Clinical Investigation as an Iteration Tool for the Design of Low-Risk Medical Devices: A Case Study of an IV Drip Monitoring System

Venkatesh, K and Karia, D and Arora, M (2021) Clinical Investigation as an Iteration Tool for the Design of Low-Risk Medical Devices: A Case Study of an IV Drip Monitoring System. In: 11th Annual IEEE Global Humanitarian Technology Conference,, 19-23 Oct 2021, Virtual, Online, pp. 131-137.

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Abstract

The design of a medical device comprises multiple stages, beginning with task clarification, and followed by conceptual design, embodiment design, detailed design, testing, and a clinical study. Involvement of stakeholders at every stage is essential for translating an idea into a usable product. In this work, we adopt a 'user-in-the-loop' approach to Engineering Design (ED), to explore the use of clinical investigation as an iteration tool. An IV drip monitoring system designed for resource-constrained settings, proposed in our earlier work, is used as a case study to illustrate this. A basic prototype was investigated at multiple clinical settings with requisite approvals. Device operation by clinicians was observed, which elicited embodiment, ergonomic and human-machine interface related issues. While establishing device efficacy, the investigation also gathered significant inputs for subsequent design stages. The adopted approach ensures that only validated designs proceed to the next stage. However, this can only be undertaken for low-risk medical devices with appropriate precautions. © 2021 IEEE.

Item Type:	Conference Paper
Publication:	2021 11th IEEE Global Humanitarian Technology Conference, GHTC 2021
Publisher:	Institute of Electrical and Electronics Engineers Inc.
Additional Information:	The copyright for this article belongs to Institute of Electrical and Electronics Engineers Inc.
Keywords:	Conceptual design, Case-studies; Clinical investigation; Clinical study; Detailed design; Embodiment design; IV drip monitoring system; Medical Devices; Monitoring system; Multiple stages; User-in-the-loop, Monitoring
Department/Centre:	Division of Mechanical Sciences > Centre for Product Design & Manufacturing
Date Deposited:	07 Feb 2022 12:14
Last Modified:	07 Feb 2022 12:14
URI:	http://eprints.iisc.ac.in/id/eprint/71259

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