1. 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 Thursday, October 13, 2011 BMES Annual Meeting 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.

2. Inspiration Emulate a real industry experience –FDA Quality System Regulations Meet ABET Requirements –design… to meet desired needs… –function on multidisciplinary teams –Identify… and solve… problems –professional & ethical responsibility –communicate effectively –knowledge of contemporary issues –techniques, skills, and modern engineering tools 2

3. 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 –Other local healthcare providers –NCSU College of Veterinary Medicine Five-Phase Design Control Process –Based on FDA’s Quality System Overview: Senior Design

4. Distinction –Magnitude of the clinical immersion All 40-50 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.

5. 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

6. Graduate Level Multidisciplinary Program Students from UNC and NCSU –Engineering, Business, Medicine, Law, Design, Etc. Four 7-week modules (1.5 credits each) Student derived projects –Clinical Immersion Primarily at UNC Health Care –Also NCSU College of Veterinary Medicine and other local healthcare providers FDA Quality System Design Control Process Overview: Medtech-ID

7. Deliverables by Module

8. Distinctions –Industry Coach Facilitates small group setting Conference room (not lecture hall) –Industry Mentors Access to Research Triangle Park Expertise –Modules Short courses allow team flexibility Ability to recruit student talent to team –Proximity/Access to UNC Health Care Course Features Challenges –Two-campus commute –Graduate student time constraints

9. Questions and Discussion