AAOS, FDA and industry discuss the future of innovation in orthopedics
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LAS VEGAS — Members of the American Academy of Orthopaedic Surgeons, the FDA and industry discussed how outcome-based decision-making and rapid changes in the medical device industry impact high-quality patient care and technology.
“We’d like to understand how our emphasis on outcome-based decision-making in orthopedic technology and procedures creates high-quality patient care that can be captured by our registries; understand how the FDA’s emphasis on total product lifestyle fosters innovation in orthopedic technology while emphasizing quality that can be captured by real-world evidence, such as our registries; then lastly, try to understand the rapid changes in the medical device industry that we can still accommodate and embrace outcomes, quality and technological innovation benefiting both patients and surgeons in a safe manner,” Felix H. “Buddy” Savoie III, MD, president of the AAOS, said at the AAOS Annual Meeting.
Registry data
One way patient care can be improved is through tracking trends with registry data, according to William J. Maloney, MD, FAAOS. He noted data collected through the American Joint Replacement Registry (AJRR) have shown trends in total knee and hip replacement, which may influence a surgeon’s decision in patient care. He added being able to link with Medicare data has been an advantage for surgeons because they can follow Medicare patients after the index procedure and produce survivorship curves for specific implants and companies.
Maloney said that data collection through a registry can help innovation by providing the infrastructure for premarket and post-market approval.
“If you have a group of surgeons that are using an implant [and] you want to track post-market, we can pull that out of the registry and we can submit it on the company’s behalf to the FDA,” Maloney said.
In addition to the AJRR, Steven D. Glassman, MD, FAAOS, said the American Spine Registry improves the utility of registry data with the inclusion of surgeon-indicated diagnosis.
“What specific procedure are they doing and why are they doing it in the mind of the surgeon?” Glassman said.
Glassman noted the AAOS and the FDA are also looking at the ability to track implants, which may involve 20 components in a spine procedure.
“So, step one in this is just going to be proof of concept that we can accurately identify the implants, track the associated complications and revisions for that and look down the road to see could this be part of a surveillance approach,” Glassman said.
Collaboration with the FDA
To balance safety and innovation in the research and product realm, the FDA works closely with submitters throughout the total product lifecycle, according to Capt. Raquel Peat, PhD, MPH, director for the Office of Orthopedic Devices and Office of Product Evaluation and Quality.
“We embrace for you all to come to us and have that discussion when you’re developing your research and development [and when] you’re developing your devices, so you can have a better understanding of the various testing,” Peat said. “Not only having a better understanding of the various testing, but it’s a symbiotic relationship where you are also educating and informing the reviewers of your particular product so they can make informed decisions moving forward.”
Peat noted that products should have a benefit and risk assessment to help committee members determine a reasonable assurance of safety and effectiveness. She added that the FDA is not solely focused on randomized clinical trials when evaluating evidence of safety and effectiveness for a product.
“There are other ways to find that particular clinical evidence, and we need to think about it more broadly,” Peat said. “It is interesting to see the conversations that are being had regarding the registry and real-world data and having that particular information and how best we can collaborate as we move forward as an organization.”
The FDA also wants to receive information regarding the intended use of a product in a patient population, including having an understanding of the condition, whether there are going to be differences in the outcomes of subpopulations, the public health indications, the current therapies available and patients’ perspectives, according to Peat.
“Oftentimes when we’re looking at a particular product area when the submitter submits documentation, we’re looking for the totality of evidence,” Peat said. “That evidence can be in the form of nonclinical, as well as clinical. It’s also where we have a better understanding of the relevance of the study endpoints, being able to observe clinical effects and the generalizability of the demonstrated benefits.”
Innovation through industry
On the industry side, Kevin A. Lobo, CEO of Stryker, noted that innovation occurs when device companies work with clinicians, institutions and regulators. Through collaboration, industry sponsors can begin to understand the unmet clinical needs of physicians, such as reducing infection risk in patients and surgeon fatigue, according to Aldo Denti, company group chairperson of DePuy Synthes.
Innovation has also changed toward a bigger focus on digital robotics and enabling technologies in the past several years, Lobo added.
“If I think about the talent we need to attract, it used to be mostly mechanical engineers. Now, I would say there is more software engineering, data analytics, biostatisticians and even cyber security talent,” Lobo said.
Denti noted this innovation in digital technology could be used throughout the surgical episode to drive better outcomes, but it has to be done in collaboration instead of individually.
“We’re all trying to build ecosystems by ourselves, and those ecosystems are not speaking to each other, and so we’re not capturing the data sets. And because we’re not capturing the data sets, we’re also not able to extract the data that we want to innovate differently,” Denti said. “We have an enormous opportunity in this industry to capture data in a different way so that we can innovate and meet the unmet needs of patients.”
Most importantly, Denti said that industry and clinicians need to collaborate better “on the equal representation of unmet needs.”
“The lack of diversity has an impact on how we innovate. Not only are we not innovating for the diverse populations that we’re treating in this country, we’re not innovating for the diverse populations across the globe,” Denti said. “Not only could we bring more diversity to our companies, but our clinical trials must evolve and they must reflect the patient populations that we’re serving.”
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AAOS/FDA townhall: Orthopaedic medical devices innovation. Presented at: American Academy of Orthopaedic Surgeons Annual Meeting. March 7-11, 2023; Las Vegas.
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