Authors:
Jordi Escuder Tisaire
1
;
Elena Martín Rodrigo
1
;
Sofia Ribeiro
2
;
Mariachiara Ricci
3
;
Juan Sebastian Cuellar
4
;
Dimitrios Zeugolis
5
;
Yves Bayon
6
and
Isabel Rocha
7
Affiliations:
1
Universitat de Barcelona (UB), Gran Via de les Corts Catalanes, 585, Barcelona and Spain
;
2
Medtronic, Sofradim Production, Avenue du Formans 116, Trevoux, France, Regenerative, Modular and Developmental Engineering Laboratory (REMODEL), National University of Ireland Galway (NUI Galway), University Road, Galway and Ireland
;
3
Department of Electronic Engineering, University of Rome “Tor Vergata” (Rome), Via del Politecnico 1, Rome and Italy
;
4
Department of Biomechanical Engineering, Delft University of Technology, Mekelweg 2, Delft and The Netherlands
;
5
Regenerative, Modular and Developmental Engineering Laboratory (REMODEL), National University of Ireland Galway (NUI Galway), University Road, Galway, Ireland, Science Foundation Ireland (SFI), Centre for Research in Medical Devices (CÚRAM), National University of Ireland Galway (NUI Galway), University Road, Galway and Ireland
;
6
Medtronic, Sofradim Production, Avenue du Formans 116, Trevoux and France
;
7
Faculty of Medicine and Cardiovascular Centre of University of Lisbon, Avenida Professor Egas Moniz MB, Lisbon and Portugal
Keyword(s):
Breast Cancer, Bioimpendance, Lymphedema, Screening, Self-Monitoring.
Abstract:
Lymphedema is a chronic and progressive condition derived from impaired lymphatic system function. Lymphedema is incurable, progressive, disfiguring, disabling and has adverse psychosocial effects. Upper extremity lymphedema is mainly the consequence of breast cancer surgery. Several methods to diagnose lymphedema exist; however, these diagnoses are performed once the disease is already close to an advanced, irreversible stage. There is a need to monitor patients at risk with an efficient device. To solve this unmet need, we propose a portable home-monitoring device for early diagnosis of lymphedema. This paper explores all the aspects of the development of a new medical device, such as the assessment of the clinical need and the state of the art, the specifications for the solution, the definition of the broad outlines of the development plan and some considerations about the usability, the risk analysis, the market and the competitors.