This is the final article in a three-part series examining orthopedic and spine surgeons' relationships with device companies and what will happen going forward. For additional coverage of the topic, read the first article answering the question "Will There be a Place for Orthopedic and Spine Surgeons to Have a Relationship With Device Companies in the Future?" or the second question "What Will Appropriate Surgeon-Device Company Relationships Look Like in the Future?"
Here are five physician and industry expert responses to the question "How has the recent scrutiny on surgeon-device company relationships impacted orthopedics?"
Bruce Darden, MD, Spine Surgeon at OrthoCarolina, Charlotte, N.C. I think this recent scrutiny has affected a lot of physicians' perceptions of products. If they've heard of a conflict, they look at that product with a jaundiced eye. It isn't good for the company or the physicians involved. The scrutiny also has the potential to affect the confidence that the patients and the public has with physicians. I worry about how these potential conflicts are going to affect our personal relationships with patients. Right now, the relationships don't come up with day-to-day patient visits, but I think they have the potential to.
Todd Albert, MD, Spine Surgeon and President, Rothman Institute (Philadelphia). The government pendulum swings back and forth and now it's swung to one side and there's an assumption that if a surgeon is working with a company, he or she isn't compliant. There are many examples of surgeons working with products, doing un-biased research where they have had bad outcomes and they bring those complications to light. When device companies are aware of those complications, they can improve the device.
Right now, the light's really shining on certain surgeons who developed products and got royalties and I'm not sure the light is appropriately shining on them. There is tussling and it's not good for surgeons or patients. I'm hoping the noise will die down and surgeons will be able to continue treating patients and advancing the field. If not, their contributions will be overshadowed by the "conflict of interest" label. There are so many people who have made great contributions. In the long run, this scrutiny could stifle innovation.
A good part of healthcare reform is the push toward cost-effectiveness. What that might drive us to do is develop techniques that are less invasive, or as invasive, but to have procedures that will provide better outcomes because they are more durable. If there is a durable outcome, overtime it becomes cost-effective because compared to the alternative, it is less expensive. If you have non-operative techniques continuing over time, you add cost to that treatment. This could lead to innovative way to treat patients in a cost-effective manner.
Tom Hackett, MD, Sports Medicine Surgeon, The Steadman Clinic (Vail, Colo.). There's no doubt that the heightened scrutiny has come down in the past several years and forced us to create new and adopt our standards of professionalism. The scrutiny is as much on the industry as it is on us surgeons. The companies have become weary of their relationships with physicians and are much more apt to follow the standards for disclosure that the department of justice is now enforcing. I think the public scrutiny will tighten up our standards even more.
Eric Muehlbauer, Executive Director, North American Spine Society. Compared to other factors, including 510(k) FDA clearance challenges, healthcare reform and a general decrease in venture capital, the scrutiny these collaborations are under is a minor obstacle to innovation. As long as there is a balance of human curiosity, patient need and a reasonable financial incentive, innovation will continue to exist and thrive.
Bill Kolter, Corporate Vice-President of Government Affairs, Public Affairs and Corporate Communication, Biomet. It's legal, compliant and necessary for orthopedic manufacturers to compensate surgeons at fair market value for legitimate services provided. Biomet prides itself on conducting itself within these relationships in an ethical and compliant fashion. We will continue to work with orthopedic surgeons to advance our product line, clinical evaluation and education programs in a way that upholds high ethical standards.
Related Articles on Orthopedic Devices:
Changes and Opportunities in the Sports Medicine Device Market: Q&A With Dave Springer of Cayenne Medical
The Big Companies Keep Growing Bigger: 15 Recent Orthopedic and Spine Device Company Acquisitions
Introducing New Orthopedic Products: 5 Tactics for Today's Market
Here are five physician and industry expert responses to the question "How has the recent scrutiny on surgeon-device company relationships impacted orthopedics?"
Bruce Darden, MD, Spine Surgeon at OrthoCarolina, Charlotte, N.C. I think this recent scrutiny has affected a lot of physicians' perceptions of products. If they've heard of a conflict, they look at that product with a jaundiced eye. It isn't good for the company or the physicians involved. The scrutiny also has the potential to affect the confidence that the patients and the public has with physicians. I worry about how these potential conflicts are going to affect our personal relationships with patients. Right now, the relationships don't come up with day-to-day patient visits, but I think they have the potential to.
Todd Albert, MD, Spine Surgeon and President, Rothman Institute (Philadelphia). The government pendulum swings back and forth and now it's swung to one side and there's an assumption that if a surgeon is working with a company, he or she isn't compliant. There are many examples of surgeons working with products, doing un-biased research where they have had bad outcomes and they bring those complications to light. When device companies are aware of those complications, they can improve the device.
Right now, the light's really shining on certain surgeons who developed products and got royalties and I'm not sure the light is appropriately shining on them. There is tussling and it's not good for surgeons or patients. I'm hoping the noise will die down and surgeons will be able to continue treating patients and advancing the field. If not, their contributions will be overshadowed by the "conflict of interest" label. There are so many people who have made great contributions. In the long run, this scrutiny could stifle innovation.
A good part of healthcare reform is the push toward cost-effectiveness. What that might drive us to do is develop techniques that are less invasive, or as invasive, but to have procedures that will provide better outcomes because they are more durable. If there is a durable outcome, overtime it becomes cost-effective because compared to the alternative, it is less expensive. If you have non-operative techniques continuing over time, you add cost to that treatment. This could lead to innovative way to treat patients in a cost-effective manner.
Tom Hackett, MD, Sports Medicine Surgeon, The Steadman Clinic (Vail, Colo.). There's no doubt that the heightened scrutiny has come down in the past several years and forced us to create new and adopt our standards of professionalism. The scrutiny is as much on the industry as it is on us surgeons. The companies have become weary of their relationships with physicians and are much more apt to follow the standards for disclosure that the department of justice is now enforcing. I think the public scrutiny will tighten up our standards even more.
Eric Muehlbauer, Executive Director, North American Spine Society. Compared to other factors, including 510(k) FDA clearance challenges, healthcare reform and a general decrease in venture capital, the scrutiny these collaborations are under is a minor obstacle to innovation. As long as there is a balance of human curiosity, patient need and a reasonable financial incentive, innovation will continue to exist and thrive.
Bill Kolter, Corporate Vice-President of Government Affairs, Public Affairs and Corporate Communication, Biomet. It's legal, compliant and necessary for orthopedic manufacturers to compensate surgeons at fair market value for legitimate services provided. Biomet prides itself on conducting itself within these relationships in an ethical and compliant fashion. We will continue to work with orthopedic surgeons to advance our product line, clinical evaluation and education programs in a way that upholds high ethical standards.
Related Articles on Orthopedic Devices:
Changes and Opportunities in the Sports Medicine Device Market: Q&A With Dave Springer of Cayenne Medical
The Big Companies Keep Growing Bigger: 15 Recent Orthopedic and Spine Device Company Acquisitions
Introducing New Orthopedic Products: 5 Tactics for Today's Market