Early feasibility studies, "allowing us to have a certain set of information with a good margin in advance of the start of the actual clinical investigation activities, provide elements of safety and effectiveness that can prove fundamental for understanding whether it is useful to start the subsequent experimentation and, if necessary, how to structure it appropriately.
It is an activity that translates into the timely identification of innovative devices and acceleration of patient access to these technologies and with potential benefits also in terms of sustainability".
The Minister of Health Orazio Schillaci explains this in his speech at the event “Early Feasibility Studies (EFS) for medical devices in Italy: a possible way?”, in which the results of an early feasibility study project on a medical device in the neurological field.
The project is the result of the development of discussions between the Ministry of Health and the Agostino Gemelli Irccs University Polyclinic Foundation, leader of a group which also includes Crea Sanità and Crispel (Interdepartmental Research Center for Political-Constitutional and Legislation Studies compared).
According to the minister, feasibility studies are “an innovative methodology, still little used in Italy, but which in other contexts constitutes a consolidated reality.
The hope is that starting from this project, early feasibility studies can find adequate and future locations also in Italy".
“I believe that - continues Schillaci - the approach tested for this project is a good practice to be promoted and encouraged.
An institution such as the Ministry of Health, when the conditions are recognized and in strict compliance with the different roles, must interface proactively with the various interlocutors to ensure that the related activities are conducted in coherence and, indeed, with a view to development with the objectives of the National Health Service".
"Another element of interest is also the object of the study - he adds -: a medical device for the home rehabilitation of neurological patients suffering from various pathologies (Parkinson's, stabilized stroke and multiple sclerosis), which allows carrying out, in a guided manner, autonomy and safety various exercises directly at your home. Furthermore, a non-secondary aspect, the patient will receive real-time feedback on the correctness of the movement performed".
"A virtuous inter-institutional collaboration - he concludes - today gives us a study that fully fits into that healthcare model that we are all working on: healthcare that is increasingly closer to the patient, allowing him to deal with the disease using the best the system can offer".
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