Dawn A. Lissy, Founder & President, Empirical10.01.20
When the full force of the COVID-19 pandemic struck, I initially shared the sense of panic and fear that so many other business owners and parents felt. How would I keep my employees and my family safe? How could we stay afloat if everything was shut down not just in the United States, but all over the world?
With travel and human contact so deeply disrupted, the immediate results were clear—I wasn’t going anywhere. People were not coming to work. My kids were not going to school. But the effects were so much more significant and further reaching. It wasn’t just people that weren’t getting to the office, it was the raw materials we needed to support our work. It wasn’t just professional and leisure travel knocked off its tracks, it was our global supply chain.
At Empirical, we were more concerned with the shortage of raw materials from China than the run on toilet paper. The stifled supply of China-sourced raw materials has hit the medical device industry on all levels as well as so many other aspects of our country’s social and economic fabric.
As both an optimist and engineer, I knew there had to be solutions. Given the brain power and generosity of our industry, I knew I could follow the wisdom of Fred Rogers’ mother and “look for the helpers.”
I have not been disappointed. I’ve seen colleagues embrace new business models that put the greater good of the community ahead of the bottom line.
I found a profound example in my friend and client Teresa Thuruthiyil. She is chief strategy officer at PrinterPrezz, a company founded three years ago to meet the 3D printing needs of small- and medium-sized companies in the medical device space.
She has a small, close-knit team that works in an industrial park in Fremont, Calif. Thuruthiyil, her co-founders, and employees are active members of their local community in the San Francisco Bay area, an early pandemic hot spot.
“When COVID hit and shelter-in-place suddenly happened, overnight everybody was locked down. Within a week or so, I started to get calls from local hospitals, partners we’ve worked with in other capacities,” she said. “The supply chain had literally shut down overnight. Things weren’t moving.”
These hospitals were desperate for a wide range of supplies—everything from basic personal protective equipment to disposable parts for powered air purifying respirators and testing equipment, Thuruthiyil said. Supply chain disruptions triggered disaster protocols and hospitals were forced to reuse disposable items to try and save lives.
“They were saying, ‘We know 3D printing allows you to make stuff. Is there anything you can do to help us?’ I never wanted to get into PPE [personal protective equipment]. That was a line of business I wasn’t interested in. But when the community asked, we thought we could help.”
Thuruthiyil and the PrinterPrezz team set to work to come up with solutions for the shortages.
“We were reverse-engineering and creating the designs ourselves,” she said “We could then share that with other people.”
PrinterPrezz went from additively manufacturing mostly spine-related technology to also producing a range of COVID-related necessities—face shields, test swabs—and more were coming off PrinterPrezz’s 3D printers and going directly into their local community. It was a new, shorter supply chain that directly benefitted the people in need around them.
“The interesting part is that they trusted us. They understood that we know what we are doing, that by adhering to the protocols in our facilities and leveraging the maker mentality of our additive manufacturing and clinical experts, we could engineer and deliver what they needed,” she said.
Her company took on a range of new challenges, and others followed suit. People and organizations that at other times competed with each other for business began sharing information and working together, Thuruthiyil said. Customers and universities called and offered help on design and engineering in order to move COVID-19-related projects along faster.
“There was a tremendous amount of collaboration,” she said. “It was new to everybody. We had to work together to figure out the fastest and most efficient way to do this because really, time was of the essence.”
In addition to contending with a shortage of raw materials and supplies, Thuruthiyil had to manage the team to minimize possible contagion and meet strict health protocols.
“I had engineers who were working all hours,” she said. “Not only did they have to work at the facility, they had to do it physically distanced. They all said, ‘Absolutely count us in.’ When there were shipments of PPE needed urgently, there were people that put them in their cars and took them [to hospitals and first responders]. There were things I couldn’t think of asking them to do, but I didn’t have to ask. I’m humbled by how much people gave of themselves to help.”
This cycle of giving has come full circle. A few months ago, Thuruthiyil heard her local fire department was conducting COVID testing for the community. The PrinterPrezz team coordinated a donation of face shields because PPE was extremely scarce at that time. In August as thousands of acres burned in the Bay Area, Thuruthiyill’s neighborhood came under an evacuation warning, and she found herself on the receiving end of that same fire department’s skills and expertise. She said that gave her an even deeper appreciation for her community coming together to care for each other.
She looked for and found helpers.
“I personally have always been a big believer in community,” she said. “This has been a great experience for me in how both the 3D printing community and the broader community pulled together to achieve something timely and important, leveraging our respective skill sets.”
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
With travel and human contact so deeply disrupted, the immediate results were clear—I wasn’t going anywhere. People were not coming to work. My kids were not going to school. But the effects were so much more significant and further reaching. It wasn’t just people that weren’t getting to the office, it was the raw materials we needed to support our work. It wasn’t just professional and leisure travel knocked off its tracks, it was our global supply chain.
At Empirical, we were more concerned with the shortage of raw materials from China than the run on toilet paper. The stifled supply of China-sourced raw materials has hit the medical device industry on all levels as well as so many other aspects of our country’s social and economic fabric.
As both an optimist and engineer, I knew there had to be solutions. Given the brain power and generosity of our industry, I knew I could follow the wisdom of Fred Rogers’ mother and “look for the helpers.”
I have not been disappointed. I’ve seen colleagues embrace new business models that put the greater good of the community ahead of the bottom line.
I found a profound example in my friend and client Teresa Thuruthiyil. She is chief strategy officer at PrinterPrezz, a company founded three years ago to meet the 3D printing needs of small- and medium-sized companies in the medical device space.
She has a small, close-knit team that works in an industrial park in Fremont, Calif. Thuruthiyil, her co-founders, and employees are active members of their local community in the San Francisco Bay area, an early pandemic hot spot.
“When COVID hit and shelter-in-place suddenly happened, overnight everybody was locked down. Within a week or so, I started to get calls from local hospitals, partners we’ve worked with in other capacities,” she said. “The supply chain had literally shut down overnight. Things weren’t moving.”
These hospitals were desperate for a wide range of supplies—everything from basic personal protective equipment to disposable parts for powered air purifying respirators and testing equipment, Thuruthiyil said. Supply chain disruptions triggered disaster protocols and hospitals were forced to reuse disposable items to try and save lives.
“They were saying, ‘We know 3D printing allows you to make stuff. Is there anything you can do to help us?’ I never wanted to get into PPE [personal protective equipment]. That was a line of business I wasn’t interested in. But when the community asked, we thought we could help.”
Thuruthiyil and the PrinterPrezz team set to work to come up with solutions for the shortages.
“We were reverse-engineering and creating the designs ourselves,” she said “We could then share that with other people.”
PrinterPrezz went from additively manufacturing mostly spine-related technology to also producing a range of COVID-related necessities—face shields, test swabs—and more were coming off PrinterPrezz’s 3D printers and going directly into their local community. It was a new, shorter supply chain that directly benefitted the people in need around them.
“The interesting part is that they trusted us. They understood that we know what we are doing, that by adhering to the protocols in our facilities and leveraging the maker mentality of our additive manufacturing and clinical experts, we could engineer and deliver what they needed,” she said.
Her company took on a range of new challenges, and others followed suit. People and organizations that at other times competed with each other for business began sharing information and working together, Thuruthiyil said. Customers and universities called and offered help on design and engineering in order to move COVID-19-related projects along faster.
“There was a tremendous amount of collaboration,” she said. “It was new to everybody. We had to work together to figure out the fastest and most efficient way to do this because really, time was of the essence.”
In addition to contending with a shortage of raw materials and supplies, Thuruthiyil had to manage the team to minimize possible contagion and meet strict health protocols.
“I had engineers who were working all hours,” she said. “Not only did they have to work at the facility, they had to do it physically distanced. They all said, ‘Absolutely count us in.’ When there were shipments of PPE needed urgently, there were people that put them in their cars and took them [to hospitals and first responders]. There were things I couldn’t think of asking them to do, but I didn’t have to ask. I’m humbled by how much people gave of themselves to help.”
This cycle of giving has come full circle. A few months ago, Thuruthiyil heard her local fire department was conducting COVID testing for the community. The PrinterPrezz team coordinated a donation of face shields because PPE was extremely scarce at that time. In August as thousands of acres burned in the Bay Area, Thuruthiyill’s neighborhood came under an evacuation warning, and she found herself on the receiving end of that same fire department’s skills and expertise. She said that gave her an even deeper appreciation for her community coming together to care for each other.
She looked for and found helpers.
“I personally have always been a big believer in community,” she said. “This has been a great experience for me in how both the 3D printing community and the broader community pulled together to achieve something timely and important, leveraging our respective skill sets.”
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
