User-Centered Design in Medical Devices: A Methodological Framework for Resilient Lymphedema Management
摘要
Lymphedema, a chronic and progressive condition caused by damage to the lymphatic system, affects 140 to 250 million people worldwide and poses significant challenges in the healthcare domain. This paper explores the application of user-centered design methodologies in the development of an orthopedic device to help manage lymphedema in upper limbs. By detailing the iterative design process and the incorporation of multidisciplinary expertise, this research highlights how user-centered design influenced the decisions and outcomes of medical device development, with a specific focus on lymphedema management. The iterative design process led to the creation of functional prototypes capable of mimicking manual lymphatic drainage techniques with dynamic and adjustable compression patterns. Early evaluations with healthcare professionals and representative participants highlighted the device’s comfort, practicality and potential to enhance self-management in home-care settings. While clinical testing with patients remains to be conducted, the results demonstrate a promising alternative to existing solutions, emphasizing the importance of user feedback in achieving a balance between technical performance and user-centered features.