Global Outreach Committee Seminar Series
|Date||02/06/17 6:00pm to 7:00pm|
|Presenter(s)||Maureen L. Mulvihill, Ph.D., President & CEO, Actuated Medical, Inc.|
|Location||102 Kern Graduate Building|
Translating Medical Research into Commercial Products: What Happens after the Science
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 7 Stages. Stages 1 and 2 are investigation and feasibility. During this time, a few prototypes are developed and tested to demonstrate potential benefit (Wow – the science is amazing here!). 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 7 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.
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.
Registration for the event is required by February 3. Refreshments will be provided.
The presentatioin will also be video conferenced to the Hershey Medical Center, 500 University Drive, Room: T2500. Hershey participants should register separately.