title: Teaching medical device design using design control.
abstract: 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.
authors.affiliation: Bioengineering Program, College of Engineering, San Diego State University, CA 9218, USA. kmaynewm@mail.sdsu.edu
authors.forename: Karen
authors.initials: K
authors.lastname: May-Newman
authors.forename: G Bryan
authors.initials: GB
authors.lastname: Cornwall
mesh_terms: D020811:Biomedical Technology / Q000193:education* / Q000295:instrumentation*; D002140:California; D003479:Curriculum; D004867:Equipment Design; D015397:Program Evaluation