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Since its inception, the Orthopaedic Surgical Manufacturers Association (OSMA) has actively participated in standards and regulatory guideline development, educated its membership on regulatory matters and provided manufacturing professionals with a forum to collaborate, communicate, cooperate and interact with worldwide regulatory agencies and healthcare professionals. The organization’s goal is to improve the application of device law and promote collaborative interaction for appropriate regulation.
OSMA members represent small, mid-size and large orthopedic companies with diverse products that value the opportunity to engage on issues of mutual importance and stay abreast of the dynamic changes in the industry.
Building upon a rich legacy, OSMA has taken steps to position itself for growth so that it will continue to meet the needs of manufacturing professionals and improve patient care. Here we share OSMA’s strategic priorities for 2024 to highlight the pressing issues orthopedic companies face and signal the need for greater collaboration within the industry.
Today’s Regulatory Priorities
OSMA has aligned its strategic focus around topics of particular importance to orthopedic companies: biocompatibility, MR testing and labeling, real-world data/evidence (RWD/RWE) and anti-infective solutions. We have formed work groups to effect meaningful change in each of these areas.
Further, OSMA’s quarterly educational meetings allow industry members to stay abreast of current issues and provide a unique forum for member interaction with invited guests such as FDA, notified bodies and regulatory and industry subject matter experts from around the globe. These meetings foster positive interactions, dialogue and collaboration between industry and regulators to promote a common understanding of important industry issues that impact patient care.
U.S. Initiatives
Our 2023 bi-annual meetings with FDA centered on the Agency’s priority topics and featured divisional updates. The Director and Deputy Director of FDA OHT6: Office of Orthopedic Devices and various FDA speakers covered numerous initiatives, including:
- e-Star PMA template
- IMDRF, QMSR and ASTM updates
- Role of the FDA ombudsman
- Deficiency trends and opportunities to improve device submissions
- Joint registry data utilization in the total product life cycle
- Future opportunities for RWE registries
- Early feasibility program/breakthrough pathways
- Predictive analytics and artificial intelligence
- Additive manufacturing at the point of care
- Anti-infective initiatives
In-depth panel discussions on biocompatibility and MR testing and labeling conveyed the unique perspectives of regulators, industry and testing facilities.
During the biocompatibility panel discussion, representatives from FDA, industry, MCRA, Nelson Labs and MED Institute outlined common deficiencies and trends, provided practical solutions for avoiding and remediating the pitfalls of chemical characterization and recommended approaches to testing methods, along with best practices in setting and implementing reporting thresholds in device extraction and leaching studies. A toxicological risk assessment tool to approach biocompatibility evaluations was also introduced.
The MR testing and labeling panel discussion covered common deficiencies and trends, relevant MR questions and an overview of MR safety evaluations, including testing and simulation. Revised standards for labeling devices for use in the MR environment and a comparison of MR requirements in the U.S. and Europe were also included. Participants from FDA, MED Institute, BDC Laboratory, TÜV SÜD, MNM Consulting and industry offered various perspectives and considerations that will help to define future opportunities and actions for OSMA working groups and subsequently orthopedic companies.
Europe Initiatives
OSMA’s European-focused content covered UKCA, BREXIT and MedTech Europe advocacy initiatives. It featured a panel discussion on EU MDR best practices, with participation from various notified body and consultant subject matter experts, including GMED North America, TÜV Rheinland, TÜV SÜD Product Service GmbH, BSI, DEKRA and AKRA TEAM GmbH. Other topics included the MDR review process, clinical requirements, labeling, audit expectations during the transition from MDD to MDR and insight from the notified bodies that related to capacity and availability of devices during MDR transition.
A European clinical perspective was also offered with speakers from MCRA, SGS, TÜV SÜD and AKRA TEAM GmbH. They outlined EU MDR clinical and postmarket surveillance requirements for high-risk and upclassified devices in the orthopedic space, and discussed the role and applicability of RWE from a notified body perspective. The transferability of RWE from different regions and future data sources was also considered.
Building for Beyond
In 2023, OSMA formalized its organizational structure around communication and engagement (fostering relationships and promoting intelligence sharing), work prioritization (facilitating meeting planning and providing structure and oversight to working groups), and structure and governance (establishing operational structure and controls). This framework will assist us as we continue to deliver quality educational programs and engage subject matter experts who can provide unique perspectives on common challenges and offer meaningful input in support of our strategic priorities.
To further our mission of advocacy and expand our reach in the orthopedic space, OSMA is also looking to grow its membership beyond the manufacturers of finished devices. We want to establish strategic partnerships with individuals and organizations that support orthopedic manufacturers in all phases of the product lifecycle, including design, development, manufacturing and delivery. These strategic partnerships include consultants, contract manufacturers, testing labs and suppliers.
While OSMA has historically been comprised of regulatory and quality professionals from its member companies, we seek to broaden our reach and increase the engagement of individuals from other functional areas. We realize clinical and R&D professionals can add valuable perspectives and expertise that will advance our strategic priorities.
Beyond these near-term goals, OSMA is participating in the evolving Orthopaedic Alliance Roundtable (OAR), a collaborative forum comprised of clinicians, regulators, researchers and industry representatives who are working within the orthopedic ecosystem to advance regulatory science and patient care. OAR builds upon the strong legacy of the American Academy of Orthopaedic Surgeons’ Orthopaedic Device Forum, which was formed in 1995 to promote access to and timely delivery of safe and effective orthopedic devices.
OAR’s mission is to foster education, communication and shared expertise that provides timely and innovative solutions to challenges impacting the delivery of safe and effective orthopedic care. OSMA is committed to leading efforts to build OAR’s operational and governance structure and to ensure its future success.
OSMA will also provide timely regulatory expertise to BONEZONE readers and will host several educational sessions at OMTEC 2024.
As OSMA looks with excitement to 2024 as a year of transformation and growth, we reflect to honor and recognize those who have made significant contributions to the association and to the industry at large. OSMA Fellows will be inducted and will continue to engage with membership, serving as mentors, speakers, advisors and active participants in the organization’s working groups.
In 2024, OSMA will celebrate its 70th year of existence. We look forward to a bright future as our organization continues to advocate, educate and facilitate the execution of meaningful solutions that make a positive impact for all members of the orthopedic community.
Sharon Starowicz is an OSMA consultant. To learn more about OSMA, visit www.osma.net or send your questions to secretary@osma.net.
