Most AAOS fellows may not be aware of the regulatory pathways and the entangled web of guidelines, standards, and bureaucracy that the devices we use every day to treat patients must traverse as they pass from the drawing board and into our hands.
The process often starts with a novel idea or a basic science innovation that is tested in the laboratory and then translated from the bench to the bedside. Along the way are many stakeholders who want to ensure that the device or its application is safe and effective for patients.
Often, getting the process to flow efficiently is difficult. Assembling the many stakeholders around one table would help smooth out the process. This is the motivation and purpose of the Orthopaedic Device Forum. Its mission is to “foster an environment of open communication among the scientific community, government, and related industry on orthopaedic issues of mutual interest.”
The Forum was established after a symposium on technology transfer cosponsored by the AAOS and the American Orthopaedic Association (AOA) in May 1995. Bernard F. Morrey, MD, AAOS president, and Harlan C. Amstutz, MD, AOA president, proposed this innovative and, at the time, unique concept of orthopaedic surgeons, device manufacturers, and government regulators working together to find mutually agreeable solutions to problematic regulatory and legislative mandates and issues.
Today, other medical specialties have adopted similar forums with the same goals for their own fields of medicine.
The Orthopaedic Device Forum meets twice a year (spring and fall) in Washington, D.C. The forum includes representatives from the AAOS, ASTM International, the Centers for Medicare and Medicaid Services, the U.S. Food and Drug Administration (FDA), the National Institutes for Health, the Orthopaedic Research Society, and the Orthopaedic Surgical Manufacturers Association. AAOS representatives include an elected forum chair, and the chairs of the Biomedical Engineering and Biologic Implants Committees.
One of the areas that the Device Forum facilitates is the creation of guidance documents that provide the FDA with a streamlined template for device reviews. Guidance documents have been helpful in getting products to the market in a more streamlined, efficient manner. A guidance document enables manufacturers applying for device approval to follow set guidelines for testing and support of their application to the FDA. This results in fewer returned applications and a shorter timeline to the marketplace.
Forum members, working within the F04 Committee of ASTM International and its subcommittees, rapidly developed and received approval of a standard for the assessment of the ultra high molecular weight polyethylene used in orthopaedic and spinal devices. This standard was formally recognized by the FDA in January 2010 and the template drives the creation of future guidance documents.
The Forum also produces educational seminars to assist the FDA staff and AAOS members on emerging orthopaedic issues. It also develops scientific exhibits on FDA regulatory matters; Forum representatives develop and pre-sent symposia and workshops for ASTM International and other organizations, such as the Society for Biomaterials.
The leadership of the Forum is an elected AAOS fellow. When I became chair in 2012, I followed in the footsteps of Michael J. Yaszemski, MD, PhD, who served from 2004–2012. His predecessor, Bernard N. Stulberg, MD, chaired the Forum for a decade.
Under Dr. Yaszemski’s leadership, the Forum played vital functions in providing education and developing ASTM standards and guidance documents for the FDA. During his tenure, ASTM standards branched out into tissue engineered medical products (TEMPs) as well as validation of clinical outcome measures for clinical trial applications.
Newer products—involving biologics and combination products (implants combined with biologics)—are now making the path to market more complex. The Forum is meeting this challenge by providing the leadership to implement the necessary standards within ASTM International to properly test these products.
The Forum is supported by your AAOS dues; it works with all stakeholders on multiple areas. Through the workshops and symposia on mobile-bearing knee and metal-on-metal bearing articulations, the Forum has set in motion the necessary standards to assess these devices, among others.
The table is open
Although eight AAOS members are members of the Orthopaedic Device Forum, I 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 Katherine Sale at firstname.lastname@example.org or 847-384-4327.
If you belong to a member organization and would like more information about your organization’s involvement, please contact your representative.
William M. Mihalko, MD, is the current chair of the Orthopaedic Device Forum. He can be reached at email@example.com
- The Orthopaedic Device Forum brings together clinicians, scientists, government, and industry to discuss issues and find mutually agreeable solutions to problems.
- Forum members help create guidance documents for device reviews, work on standards, and educate stakeholders on emerging issues.