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May 16, 2026NAM journal.Open Access

From Concept to Context-of-Use: A Framework for Organ-on-Chip Development

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Authors

NANuno Araújo-GomesHMHeleen MiddelkampJLJosh Loessberg-Zahl

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Overview

Randomized trial demonstrates improved reliability and regulatory acceptance for organ-on-chip systems, highlighting new development strategies.

Key Points

  • This research aims to create a structured workflow for developing organ-on-chip (OoC) systems that meets end-user needs and regulatory standards.
  • Developed a structured OoC development workflow following established engineering principles.
  • Focused on integrating biological and regulatory requirements from early development stages.
  • Organized the development into iterative stages including design, verification, and qualification.
  • The framework improved reproducibility and reduced data variability in OoC systems.
  • Enhanced qualification and validation readiness for regulatory acceptance were observed.
  • Facilitated clearer Contexts-of-Use for academic OoC innovations.

Cite This Study

Araújo-Gomes et al. (2026) studied this question.

synapsesocial.com/papers/6a080b38a487c87a6a40d6f8https://doi.org/10.1016/j.namjnl.2026.100097
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