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Simulation-based development: shaping clinical procedures for extra-uterine life support technology.

J S van Haren1,2, M B van der Hout-van der Jagt3,4,5, N Meijer3

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Summary
This summary is machine-generated.

Developing an artificial placenta and artificial womb (APAW) procedure for extremely premature infants requires clinician input. Simulation-based participatory design safely integrates user perspectives for novel obstetric protocols.

Keywords:
Artificial placentaArtificial wombCo-creationExtra-uterine life supportParticipatory designPerinatal life support technologySimulation-based development

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Area of Science:

  • Biomedical Engineering
  • Neonatal Medicine
  • Human Factors Engineering

Background:

  • Artificial placenta and artificial womb (APAW) technology shows promise in animal studies for extremely premature infants (<28 weeks gestation).
  • Translating APAW technology to human use is complex due to the procedure's novelty and low incidence.
  • The obstetric procedure for infant transfer to an APAW system is not yet established for human patients.

Purpose of the Study:

  • To use participatory design principles within a simulation context to develop a human patient transfer protocol for APAW technology.
  • To integrate user perspectives from clinicians into the early design phase of the novel APAW procedure.

Main Methods:

  • Developed simulation protocols and prototypes using an iterative, participatory design approach.
  • Conducted usability testing with clinical experts from various disciplines, gathering general and task-specific feedback.
  • Utilized fetal and maternal manikins, animations, and protocol task cards in the simulation.

Main Results:

  • Physical simulation involving clinicians facilitated knowledge sharing and developed a shared understanding of procedure requirements.
  • Participant input was iteratively incorporated into simulation protocols and design adjustments.
  • The participatory approach refined the procedure and identified key implementation values.

Conclusions:

  • Simulation-based participatory design is effective for developing and refining clinical procedures.
  • This approach aids in shaping future clinical product development and rehearsing implementation strategies.
  • Integrating healthcare professionals' perspectives early is crucial for novel medical technologies like APAW.