The Collaboration between the Medical Device Industry and Surgeons Continues to Drive Advancements in Patient Care

As medical technology continues to advance, the role of the medical device industry in supporting aspects of orthopaedic surgery, including patient care, research, and resident education, is expanding. There has been concern about the potential conflicts of interest and introduction of bias when industry becomes financially involved in these areas. Although orthopaedic surgeons and industry have shared goals—improving patient care—they differ somewhat in their priorities. Orthopaedic surgeons are expected to prioritize the well-being of patients; strive to provide the best treatments for patients; and, when indicated, use the appropriate medical devices and implants to execute that care.

Successful medical device companies also prioritize patient well-being and optimization of care; however, as businesses, they must generate profits to remain viable in the competitive market. Although the financial success of a medical device company can further support medical advances, it also can create an inherent conflict with medical professionals. Methods used by companies to encourage surgeons to use their products, including company dinners, payments for travel and lodging, and consulting fees, can be perceived as unethical tactics to “buy” the support of surgeons, which can directly conflict with their obligations to their patients.

Industry involvement in orthopaedic practice
Which implant company should a new surgeon right out of fellowship use for a particular surgery, such as a knee arthroplasty, cephalomedullary nailing, or spine fusion? Many companies generally carry similar products, so it is natural to use familiar instrumentation. Sometimes the choice is based on knowledge of the representative and the quality of the service they provide. Concerns arise when companies provide services that can be perceived as gifts in return for the use of their devices.

Offering to take surgeons and their teams to dinners or pay for travel and lodging for education on company products could potentially function as incentives to use that company’s devices. The payments can be substantial when surgeons are participating in the design of implants or receiving royalties. These payments and services have the potential to affect patient care if the royalties are the motivating factor for the surgeon to use the implant.

To mitigate these concerns, the Physician Payments Sunshine Act was enacted by Congress in 2010 to increase transparency in the relationship between physicians and the medical device industry. The Sunshine Act required reporting of company payments to surgeons for speaking fees, consulting fees, meals, travel expenses, and research funding. The disclosed information is publicly available on the Centers for Medicare & Medicaid Services (CMS) website, with the aim to reduce conflicts of interest and maintain the integrity of medical practices. A recent study found that 69 percent of all orthopaedic surgeons were listed on the CMS Open Payments database, with most payments coming from royalties. They also found that orthopaedic surgeons were more likely to receive money for travel and royalties than other specialties.

Industry support for research and education
The prevalence of industry-funded grants in orthopaedic-related research is increasing. There is significant variability in the size and distribution of industry payments among academic orthopaedic surgeons.

Buerba and colleagues observed that the h-index, a measure of academic productivity, showed a weak correlation with both the dollar amount and total number of industry research payments among non-academic orthopaedic surgeons. Only 9 percent of academic surgeons received industry research support, and 1 percent received National Institutes of Health support. Those receiving these payments demonstrated a notably higher mean h-index and more publications compared to those without such support. However, for non-research industry payments, the correlation between the h-index and payment metrics was weak. The authors suggested that industry bias may play a smaller role in orthopaedic literature than previously believed.

Industry payments can also influence residency training. Hogan and colleagues reported in JAMA Network Open that differences exist in industry payment reporting by medical specialty, program director behavior, and sponsoring institution. They found that residents in privately controlled sponsoring institutions were 3.5 times more likely to accept payments compared to those in federally controlled institutions. Orthopaedic surgery and urology demonstrated the highest risk of accepting payments.

Conflict-of-interest disclosures
Updated disclosure forms are required for membership in AAOS. Most medical institutions require these conflict-of-interest forms when a surgeon obtains hospital privileges. Surgeons are expected to disclose to patients their involvement in implant design or royalties if they are using that device on their patients.

In research, institutional review boards and journals require documentation of the source of funding. For publications and research talks, all disclosures must be reported. For presentations at major orthopaedic society meetings, the first slide must list the disclosures, including financial support and consultation agreements relevant to the talk.

A recent study cross-referenced author disclosure statements with corresponding author CMS data for three journals: Foot & Ankle International, Journal of Bone and Joint Surgery, and Journal of Arthroplasty from 2014 to 2016. A total of 3,465 authorships were analyzed, revealing that 7 percent had undisclosed conflicts of interest and 2 percent had inconclusive disclosure data due to missing information. Further analysis within this group indicated that 26 percent correctly disclosed potential conflicts, 21 percent disclosed when no payments were found, and 44 percent correctly reported no conflicts. Notably, 13 percent of articles had a first and/or last author with a discrepancy.

For resident and surgeon education, many orthopaedic device companies have partnered with surgical education groups such as the AAOS Orthopaedic Learning Center, AO North America, and the Arthroscopy Association of North America to provide equipment and implants for their hands-on instructional courses all over world. These are extremely important courses which provide hands-on instruction to young surgeons who want to practice procedures before implementing them into their practice. At these meetings, company brands are not mentioned in the lectures to avoid the appearance of advertising.

In conclusion, the expanding role of the medical device industry in orthopaedic surgery brings to light the delicate balance between advances in patient care and the potential for conflicts of interest. Although both orthopaedic surgeons and industry share the common goal of improving patient outcomes, their priorities may differ due to the inherent nature of business profitability. The implementation of regulations such as the Physician Payments Sunshine Act has been a crucial step in increasing transparency and reducing conflicts of interest. However, ongoing vigilance and adherence to disclosure protocols are essential to maintaining the integrity of orthopaedic practice, research, and education. By fostering transparency, promoting ethical conduct, and prioritizing patient well-being, the collaboration between orthopaedic surgeons and the medical device industry can continue to drive advancements in orthopaedic care while upholding professional integrity and trust.

Michael DeRogatis, MD, MS, is an orthopaedic surgery resident at St. Luke’s University Health Network in Bethlehem, Pennsylvania. He serves as a resident-at-large member on the Editorial Board for AAOS Now.

Margaret Higgins, MD, is an orthopaedic surgery resident at St. Luke’s University Health Network in Bethlehem, Pennsylvania.

Paul S. Issack, MD, PhD, FAAOS, FACS, is a clinical associate professor in the Department of Orthopaedic Surgery, Weill Cornell Medical College, and a trauma and adult reconstruction orthopaedic surgeon at New York–Presbyterian/Lower Manhattan Hospital. He is also a member of the AAOS Now Editorial Board.