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. 2023 Dec 2;8(1):29.
doi: 10.1186/s41077-023-00267-y.

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

J S van Haren  1   2 , M B van der Hout-van der Jagt  3   4   5 , N Meijer  3 , M Monincx  6 , F L M Delbressine  6 , X L G Griffith  3 , S G Oei  3   4
Affiliations

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

J S van Haren et al. Adv Simul (Lond). .

Abstract

Background: Research into Artificial Placenta and Artificial 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 integrate 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-specific 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 diffusion 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.

Keywords: Artificial placenta; Artificial womb; Co-creation; Extra-uterine life support; Participatory design; Perinatal life support technology; Simulation-based development.

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Conflict of interest statement

JSvH, MM, MBvdH-vdJ, FLMD, and SGO are coauthors on a patent entitled ‘Transfer Of A Preterm Baby From A Natural Womb’ (Patent no. WO2022066014). JSvH, MM, FLMD, and SGO are coauthors on a patent entitled ‘Transfer Of A Preterm Baby From A Natural Womb’ (Patent no. WO2023027584A1). The remaining authors have no competing interests to disclose.

Figures

Fig. 1
Fig. 1
Setup of the physical simulation room in phase V
Fig. 2
Fig. 2
Participant and phase overview
Fig. 3
Fig. 3
Simulation session of a liquid-based transfer procedure with the manikin being delivered into a transferbag
Fig. 4
Fig. 4
Simulation-based procedure development cycle, with intermittent literature study, interview, and simulation cycles. Legend: Hi-fi and lo-fi refer to high and low fidelity, respectively
See this image and copyright information in PMC

References

    1. Patel RM. Short- and long-term outcomes for extremely preterm infants. Thieme Medical Publishers, Inc.; 2016. - PMC - PubMed
    1. Morgan AS, Mendonça M, Thiele N, David AL. Management and outcomes of extreme preterm birth. The. BMJ. 2022;376 10.1136/bmj-2021-055924. - PMC - PubMed
    1. De Bie FR, Davey MG, Larson AC, Deprest J, Flake AW. Artificial placenta and womb technology: Past, current, and future challenges towards clinical translation. Prenat Diagn. 2021;41(1):145–158. doi: 10.1002/pd.5821. - DOI - PubMed
    1. van der Hout-van der Jagt MB, Verweij EJ, Andriessen P, de Boode WP, Bos AF, Delbressine FL, et al. Interprofessional consensus regarding design requirements for liquid-based Perinatal Life Support (PLS) technology. Frontiers. Pediatrics 2022. 10.3389/fped.2021.793531. - PMC - PubMed
    1. Partridge EA, Davey MG, Hornick MA, McGovern PE, Mejaddam AY, Vrecenak JD, Mesas-Burgos C, Olive A, Caskey RC, Weiland TR, Han J, Schupper AJ, Connelly JT, Dysart KC, Rychik J, Hedrick HL, Peranteau WH, Flake AW. An extra-uterine system to physiologically support the extreme premature lamb. Nat Commun. 2017;8:1–15. doi: 10.1038/ncomms15112. - DOI - PMC - PubMed

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