Study of critical medical devices towards an open-source implementation

Details

Supervisors

Bol, David ; Herman, Benoît

Faculty

Ecole polytechnique de Louvain

Degree label

Master [120] : ingénieur civil électricien, à finalité spécialisée

Abstract

The World Health Organization (WHO), the United Nations’ specialized agency for international public health, states in its constitution of 1946 that: “The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition”. Many aspects must be combined to achieve this optimal state. Among these aspects, Medical Devices (MDs) play an indispensable role. A new way of designing Medical Devices is emerging. This is the creation of open-source devices, i.e. allowing anyone to freely use, copy, modify and redistribute, under defined conditions, the result of development. What could this method bring to the development of classic medical devices? It could help address two major problems in the medical device industry. Firstly, open-source medical devices might turn out to be useful in crisis situations affecting the availability of critical devices. For this, upstream documentation work is essential to tackle such a crisis. Secondly, it could well overcome some of the barriers to access to medical devices worldwide. In this work, these promising ideas will be put into perspective with feedback from the replication of an open-source medical device solution. The solution chosen is a multi-parameter patient monitor, the HealthyPi from Protocentral . This work is in line with Open Medtech’s commitment to develop open-source medical devices. The latter is a non-profit organization that emerged following a spontaneous initiative to design an open-source repirator during the covid 19 crisis.