The development of biomedical technologies and devices and their translation to the healthcare market requires a strong foundation in science and engineering, an understanding of clinical need, and well-honed entrepreneurial skills. Tulane University’s Bioinnovation PhD program was initiated in 2012 through the National Science Foundation’s Integrative Graduate Education and Research Training (IGERT) grant mechanism to provide emerging entrepreneurial scientists and engineers with the skills needed to bring research from “bench to bedside.” A hallmark of the program is a summer internship at the Food and Drug Administration (FDA) in the Division of Postmarket Surveillance – this is a Division in the Office of Surveillance and Biometrics of the Center for Devices and Radiological Health (CDRH). All degree candidates spend the summer working at the FDA in Silver Spring, MD after the first year of academic study to understand the practical and regulatory considerations that are required for the successful development of biomedical technologies and devices.
Over the past three years, twelve fellows in three cohorts have participated in this summer internship program. The internships were a first for FDA; as such, expectations about what could be accomplished over a 12-week period were minimal. What occurred in the first couple of years was remarkable: Bioinnovation fellows were given considerable latitude and opportunity to discover and work on real world issues that the FDA needed to address. Fellows matriculated through the FDA along a path of relatively unstructured discovery, wherein they learned about the agency and the processes and issues associated with product regulatory practices. Likewise, the agency came to realize the value of an exploratory approach to orientation and training that is currently under consideration for new FDA analysts.
The FDA internship has also proven to be influential to the professional growth of the graduate fellows. They found particular value in their role as “active witnesses” to the agency’s Signal Review Meetings, where they were able to observe, reflect and follow up with professionals on the decision making process associated with the adverse effects of a medical device. These interactions taught them how to network and learn through observation and to work within the confines of a hierarchical non-academic organization. The process also challenged analysts to expand their understanding of what is possible by considering new approaches to confronting regulatory issues.
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