Medical Device Design and Innovation; Orthopaedic Implant Failure Analysis and Redesign

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PROJECT SUMMARY The proposed team-based Medical Device Design and Innovation course will prepare undergraduate junior and senior biomedical engineering students with a robust toolkit to be innovators of medical technologies with the skills necessary to design devices that reduce medical errors and device failure hazards. A summer clinical immersion, with a focus on identifying potential sources of preventable complications from medical device adverse events and failures, will provide the students a widened perspective regarding the safe delivery of healthcare. In addition, training during the semester long course in analyses of common causes of medical device failure will provide the students the skills to develop devices responsibly. The program will start in the summer with a clinical immersion for up to 10 students rotating through an 8-week long rotation with Yale physicians and surgeons from 6 different specialties. Students will work with their physician mentors to identify causes of preventable medical/surgical errors, device user-related hazards and device failure hazards, with the goal of addressing these preventable complications with medical device design projects. In addition, students will participate in didactics with a structured summer curriculum focusing on needs identification, assessment and risk management. In the Fall, the 10 summer students will continue their clinical immersions by shadowing 1 day a week, and participate in a campus wide “device design speaker series”. Within the Spring semester course, each summer Fellowship student will form the nucleus of a design team of 3-5 members. Based on needs / problems / preventable medical errors identified within the summer and fall clinical immersion, the students, following the biodesign innovation process, will design a functioning prototype and commercialization plan. Concurrently, throughout the Spring semester, students will work on a separate failure analysis project to learn how to pinpoint and simulate potential critical medical device failure mechanisms. Didactic lectures will include topics such as the device design process, regulatory affairs, human factors engineering, responsible conduct of research, and off-campus trips to medical device R&D facilities. At the end of the course, open access content will be published as a free online curriculum, and students will submit papers to PubMed indexed journals. The innovation of this application is to embed engineering students within a clinical environment, exposing them to potential sources of preventable medical complications and device failures, as well as teaching them how to identify, simulate and model critical failure mechanisms. This course, which seeks to attract underrepresented minorities, will result in an improved pipeline of future scientists whose practical experience in a clinical environment will facilitate their entry into biomedical engineering careers. The course will utilize the engineering, innovation and medical research resources at Yale University. The University biomedical engineering ecosystem will also benefit from collaboration between engineering faculty and clinicians.