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OAR Mission and Structure

To foster education, communication, and shared expertise to provide timely and innovative solutions to challenges impacting safe and effective orthopaedic treatment delivery to patients.

Convened by the Orthopaedic Surgical Manufacturers Association (OSMA), OAR establishes a structured forum for cross stakeholder engagement. The structure includes 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 within the orthopedic community. 

Key Stakeholders

Clinical Community

Research Community

Standards Community

Industry

Patient Advocacy Groups

Regulatory Agencies

FDA Collaborative Community Designation

Since July 2022 , OAR has been provisionally approved by FDA as a CDRH collaborative community. An executed charter, reflecting current leadership, will be submitted to FDA to achieve full collaborative community designation.

FDA collaborative community status would establish it as the first and only orthopaedics-focused collaborative community within FDA’s Center for Devices and Radiological Health (CDRH), widening the footprint for broader engagement throughout the orthopaedic ecosystem. There are currently fewer than 20 formally designated collaborative communities.

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What is an FDA Collaborative Community?

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A collaborative community is a continuing forum in which private- and public-sector members, which can include the FDA, work together on medical device challenges to achieve common objectives and outcomes. They are convened by interested stakeholders and may exist indefinitely, produce deliverables as needed, and tackle challenges with broad impacts. Collaborative communities may develop for a number of reasons, including when: 

  • Challenges are ill-defined or there is no consensus on the definition of the challenges
  • Challenges and outcomes are complex
  • Partners are interrelated
  • Incremental or unilateral efforts to address the challenge have been ineffective
  • Partners seek to optimize efforts, including preventing duplication of efforts
  • Better outcomes could be achieved with integrating different perspectives, experiences, resources, and expertise.

For more information: Collaborative Communities: Addressing Health Care Challenges Together | FDA 

OAR Value Proposition

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Cross-Stakeholder Communication and FDA Collaboration

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Standards Development for New/Emerging Technologies

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Patient Access to Custom and Compassionate Use Devices

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Expanded Use of Real World Evidence and Registries

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Orthopaedic Research Data Analysis and Standardization

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Reimbursement Strategies

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Additional Opportunities

Be part of a dynamic community committed to elevating orthopaedic excellence

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Cross-Stakeholder Communication and FDA Collaboration

OAR serves as the only orthopaedics-focused forum uniting all six key stakeholder groups, providing:

  • Forum for shared challenges: Bring emerging issues to a structured setting, discover common problems, and engage in two-way learning that strengthens decision making.
  • Cross-sector understanding: Build awareness of diverse perspectives and uncover critical details that single stakeholder viewpoints miss.
  • Strategic FDA partnership: OAR’s comprehensive format enables focused work on issues requiring multi-stakeholder input (e.g., AAOS/FDA Town Hall). Clear priorities help FDA direct its engagement and resources, with FDA actively supporting OAR’s mission.
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Standards Development for New and Emerging Technologies

OAR could serve as a forum for:

  • Identifying gaps in existing standards
  • Prioritizing standards development activities
  • Connecting OAR members with appropriate ASTM subcommittees
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Patient Access to Custom and Compassionate Use Devices

OAR can play a role in:

  • Custom device submissions: OAR collaborative efforts may explore ways to streamline the process and reduce burden on both manufacturers and FDA
  • Compassionate use procedures: OAR can address access challenges, particularly for discontinued devices when needed for a revision surgery
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Expanded Use of Real World Evidence and Registries

The orthopaedic community recognizes the tremendous value in existing device data. The key challenge is determining how to harness this information effectively without compromising regulatory decision-making rigor. A multi-stakeholder approach could address:

  • Standardization of data collection and analysis methodologies
  • Development of best practices for using RWE in regulatory submissions
  • Coordination between registries and regulatory requirements
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Orthopaedic Research Data Analysis and Standardization

OAR recognizes the importance of data analysis for understanding the burden of musculoskeletal disease and improving patient care. ORS’s pillars of data-driven advocacy and education align well with OAR’s mission. 

Specific opportunities include:

  • Standardizing assessment methodologies (e.g., radiolucency evaluation)
  • Developing consistent characterization approaches across stakeholders
  • Aligning research, industry, and regulatory perspectives on data interpretation
  • Different stakeholders may evaluate the same issue (such as radiolucency) using different methods, and OAR could facilitate alignment through standardization efforts.
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Reimbursement Strategies

OAR provides a cross collaborative framework to improve patient outcomes by supporting providers and patients, particularly in areas of bone health and secondary fracture prevention. 

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Additional Opportunities

OAR participation provides:

  • Quarterly landscape reviews: Participate in think tank meetings to stay informed on emerging trends and challenges across the orthopaedic field
  • Cross-event collaboration: Enhanced networking and partnership opportunities at annual meetings across member organizations
  • Workforce development: Access to mentorship and training programs for industry trainees and emerging professionals
  • Research advocacy: Collective voice in supporting funding initiatives for orthopaedic research priorities
  • Direct stakeholder access: Engage with clinical societies and patient advocates to understand real-world needs and perspectives
  • Leverage existing work: Gain visibility into current initiatives across the ecosystem, build on established efforts, and expand successful approaches to new orthopaedic areas"
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