Dawn A. Lissy, President, Empirical05.09.23
It was standing room only at the first Orthopedic Medical Devices Innovation AAOS/FDA town hall for a frank discussion about the state of our industry. Originally scheduled for 2020 but delayed by the pandemic, we’d finally gotten key stakeholders into the room for a two-hour discussion about the challenges and possibilities of orthopedics.
Despite fears about lagging attendance in the wake of COVID-19, lack of interest, or conflicting priorities, hundreds gathered to hear from panel members. They stood in the gaps not filled by chairs to hear from a cross section of regulatory, corporate, and industry association representatives brokering the first of (hopefully) many future pulse checks on the state of the industry.
Three years overdue but 10 years in the making, the idea of an orthopedics town hall sprang from discussions I was part of as a participant in the U.S. Food and Drug Administration’s (FDA) Entrepreneur-in-Residence (EIR) program in 2012 and 2013. Through my time in the EIR, I learned the cardiovascular industry held annual talks for its members where they gathered to learn about breakthroughs, adverse effects of devices, how to combat infections—a wide range of topics geared toward educating the men and women who make up that segment of medicine. That community pulled together every year to have honest, sometimes difficult conversations with the goal of sharing information in support of the greater good—a model that would greatly benefit orthopedics.
We began working on hosting a similar event with enthusiastic support from FDA, American Academy of Orthopaedic Surgeons, and Orthopaedic Surgical Manufacturers Association. The first event scheduled for 2020 received so many RSVPs, we had to scale it back. At that point, we struggled with how to make it accessible to a wider audience online. Post-pandemic, that’s thankfully no longer an issue.
So when both the main room and the overflow room were filled March 7 at the Venetian Convention and Expo Center (Las Vegas), the “real talk” began. David Jevsevar, chair of research and quality control for AAOS, focused on data quality and how that impacts patient outcomes. Various registries are popping up around the world for specific types of surgeries, but there is no single registry of record for all of orthopedics.
With such a diverse field of medical devices, it’s hard to accumulate, track, and report that data. One example that Steven Glassman, ASR Executive Committee chair and AAOS Registry Oversight Committee member cited: We have both neurosurgeons and orthopedic surgeons who operate on spines, but each has its own processes and even language for how those surgeries are performed. Standardized language will improve data sharing and understanding of what’s working and what’s not.
Capt. Raquel Peat, director, Office of Orthopedic Devices, Center for Devices and Radiological Health (CDRH) at FDA, also took the floor. She explained the major structural overhaul the FDA underwent in 2017 to improve quality systems and tracking. She introduced Orthopedic Rapid Comparative Analysis (ORCA), a set of databases FDA designed for tracking testing data from historical submissions. It’s a resource to identify predicate devices during review and share information to improve transparency in the review process. She shared new tools and guidance documents designed to bolster the quality of information being gathered and shared to support those better patient outcomes.
Her colleague, CDRH Director Jeff Shuren, also focused on the importance of accessible information. He said FDA is looking at how to use registry data to improve lines of communication and patient outcomes with the Medical Device Information & Analysis Sharing Initiative (MDIAS). This is a voluntary partnership between the government and the private sector designed to move from fragmented, reactive data to systemic and predictive data. He talked about making better use of trial data to speed up the progression of device improvements, which can be hampered by a complex path to market. He shared his goal of “first in human, first in the U.S.” He noted how in the past, it has been easier to get new technology on the market in Europe, which led to U.S. patients traveling abroad for treatments not yet available in the United States. That has shifted, in part due to changes stemming from new regulatory guidance from the European Union. He wants to keep the U.S. on the leading edge of advancement and access to life-improving care, he said.
A panel discussion followed the list of presenters. There were some tense conversations. One focused on the struggle of convincing surgeons to provide information for registries and databases. One surgeon said he’d be “strung out” by his peers if he suggested a mandate requiring them to provide the kind of information these registries and databases require. This led to a discussion on the appropriate role of the patient, who is also in a position to provide valuable information that will benefit other end-users of medical technology.
All of these discussions led to questions about who will pay for such registries, maintain them, provide access, and regulate them. There were no easy answers to those inquiries—I hope we can continue the conversation at future town halls.
I appreciate that level of honest communication, and recognize the challenges of building community across industry divisions. But I also believe that despite our niches and titles, we are all committed to the greater good at a fundamental level.
As an engineer, I know that if we study outcomes, that gives us valuable information about how to better manage patient care. I’m encouraged by the cultural shift I’ve seen over the past 20 years to embrace this concept. Open dialogue like the one at the AAOS Orthopedic Town Hall is a critical first step. Without them, we’re siloed. We’re focused solely on our specific problems and frustrations. When we make ourselves vulnerable enough to admit our struggles, we invite collaboration from our colleagues and make space for solutions.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, Empirical Technologies Corp. has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
Despite fears about lagging attendance in the wake of COVID-19, lack of interest, or conflicting priorities, hundreds gathered to hear from panel members. They stood in the gaps not filled by chairs to hear from a cross section of regulatory, corporate, and industry association representatives brokering the first of (hopefully) many future pulse checks on the state of the industry.
Three years overdue but 10 years in the making, the idea of an orthopedics town hall sprang from discussions I was part of as a participant in the U.S. Food and Drug Administration’s (FDA) Entrepreneur-in-Residence (EIR) program in 2012 and 2013. Through my time in the EIR, I learned the cardiovascular industry held annual talks for its members where they gathered to learn about breakthroughs, adverse effects of devices, how to combat infections—a wide range of topics geared toward educating the men and women who make up that segment of medicine. That community pulled together every year to have honest, sometimes difficult conversations with the goal of sharing information in support of the greater good—a model that would greatly benefit orthopedics.
We began working on hosting a similar event with enthusiastic support from FDA, American Academy of Orthopaedic Surgeons, and Orthopaedic Surgical Manufacturers Association. The first event scheduled for 2020 received so many RSVPs, we had to scale it back. At that point, we struggled with how to make it accessible to a wider audience online. Post-pandemic, that’s thankfully no longer an issue.
So when both the main room and the overflow room were filled March 7 at the Venetian Convention and Expo Center (Las Vegas), the “real talk” began. David Jevsevar, chair of research and quality control for AAOS, focused on data quality and how that impacts patient outcomes. Various registries are popping up around the world for specific types of surgeries, but there is no single registry of record for all of orthopedics.
With such a diverse field of medical devices, it’s hard to accumulate, track, and report that data. One example that Steven Glassman, ASR Executive Committee chair and AAOS Registry Oversight Committee member cited: We have both neurosurgeons and orthopedic surgeons who operate on spines, but each has its own processes and even language for how those surgeries are performed. Standardized language will improve data sharing and understanding of what’s working and what’s not.
Capt. Raquel Peat, director, Office of Orthopedic Devices, Center for Devices and Radiological Health (CDRH) at FDA, also took the floor. She explained the major structural overhaul the FDA underwent in 2017 to improve quality systems and tracking. She introduced Orthopedic Rapid Comparative Analysis (ORCA), a set of databases FDA designed for tracking testing data from historical submissions. It’s a resource to identify predicate devices during review and share information to improve transparency in the review process. She shared new tools and guidance documents designed to bolster the quality of information being gathered and shared to support those better patient outcomes.
Her colleague, CDRH Director Jeff Shuren, also focused on the importance of accessible information. He said FDA is looking at how to use registry data to improve lines of communication and patient outcomes with the Medical Device Information & Analysis Sharing Initiative (MDIAS). This is a voluntary partnership between the government and the private sector designed to move from fragmented, reactive data to systemic and predictive data. He talked about making better use of trial data to speed up the progression of device improvements, which can be hampered by a complex path to market. He shared his goal of “first in human, first in the U.S.” He noted how in the past, it has been easier to get new technology on the market in Europe, which led to U.S. patients traveling abroad for treatments not yet available in the United States. That has shifted, in part due to changes stemming from new regulatory guidance from the European Union. He wants to keep the U.S. on the leading edge of advancement and access to life-improving care, he said.
A panel discussion followed the list of presenters. There were some tense conversations. One focused on the struggle of convincing surgeons to provide information for registries and databases. One surgeon said he’d be “strung out” by his peers if he suggested a mandate requiring them to provide the kind of information these registries and databases require. This led to a discussion on the appropriate role of the patient, who is also in a position to provide valuable information that will benefit other end-users of medical technology.
All of these discussions led to questions about who will pay for such registries, maintain them, provide access, and regulate them. There were no easy answers to those inquiries—I hope we can continue the conversation at future town halls.
I appreciate that level of honest communication, and recognize the challenges of building community across industry divisions. But I also believe that despite our niches and titles, we are all committed to the greater good at a fundamental level.
As an engineer, I know that if we study outcomes, that gives us valuable information about how to better manage patient care. I’m encouraged by the cultural shift I’ve seen over the past 20 years to embrace this concept. Open dialogue like the one at the AAOS Orthopedic Town Hall is a critical first step. Without them, we’re siloed. We’re focused solely on our specific problems and frustrations. When we make ourselves vulnerable enough to admit our struggles, we invite collaboration from our colleagues and make space for solutions.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, Empirical Technologies Corp. has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
