MHealthFQ
MHealthFQ: Self-care system for pancreatic enzyme therapy in cystic fibrosis via a mobile app.
Cystic fibrosis (CF) is a genetic disease that causes pancreatic insufficiency and requires enzyme replacement therapy for adequate nutritional status. However, patients lack a method and support tool that allows them to adjust the enzyme supplement dose to the characteristics of each food, leading to malabsorption, weight stagnation and a reduced quality of life in paediatric patients. To address this challenge, our group carried out an R&D&I project funded by the Horizon 2020 programme. We established a method based on scientific evidence, which was integrated into a mobile self-management app. The use of this app in a European multicentre clinical trial demonstrated an improvement in clinical indicators. However, the self-management system does not meet the legal and quality standards required to obtain the CE mark, thus preventing its use as a medical device, and it is therefore not currently available to patients.
This project proposes the refinement of the system, including development in accordance with strict quality standards that will enable the transformation from an experimental app to a medical device. The work plan brings together multidisciplinary tasks, from advanced modelling of experimental results for a more robust predictive algorithm for the optimal enzyme dose, to the development of software in accordance with the relevant regulations for medical devices. The objectives also include identifying a suitable technology company as a candidate to certify the system with the CE Mark, making the app a valid and functional tool that can overcome innovation barriers and reach clinical practice through the defined business model.