To Help Protect Vulnerable Newborns, Stanford Biodesigners Create New Tool
Stanford’s Biodesign Innovation course brings together multidisciplinary teams of graduate students to identify unmet medical needs, invent new health technologies to address them, and map the way forward to bring their solutions into patient care. The high-energy, project-based course attracts students with a passion for entrepreneurship and a commitment to using technology to improve healthcare.
Two individuals from the Biodesign Innovation course, Eric Chehab, a graduate student in bioengineering, and Carl Dambkowski, a medical student, became part of a team assigned to identify and address an important unmet need related to blood stream infections contracted in hospital settings. “Finding a specific and compelling need was our first and most significant application of the biodesign innovation process,” recalls Chehab. “Once you get the need right, everything else starts to fall into place.”
To better understand unmet needs related to these potentially deadly infections, the team launched a multi-pronged research effort. “We picked six areas of treatment involving catheters, which are often linked to blood stream infections. Then we dove into medical literature, public health information, and other online research to better understand the problem areas,” says Chehab. They were intrigued and troubled when they learned that, although pediatric patients require catheters far less often than adults, they acquire catheter-related infections at a rate that is five times higher.
Narrowing their focus to pediatrics, the team quickly learned that umbilical cord catheters, which are used to provide food and medication to low-birthweight newborns, have an especially high infection rate. “When we started pulling up pictures, we saw that the mechanism being used to hold umbilical catheters in place on tiny newborns was a bridge the nurses would make out of surgical tape. It didn’t look anything like the sleek, sterile devices that protect and support central line catheters in adults,” says Dambkowski.
Further research and interviews with nurses and doctors validated the need for a better pediatric solution. The overall market size was small—just 200,000 newborns receive umbilical cord catheters each year—but it was the need was compelling, with one in five of those babies acquiring a costly and dangerous infection, and 1,000 babies a year dying as a result. “All for a condition that is largely preventable,” says Dambkowski.
The team committed to inventing a solution. Key design challenges included the fact that the umbilical cord stump is naturally dying, and so must remain open to the air. And unlike an adult catheter, in which the central line is placed flush against the skin, the umbilical cord catheter line rises from the stump perpendicularly. They addressed these and other issues with LIFEBubble, a small, semi-rigid, open dome that can be taped to the baby’s skin to secure the catheter in place while protecting and isolating the umbilical area from infection-causing bacteria.
Although the device offered great promise, the team had other academic obligations to fulfill and temporarily put its project on hold when the class was over. Nearly a year later, Dambkowski brought the project to the attention of James Wall, a pediatric surgeon and the assistant director of the Biodesign Innovation Fellowship program. With Wall’s help, Dambkowski and Chehab secured a grant from the Coulter Foundation that allowed them to recruit new team members and begin to move LIFEBubble forward again. One of their first steps was to launch a series of studies that would help them refine and improve LIFEBubble’s design, including biologic testing to measure protection from bacterial contamination, mechanical testing to assess stability, and usability testing to get feedback from the NICU nurses who would be the actual users of the product.
“The user feedback has been especially valuable,” says Dambkowski. “While physicians like the idea of LIFEBubble, it’s the NICU nurses that actually have to put the device in place, and deal with it throughout the course of care. We learned that, in order for them to want to use it, it has to be quicker and easier than existing solutions, and not disrupt their established workflow.”
The nurses had other design requirements as well. “For example, we wanted to make it rigid to maximize stability, but the nurses were extremely uncomfortable with that,” says Chehab. “Babies are soft and delicate, so whatever you put on them has to be soft and delicate too.”
The team is currently in the final stages of bench testing and design iteration, and is working closely with a number of hospitals that are eager to help develop the device and participate in pilot testing. For their part, Dambkowski and Chehab are thrilled to be moving forward again and one step closer to protecting babies from preventable complications during their earliest days of life.