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Capstone as a Vehicle for Translational Research Timothy Allen, Ph.D. David Chen (UVA Coulter Director) Shayn Peirce, Ph.D. The DEPARTMENT of BIOMEDICAL ENGINEERING School of Engineering and Applied Science School of Medicine Clinical Problem: Otitis Media with Effusion (OME) • Fluid in middle ear • Symptoms of ear pressure, fullness, hearing loss, and balance difficulties • Untreated, OME can cause permanent hearing loss and speech and language difficulties – seen most commonly in children Current Standard of Care Treatment Myringotomy with ventilation tube insertion: • Decreases pain • Restores hearing • Prevents reaccumulation of fluids • Ventilates middle ear space • Improves balance Clinical Need: Improve existing surgical technique • Instruments unable to hold and precisely manipulate the small ear tubes; multiple instruments required to insert the tube risk of damage to ear canal It started with a BME Capstone Team... Orthopaedic Surgery Michael Pannunzio, M.D. Kornelis Poelstra, M.D. Otolaryngology Brad Kesser, M.D. Biomedical Engineering Shayn Peirce-Cottler, Ph.D. Anu Roy Lisa Killen Danielle Gause Early Prototypes Prototype 1A Prototype 2A It continued with a Capstone Team... Otolaryngology Brad Kesser, M.D. Nursing Deborah Conway, R.N., M.S.N. Biomedical Engineering Shayn Peirce-Cottler, Ph.D. Isi Azeke Craig Conta Ashley Davenport Kristen Melnyczuk Trevor Royce Daniel Walters Provisional Patent Identify Potential Licensees Prototype 1B NDAs Pre-clinical Trial, Clinical Trial, & International Licensing Deal Time Required for Ear Tube Insertion Time (seconds) 150 125 100 p = 0.062 75 50 25 0 Chinchilla Model Standard PROTOTYPE of Care 1B Capstone as a Mechanism for Upstream Innovation • How can we involve BME undergraduates in translational research? • Research for credit • Capstone sequence – “Project Fair” – Topics include design, IP, market research, and FDA regulation – Fall Proposal & Spring Capstone Symposium • Novel design-for-credit course (“D-teams”), funded by NCIIA • How can involving our undergraduates in translational research bolster an environment of innovation? • Many of our students are medically-motivated… and creative! • Interdisciplinary Solutions Workshops • High-throughput (Capstone “incubator” for new ideas) U.Va. BME Capstone Design Achievements over Three Years (avg. 53 students/yr) Projects Resulting in… Number of Projects Scientific Peer Reviewed Publications (Papers & Abstracts) 20 Provisional Patents Filed 10 Full Patent Applications (U.S. and International) 3 Challenges • Intellectual property (…who owns it?) • Timing issues related to the academic calendar • Continuing the project over consecutive years and offering the same types of “design” experiences