As a patient undergoing chemotherapy, the last thing that should be on your mind is if you will receive the right dose of medication during treatment. And for parents of pediatric chemotherapy patients, where lifesaving doses are even smaller, trust in health care providers to deliver accurate measurement of medication doses is especially important.
One University of North Carolina at Chapel Hill startup is giving patients peace of mind with its novel, simple and affordable medical device. Assure Technologies, founded by Stephen Eckel, offers Precynge, a preparation-assist device that connects to the syringe and uses the volumetric process to provide consistently accurate and precise measurements for all drug preparations.
“We know that medication errors in pediatrics occur at a rate much greater than what anybody would want,” said Eckel, associate dean for global engagement and a clinical associate professor at the Eshelman School of Pharmacy. “If you are able to consistently measure accurate doses for even the smallest neonates, then one can bring safety and assurance to care that currently doesn’t exist.”
Neonatal and early pediatric patients are particularly vulnerable to medication errors. Studies have found that up to 17.8% of hospitalized children are subject to dosing errors, and an even higher medication error rate of 34.7% for children receiving pre-hospital care.
Precynge consistently provides a more accurate reading than the common syringe. Although minimal error rates are factored into the design of the syringes, human manipulation of the device through medication preparation can exaggerate this error further. For example, there may be a pediatric patient whose dosage of medicine should be 0.1 milliliter, a small but common volume for a dose. If a person is off 0.02 milliliter, this would be a 20% variation of the dose. For doses this small, this variation can occur because the manipulation of the syringe is extremely slight.
Although that variation might be a micro amount, a baby may not be able to handle that 20% dose variation. Unfortunately, there is no technology currently in the marketplace to minimize this variation. Precynge is looking to change that issue.
As part of his research at the Eshelman School of Pharmacy, Eckel was looking at the accuracy and precision of using syringes to measure chemotherapy dosing at UNC Medical Center. As he looked at what the physician prescribed, compared to what the pharmacy department was measuring, he discovered there were issues with accuracy and precision.
“At that point in time, I had responsibility at UNC Medical Center for the cancer pharmacy,” said Eckel. “We needed to make sure that we were accurately preparing exactly what the physician was prescribing and we couldn’t do that. It led me to try to identify certain technologies that we could implement to help improve patient care with chemotherapy dosing at UNC Medical Center.”
Eckel’s team quickly discovered there were no technologies used in hospitals to measure doses less than 1.0 ml, except the manual method, which has limited accuracy. As a result, he came up with the idea for Precynge.
In addition, Eckel wanted to keep the technology simple so that little training would be required for health care professionals to use the medical device. To further develop his idea for Precynge, Eckel turned to additional resources at Carolina.
“I worked with four undergraduates in the UNC biomedical engineering program,” added Eckel. “They were able to design and develop something that could help fix the problem. They did a fantastic job and had a unique way to think about it. In fact, the invention we worked on together led to a patent.”
As a UNC-affiliated startup, the Assure Technologies engaged with KickStart Venture Services, a core program of Innovate Carolina, which is the University-wide initiative for innovation and entrepreneurship at UNC-Chapel Hill. The KVS program supports faculty startup formation, business development and growth by providing coaching and mentoring, early-stage funding, connection with key service providers, management, investors and space. In addition, KVS offers commercialization awards of its own to Carolina IP-based companies, including Assure Technologies.
“The Kickstart Venture Services award was instrumental for us,” said Eckel. “We were able to conduct additional customer discovery as well as develop the working prototype that allows us to collect data needed for FDA approval and commercialization.”
As a faculty member and entrepreneur, Eckel appreciates the value and support of being part of the Carolina entrepreneurial community.
“I cannot say enough about the culture of UNC,” said Eckel. “Whether it’s the Eshelman School of Pharmacy, Kickstart Venture Services, NC TraCS or just talking to individuals in the ecosystem, everyone has been willing to lend their perspectives and thoughts.”
In addition to KVS, Eckel’s company has received support from a variety of campus programs, including the Eshelman Institute for Innovation, which worked with KVS to help fund grant writing services, as well as Innovate Carolina’s market landscape research service, which helps Carolina-based startups assess their technologies, the marketplace and potential investment funding.
Even throughout the COVID-19 pandemic, Eckel continues to gain momentum with Precynge and is looking to move the device through FDA regulatory approval as well as create a go-to-market strategy.
“We need to accurately dose the drug for the patient,” said Eckel. “Precynge is significantly more accurate and precise in measuring doses < 1.0 ml than a manual syringe, and there is nothing on the market that can be used for these small doses. With this device, we can accurately and repeatedly bring the exact dose to patients, even the smallest ones.”