Designing a Wearable Hemodialysis System: a Human Factors Engineering Approach

Abstract

End-stage renal disease (ESRD) is a medical condition of permanent kidney failure requiring a patient to either receive a kidney transplant or adhere to long-term dialysis treatments. Dialysis is a life-sustaining method of cleaning and filtering a patient's blood using a dialysis device. The majority of ESRD patients receive hemodialysis treatments where the patient's blood is cleaned and filtered outside of the patient's body using a hemodialysis system. Current hemodialysis systems have not been significantly updated since first pioneered in 1943. Patients still carry a high symptom burden with loss of mobility and independent living while undergoing treatment. However, recent technological advances in hemodialysis treatments allow for the development of a new generation of wearable hemodialysis systems bringing hope to improve ESRD patients' quality of life. Despite the potential to transform the lives of dialysis patients, many obstacles have impeded the development and use of a wearable hemodialysis system. One major hindrance to its development is the lack of adopting a human factors engineering design process that incorporates users' perspectives throughout the entire design process. To this day, no studies exist that gather and characterize the perspectives of distinct user groups at the beginning of the design cycle for a wearable dialysis system. This dissertation aims to fill that gap. The overall goal of this dissertation is to identify users' perspectives on a wearable hemodialysis system. In particular, by gathering responses from distinct user groups and employing both qualitative and quantitative methods, this dissertation aims to answer four research questions: (R1) what are patients' and care partners' needs and perspectives of a wearable hemodialysis system? (R2) What are patients' and care partners' needs and expectations for monitoring and training procedures for a wearable hemodialysis system? (R3) What are clinicians' perspectives on a wearable hemodialysis device? and (R4) What is the relationship among user characteristics, human factors design principles, and proposed design concepts of a wearable hemodialysis device? The results from research questions R1-R3 aim to help developers of a wearable hemodialysis system set design and usability goals to help ensure an optimal design process with a resulting system that meets and supports users' needs. Additionally, the results from research question R4 aim to help developers better understand the relationship among users' demographic characteristics, human factors design principles for wearable medical devices, and designs of a wearable hemodialysis device. Understanding this relationship may help identify important factors that contribute to users' adoption behaviors. As a result, researchers and designers may refine their objectives to help ensure a wearable hemodialysis system that is designed in accordance with users' needs.