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The Orthopaedic Surgical Manufacturers Association (OSMA) is taking steps to revive the Orthopaedic Alliance Roundtable (OAR), which was originally launched in 2019 at FDA offices as the successor to the AAOS-led Orthopaedic Device Forum.
When the Forum was retired by AAOS after a 24-year run, it was viewed not as a failure but as a celebration of its many accomplishments in driving ASTM standards development and reclassification efforts. Following the Forum’s end, OSMA took the lead in attempting to re-establish OAR.
OAR’s mission is to foster education, communication and shared expertise to provide timely and innovative solutions to challenges that impact safe and effective orthopedic care. Being able to bring multiple stakeholders together to discuss where we should launch new efforts in orthopedics, or even how we can improve education and communication across those groups, is critical.
At the center of these efforts are patients. We want to make sure safe and effective orthopedic care is accessible to the people who need it.
Framework for Success
Over the past several years, OAR has been in a reforming and regrouping phase as leadership has changed and new issues have emerged. OSMA applied for OAR to become an FDA collaborative community, which was provisionally approved in July 2022, and is in the process of completing the steps necessary to achieve full designation.
There are currently fewer than 20 collaborative communities designated by FDA’s CDRH. Once designated, which is expected to occur this year, OAR would be the first and only orthopedics-specific collaborative community within FDA’s CDRH. These efforts have been led by OSMA Board Member Brianna Prindle of restor3d and OSMA Fellow Sharon Starowicz.
OAR will comprise representatives from the clinical community (AAOS), research community (Orthopedic Research Society), standards community (ASTM), Industry (OSMA), patient advocacy organizations and regulatory agencies (FDA/CDRH).
Patient advocacy organizations will ensure that patient needs and outcomes remain central to every discussion, while regulatory participation from FDA’s CDRH will bring important insight into regulatory expectations and public health considerations.
The structure will include a steering committee with representatives from each constituent group, working groups aligned with strategic priorities and broader think tank sessions open to all interested stakeholders.
The goal is to get OAR off the ground with a U.S.-based, FDA-focused regulatory framework. But as we’ve seen with other collaborative communities, once they take shape, they often expand beyond the U.S. into other regions and organizations.
OSMA would serve as the convener, bringing all representative parties together and leading logistics and management. The plan is to have members at large who represent all interested parties, beyond just the individual stakeholder groups already identified.
Rather than relying on ad hoc or bilateral interactions, OAR creates consistent opportunities for dialogue and collaboration among all six advocacy groups. Governance will be provided by a steering committee with representation from each stakeholder community, ensuring balanced oversight and alignment with OAR’s mission.
Together, this structure reflects OAR’s commitment to sustained, multi-stakeholder collaboration and positions the Roundtable as a trusted forum for addressing systemic challenges in orthopedics and advancing solutions that benefit patients.
Providing Added Value
Plans to bring OAR back online reflect a renewed recognition that many of the most pressing challenges in orthopedics cannot be solved in isolation. OAR was created to serve as a neutral, multi-stakeholder forum where the full orthopedic ecosystem can come together to address emerging issues, share perspectives and work toward practical solutions.
At its core, OAR is designed to facilitate communication and education across stakeholder groups. The Roundtable provides a structured environment where participants know they can raise concerns early, compare experiences and determine whether challenges are isolated or systemic.
As important, OAR enables bidirectional education: Stakeholders not only learn from one another, but also gain insight into how their own decisions and constraints are perceived across the ecosystem. This cross-pollination of perspectives helps create more informed decision-making and reduces friction caused by misaligned assumptions.
A defining element of OAR’s value is its ability to engage FDA in a multi-stakeholder setting. While individual groups already maintain bilateral communication channels with the agency, OAR brings all six stakeholder groups into the same conversation, allowing complex, cross-cutting issues to be discussed holistically.
This structure has proven particularly valuable for topics that benefit from collective input, such as joint town halls and priority-setting discussions. Clear articulation of shared priorities also helps FDA determine how best to engage and support OAR’s work, reinforcing the agency’s ongoing commitment to the group’s success.
OAR also has the potential to play a more visible role in standards development. By convening diverse stakeholders, the Roundtable can help identify gaps in existing standards, prioritize where new standards are most needed and connect participants with the appropriate ASTM subcommittees. OAR can act as a catalyst to align clinical, regulatory and industry perspectives before formal standards work begins.
Another area of focus is the growing importance of real-world evidence and registries in orthopedics. Industry leaders increasingly recognize the value of existing devices and outcomes data, but questions remain around how to use that information effectively and without compromising regulatory rigor.
A multi-stakeholder OAR forum offers a path forward, enabling discussions around standardized data collection and analysis methods, best practices for incorporating real-world evidence into regulatory submissions and better coordination between registries and regulatory expectations.
Data analysis and assessment standardization are related opportunities. OAR aligns closely with the Orthopaedic Research Society’s emphasis on data-driven advocacy and education, particularly in understanding disease burden and improving patient outcomes.
By bringing stakeholders together, OAR can help standardize assessment methodologies, develop consistent characterization approaches and align how research, industry and regulators interpret and apply data. This kind of alignment is critical when diverse groups are evaluating the same clinical issue through different analytical lenses.
The Roundtable also provides a collaborative framework for addressing reimbursement and patient access challenges. By convening stakeholders around bone health and secondary fracture prevention, OAR can support efforts that improve patient outcomes while helping providers navigate complex reimbursement landscapes.
Similarly, OAR can play a constructive role in discussions around access to custom and compassionate-use devices, exploring ways to streamline custom device submissions and address access challenges when discontinued devices are needed for revision procedures.
A Worthy Goal
Reactivating OAR would restore a platform for ongoing engagement across the orthopedic community. Quarterly think tank meetings would offer a structured way to assess the evolving orthopedic landscape, while annual meeting collaborations will increase visibility and momentum.
The Roundtable also creates opportunities to support industry trainees, advocate for research funding, engage directly with clinical societies and patient advocates, and build on existing initiatives by expanding them into new orthopedic areas.
Getting OAR back online is an important way to bring together a dynamic group of clinicians, regulators, researchers and industry representatives. I’m excited to see it happen and what it could mean for the future of orthopedic care. BZ
Ryan Belaney is President & CEO of Phoenix Kinetics and President of OSMA.
Industry associations and patient advocate groups are welcome to join OAR. Please reach out to reach out to OSMA learn more.
