Teaching medical device design using design control.

Area of Science:

• Biomedical Engineering Education
• Medical Device Design
• Product Development

Background:

• Traditional education struggles to teach the multifaceted nature of medical device design.
• A gap exists in practical, context-driven learning for aspiring medical device engineers.
• Effective pedagogical approaches are needed to bridge theory and practice in medical device development.

Purpose of the Study:

• To evaluate the effectiveness of challenge-based learning (CBL) in medical device design education.
• To implement and assess a novel course structure incorporating real-world design challenges.
• To enhance student engagement and knowledge acquisition in medical device engineering.

Main Methods:

• A course at San Diego State University utilized CBL with focused design challenges in cardiovascular and orthopedic medicine.
• An immersive needs-finding experience was integrated to foster practical understanding.
• US Food and Drug Administration (FDA) design control principles structured the problem-solving and documentation process.
• Learning was supplemented with lectures, guest industry expertise, readings, and internet research.

Main Results:

• Students demonstrated a significantly increased knowledge base in medical device design.
• Competence in medical device design was substantially improved compared to pre-course levels.
• The CBL approach fostered deeper understanding and practical application of design principles.

Conclusions:

• Challenge-based learning is a highly effective pedagogical strategy for medical device design education.
• Integrating industry standards like FDA design controls prepares students for real-world challenges.
• The implemented course successfully enhanced students' skills and readiness for the medical device industry.