Practical Tools For Medical Device Design

Catalog description

This course provides training in the systematic design, fabrication, testing and documentation process required for commercial development of medical devices. Two devices related to cancer treatment, one diagnostic and the other therapeutic, will be used as semester-long case studies to illustrate the development process to students. The course will be based on an apprentice model, and project kits will be provided to the students that will help them in performing coursework. Topics covered include introduction to product development life cycle, FDA regulated design documentation activities, concept generation and evaluation, computer-aided device design, design review process, design for manufacturing, bio-safe material selection, manufacturing processes available for medical device fabrication, testing methods, and preparation of documents for regulatory submission.