The Development and Testing of a Novel Automatic Organoid/Microsphere Movement Device; Framework Modeling Within the Field of Regenerative Medicine for an Automated Microsphere Device

SOCIOTECHNICAL SYNTHESIS

The design of an innovative medical device and corroborating its application within the field of regenerative medicine collectively aids in exploring the implications of automation within a technologically fueled healthcare. Beginning at the research level, the technical project aims to address an industry wide issue regarding the automation of cell or microsphere movement through media including water and hydrogels through the development of a novel device. The device, through precisely locating and determining the position vectors of a microparticle, can allow for the placement of organoids within a biomaterial in any formation allowing for rapid testing within the field of regenerative medicine. The science, technology, and society (STS) research provides an analysis for the societal impact of device design and automation in the field of regenerative medicine. The tightly coupled technical and STS topics illustrate the effect that device designers have on regenerative medicine and its applicability during the design process of creating an automated cell or microsphere movement device.

The technical report outlines the development and testing of an automated cell or microsphere movement device to examine its functionality in increasing the scalability of organoid and cell spheroid studies. The current methods of moving organoids requires the use of vacuum aspiration by hand which allows for human error through imprecise placement and limits the available research within drug design, cancer research/development, and disease progression. The proposed design implements commercially available products alongside CAD-created components in conjunction with Python programming to create an embedded system capable of identifying microparticles within a well and performing a pick and placement of the microparticle into user-defined locations. Testing was performed over a 50-sample movement trial and 10 speed-based trials.

The study demonstrated a proof-of-concept for the novel device with a cumulative success rate of 45.97% where success was defined as the cumulative rate of withdrawing and placing the microparticle within the desired location. The device also demonstrated a statistically significant time-based correlation when compared to the manual alternative. Though the results presented in our work show the promising nature of the device to lower the active time to perform organoid research, there are still limitations regarding the low success rate of the device. Future iterations and testing will be necessary to increase the viability of the device although the current work demonstrates the target corrections that could potentially be made to increase the success rate of the device and improve overall performance and the impact it could have upon the scalability and scope of organoid research.

As automation increases the scalability of research within the field of regenerative medicine, the designer must begin to consider the implications of human values behind the device along with the role that the device will have as the technology further matures. The nature of automation in research can result in various unintended consequences to actants throughout various domains and through the multi-faceted device design process. The STS report examines current ethical implementation of organoid research in the context of moral status of human life, the role of humans and automations, governmental influences, and case studies from the perspective of gene therapy and societal implications. Actor Network Theory (ANT) by Law and Latour contextualizes the various actants within the device design process while Normalization Process Theory (NPT), first introduced by Murray and colleagues, allows for the roles of humans and their interactions to be elucidated within the implementation of the device within society.

The research found demonstrates the concerns on prohibitive cost from the patient’s standpoint and the worries of regenerative medicine going against nature alongside the role of automation in research. Based on the case studies by the STS research, a generalized framework for device design was developed in which the coupling of NPT, ANT, and IEC 62304 would allow for the necessary regulatory requirements of device manufacturers to be met alongside the broader implication for products on patients and society. Specifically, ANT provides the framework to conceptualize the various actants and their roles within the device design while NPT provides the framework for continuous monitoring and implementation to ensure safe and ethical use throughout the devices design within the components of coherence, cognitive participation, collective action, and reflexive monitoring while the IEC 62304 standard maintains conformity within regulations of the medical device schema.

The implications of a generalized framework to account for societal impacts has the ability to further research while having the potential to shape social values as demonstrated through the technical in its pursuit to simplify the nature of organoid research and explored through the STS research’s dissemination of societal concerns of automation and regulation.

School of Engineering and Applied Science
Bachelor of Science in Biomedical Engineering
Technical Advisor: Christopher Highley
STS Advisor: Catherine Baritaud
Technical Team Members: Kaden Hoffman, Jack Maschler, Joshua Sanderson