Neola’s CEO: “The results from the usability study confirm our product”
Neola Medical’s lung monitoring is user-friendly and safe. These are the results of the usability study cunducted during the spring.
– Successful study results are of great importance as we will use them as part of our upcoming FDA application for market approval in the US, says Neola CEO Hanna Sjöström.
Lund-based Neola Medical has developed the medical device Neola, for continuous monitoring of oxygen concentrations in the lungs of premature infants. The medical device enables healthcare professionals to detect and treat complications much earlier than is possible with today’s technology.
During the spring, the company conducted a usability study to see how well healthcare professionals in neonatal intensive care units interact with Neola. The aim has also been to demonstrate that it is safe for its intended use.
Test centre in Boston
The usability study was completed in March, and the collected data has since been evaluated. It was conducted at a test center in Boston in collaboration with Custom Medical, who are global experts in usability studies.
– The study center is designed as a neonatal intensive care unit and the participants in the study consist of 15 neonatal nurses with varying experience from several different neonatal intensive care units in the US, says Neola’s CEO Hanna Sjöström to BioStock.
Positive feedback from the nurses
A number of employees from Neola Medical were on site to train the study participants in the use of Neola. Magnus Johnsson, Director Quality Assurance and Regulatory Affairs, was one of them: Top of the form
– It has been valuable to be on site and see the implementation of the usability study. We have had the opportunity to meet and train the participating neonatal nurses and heard their positive feedback about the potential of Neola.
According to Magnus Johnsson, the nurses found Neola easy to use. In addition, they were able to see the clinical benefit of lung monitoring, which can create good conditions for the product to be well integrated into neonatal intensive care.
Preparing for the FDA application
Neola Medical designed the study after consultation with the US Food and Drug Administration (FDA), in a so-called pre-submission meeting. The final results will be used as part of the company’s upcoming FDA application for market approval in the US.
– Evaluation of usability is a regulatory requirement from the FDA and in order to be approved in the usability study, it is required to be able to demonstrate that the product is safe to use and that risk reduction measures must be deemed effective, concludes Hanna Sjöström.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
