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

Juliette van Haren (Corresponding author), M.B. (Beatrijs) van der Hout-van der Jagt, Nikki Meijer, Marlou Monincx, Frank L.M. Delbressine, X.L.G. Griffith, S.G. (Guid) Oei

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Background Research into Artificial Placenta and Artifcial Womb (APAW) technology for extremely premature infants (born < 28 weeks of gestation) is currently being conducted in animal studies and shows promising results.
Because of the unprecedented nature of a potential treatment and the high-risk and low incidence of occurrence, translation to the human condition is a complex task. Consequently, the obstetric procedure, the act of transferring the infant from the pregnant woman to the APAW system, has not yet been established for human patients. The use of simulation-based user-centered development allows for a safe environment in which protocols and devices can be
conceptualized and tested. Our aim is to use participatory design principles in a simulation context, to gain and inte‑ grate the user perspectives in the early design phase of a protocol for this novel procedure.
Methods Simulation protocols and prototypes were developed using an iterative participatory design approach; usability testing, including general and task specifc feedback, was obtained from participants with clinical expertise from a range of disciplines. The procedure made use of fetal and maternal manikins and included animations and protocol task cards.
Results Physical simulation with the active participation of clinicians led to the difusion of tacit knowledge and an iteratively formed shared understanding of the requirements and values that needed to be implemented in the procedure. At each sequel, participant input was translated into simulation protocols and design adjustments.
Conclusion This work demonstrates that simulation-based participatory design can aid in shaping the future of clinical procedure and product development and rehearsing future implementation with healthcare professionals
Originele taal-2Engels
Aantal pagina's17
TijdschriftAdvances in Simulation
StatusGepubliceerd - 2 dec. 2023


This work was funded in part by the European Union via the Horizon 2020: Future Emerging Topics call (FET Open), Grant EU863087, project PLS. PLS Consortium of Project “Perinatal Life Support System: Integration of Enabling Technologies for Clinical Translation” Under Horizon 2020 FET Open Grant EU863087. We would like to thank the participants of our study. We thank our colleagues Chet Bangaru and Jasper Sterk for their help in the fabrication of devices.

European Commission
Horizon 2020EU863087


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