KHI Current Project

2nd Edition of Technology Roadmap for Innovative Approaches to Kidney Replacement Therapy: Artificial Kidney

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, minimum performance benchmarks, where innovative products are 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 "market pull" meaning innovative kidney replacement therapy options should be designed to meet the needs of a specific market. That market is determined through a process of identifying and prioritizing problem statements, populations, and outcomes.

This project is divided into three phases:

  1. Identifying and prioritizing problem statements, populations, and outcomes related to the treatement of kidney failure.
  2. Translating the needs of the market into minimum performance benchmarks that serve as the boundaries of a "black box" that address a problem statement(s) and the desired outcomes for a population.
  3. Publishing the minimum performance benchmarks and mapping existing "artificial kidney" concepts against their progress meeting the benchmarks in a 2nd version of the Technology Roadmap for Innovative Approaches to Kidney Replacement Therapy: Artificial Kidney

Stakeholder Engagement

Transparency and consensus are essential to the success of this effort. Each of the steps above will be completed in consultation with the relevant stakeholders through generative interviews and workshops. As deliverables are produced, they will be publicly available in publications and at scientific meetings. Additionally, an Advisory Committee representing people with kidney disease, 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 and Minimum Performance Benchmarks published
  • Q2 2022 – 2nd Edition of Technology Roadmap for Innovative Approaches to Kidney Replacement Therapy: Artificial Kidney

Deliverables

At least two peer reviewed manuscripts in 2021 describing 1) patient scenarios and user needs, 2) product requirements.