BME Professor of Practice Develops Life Saving Medical Device
A new medical device developed at The Ohio State University could mean the difference between life and death in high-stress combat and trauma situations.
Bleeding to death is the leading cause of preventable fatalities, including 90% of combat and 40% of civilian fatalities. Nearly 20% of these deaths occur due to uncontrolled bleeding at the junction of the torso and an appendage, such as the armpit or groin region.
Tanya Nocera, a biomedical engineering associate professor of practice, co-invented the Journiquet™, a noninvasive, single-use medical device designed to stop junctional bleeding quickly and effectively. It can be deployed within approximately 20 seconds in high-stress environments such as the battlefield, motor vehicle crashes and active shooter situations. Nocera is also a co-founder and vice president of research and development for startup company HDO Health, which has licensed the technology.
“While specialized junctional tourniquets exist in the market, they require multi-step assembly, use of fine and gross motor movements, and have a high-rate of displacement during patient transport,” Nocera said. “Our big priorities with this device were quick application, use of gross motor skills only, and that it remains lightweight and compact, which is particularly important in the military setting.”
Usability was another important aspect to the team so that the technology could be accessible to the civilian population as well, such as law enforcement and emergency medical services.
The Journiquet™ has been several years in the making, according to Nocera. It started in 2017 when she was mentoring a senior capstone team of Integrated Business and Engineering students who were tasked with solving a medical device challenge. The team collaborated with J. Allen McElroy, MD, trauma surgeon and, at the time, surgery and critical care fellow at Ohio State’s Wexner Medical Center, and his colleague Nadi Graham, an Ohio State Highway Patrol officer and member of its special response team. With their backgrounds in tactical medicine, McElroy and Graham knew the limitations of existing junctional tourniquets and had ideas on how to improve them.
“We worked with the capstone students to define the root of the problem and what the market landscape would be like, and what kinds of opportunities were out there,” said Nocera. “The students had some concept ideas, but nine months goes by really fast. They all graduated and went on to the next steps in their careers. But Nadi and Allen were really passionate about continuing to move forward.”
Nocera, McElroy and Graham pushed ahead, utilizing as many Ohio State resources as possible. A voucher from the Center for Clinical and Translational Science paid for the opportunity to work with the Center for Design and Manufacturing Excellence (CDME) to design a prototype of the device. In 2020, the team earned a $150,000 Accelerator Award, which supports external validation and de-risking activities to demonstrate commercial viability of a technology. Administered through the Keenan Center for Entrepreneurship, the program is funded by the university with matching funds from the Ohio Third Frontier Technology Validation and Startup Fund.
The Accelerator Award allowed the group to continue collaborating with CDME along with faculty Michael Rayo and Gary Allread from the Department of Integrated Systems Engineering to enhance the ergonomics and usability of the device. By 2021, the team had produced some early-stage functional prototypes and by 2022, they had a new CEO on board, Ohio State alumnus Bryan J. Stewart. Together the group formed HDO Health, which stands for “heart led, data driven, outcome focused.”
The company has earned additional funding to advance its patent-pending tourniquet technology and is receiving support from Rev1 Ventures, a startup studio and incubator in Columbus.
Nocera and the HDO Health team recently received positive feedback from the Food and Drug Administration (FDA) on a preliminary submission to determine if their proposed testing plans align with requirements for a full FDA approval application.
“We're really excited and hopeful that by the end of this year we will be on our way toward, or even have FDA clearance so that we can take this device out to the people who need it,” said Nocera.
The team is also hopeful that the Journiquet™ is the first of many life-saving technologies they can produce.
“We don't want HDO Health to just be this ‘one and done’ medical device start-up,” Nocera continued. “We have an amazing advisory board that has expertise across military, law enforcement, trauma surgery and engineering. There are so many opportunities in that space that we could innovate within and other challenges we can solve.”
Nocera is excited to train other engineers to solve similar challenges. She is currently working on a new master’s degree track within BME focused on medical product development.
“It’s the perfect embodiment of all the things I saw myself doing some day,” she said. “Using my skill set as a biomedical engineer to help make a difference and improve or save someone else's life, along with the ability to train students—I’m just very fortunate.”
Piece originally appeared on COE website