University of North Carolina at Chapel Hill and North Carolina State University Joint Department of Biomedical Engineering Andrew J. DiMeo, Sr., Ph.D. Program Funding primarily via gifts from individuals and industry Wednesday, October 12, 2011 BME-IDEA Workshop You may use this template or slides of your own design. However, please limit your slides to only 5, and prepare for a 5 minute presentation, so there is plenty of time for discussion of the snapshots. If using this deck, please delete this textbox.

Graduate Level Multidisciplinary Program BME Senior Design Capstone –Undergraduate Seniors in BME at NCSU –Two-Semester Capstone (6 credits) –40-50 Students (8-10 teams) –All projects student derived –Clinical Immersion WakeMed Health & Hospitals NCSU College of Veterinary Medicine Other local healthcare providers –Five-Phase Design Control Process Based on FDA’s Quality System Regulations Overview

Distinction –Magnitude of the clinical immersion All students participate Interviews and observation –Needs assessment ~ 8 weeks –Product Requirements & Ideation ~ 5 weeks Clinical Feedback and User Evaluation –Proof of Concept Design ~ 5 weeks –Manufacturing ~ 6 weeks –Qualification ~ 4 weeks Course Features Challenge –Hospital Orientation Includes Immunizations, Criminal Background Checks, Confidentiality, etc.

Three provisional & one full patent application One licensing deal One spinout company –Augment Medical Won Inaugural NCIIA BMEstart Competition Industry feedback on new hires “Students taking your class show a level of preparedness for medical device development…providing them skills that are critical to succeed in a company like Smith & Nephew.” – F. Javier de Ana, Biologics and Spine Five Year Outcomes

University Policy –NCSU does not assert ownership of undergraduate IP –If a graduate student, faculty, staff, or clinician is a co-inventor, then assignment is case-by-case Student Preparation –Multiple guest lectures by university tech transfer and outside patent council –Topics include IP basics, patent landscape, freedom to operate, etc. Intellectual Property

Questions and Discussion