Changing a person with kidney failure’s story is the purpose of kidney replacement therapy innovations. To do that, product developers need to understand the stories they are trying to change. Human-centered design is a tool for gleaning needs and problem statements from consumer’s stories and integrating them into the design of products. The Human-Centered Design Toolkit for Kidney Failure provides pre-clinical innovators and early-stage start-ups developing kidney replacement therapies with empathy tools to facilitate their interactions with people with kidney failure, enable market segmentation, and provide a framework for a customer requirements document.

Despite increased public interest in artificial kidneys as alternatives to current kidney replacement therapy options, there is no community consensus on the target market, product definitions, evaluation criteria, the status of innovative products on the road to commercialization, or what problem artificial kidney concepts are trying to solve. Answering these questions gives clarity to the funders, regulators, payors, clinicians, and patients who are necessary for commercialization and adoption of new treatment options. By utilizing an industry standard product development process along with the Kidney Health Initiative’s pre-competitive, community consensus approach, these questions can be answered. The philosophy behind this approach is patient-centered design derived from a hierarchy of patient needs and supporting clinical and non-clinical factors. That philosophy was executed through a process of identifying and prioritizing problem statements, populations, and outcomes in consultation with the relevant stakeholders through generative interviews and workshops; validating that data with people with kidney diseases and care partners; and translating the data from previous phases into patient-centered design criteria and key performance indicators for artificial kidney concepts.