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

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.