Teaching Medical Device Design Using Design Control

Expert Rev Med Devices. 2012 Jan;9(1):7-14. doi: 10.1586/erd.11.63.


The design of medical devices requires an understanding of a large number of factors, many of which are difficult to teach in the traditional educational format. This subject benefits from using a challenge-based learning approach, which provides focused design challenges requiring students to understand important factors in the context of a specific device. A course was designed at San Diego State University (CA, USA) that applied challenge-based learning through in-depth design challenges in cardiovascular and orthopedic medicine, and provided an immersive field, needs-finding experience to increase student engagement in the process of knowledge acquisition. The principles of US FDA 'design control' were used to structure the students' problem-solving approach, and provide a format for the design documentation, which was the basis of grading. Students utilized a combination of lecture materials, industry guest expertise, texts and readings, and internet-based searches to develop their understanding of the problem and design their solutions. The course was successful in providing a greatly increased knowledge base and competence of medical device design than students possessed upon entering the course.

Publication types

  • Review

MeSH terms

  • Biomedical Technology / education*
  • Biomedical Technology / instrumentation*
  • California
  • Curriculum
  • Equipment Design
  • Program Evaluation