Published 9/1/2007
Annie Hayashi

What is the Orthopaedic Device Forum?

AAOS-sponsored organization made major breakthroughs in regulatory processes

In 1995, the relationship between orthopaedic societies and the U.S. Food and Drug Administration (FDA) was strained due to problems emanating from lengthy regulatory processes. The FDA was unable to meet its own performance levels for product reviews. By the time pro-ducts reached the U.S. market, approximately half of them were obsolete—and millions of taxpayer dollars had been wasted.

Although Congress subsequently ordered a reorganization and modernization of the agency with the 1997 passage of the Food and Drug Administration Modernization Act, at the time, physicians, industry, and the regulators themselves felt frustrated and dismayed.

Following a symposium on technology transfer cosponsored by the AAOS and the American Orthopaedic Association (AOA) in May 1995, Academy president Bernard F. Morrey, MD, and Harlan C. Amstutz, MD, president of the AOA, proposed an innovative concept. Could orthopaedic surgeons, device manufacturers, and government regulators work together to find mutually agreeable solutions to problematic regulatory and legislative mandates and issues?

Thus was born the Orthopaedic Device Forum (the Forum), an opportunity for regularly scheduled interactions among representatives of the scientific and clinical orthopaedic community, the FDA and other governmental agencies, and representatives of industry related to musculoskeletal health and diseases. These interactions were consistent with the intent of federal law.

Taking the first important steps
“We were representing an orthopaedic community of about 20,000 members,” says Dr. Morrey. “It was appropriate to be involved in an initiative that would streamline, facilitate, enhance, and improve regulatory processes to bring products into the hands of orthopaedic surgeons. The idea was to communicate about those issues that could be resolved and that would facilitate the approval of those devices and implants that had an opportunity to improve patient care.”

Dr. Morrey still remembers the critical nature of those first discussions. “After that meeting, we had a document that outlined how we were going to go forward. It was really groundbreaking. I remember sitting in a side room hammering out this document because I didn’t want anyone leaving unless we had something tangible. So we developed a document that would serve as the basis for everything that has happened since then—an outline for how the Forum would operate and how the FDA would interact with industry and organized orthopaedics in that setting.”

The mission of the Orthopaedic Device Forum is to “foster an environment of open communication among the scientific community, government, and related industry on orthopaedic issues of mutual interest.”

Dr. Morrey believes that the Forum has as much value today as when it was first started. “I think it has been of tremendous value in terms of a neutral forum where people can talk and visit and share ideas. For example, when the issue of biologics came up, the FDA did not know how to assess it or how it should be organized. The FDA used the Forum for input to help them understand how biologics should be assessed in a regulatory setting.”

The Forum also drafts guidance documents that provide the FDA with a streamlined template for device reviews. Guidance documents have been helpful in getting products to the market more expeditiously, according to the FDA white paper, “Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products” (www.fda.gov/initiatives.html).

Broad representation from disparate organizations
AAOS fellow Michael J. Yaszemski, MD, PhD, has served as chair/chair-elect since 2004. His predecessor, Bernard N. Stulberg, MD, served as chair for a decade. The complexities of the regulatory environment and the lengthy learning curve require leaders who are willing to commit years—up to a decade or more—of their time. Other AAOS members who serve on the Orthopaedic Device Forum are Scott D. Boden, MD; Richard D. Coutts, MD; A. Seth Greenwald, D Phil (Oxon); John S. Kirkpatrick, MD; E. Anthony Rankin, MD; and Joseph D. Zuckerman, MD.

The Forum now boasts broad representation among seemingly disparate organizations. Liaisons include representatives from the AOA, Orthopaedic Research Society, American Society for Testing and Materials (ASTM), Orthopaedic Surgical Manufacturers Association, FDA, National Institutes of Health (NIH) and the Centers for Medicare and Medicaid Services (CMS). The FDA’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are also represented. The NIH has representatives from the National Institute of Biomedical Imaging and Bioengineering and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

The Forum’s mission: Education and guidance
According to Dr. Yaszemski, the current priorities of the Forum include “communication among the various organizational entities that participate in bringing novel, safe, and effective devices to orthopaedic patients and education on the nature of orthopaedic devices and biologics from both safety and performance perspectives.” He finds that the Forum provides opportunities for important formal and informal communication that would not otherwise occur.

Dr. Yaszemski believes that the Forum plays two vital functions in orthopaedics: “To provide education and to develop ASTM standards and guidance documents for the FDA.” As a result of discussions held at the Forum, members found that a guidance document for “novel hip systems” clinical trials was necessary. He cites this as a “successful progression from working with our colleagues in the different organizations to identifying issues that will make safety and effectiveness evaluations smoother.” He acknowledges that the regulatory process is still lengthy.

Because the Forum is supported by AAOS member dues, Dr. Yaszemski wants fellows to know that the Forum has a number of projects in the pipeline, including a draft guidance for cartilage repair and another for preclinical and clinical trial designs for artificial spinal disks. As these ideas are being developed into guidance documents, a parallel process is also ongoing to formulate ASTM standards. The Academy obtains input into all facets of these guidance documents from various stakeholders.

Forum members, particularly those from the AAOS, provide educational seminars for the FDA staff that do not have the opportunity to attend the AAOS annual meetings. “We have had three of these educational seminars during the past three years and we are organizing our fourth one now,” explains Dr. Yaszemski. “The FDA has an educational budget that allows outside entities to provide a seminar to their staff. It is a good use of our time and resources to provide educational venues to highlight clinical issues with medical devices and biologics.”

A seminar on hip systems, taught by some of the most respected hip surgeons and researchers, was held at the FDA’s device center. Another distinguished group presented a class on spinal instrumentation. “These are the real functions of the Forum—to provide clinical expertise to the people who make decisions and to develop ASTM standards and guidance documents for the FDA,” says Dr. Yaszemski.

The table is open
Although there are eight AAOS members on the Orthopaedic Device Forum, Dr. Yaszemski would like to invite the participation of the entire Academy membership. If you have a suggestion, question, idea, or would like the Forum to address a particular concern you have, please contact the Board of Specialty Societies at www4.aaos.org/specialty.cfm.

If you are a member or representative of an allied Forum association or organization, please contact the organization directly.

For more information on the Orthopaedic Device Forum, visit its Web site, www.orthopaedicdeviceforum.org.

Annie Hayashi is the senior science writer for AAOS Now. She can be reached at hayashi@aaos.org.