Bridging the Gap between biomedical engineering education and medical device industry practice: A curriculum and skills analysis

The medical device industry operates within a highly regulated, risk-sensitive, and innovation-driven environment. Engineers entering this sector must possess not only technical design skills but also competence in regulatory pathways, quality systems, risk management, clinical evaluation, and cross-functional collaboration. However, biomedical engineering (BME) curricula traditionally prioritize analytical and technical rigor over translational and regulatory preparedness.  Bridging this gap requires deliberate curriculum reform and structured academia industry collaboration