# Developing a Round-Robin Module For The Integration Of Consensus Standards In a BME Course Using a Custom Tensile Testing Device

## TL;DR

This paper introduces a new educational module for biomedical engineering students that teaches them to work with medical device standards through hands-on testing.

## Contribution

A novel standards-based learning module using round-robin tensile testing to improve students' ability to interpret and revise consensus standards.

## Key findings

- Students reliably applied mock standards to their own tensile testing protocols.
- Teams revised standards to address identified adulterations in testing devices.
- Students gained confidence in standards implementation and verification processes.

## Abstract

Proficiency with consensus standards is essential for biomedical engineers to develop effective, safe, and compliant medical devices. Here, we describe a novel, standards-based module that enhances student ability to interpret, apply, and revise consensus standards through round-robin testing.

A hands-on learning module was designed and implemented in an upper-level biomedical engineering course. The curriculum incorporated the use of a custom-designed tensile testing device alongside a mock standard to introduce students to protocol development, standards revision, and real-world challenges in testing variability. Eight student teams conducted round-robin testing using devices configured with deliberate adulterations. Learning objectives (LO) include (1) defining round-robin testing, (2) interpreting a consensus standard, and (3) revising a consensus standard. Assessment included a Standard Revision Report and a post-module survey.

From the post-module survey, students were only somewhat able to define round-robin testing (LO1; average score of 0.4/1). From the Standard Revision Report, teams reliably identified elements from the mock standard to apply for their own tensile testing (LO2; average score of 2.5/3). Also from the Report, teams reliably revised the mock standard to address the adulterations they found (LO3; average score 1.5/2). After the module, students reported confidence in extracting requirements from standards, applying them to verification testing, and identifying potential limitations in testing protocols. Moreover, students found the activity effective for increasing their confidence in preparing them for industry applications, though some suggested extending the module duration and improving instructional clarity for increased effectiveness.

This study describes the development and implementation of a standards-based module in biomedical engineering. Ultimately, students engaged in higher-order problem-solving and improved their understanding of standards implementation, testing variability, and collaborative verification processes. The findings suggest that this curriculum model could be expanded across engineering disciplines to enhance workforce preparedness in quality engineering and R&D roles.

The online version contains supplementary material available at 10.1007/s43683-025-00200-x.