UNIVERSITY PARK, Pa. -- In 2008, Actuated Medical Inc., a Centre County company that develops, manufactures and markets medical devices, needed feedback on a new product under development: a system for clearing clogged patient feeding and decompression tubes.
Through her own research, company President Maureen Mulvihill discovered a publication by Janice Penrod, director of the Center for Nursing Research at Penn State’s College of Nursing, reporting a study of patient comforting techniques used by nurses during insertion of nasogastric tubes. Believing the Penn State nursing faculty could provide the assistance she needed, Mulvihill contacted Penrod about the possibility of conducting a usability study.
“We wanted feedback from clinicians — potential users who could tell us if it was easy to operate and use correctly,” Mulvihill said.
Penrod and assistant professor Lisa Kitko lent their research expertise as nurse consultants, conducting focus groups in local health care facilities and gathering feedback from more than 70 clinicians.
“It’s great that Actuated Medical had the foresight to involve end users — the nurses — in their product development process,” Kitko noted. “That’s not typical in health care product development.”
Actuated Medical’s TubeClear system uses a mechanical motion technology to clear clogs in tubes without removing them from the patient, which can be costly and disruptive to patient care.
“Previously, when a tube clogged, the nurse had to take it out and replace it,” Kitko noted. “Additional procedures like these can be uncomfortable and risky for patients. They can also delay feedings and medication delivery, which further impacts patient care in a negative way.”
“Clogging is a significant problem that occurs in about 25 percent of feeding and decompression tubes,” Mulvihill said. “With the TubeClear system, we had the potential to make a significant impact on the bottom line by saving hundreds of thousands of dollars annually for a typical health care facility. But before we could get clearance from the U.S. Food and Drug Administration (FDA) to market TubeClear, we needed to meet standards for end-user testing and training.”
Pilot testing was conducted in focus groups where testers were instructed on how to use TubeClear and then had a chance to try it out on a benchtop model. The testers came from a variety of backgrounds. Some worked in health care settings such as hospitals and long-term care facilities. Others were nurse educators responsible for teaching procedures to nursing students.
Once the testers had a chance to try the product, they provided feedback on its functionality and ease, which proved invaluable in helping Actuated Medical to make necessary improvements.
“In the initial trials, nurses felt the device was too noisy,” noted Kitko. “It was uncomfortable to hold. They didn’t like the size.”
Once adjustments were made, the next step was to test the device in a patient care setting — a necessary step for obtaining FDA approval. For this purpose, Actuated Medical utilized the College of Nursing’s Simulation Laboratory, which has high-tech mannequins that simulate conditions nurses are likely to see in live patients.
Faculty and staff from both the college and company took part in producing a training video to instruct users on how to set up and operate TubeClear correctly. The finished instruction video is available on the TubeClear website.
“It was such an advantage to use the Nursing Simulation Laboratory because we didn’t have the resources ourselves,” Mulvihill noted. “They were instrumental in helping us produce a professional-level training video. We couldn’t have done it without Penn State.”
When testing was complete, TubeClear received FDA clearance for U.S. sales. Currently, Actuated Medical has clearance for TubeClear models specific to four types of feeding and decompression tubes: nasogastric, nasoenteral, gastrostomy and jejunostomy. The system — marketed directly to clinical professionals — is also CE marked for sales in Europe, the Middle East and North Africa. TubeClear is a finalist for Pennsylvania Bio’s 2013 Patient Impact Award; the winner will be announced in March.
This example of “translational science in action — from lab to bedside to market" — benefits all parties involved, said Penrod.
“It’s a perfect case of integrating engineering with clinical nursing to produce medical devices that meet patient needs,” she added. “The College of Nursing was involved from initial concept through development and testing, then creating instructional materials. FDA clearance now opens the door for use in clinical settings.”
For practicing nurses, Kitko said, “the device not only makes their job easier, but also has profound implications for improved patient outcomes.”
And Mulvihill summed up her perspective: “The focus groups and the chance to use the simulation setting were a huge asset for a small business with limited resources. The College of Nursing truly helped a small business succeed.”