Dawn A. Lissy, Founder & President, Empirical05.02.22
For the second time in less than a year, I surveyed the exhibit hall of the American Academy of Orthopedic Surgeons’ biggest event. I hardly recognized it from the previous year’s conference.
Seven months earlier, I’d walked the halls in the San Diego Convention center, where everyone was masked and people gave each other wide berth. Convention support staff checked vaccination cards repeatedly and at multiple locations. There were even a few booths set up with laptops displaying a company representative via Zoom, rather than a live body on site.
It was surreal, but also reassuring—a major industry meeting was back. I was interacting with clients again face to face, albeit mask to mask. Attendance was down dramatically; many hospitals wouldn’t allow staff to travel for fear of the Delta variant. Still, it was a tentative step toward a return to normal.
Fast forward just over half a year, and the scene I saw at McCormick Place in Chicago was almost what it would’ve been three years ago. The numbers were lower than standard attendance, for sure, but clearly higher than in San Diego in 2021. Vaccinations were still required but masks and social distancing were mostly gone. Displays felt bigger, bolder, almost as if everyone was competing harder for attention after two years of isolation.
I found myself shrinking back as people closed space to get near me. It was the auto-response from two years of fearing contagion at every turn. The pandemic has profoundly changed the way I interact with people and how I present myself to others.
Meredith May, my director of consulting, had a similar reaction. Despite multiple vaccinations, May has had COVID-19 twice. Like me, May still has concerns about human contact.
“What I found disturbing is that people really acted like nothing was going on—hugging, handshaking, standing too close to me,” May said. “My assessment on that was surgeons never got to isolate. They’ve had to work in this environment, so it feels more normal to them. I got to stay home for two years and got used to being by myself.”
I took the surge in contact as one of several symptoms of pandemic fatigue at AAOS. The World Health Organization defines that as “distress which can result in demotivation to follow recommended protective behaviors, emerging gradually over time and affected by a number of emotions, experiences and perceptions.”
Translation: We’re sick of being sick.
Because the medical industry has remained on the front lines of COVID-19, it makes sense to me that particular brand of fatigue hits hard. These are people who’ve had to live with the highest level of threat for the longest time. I can see why and how they’d adapt and burn out faster than those of us who could work from home.
I saw other signs that a considerable portion of us are over COVID from an emotional standpoint. Attendees were dressed down considerably. This used to be a suit-and-tie event. But jeans and tennis shoes were the norm this year. The products I saw throughout the hall seemed more geared toward total body health than just orthopedic-specific—massage, TENS units, vibration plates. Maybe a global health scare has broadened our definition of health and brought our attention back to the entire body, rather than a specific bone or joint?
I also noticed a surge in virtual reality (VR) experiences at various booths. Participants would don Oculus-like devices to perform virtual surgery that played out on multiple screens behind them. Some were straight-up video games; some featured robotics as supplements for surgeons. I wondered: is VR a treatment for those of us wanting to escape the current reality?
May got a sharp reality check from a South American client. She learned this particular company considered manufacturing in the United States versus their home country. The client told May that inflation rates and the roils of the American economy echoed those of South America prior to a major crash, so they decided to keep manufacturing on home turf and only open an office in the U.S. The client also changed their office search from Miami to Jacksonville, Fla., after Miami rents spiked 50 percent in under a year’s time.
“[The client] told me, ‘You guys have no idea what you’re in for,’” May said. “If companies outside the U.S. are concerned about our economic stability, it’s probably indicative of a little bit of a slowdown we might see on imports or foreign companies seeking clearance.”
Another slowdown we’ve noticed: Emergency use authorizations (EUAs) have stalled.
“I think EUAs are coming to an end,” May said. “I have an EUA for an antibody test kit that can distinguish between the vaccine antibody and the natural antibody so you can determine if the vaccine worked. It’s especially important for people with autoimmune diseases. It’s been rejected four times.”
If products related to combatting COVID-19 are no longer priority clearances, does that mean regulatory bodies are also suffering from pandemic fatigue?
The U.S. Food and Drug Administration (FDA) wasn’t even on site. Travel restrictions within the agency kept their folks off the floor. Unlike prior conventions, reviewers weren’t there to assess advertising claims or hear about new studies during education sessions.
May and I both heard repeated concerns about supply chain issues, sourcing materials, and global instability.
“Everybody seems to be concerned about the supply chain getting worse instead of better because of the war in Ukraine,” May said. “Almost all of our titanium comes from China. Everybody watches those relationships carefully.”
So even though so many of us seem to be over COVID-19 from a mental standpoint, lingering pandemic symptoms remain. Our physical immunity may be bolstered by boosters to the point that we’re no longer afraid to shake hands, but our industry can’t be fully inoculated against the long-term effects of COVID-19.
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.
Seven months earlier, I’d walked the halls in the San Diego Convention center, where everyone was masked and people gave each other wide berth. Convention support staff checked vaccination cards repeatedly and at multiple locations. There were even a few booths set up with laptops displaying a company representative via Zoom, rather than a live body on site.
It was surreal, but also reassuring—a major industry meeting was back. I was interacting with clients again face to face, albeit mask to mask. Attendance was down dramatically; many hospitals wouldn’t allow staff to travel for fear of the Delta variant. Still, it was a tentative step toward a return to normal.
Fast forward just over half a year, and the scene I saw at McCormick Place in Chicago was almost what it would’ve been three years ago. The numbers were lower than standard attendance, for sure, but clearly higher than in San Diego in 2021. Vaccinations were still required but masks and social distancing were mostly gone. Displays felt bigger, bolder, almost as if everyone was competing harder for attention after two years of isolation.
I found myself shrinking back as people closed space to get near me. It was the auto-response from two years of fearing contagion at every turn. The pandemic has profoundly changed the way I interact with people and how I present myself to others.
Meredith May, my director of consulting, had a similar reaction. Despite multiple vaccinations, May has had COVID-19 twice. Like me, May still has concerns about human contact.
“What I found disturbing is that people really acted like nothing was going on—hugging, handshaking, standing too close to me,” May said. “My assessment on that was surgeons never got to isolate. They’ve had to work in this environment, so it feels more normal to them. I got to stay home for two years and got used to being by myself.”
I took the surge in contact as one of several symptoms of pandemic fatigue at AAOS. The World Health Organization defines that as “distress which can result in demotivation to follow recommended protective behaviors, emerging gradually over time and affected by a number of emotions, experiences and perceptions.”
Translation: We’re sick of being sick.
Because the medical industry has remained on the front lines of COVID-19, it makes sense to me that particular brand of fatigue hits hard. These are people who’ve had to live with the highest level of threat for the longest time. I can see why and how they’d adapt and burn out faster than those of us who could work from home.
I saw other signs that a considerable portion of us are over COVID from an emotional standpoint. Attendees were dressed down considerably. This used to be a suit-and-tie event. But jeans and tennis shoes were the norm this year. The products I saw throughout the hall seemed more geared toward total body health than just orthopedic-specific—massage, TENS units, vibration plates. Maybe a global health scare has broadened our definition of health and brought our attention back to the entire body, rather than a specific bone or joint?
I also noticed a surge in virtual reality (VR) experiences at various booths. Participants would don Oculus-like devices to perform virtual surgery that played out on multiple screens behind them. Some were straight-up video games; some featured robotics as supplements for surgeons. I wondered: is VR a treatment for those of us wanting to escape the current reality?
May got a sharp reality check from a South American client. She learned this particular company considered manufacturing in the United States versus their home country. The client told May that inflation rates and the roils of the American economy echoed those of South America prior to a major crash, so they decided to keep manufacturing on home turf and only open an office in the U.S. The client also changed their office search from Miami to Jacksonville, Fla., after Miami rents spiked 50 percent in under a year’s time.
“[The client] told me, ‘You guys have no idea what you’re in for,’” May said. “If companies outside the U.S. are concerned about our economic stability, it’s probably indicative of a little bit of a slowdown we might see on imports or foreign companies seeking clearance.”
Another slowdown we’ve noticed: Emergency use authorizations (EUAs) have stalled.
“I think EUAs are coming to an end,” May said. “I have an EUA for an antibody test kit that can distinguish between the vaccine antibody and the natural antibody so you can determine if the vaccine worked. It’s especially important for people with autoimmune diseases. It’s been rejected four times.”
If products related to combatting COVID-19 are no longer priority clearances, does that mean regulatory bodies are also suffering from pandemic fatigue?
The U.S. Food and Drug Administration (FDA) wasn’t even on site. Travel restrictions within the agency kept their folks off the floor. Unlike prior conventions, reviewers weren’t there to assess advertising claims or hear about new studies during education sessions.
May and I both heard repeated concerns about supply chain issues, sourcing materials, and global instability.
“Everybody seems to be concerned about the supply chain getting worse instead of better because of the war in Ukraine,” May said. “Almost all of our titanium comes from China. Everybody watches those relationships carefully.”
So even though so many of us seem to be over COVID-19 from a mental standpoint, lingering pandemic symptoms remain. Our physical immunity may be bolstered by boosters to the point that we’re no longer afraid to shake hands, but our industry can’t be fully inoculated against the long-term effects of COVID-19.
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.
