As the famous proverb states, “Necessity is the mother of invention.” And it was necessity that inspired a team of entrepreneurs and manufacturers from Southern Maryland to invent a device capable of solving a critical problem for health care workers as they continue to battle the ongoing COVID-19 pandemic.
Tommy Luginbill is the director at TechPort, a UAS Business Incubator and Community Innovation Hub located in the St. Mary’s County Airport Innovation District. Matt Hayes is the owner and founder of Unmanned Propulsion Development, a manufacturer of hybrid power systems for unmanned aircraft headquartered within TechPort. In March, after the pandemic shut down the majority of their operations, Luginbill, Hayes, and a few of their TechPort colleagues put their heads together to try to come up with a way to help during the crisis.
“There were just a few of us left in the large, empty TechPort building, which gave us a safe workspace to start designing and prototyping products to support people during the pandemic,” says Luginbill. “We started out making masks and face shields, but the demand for PPE was so high, it was just impossible to keep up. Then we realized what health care facilities really needed was a method to clean and reuse the PPE they already had.”
After experimenting with different methods – including UV light, which wasn’t practical because the lightbulbs were expensive and hard to obtain, and hydrogen peroxide, which was too energy intensive to make and too hazardous to use safely – Hayes came up with the idea to build a giant oven that would clean PPE by simply “baking” it with dry heat.
The idea grew from concept to reality in record time. To get the prototype of the oven developed, Hayes established a 501c(3) non-profit organization, Southern Maryland Loves You, and began reaching out to local manufacturers for potential partners. When they approached Triton Defense, who specializes in building electromagnetic (EMP) and high-altitude electromagnetic pulse (HEMP) protection modules that were similar in concept to the oven Hayes had designed, they quickly jumped in to help.
“When Matt first came to us, he asked us if it was possible to sandblast and paint existing containers in about four days, which we couldn’t do,” says Jason Norris, vice president of Operations at Triton Defense. “But once we understood his idea, we realized it would be much faster to design and build the structure if we started with raw materials. We knew it was for a good cause, and we wanted to do our part to help the community, so we offered to donate our time and the materials. Our management team was heavily involved, and I put five or six of my top guys on the project, and we worked to get it done as quickly as we could.”
Using galvanized steel and A36 grade steel, Triton built the model within one week. At the same time, local heating contractor Burch Oil volunteered to install the oven’s HVAC equipment, and Southern Maryland Loves You soon had a working prototype of their 16-feet long, 8-feet wide, and 8-feet high “Hot Box”, officially named the Semi-Automated Heat Bioburden Reduction Module.
With the Hot Box built, the team now needed a partner to test it and ensure it was indeed effective in cleaning PPE for repeated use.
“We called the University of Maryland Charles Regional Medical Center in Charles County, because they seemed like the perfect fit for us, given they were in our local health care community, and both they and TechPort are in the University of Maryland System,” says Luginbill. “We offered to donate the Hot Box to them in exchange for helping us test it, and the CEO of the hospital said, ‘this is exactly what I need’ and agreed. Within a week of assembling it, we set up the prototype outside the hospital and started running tests and collecting data we could provide to the FDA.”
With guidance from the FDA, the team tested to make sure their dry heat process effectively reduced the biomass of the COVID-19 virus, as well as other viruses and bacteria, without hurting the integrity of N95 masks and other PPE equipment. Even Dr. Peter Tsai – the retired scientist who invented the N95 mask, got wind of their research and reached out to offer his advice and guidance.
After eight months of testing and submitting data, in November, the Southern Maryland Loves You team achieved a significant milestone – the FDA published new guidelines on using dry heat to support single-user reuse of N95 masks and verified the Semi-Automated Heat Bioburden Reduction Module falls within these guidelines and has a Tier-3 Rating in the Bioburden Reduction Module category. This announcement officially allowed staff at UM Charles Regional Medical Center to reuse their N95 masks after being treated in the Hot Box and allowed Hayes and Luginbill to begin offering the device to other health care facilities. To date, they have already sold three modules – two to the St. Mary’s County Health Department and one to the Charles County Health Department – and are currently working with Triton Defense and Burch Oil to fulfill these orders.
“We came up with a concept and proved that it worked,” says Luginbill. “It had never been proposed to the FDA that dry heat could be used to kill a virus.”
Capable of cycling 24,000 masks per day, the Hot Box can dramatically impact a hospital’s ability to fill its PPE needs and protect staff as they care for patients through the most recent surge of COVID-19 patients. Luginbill and Hayes are now applying for 510(K) Clearance with the FDA, which will allow them to make the Hot Box more widely available, hopefully to government agencies and first responders. They are also continuing the collect data for the FDA to prove the Hot Box can also be effectively used on gloves, gowns, and other PPE equipment.
This story is just one example of how Maryland’s manufacturing community has demonstrated its innovation and resourcefulness throughout this crisis. It also proves Maryland’s manufacturers are, in fact, a community, as small and large business owners alike came together to bring an idea to fruition that would help people in need.
“When we first came up with this idea, not a lot of people took us seriously. Mike Kelleher at Maryland MEP was one of the first people who took us seriously and pledged his support for a grant application, and that meant a lot to us,” says Luginbill. “Then, the fact that we were able to gain support from an established metal manufacturing facility and a large HVAC company who both generously donated their materials, time and manpower to help us build the prototype so quickly – that support made all the difference in getting this done and helping us move forward. Now, we encourage anyone who likes our idea to please tell other people about it and share it with your local legislators – our Hot Box is not an expensive product, it’s simple to use, and it will drastically help our medical community.”
To learn more about the Semi-Automated Heat Bioburden Reduction Module, please visit https://www.somdlovesyou.org/.