Neola Medical develops Neola., a medical device for continuous monitoring of the lungs of premature babies. The product is designed to detect complications better and faster, which enables early treatment and better care. The hope is that more neonatal babies will survive and live a life without serious disabilities. The company also believes that the system will be able to facilitate work in the neonatal intensive care unit, which should ultimately result in savings for the healthcare system.
Several activities are currently underway to prepare the product for market registration in the US. The most important component will be to conduct a clinical study in the country, to follow up on the good results seen in the Irish study conducted at the University of Cork. Another requirement for being allowed to launch medical devices in the US is to conduct a usability study to see how users interact with the product and that it is safe to use in a neonatal care clinic.
Usability study initiated
Neola recently announced that it has started just such a study, led by Custom Medical, who are specialists in the field. The study will be conducted during March at a study center in Boston and a total of 15 nurses from several neonatal intensive care units will participate. The participants have different levels of experience and will receive training in how to handle the system prior to the study.
Neola has previously agreed on the study design with the FDA and the final report will be part of the company's application to the agency for market approval. The results will also provide important information about how well the Neola product works as part of the US neonatal intensive care unit.
Comments from the CEO
BioStock has contacted Neola's CEO Hanna Sjöström to find out more about the study.
To begin with, how does a usability study like this work?
– The goal of the study is to see how well participants interact with Neola and demonstrate that it is safe for its intended use by healthcare professionals in neonatal intensive care units. The study is led by Custom Medical, who are global experts in usability studies and have designed the study design together with the Neola Medical team. During a pre-submission meeting with the US FDA, the study design has been agreed upon, which means that we now feel confident about initiating the study at a study center in Boston, USA.
– The study center is designed exactly like a neonatal intensive care unit and the study participants consist of 15 neonatal nurses with varying experience from several different neonatal intensive care units in the US. Neola Medical employees will be on site to train the study participants in the use of Neola. After the study is completed, the collected data will be evaluated.
What are the most important requirements for a medical device to be considered to have passed a usability study?
– 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 reduction measures are deemed effective.
From the outside, Neola seems to be a relatively safe product to use, but is there anything that you see that could be a challenge for users?
– The product has been developed and designed in close collaboration with neonatologists and neonatal nurses to fit into the workflow, as well as to be as user-friendly as possible.
– An independent study by an Irish research team at the INFANT Center at University College Cork showed that Neola, in a research version, and our GASMAS technology are safe to use and well tolerated in premature infants. The study successfully performed measurements with Neola on 100 newborns and overall this provides some reassurance ahead of the usability study in the US and we do not expect any particular challenges for users.
Finally, when do you expect the results from the study?
– The study report is expected for evaluation in the spring and the results will be part of the application we submit to the FDA to obtain market approval in the US.