THE CUSP OF COMMERCIALIZATION FOR A HIGH-PRIORITY, CLINICIAN-NEED-DRIVEN PEDIATRIC TECHNOLOGY
OUR ROLE IN THE TRANSFORMATION OF IV INFILTRATION
The Children’s Healthcare of Atlanta Pediatric Technology Center at Georgia Tech plays a multifaceted role in the development of life changing new medical technologies for pediatric patients.
“Every project to which we contribute our expertise and active available funding sources originates directly from clinician-stated, unmet needs for improvement in pediatric care,” said Chief Engineer Leanne West. “When I asked a group of doctors and nurses at Children’s Healthcare of Atlanta back in 2014 if we could fix one thing to improve patient care, IV infiltration was the answer.”
Enter Omer Inan, Professor and Linda J. and Mark C. Smith Chair in the School of Electrical and Computer Engineering, and Adjunct Professor of Biomedical Engineering at Georgia Tech. Inan joined the Institute in 2013. From his Institute bio, he received his “B.S., M.S., and Ph.D. degrees in Electrical Engineering from Stanford University in 2004, 2005, and 2009, respectively. From 2009-2013, he was a visiting scholar in the Department of Electrical Engineering at Stanford.”
“IV infiltration is a risk to patient safety. It can cause swelling, ballooning, tissue death and permanently disfigured skin,” Inan said.
From Georgia Tech Research Horizons,
“After an IV needle has been inserted into a vein, there are various factors that can cause it to leak, either just beneath the skin or even deeper, into surrounding tissues. This painful process of unintended leakage is called infiltration. In a related process called extravasation, the leakage of certain medicines like chemotherapeutic drugs directly causes tissue damage. Nurses are trained to catch these events before harm occurs, but mild cases of clinically insignificant infiltration are thought to happen with surprising frequency, at rates ranging from 23 to 87% in children. “
The Inan Research Lab at Georgia Tech focuses its work on physiological monitoring and modulation in the interest of designing technologies for human health and performance.
“I was aware of Omer’s lab and had high confidence in his ability to help deliver the technology to meet the stated clinical need,” West said. “We introduced him to Children’s Dr. Kevin Maher and pediatric nurses Lynn Pogue and Amy Parker. The team went straight into problem solving, design, and development for a device that seeks to significantly reduce, if not eliminate, the negative effects of IV infiltration in pediatric care.”
Again from Research Horizons:
The current setup of the device is a set of four electrodes connected to an iPod-sized electronics hub. A doctor or nurse places two of these electrodes above the IV site on the arm and two below. The hub contains the computing hardware and sensor circuitry that delivers and processes the bioimpedance signal.
Since the pilot study began, pediatric cardiac intensivist Zahidee (Saidie) Rodriguez has led the patient testing. Initial deployments identified a few unexpected challenges. Although small, the size of the device makes it ungainly for babies. Toddlers often kick and tear the device off their arms, and older children are a little easier. They dislike having one more thing attached to them when they are bored, bedbound, and sick.
“That was a good learning experience,” Rodriguez said. “That was very humbling,”
But when patients wear it, the device has proven its capability. In the 60 patients that the researchers have monitored, nurses have manually detected two overt infiltrations, logging them in the patients’ electronic healthcare records. Retrospective analysis of the sensor data taken from these patients shows that infiltrations were indeed happening, according to Mabrouk and Rodriguez, confirming the device’s ability to detect the events.
An Ecosystem of Medtech Expertise and Funding Aligns
Using her expertise in wearable health technologies, West supplements GTPT’s typical collaborative work to identify the unmet clinical need, activate funding sources, and make introductions to experts external to the Center including the FDA, GCMI, Pediatric Devices Consortiums, Biolocity, the Georgia Research Alliance, etc.
“Leanne played a leading, integral role on the project team from the very beginning,” Inan said. “Her expert input on engineering challenges and solutions made a direct impact on the project’s advancement at every point in its pathway toward future commercialization and expanded patient impact.”
The Last Mile and The Cusp of Commercialization
“Our stretch goal is that it might be used on every IV site,” Inan told Research Horizons. Children’s lists checking IVs as a priority ‘quality initiative,’ a vital task for ensuring high-quality patient care.
Through a combination of seed money from the Pediatric Technology Center, a seed grant from the Coulter Translational Research Program, funding and support from the Georgia Research Alliance, Georgia Tech Foundation, and endowment funding, the team has taken an unmet clinical need to a mature prototype and algorithm that is imminently ready for design freeze and is now on the cusp of translation towards clinical use following regulatory clearance and commercialization.
“If not for Georgia Tech Pediatric Technologies and Children’s Healthcare of Atlanta, we would have never worked on this problem,” Inan said. “We had an interesting bioimpedance wearable technology focused on an application for the U.S. Department of Defense (DARPA). Because this team from PTC matches unmet pediatric needs straight from the clinicians with the Institute’s considerable engineering expertise, funding sources, and ability to overcome inevitable roadblocks, we have matched the right technology with an unmet clinical need that will improve safety of pediatric care at scale.”
“We are actively planning for clinical studies and an FDA 510k submission, which we think has an outstanding chance of ‘winning clearance,’ West said. “The technology is as close to entirely de-risked for an industry partner to fully commercialize as it can possibly be. We can’t wait to see it reach its full potential.”