Neola initiates usability study ahead of FDA approval
Lund-based Neola Medical continues to advance towards clinical studies with its lung monitoring system. The company is now starting a usability study – an important part of the process to be able to launch the product in the US. BioStock spoke to CEO Hanna Sjöström to find out more about the study.
Neola Medical develops Neola, a medical device for continuous monitoring of the lungs of premature infants. 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 unconstrained by serious disabilities. The company also believes that the system will be able to facilitate the work at the neonatal intensive care unit (NICU), which, in the long run, should provide 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 conducting a usability study to observe how users interact with the product and make sure that it is safe to use in neonatal care clinics.
Usability study initiated
Neola recently announced that it has started such a study, which is led by Custom Medical, who are specialists in the field. The study will be conducted this March at a study centre 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 for the study.
Neola has previously checked the study design with the FDA, and the final report will be part of the application that the company submits 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 NICUs. The study is led by Custom Medical, who are global experts in usability studies and have designed the study together with Neola Medical’s team. During a pre-submission meeting with the FDA, the study design has been reconciled, which means that we now feel confident in initiating the study at a study centre in Boston, USA.
– The study centre is designed just like 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. Neola Medical’s employees will be on site to train the study participants in the use of Neola. After completion of the study, the collected data will be evaluated.
What are the most important requirements for a medical device to be considered to pass a usability study?
– 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 mitigation measures must be deemed effective.
From the outside, Neola seems to be a relatively safe product to use, but is there anything that you see 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, and to be as user-friendly as possible.
– An independent study by an Irish research team at the INFANT Centre at University College Cork showed that Neola, in a research version, and our GARMAS technology are safe to use and well tolerated in premature babies. In the study, successful measurements were carried out with Neola on 100 newborns . All in all, it provides some reassurance ahead of the usability study in the US and we do not expect any particular challenges for the users.
Finally, when do you expect the results of the study?
– The study report is expected for evaluation in the spring, and the results will be part of the application that we submit to the FDA to obtain market approval in the US.
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