- As seen in the case of wireless sensors being developed for infants in the NICU, the process of getting new healthcare technology to market can be demanding.
- Researchers are working to prove that the new technology provides the same or better quality of care while enhancing the patient experience.
- The new technology also shows the potential to lower costs by reducing complications in care episodes and allowing clinicians to do their jobs more efficiently.
A Northwestern University interdisciplinary team of engineers, materials scientists, pediatricians and dermatologists has developed wireless sensors to monitor infants’ vital signs in hospital NICUs. Although the sensors show potential to provide the same level of care as the previous standard but in a more efficient way, rolling out new technology in the highly regulated healthcare industry takes substantial time and effort.
“Any technology that offers a new window of safety or an enhancement to an existing technology is something that could improve care,” says Mitchell Goldstein, MD, chair of the Executive Committee of the American Academy of Pediatrics’ Section on Advances in Therapeutics and Technology. “But it’s also important for any technology produced to be accompanied by evidence-based solutions.”
Through testing on infants at two of Northwestern Medicine’s Chicago-based facilities, Prentice Women’s Hospital and Ann & Robert H. Lurie Children’s Hospital, researchers note the sensors’ capacity to improve quality of care and control costs.
Collaborating to evaluate new technology
Cross-functional collaboration between researchers and providers is essential to developing devices that ensure the same or better quality of care, testing innovations on human subjects and ensuring proper approvals. All parties adhere to Northwestern’s stringent conflict-of-interest policy.
“In developing this technology, the most important thing that we have done is directly engage with the NICU nurses,” says study researcher Steve Xu, MD, medical director of the Center of Bio-Integrated Electronics at Northwestern, instructor of dermatology at the Feinberg School of Medicine and dermatologist at Northwestern Medicine. “They’re the ones who truly understand the problem and appreciate what we’re trying to do.”
How the vetting process showcases the potential ROI of wireless sensors
The current standard of care for infants in the NICU is hard-wired sensors, which consist of adhesives and multiple wires to monitor vital signs. While providing essential data, this technology also presents challenges such as limiting infant movement, interfering with skin-to-skin contact and complicating basic clinical care. Additionally, the adhesives may injure infant skin, potentially resulting in additional health risks such as sepsis.
To conduct a side-by-side comparison, a Northwestern research team has tested the wireless technology alongside traditional monitoring on more than 80 infants ranging from 11 weeks preterm to full-term. The results have indicated that wireless sensors provide the same needed data, improve patient experience and may control costs.
Enhancing quality of care. Featuring one sensor placed on the infant’s back or chest and the other wrapped around a foot, the new technology captures the same information as the wired-based sensors, including heartbeat, breathing, blood oxygen and blood pressure. The sensors send data through transmitters under crib mattresses to an external device at the nurses’ station.
The wireless sensors also capture information that isn’t readily available using wired sensors, such as differences in temperature between the foot and the chest to better determine blood flow and cardiac function. Infants can continue wearing these devices during X-rays, MRIs and CT scans, ensuring more comprehensive data is gathered.
“Providing the same monitoring, these devices eliminate so much manipulation when it comes to picking up the babies, the parents’ ability to hold them and having to worry about tangled wires,” says study researcher Aaron Hamvas, MD, Raymond & Hazel Speck Berry Professor of Neonatology and chief of neonatology at Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University Feinberg School of Medicine. “The real ROI is going to be the ease of handling the babies.”
The wireless technology more easily facilitates skin-to-skin contact. In patient surveys, parents of infants participating in the study have responded that these devices contributed to a more positive NICU experience by decreasing barriers to critical physical and emotional bonding. Ensuring skin-to-skin contact has other potential value, such as an estimated 78% reduction in risk of hypothermia. Additionally, providers are better able to determine the benefits of skin-to-skin contact by continuing to measure vital signs while parents hold their infants.
Controlling costs. The research team anticipates these devices — averaging about $30 per day and covered under the existing DRG — will cost the same as the wired sensors.
Lighter-weight and requiring less adhesive strength to stay attached, these elastic silicone sensors are gentler on infant skin. Testing has not found evidence of skin damage resulting from the sensors, demonstrating the potential to deliver additional value by better preventing complications such as sepsis, which can cost up to $12,000 per case.
“So much time goes into working around all these wires, and being able to reduce that labor and effort leads to more productivity,” Xu notes. “Our nursing colleagues have indicated the time-savings benefit of this technology.” The research team has trained more than 50 NICU nurses to use the wireless sensor system. In staff surveys, users have noted reduced labor time from the technology, which can produce up to $2,000 in cost savings per nurse per year.
With the wireless sensors communicating data to a central device instead of to individual monitors, there is the potential for vital savings for smaller hospitals.
Next steps in bringing the technology to market
The research team expects to receive initial FDA approval for the technology’s use as physiological sensors in early 2020, estimating rollout to hospitals in the next two or three years. Additional approval will be required for use in the critical care setting, and researchers continue to examine long-term benefits as well as potential utilization on infants at gestational ages as young as 23 weeks.
In addition to wider implementation, researchers are also testing enhanced functionalities such as algorithms that can identify trends in vital signs to alert staff to potential dangers, including cardiopulmonary arrest, before they occur.
As researchers navigate regulatory approvals and the implementation process, they continue to explore ways to increase the value of care. “The focus is really making technology work for us, and so anytime we can get more information in a more efficient fashion, that’s where a lot of this is going,” Hamvas says.
Interviewed for this article: Mitchell Goldstein, MD, FAAP, chair, Executive Committee of the American Academy of Pediatrics Section on Advances in Therapeutics and Technology; professor of pediatrics at Loma Linda University Children’s Hospital, Loma Linda, Calif.; and emeritus medical director of the NICU at Citrus Valley, West Covina, Calif. … Aaron Hamvas, MD, Raymond & Hazel Speck Berry Professor of Neonatology and head of the Division of Neonatology, Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University Feinberg School of Medicine. … Steve Xu, MD, instructor of dermatology at the Feinberg School of Medicine, dermatologist at Northwestern Medicine and medical director of the Center of Bio-Integrated Electronics at Northwestern.