Practical Medical Device Design
Overview: Imaging scanners used for disease diagnosis, robots used for surgical procedures and implantable defibrillators that continuously function inside a patient for years are all examples of instruments classified as medical devices by the Food and Drug Administration (FDA). Despite staggering differences in their end application, working principles and construction, these medical devices are all developed following a common design process established with guidance from the FDA and the standards organization such as the ISO. The crucial difference between medical device design and mechanical design lies in the need to ensure patient safety by anticipating and minimizing the impact of failure. In prior courses you may have performed parametric or rule-based design of mechanical components, and selected optimal configuration of components by examining engineering trade-offs. The emphasis of this course will be on the design process, along with documentation and other procedures that underly commercial medical device development, essential for regulatory approval.
Using a hands-on, case-study based approach, the course will provide an introduction to the regulatory and quality control considerations that govern medical device design. Specific examples of three devices, (i) orthopedic screw, (ii) vascular catheter, and (iii) percutaneous ablation probe will be used to familiarize students with key aspects of the design process and facilitate industry relevant project work.
We are grateful to receive medical devices and other support from Angiodynamics to enhance the learning experience of students taking this course!
History: This course was previously taught as an BME elective in the City College of New York as part of a NIH program grant. The course provided training in the systematic design, fabrication, testing and documentation process required for commercial development of medical devices. Two devices, one diagnostic and the other therapeutic were used as semester - long case studies to illustrate the development process to the students. The course was based on an apprentice model, and project kits were provided to the students to help complete their course work.
To be updated soon.