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

Area of Science:

• Biomedical Engineering Education
• Medical Device Development
• Standards Compliance

Background:

• Proficiency in consensus standards is critical for biomedical engineers in medical device development.
• Existing curricula may not adequately prepare students for the practical application and revision of standards.
• Understanding testing variability and protocol limitations is essential for regulatory compliance.

Purpose of the Study:

• To develop and implement a novel, standards-based learning module for biomedical engineering students.
• To enhance students' ability to interpret, apply, and revise consensus standards.
• To introduce students to the challenges of testing variability and protocol development through hands-on experience.

Main Methods:

• A hands-on module was integrated into an upper-level biomedical engineering course.
• Students used a custom tensile testing device and a mock standard for round-robin testing.
• Deliberate adulterations were introduced to simulate real-world testing challenges.

Main Results:

• Students demonstrated reliable application and revision of the mock standard (LO2, LO3).
• Post-module surveys indicated increased student confidence in applying standards and identifying protocol limitations.
• While students showed some difficulty defining round-robin testing (LO1), overall confidence in industry preparedness improved.

Conclusions:

• The standards-based module effectively engaged students in higher-order problem-solving related to standards implementation.
• The curriculum enhanced understanding of testing variability and collaborative verification processes.
• This model can be expanded to other engineering disciplines to improve workforce preparedness in quality engineering and R&D.