting from partnering too closely with industry. Like all successful companies, our implant manufacturers have one ultimate goal: to increase shareholder value. There is nothing wrong with that, but their perspective may often be diametrically opposed to ours. Our professional organizations insist that we disclose relationships with industry, specifically because they know that such relationships affect our motives when we discuss related issues.

Although it is true that no one better understands the nuances of orthopaedic implants and instrumentation than us, practicing orthopaedic surgeons who are financially involved with industry run the risk of damaging their neutrality and the perception that the patient is the ultimate concern.

Douglas W. Lundy, MD, MBA, FACS, is copresident of Resurgens Orthopaedics in Atlanta and has served as a consultant to a major orthopaedic manufacturer in the past. He currently has no relationship with industry.

References

  1. Selweski C: Lawmakers Enjoy Secret Junkets Financed by Lobbyists. Available at: https://www.politicscentral.org/lawmakers-enjoy-secret-junkets-financed-by-lobbyists/. Accessed September 3, 2019.
  2. Bayer BE: The Contractor Agreement: 7 Steps to an Iron-Clad Contract. Available at: https://www.houselogic.com/remodel/budgeting-contracting/contractor-agreements/. Accessed September 3, 2019.

How do you manage conflicts of interest in care?

Eeric Truumees, MD

As U.S. venture capitalist John Doerr said, “No conflict, no interest.” Here, we have an excellent debate between Bruce H. Ziran, MD, FACS, and Douglas W. Lundy, MD, MBA, FACS, on the involvement of orthopaedic surgeons in the implant industry. Both make great points. Most classes on entrepreneurism and innovation begin with the premise: “Try to solve a real problem.” Who knows the technical limitations of current orthopaedic techniques and implants better than the surgeons using them? On the other hand, as Dr. Lundy notes, patients’ trust in our recommendations is critical to our ability to provide care. Keep in mind:

  • Physicians are human.
  • As humans, physicians are far more vulnerable to conflicts and bias than we will admit.
  • Conflicts cannot be entirely eliminated but must be managed.

At AAOS Now, we are interested in our readers’ thoughts and suggestions for managing conflicts of interest and industry relationships. For example, although a designer knows the technology best, how much can that opinion be trusted in appropriate use criteria? Send your thoughts to AAOS Now Publisher Dennis Coyle at coyle@aaos.org.

Eeric Truumees, MD, is the chair of the AAOS Now Editorial Board, editor-in-chief of AAOS Now, and an orthopaedic spine surgeon in Austin, Texas, where he is also professor of orthopaedics at the Dell Medical School, University of Texas.