– Successful results from the study are of great importance as we will use them as part of our upcoming FDA application for market approval in the US, says CEO Hanna Sjöström.
Lund-based Neola Medical has developed Neola, a medical device for continuous monitoring of oxygen concentration in the lungs of premature babies. The product enables healthcare professionals to detect and treat complications much earlier than is possible with current technology.
The company conducted a usability study this spring to see how well healthcare professionals in neonatal intensive care units interact with Neola. The aim was also to demonstrate that it is safe for its intended use.
Boston test center
The usability study was completed in March and the collected data has since been evaluated. The study 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 Johnson, 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 hear their positive feedback about the potential of Neola.
According to Magnus Johnsson, the nurses found Neola easy to use. They also saw the clinical benefit of lung monitoring, which could create good conditions for the product to be well integrated into neonatal intensive care.
Preparations for 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 marketing approval in the United States.
– Usability evaluation is a regulatory requirement from the FDA and in order to be approved in the usability study, it is necessary to be able to demonstrate that the product is safe to use and that risk-reducing measures are deemed effective, concludes Hanna Sjöström.