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Jeffrey Shuren, M.D., J.D., stood on a dais during a town hall at the recent American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas, and told industry leaders that outcomes-based data has the potential to advance innovation in their field and streamline medical device regulation.
“Traditional clinical trials do not always provide a complete understanding of a technology’s potential. Real-world use is necessary to fully comprehend the effectiveness and risks associated with it,” Dr. Shuren said. “Data collection informs us about uses of devices in the marketplace and improves our understanding of new technology.”
Dr. Shuren, Director of the Center for Devices and Radiologic Health (CDRH) at FDA, was one of several featured panelists during the AAOS/FDA sponsored town hall that was billed as an interactive forum for rethinking how surgeons, orthopedic companies and regulatory bodies embrace technological advancement.
He was joined by a host of experts, including:
- Captain Raquel Peat, Ph.D., Director of the CDRH’s Office of Orthopedic Devices at FDA
- Aldo Denti, Company Group Chairman of DePuy Synthes
- Kevin Lobo, Chair & CEO of Stryker
- David Jevsevar, M.D., Chair of the AAOS Research and Quality Council
- William J. Maloney, M.D., Chair of the AAOS Registries Oversight Committee
- Steven D. Glassman, M.D., ASR Executive Committee AAOS Chair and AAOS Registry Oversight Committee (ROC) Member
The two-hour event was filled with big ideas and bigger head nods as the panelists presented a roadmap for revamping the orthopedic device regulatory process. Whether the conversations were standard fare bureaucratese or meaty insights that the industry can sink its teeth into remains to be seen.
Changing the Regulatory Landscape
One of FDA’s main goals is to incorporate real-world evidence and data into the regulatory process to balance safety with innovation across a device’s entire lifecycle. The agency wants to build robust systems and infrastructure that can quickly provide meaningful data to industry and surgeons.
Dr. Shuren emphasized that the current regulatory law in the United States does not mesh with these goals. “We want to move away from arbitrary pre- and postmarket distinctions,” he explained. “Without changes to the law, we cannot implement a single review program for medical devices to match what’s done in other countries.”
FDA has been working with industry to propose legislation that addresses this issue and has publicly committed to leading efforts to create such a program, according to Dr. Shuren. “We’ve heard that the U.S. regulatory environment is improving,” he said. “If we don’t fix the law in the next five to ten years, the gains will be lost.”
Dr. Shuren is excited about FDA’s efforts to create an Orthopedic Coordinated Registry Network (Ortho-CRN), which captures reliable real-world data for a variety of devices. The agency is exploring pilot projects with the American Spine Registry and is collaborating with the AAOS Registry Program to conduct safety studies related to hip replacement. It’s also collaborating with the Medical Device Innovation Consortium (MDIC) to develop the National Evaluation System for Health Technology (NEST), a systematic method of data collection that will improve the quality of real-world evidence.
“Generating better data more quickly and at a lower cost will help orthopedic companies bridge the ‘valley of death’ in the product development process,” Dr. Shuren said.
In January, FDA launched a pilot program that focuses on gathering real-world evidence related to the use of cardiovascular devices. “We would love to partner with you on this initiative moving forward,” Dr. Shuren told the town hall crowd. “Orthopedics will have its day in the sun.”
Dr. Glassman, who spoke to us after the town hall, said that it’s hard to be optimistic about changing any regulatory landscape. “FDA leaders said they are bound by existing legislation, which may conflict with common sense regulatory changes that they would otherwise support,” he added. “I also see that as an opportunity for a shared advocacy platform in some instances. We need to keep working at it.”
FDA leaders recognized that existing pathways for regulatory approval are inherently unable to keep up with the speed of digital evolution, particularly for AI applications. “They identified a role for regulatory oversight that permits iterative change, within certain parameters, without the burden of a continuous reassessment process,” Dr. Glassman said. “Moving that concept from theory to practice will be an interesting journey.”
Emerging Sources of Information
Patient-reported outcomes data is currently captured in less than 5% of orthopedic cases, according to Dr. Jevsevar. “It’s essential not only to collect outcomes data, but to educate surgeons on its importance in providing excellent patient care,” he said. “The benefits of devices and technology cannot be accurately assessed without appropriate outcome measurements.”
Dr. Maloney said that registries and databases can help drive surgical innovation by providing industry with arm’s length data that can be used to obtain premarket approvals or conduct post-market surveillance. These factors could add value to data collection efforts for orthopedic device manufacturers.
Lobo said that large patient registries allow real-world data to be mined on a much larger scale. “When machine learning is used, vast amounts of data are needed to learn effectively,” he explained. “Registries are a potent tool in this regard.”
However, significant barriers impede the collection of reliable data that will drive innovation and improve patient care. Collecting it can be expensive and onerous. Who will shoulder the financial burden? Who will educate surgeons on why patient-reported outcomes matter? How will the information be gathered, organized and used to better define value?
“Surgeons are interested in collecting granular data that offers meaningful insight into quality and effectiveness,” Dr. Glassman said. “This data is complex. Understanding and synthesizing it accurately is an ongoing challenge.”
Real-world data presents a promising future, but there are challenges ahead, Lobo said. “We’ve talked about the need to assess the volume and quality of data and decide on the metrics we choose to measure,” he added. “Improving the innovation, quality and safety of our products is a definite possibility with registries, but it’s not an easy fix.”
Breaking Down the Silos
Tremendous amounts of data are available throughout entire episodes of care, but orthopedic companies are building independent digital ecosystems. “As a result, we’re not capturing the data sets needed to innovate and meet the unmet needs of patients,” Denti said. “This presents a significant opportunity to capture data in a different way so that industry can innovate more effectively.”
Linking patient registries to other data sources would make the collective information more valuable. “If industry collaborates more as an orthopedic ecosystem and focuses less on protecting proprietary information, we can gather and share data to bring products to market more quickly,” Captain Peat said.
Would orthopedic manufacturers be willing to share proprietary data for the greater good of the industry, even if it’s blinded and kept confidential? That’s a big ask for companies that invest heavily in developing digital databases and registries of their own.
To address this issue, FDA is working to establish the Medical Device Information and Analysis Sharing (MDIAS) initiative, which allows for the distribution of confidential and de-identified data. The goal is to improve patient safety and surgical outcomes and promote innovation in the industry through shared knowledge.
Orthopedic companies are also facing a significant challenge due to the rising cost of regulations and uncertainty about whether the real-world data they’re generating will be accepted by regulatory bodies across the globe.
“This uncertainty affects our ability to innovate and sell products in certain markets,” Denti said. “The burden of generating data that meets regulatory standards is substantial, and it affects the entire community. We must rely on regulatory bodies to address our needs as an industry.”
Louder than Words
FDA has strengthened the orthopedic ecosystem in recent years, according to Lobo.
“Captain Peat’s vision of bringing products first to American patients is becoming a reality, and it’s been an incredible journey over the past decade,” he said. “Even with digital technologies, U.S. regulatory agencies are leading the world with significant software upgrades.”
Moving forward, Lobo said, FDA and industry need to get more surgeons to input their outcomes into national registries to ensure the data is clean and reliable. “It’s a big task that requires collaboration and buy-in from all sides, whether it’s funding or general support,” he said. “We’re ready to be a part of the solution.”
The town hall provided opportunities to highlight the need for identifying and obtaining critical evidence to support innovation, according to Capt. Peat. “Generating the necessary data that inform these decisions can involve different approaches, including clinical and non-clinical evidence,” she said after the event. “Ultimately, the data must demonstrate a reasonable assurance of safety and effectiveness of the device, and that the probable benefits outweigh its probable risks.”
Dr. Glassman was encouraged by the discussion. “There was broad agreement that high-quality, accessible data offers the potential to support innovation and promote the safe and effective use of orthopedic implants,” he said. “All of the constituencies seemed to be pulling in the same direction. Hopefully, we can turn that into progress.”
Time will tell whether the productive dialogue from the town hall turns into difference-making action where the rubber hits the road. A long journey to change awaits.
