Todd Albert, MD, Spine Surgeon and President, Rothman Institute (Philadelphia). The short answer is there will be and there must be because this relationship is really important for innovation. We must figure out a way for surgeons to be involved and work in a compliant way with device companies. We acknowledge there is going to be a conflict of interest sometimes, but there's a difference between working with companies on innovation and being cheerleaders for a particular company. Many surgeons are developing devices that are a significant contribution and they hold patents on devices as their intellectual property.
Tom Hackett, MD, Sports Medicine Surgeon, The Steadman Clinic (Vail, Colo.). Absolutely, yes. I think the relationships are very important in terms of the development of new devices or improvements on old devices. I think those relationships, if they are managed properly, can be very fruitful, especially for patients. These relationships can also be beneficial for the surgeons and the device companies during product development. Many companies fund research and foster surgeon education. All of these relationships can be managed ethically by following the American Academy of Orthopaedic Surgeons standards of professionalism. If surgeons follow those standards and adhere to the concept of full disclosure, there shouldn't be a problem.
Eric Muehlbauer, Executive Director, North American Spine Society. Absolutely! Innovation cannot take place in a vacuum. Through thoughtful and ethical collaboration, medical professionals and device companies can continue to improve patient care and advance medical science, including the development of cutting-edge devices in spine care.
NASS believes so strongly in the value of this type of collaboration that it has created one of the most stringent mandatory codes of conduct for itself, its members and outside companies conducting business with NASS. With clear, ethical guidelines before them, physicians can continue to share their expertise as inventors, scientific advisors and consultants to industry and provide patients with the very best spine care.
Bill Kolter, Corporate Vice-President of Government Affairs, Public Affairs and Corporate Communication, Biomet. It's going to remain necessary for orthopedic manufacturers to continue to have working relationships with orthopedic surgeons because we can't do our jobs without their input. There are several key areas where the involvement of orthopedic surgeons is necessary in order to address unmet clinical needs. Orthopedic surgeons provide essential input into the development of new products.
Before the devices can be made available to orthopedic surgeons for use with their patients, we need their input on how to design products that perform as intended in their hands. We also need their help to evaluate that performance. The population of clinical studies is also important. The Food and Drug Administration often requires clinical studies as part of submissions for clearance or approval to market new products. We need orthopedic surgeons who can conduct these studies and continue with post-market surveillance of those products.
Educating surgeons on the safe and effective use of the products is another critical area of interaction with surgeons. We frequently conduct cadaveric and other training on our products to teach surgeons about the safe and effective use of our products. In order to conduct these trainings, we need orthopedic surgeons to help lead these educational sessions. That's a critical part of our mission. We can't do our job without that kind of assistance and collaboration.
Bruce Darden, MD, Spine Surgeon at OrthoCarolina, Charlotte, N.C. I definitely think there is a place for orthopedic and spine surgeons to have a relationship with device companies in the future. There are a number of people in our group who work with companies and provide consultation. I think it's necessary to have physicians working with companies to design products because when we've had instruments designed by just engineers without a medical background, they don't always work well for physicians.
Where it becomes muddy is that some surgeons have consulting agreements where the guidelines aren't specific as to what they are doing with the company or whether they are adding value to the product. I think some of those relationships will die pretty quickly. At our practice, the basic premise that we use when we negotiate a consulting agreement is based on a numeric amount of what we generate — our value for one day of work. We document everything we are doing and we basically work on an hourly rate based on the number of hours we are working with the company, as opposed to some nebulous number. Everything is clean with that agreement and it's pretty clear what we are doing with the consulting firm. These are the types of relationships that will stick around in the future.
Bal Raj, MD, Orthopedic Surgeon, Beverly Hills (Calif.) Orthopedic Institute. Spine and orthopedic surgeons used to have a much closer relationship with device companies, but because of the potential bias these relationships have changed. There have been several issues in regards to these ongoing relationships, including surgeons who have benefitted from using the implants of companies they have a relationship with. We've seen a lot of these relationships dissipate and it's to protect patients.
I think surgeons and device companies will be able to have legitimate relationships in the future and we will get rid of the illegitimate relationships. Even when the relationship is legitimate, it is the surgeon's responsibility to disclose them publicly. The recent scrutiny on these relationships is great in the sense that it is protecting people. It's cleaning up the whole scenario — there are only a few bad seeds who have led to this problem. The surgeons in legitimate relationships with companies don't have anything to worry about.
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Will There Be a Place for Orthopedic and Spine Surgeon Relationships With Device Companies in the Future? 6 ResponsesWritten by Laura Miller | July 22, 2011
Six orthopedic and spine surgeons and industry members discuss the current state of surgeon relationships with device companies and what might be in store for the future.
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