This course is focused on the fundamentals of modern biomedical device and diagnostics design. Students will design and build an alpha prototype in this project based course. The course is aimed at undergraduates who have completed most of the engineering core coursework (second semester sophomore and above). Mechanical and Biomedical Engineering concepts are introduced and elaborated on in the context of specific applications. Topics include: materials classes; materials selection for medical devices and diagnostics; elementary mechanics of materials topics in the context of design for manufacturing (stress, strain, toughness, torsion, bending, buckling); fracture, fatigue and yielding; failure analysis; biocompatibility; regulatory requirements as they pertain to design, manufacturing and marketing; technology assessment strategies; and engineering ethics. Several case studies of successful and unsuccessful biomedical device design are introduced and discussed throughout the course.