KHI Current Project

Design Principles and Key Performance Indicators for Artificial Kidneys

Unmet Need

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 will give clarity to the funders, regulators, payors, clinicians, and patients who are necessary for commercialization and adoption of new treatment options.

Approach

By utilizing an industry standard product development process along with KHI'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 is executed through a process of identifying and prioritizing problem statements, populations, and outcomes in consultation with the relevant stakeholders through generative interviews and workshops.

This project is divided into three phases:

  1. Identifying and prioritizing problem statements, populations, and outcomes related to the treatement of kidney failure.
  2. Validating the data from phase one with people with kidney diseases and care partners.
  3. Translating the data from previous phases into patient centered design criteria and key performance indicators for artificial kidney concepts.
  4. Stakeholder Engagement

    Transparency and consensus are essential to the success of this effort. As deliverables are produced, they will be publicly available in publications and at scientific meetings. Additionally, a Working Group and Advisory Committee representing people with kidney diseases, government stakeholders, industry, and clinicians, will inform each step of the process.

    Timeline

    • Q3 2021 – Phase 1 complete and Phase 2 begun
    • Q4 2021 – Phase 2 complete
    • Q1 2022 – Phase 3 complete and deliverables published

    Deliverables

    At least two peer reviewed manuscripts describing pateint centered design criteria, key performance indicators, and the market for artificial kidneys.

    Please contact ASN Artificial Kidney Product Specialist Zach Cahill at zcahill@asn-online.org with any questions about this project.

    Updated on 10/20/21