Development of a hybrid manikin for extra-uterine life support technology innovation.

Abstract

Background: Preclinical studies have shown successful maintenance of fetuses on extra-uterine life support technology. This technology has the potential to offer a liquid-based alternative for the care of extremely premature infants.

Methods: To bridge the gap between preclinical research and clinical translation, and to provide a low-risk environment, we developed a hybrid fetal manikin to complement animal studies and facilitate technology development and clinician training. Through these fetal manikins, characteristics of extremely premature infants can be mimicked through integrated actuators that respond to physiological parameters, which are monitored through integrated sensors.

Results: Utilizing clinical data, we designed the manikin to realistically replicate anatomical structures, physiological properties, and symptom display. A wireless connection to a fetal digital twin enables sensor data transmission and downstream cascade calculations for symptom display on the manikin. Evaluation included qualitative and quantitative realism assessments, either comparing with patient data or clinician assessments.

Conclusions: Our study demonstrates the applicability and potential of using simulation technologies for high-risk, human-centered MedTech development. It allows expanding stakeholder involvement during development, and it may better equip a medical team through simulation training and enhance the technology development.