Nextkidney’s Journey in the USA: Advancing Our Device Through Pre-Summative Testing

Nextkidney’s Journey in the USA: Advancing Our Device Through Pre-Summative Testing

January 30, 2025 - Author : Gaëtan Pannetier
At Nextkidney, innovation goes beyond technology—it’s about ensuring our device is safe, intuitive, and effective in real-world use. Recently, our Human Factors Engineering team traveled to the U.S. for pre-summative testing, a key step in refining our device as we progress toward FDA approval.

Why Pre-Summative Testing Matters

Though not required by regulators, pre-summative testing is crucial to our commitment to usability. This phase helps us:

  • Observe real-world interactions with our device
  • Identify potential challenges in setup and operation
  • Gather user feedback for design improvements
  • Reduce the risk of human errors before official testing
Testing in the U.S. ensures our device aligns with local healthcare practices. User tests have also been conducted in the Netherlands, France, and Switzerland. By performing (pre-)summative tests in the U.S., results can support both European and American certification.

Learning From Real Users

Our team collaborated with healthcare professionals and users to assess how they interact with our device. Beyond testing functionality, we focused on ease of setup, intuitive use, and potential pain points.
Even small refinements can make a significant impact, and this hands-on experience revealed valuable insights for improving safety and user experience.

Preparing for the Future

These findings will directly shape the next phase of development, ensuring our device is as seamless and user-friendly as possible before summative testing and FDA submission.
At Nextkidney, we believe meaningful innovation comes from deep understanding. By prioritizing human-centered design and rigorous testing, we ensure our technology meets the real needs of both patients and healthcare providers.