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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-GomesInstitute for Disease ModelingHMHeleen MiddelkampInstitute for Disease ModelingJLJosh Loessberg-ZahlUniversity of Twente

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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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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Advancing Organ-on-a-Chip Technologies: A Review on the Multi-Organ Approach for Precision Disease Modeling and Drug Screening2026
  2. 2State-of-the-Art Organ-on-Chip Models and Designs for Medical Applications: A Systematic Review2025 · 8 citations
  3. 3Organ‐on‐a‐Chip Technology and Global Multi‐Omics: Current Applications and Future Directions2026
  4. 4From Organ to System: Multiorgan-on-a-Chip Platforms as Next-Generation Biomedical Simulators2025 · 7 citations
  5. 5Bridging Organ‐on‐a‐Chip and Omics: A Multi‐Dimensional Frontier in Biomedical Research2026