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.@en