Dawn A. Lissy, President & Founder, Empirical02.03.21
The first week of 2021 shattered the sweet fantasy I clung to that the midnight chime of the clock on Jan. 1 would ring in an easier new year. As of this writing, the U.S. Capitol has been stormed by rioters, and the nation set a new high record of reported COVID-19 deaths on the same day.
It’s almost enough to make me wax nostalgic for 2020—I can’t remember a year with higher levels of continuous chaos than last year. Personally and professionally, I’ve never had to adapt more quickly and intensely on an ongoing basis than I did last year.
But chaos is not inherently bad. Neither is being squeezed through a cocoon I didn’t willingly spin for myself. It’s a different kind of butterfly effect—the storm of 2020 tested our wings in ways we never could’ve imagined. It’s pushed some of us to new heights.
My consulting company worked on a record number of submissions to regulatory agencies in 2020. My mechanical testing company received a steady stream of parts from clients during a year I expected my businesses to struggle. I was pleasantly surprised that despite the battering our global economy took last year, the medical device industry seemed to follow the example of all of us who found ourselves twisting our lives and expectations so that we could all keep going.
It sparked new levels of innovation. Not just in terms of how to craft better product, but how to work through the unique challenges and ripple effects of a global health crisis.
“We were facing certain objectives and expectations that fostered a can-do attitude to tackle [the question] ‘How do we get this done?’” said Michael Wefers, principal at Synapt MedTech Consulting LLC.
Wefers cited the example of a client needing to conduct a cadaver lab—a near impossibility during lockdown, but a requirement for a particular device that impacted the development timeline.
“We couldn’t do a lab for a long time. When we finally ended up being able to do it, we couldn’t get all the surgeons there [due to institutional restrictions],” he said. “It was a challenge we’d never faced before. It took a unique combination of the lab, videoconferencing, and follow-up to get the contributions we needed.”
Pandemic restrictions may have also diminished certain advantages large companies hold over small and mid-sized competitors, Wefers said. Giant corporations with robust staff and high-dollar travel budgets could no longer fly in experts or even gather their full internal teams in the same room. With conferences and other group events on hold, most of us found ourselves in the same position—at home.
“Any company can have a Zoom call,” Wefers said. “That doesn’t cost any money. With folks locked down and frozen in, everyone’s in the same space. Companies with a lot of in-house resources were limited in their ability to use them. When a company stops being able to leverage its scale, it means the playing field for the smaller player is leveled.”
For startup companies with no expectation of profit in 2020 and funding secured, it was basically business as usual, said Raymond Cloutier, founder of NovApproach Spine LLC. His nascent company is poised to launch both a new device and patented surgical procedure later this year.
“It turns out we are in a better position as a startup,” Cloutier said. “We didn’t have a physical location [for the company]. We were already working out of our homes. As a startup, you’re not worrying about fulfilling orders. We’re developing product. It’s a different animal.”
With so many surgeons sidelined from elective procedures, device developers had much better access to surgeons’ expertise and feedback, Cloutier said.
“The surgeons were more available [for consultation] since they were shut down,” Cloutier said. “In a way, the pandemic helped accelerate our product development.
“We did a lot of Zoom. We didn’t travel as much [as expected]. That saved money and was more efficient. That allowed us to advance faster.”
Many mid-sized companies maintained forward momentum, from what I saw. The influx of FDA new product submissions that my team worked on—mostly from mid-sized companies—happened in part because people finally got to the project backlog that had built up in the past due to the need to focus on existing product demand. With a shutdown of elective orthopedic procedures, that demand decreased. Talent and resources were diverted to aspects of device development that would otherwise be cooling on the back burner. The pace and volume picked up the closer we got to the end of 2020.
At Empirical Testing and Empirical Consulting, we found ourselves finally able to close out projects that had lingered because the client didn’t have the time or resources to devote to administrative tasks. I know of at least six products that went through development, testing, and clearance in 2020. Those innovators are poised to introduce new products when people come back together and things return to “normal,” whenever that is and whatever it eventually looks like.
Last year was not particularly fun, but it was profoundly empowering. We’re still here despite the challenges, the losses, and the instability. Our industry is intact and functional. Thanks to the men and women who weathered the challenges of 2020, I know we’re capable and ready for what this new year brings.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) 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.
For more information about Empirical Technologies Corp. visit www.EmpiricalTech.com
It’s almost enough to make me wax nostalgic for 2020—I can’t remember a year with higher levels of continuous chaos than last year. Personally and professionally, I’ve never had to adapt more quickly and intensely on an ongoing basis than I did last year.
But chaos is not inherently bad. Neither is being squeezed through a cocoon I didn’t willingly spin for myself. It’s a different kind of butterfly effect—the storm of 2020 tested our wings in ways we never could’ve imagined. It’s pushed some of us to new heights.
My consulting company worked on a record number of submissions to regulatory agencies in 2020. My mechanical testing company received a steady stream of parts from clients during a year I expected my businesses to struggle. I was pleasantly surprised that despite the battering our global economy took last year, the medical device industry seemed to follow the example of all of us who found ourselves twisting our lives and expectations so that we could all keep going.
It sparked new levels of innovation. Not just in terms of how to craft better product, but how to work through the unique challenges and ripple effects of a global health crisis.
“We were facing certain objectives and expectations that fostered a can-do attitude to tackle [the question] ‘How do we get this done?’” said Michael Wefers, principal at Synapt MedTech Consulting LLC.
Wefers cited the example of a client needing to conduct a cadaver lab—a near impossibility during lockdown, but a requirement for a particular device that impacted the development timeline.
“We couldn’t do a lab for a long time. When we finally ended up being able to do it, we couldn’t get all the surgeons there [due to institutional restrictions],” he said. “It was a challenge we’d never faced before. It took a unique combination of the lab, videoconferencing, and follow-up to get the contributions we needed.”
Pandemic restrictions may have also diminished certain advantages large companies hold over small and mid-sized competitors, Wefers said. Giant corporations with robust staff and high-dollar travel budgets could no longer fly in experts or even gather their full internal teams in the same room. With conferences and other group events on hold, most of us found ourselves in the same position—at home.
“Any company can have a Zoom call,” Wefers said. “That doesn’t cost any money. With folks locked down and frozen in, everyone’s in the same space. Companies with a lot of in-house resources were limited in their ability to use them. When a company stops being able to leverage its scale, it means the playing field for the smaller player is leveled.”
For startup companies with no expectation of profit in 2020 and funding secured, it was basically business as usual, said Raymond Cloutier, founder of NovApproach Spine LLC. His nascent company is poised to launch both a new device and patented surgical procedure later this year.
“It turns out we are in a better position as a startup,” Cloutier said. “We didn’t have a physical location [for the company]. We were already working out of our homes. As a startup, you’re not worrying about fulfilling orders. We’re developing product. It’s a different animal.”
With so many surgeons sidelined from elective procedures, device developers had much better access to surgeons’ expertise and feedback, Cloutier said.
“The surgeons were more available [for consultation] since they were shut down,” Cloutier said. “In a way, the pandemic helped accelerate our product development.
“We did a lot of Zoom. We didn’t travel as much [as expected]. That saved money and was more efficient. That allowed us to advance faster.”
Many mid-sized companies maintained forward momentum, from what I saw. The influx of FDA new product submissions that my team worked on—mostly from mid-sized companies—happened in part because people finally got to the project backlog that had built up in the past due to the need to focus on existing product demand. With a shutdown of elective orthopedic procedures, that demand decreased. Talent and resources were diverted to aspects of device development that would otherwise be cooling on the back burner. The pace and volume picked up the closer we got to the end of 2020.
At Empirical Testing and Empirical Consulting, we found ourselves finally able to close out projects that had lingered because the client didn’t have the time or resources to devote to administrative tasks. I know of at least six products that went through development, testing, and clearance in 2020. Those innovators are poised to introduce new products when people come back together and things return to “normal,” whenever that is and whatever it eventually looks like.
Last year was not particularly fun, but it was profoundly empowering. We’re still here despite the challenges, the losses, and the instability. Our industry is intact and functional. Thanks to the men and women who weathered the challenges of 2020, I know we’re capable and ready for what this new year brings.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) 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.
For more information about Empirical Technologies Corp. visit www.EmpiricalTech.com
