Clinical Immersion with Health Professionals and Industry Advising in Undergraduate Biomedical Engineering Capstone Design

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This proposal is to develop a new senior year capstone design course and summer immersion program for Bioengineering students at George Mason University. Recognizing the importance of introducing the biomedical design process early and building on this throughout the undergraduate program, our Bioengineering Department has introduced a new curriculum where design is taught in each of the four years. The curriculum begins with an introductory Computer-aided design based experience in the freshmen year, followed by a biomaterials design project in the sophomore year and a course with a product development component in parallel with a course in clinical medicine (taught by physicians) in the junior year. The new proposed capstone design course builds upon this foundation beginning with a summer clinical immersion program that leads into an analysis phase of identified clinical needs in the capstone design course. To further support our design teams in addressing patient-oriented clinical needs and emerging opportunities involving health informatics and health policy, we will include a senior student from nursing, health informatics or health policy into each design team, based on a skill set analysis of each project. The design teams are supported by advising teams composed of faculty from Bioengineering, Nursing, Health Informatics and Health Policy and by industry advisors selected from our new industry advisory board, the Mason Bioengineering Alliance. Design teams will have access to university and medical center resources and follow an industry standard product design and development process. Our approach includes a practical early stage assessment of clinical importance and market potential including the important aspects of intellectual property, regulatory considerations, ethics and reimbursement. This proposal aims to 1) establish a multidisciplinary summer clinical immersion program leading into the Bioengineering capstone course at 3 clinical centers : Inova Fairfax Medical Campus, Children’s National Medical Center and Georgetown University Medical Center 2) integrate Nursing, Health Informatics, and Health Administration students and faculty into Bioengineering Design teams (students) and advisory groups (faculty) and 3) apply in a real world clinical context our new curriculum’s foundation of multiyear design and courses in i) Clinical Medicine and ii) Intellectual Property, Regulatory Concepts, Product Development, responding to newly identified clinical needs. A design control approach with inclusion of relevant standards and risk analyses are included. Workshops will teach ethics, reimbursement and oral communications. Using this integrated, translational approach to learn design will better prepare our students to be biomedical technology innovators. Incorporating a clinical needs finding approach and working with health professional students involved in patient care and health administration will give our students a unique real world experience in patient-oriented bioengineering design. With this senior design course under their belt, our students will be prepared for industry positions, for starting their own companies, or for further graduate education. 1