Graduate School Alumni Society Global Outreach Committee Seminar Series

January 25, 2017

UNIVERSITY PARK, Pa. — The Graduate School Alumni Society Global Outreach Committee seminar series will continue on Feb. 6, with a presentation by Maureen L. Mulvihill, titled "Translating Medical Research into Commercial Products: What Happens after the Science." The seminar will be held in 112 Kern Graduate Building on the University Park campus and will start at 6 p.m.

Registration for the event is required by Feb. 3. Refreshments will be provided. The event will also be livestreamed at http://bit.ly/2iEDKsZ.

The Penn State College of Medicine will be offering a video conference of the event and will be providing refreshments thanks to the Penn State Clinical and Translational Science Institute. To register for the Hershey event visit http://bit.ly/2jKOEPm

About the Presentation

Why do so many innovative devices that you hear about on newsfeeds ultimately die shortly after the prototype stage? Primarily because Verification and Validation of efficacy and safety are extremely challenging and costly. The typical project cycle for medical device development has seven stages. Stages 1 and 2 are investigation and feasibility. During this time, a few prototypes are developed and tested to demonstrate potential benefit. In Stage 3, beta prototypes are fully developed and tested to show reproducible performance. Stages 4 and 5 are verification and validation. These stages are where the product specification and intended purpose are tested. The sample size statistics are key considerations and data is often used for regulatory approvals. Stage 6 is manufacturing scale up, which is usually after regulatory approval where production level scaling occurs. In Stage 7, production and sales begin. To commercialize a medical device a strong, reproducible quality management system is key to completing the seven stages. There is significant testing required to commercialize a medical device and often inventors do not have the capital to complete the development. Additionally, strategic plans for intellectual property, reimbursement, and health economics of the device need to be considered from the very beginning. It takes a lot to carry an innovative medical device over the "valley of death," but with the right funding, strategy, and interdisciplinary team, commercialization is possible.

About the Global Outreach Committee of the Graduate School Alumni Society

The mission of the Global Outreach Committee is to connect international Penn State graduate students with the larger Penn State community throughout their years of enrollment and after graduation. The committee engages international Penn State graduate students through group/panel discussions, student forums and formal presentations. These interactions establish open lines of communication, enhance the student experience, and foster a sense of community among graduate alumni.

Last Updated February 01, 2017