University of North Carolinaat 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, 2011BME-IDEA Workshop

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• 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 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.

• 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