FDA
Combination Product Policy Analyst
Biomedical Engineer and Lead Reviewer
Erin Keegan is an Alumni of the CMTI Master’s program and of the University of Rochester as a Biomedical Engineering undergrad. She is currently celebrating over 7 years working at the Food and Drug Administration in the Office of Device Evaluation for the Division of Neurological and Physical Medicine Devices (DNPMD). Erin initially began as a Biomedical Engineer and Lead Reviewer for roughly 3 years, and has moved into a Combination Product Policy Analyst position.
My job involves a little bit of everything! Which is why my time spent in the CMTI Medical Technology Innovation Master's Program was so valuable. The CMTI program provided me with explicit regulatory knowledge through the joint IP/FDA course but also equipped me with tools throughout the entire program that I use every day at the FDA. Furthermore - I met my FDA contact through this same FDA/IP course which is what has landed me a job that I love!
The CMTI program provides knowledge about the entire device development process through topics such as business/entrepreneurship, IP, regulatory, human factors, manufacturing processes, standards recognition, QSR, testing plans (with specifications and acceptance criteria!!), as well as extended knowledge in many different engineering fields. These topics have prepared me for interactions with sponsors and the review of the data in the submissions. This has been especially helpful as an EFS rep where I advise sponsors very early on in their device development process. CMTI enables me to 'take a walk in their shoes' because through the program we have been exposed to that early stage development of a device. Additionally, skills such as public speaking, facilitating interactions between people with many different specialties and problem finding/defining are skills that I use every day. Finally, as a Senior Design TA I have directly applicable experience in reviewing device development documents which isn't so different than what I do here now.
In general, the CMTI curriculum is comprehensive and provides a solid foundation for students to branch off in any direction they find interests them. I think that having the global understanding of the device development process is something that is not easy to find in recent graduates but the CMTI program has given me the knowledge and the confidence to be an active member of the medical device regulatory community right out of school. I highly recommend the CMTI program for whatever future career you anticipate within the medical device industry and can't state enough how much I value the time I spent at the University of Rochester.