Undergraduate Research Student Profile: Medical Device Data Analytics with the FDA

PITTSBURGH (December 6, 2017) Julie Constantinescu, a sophomore bioengineering student, spent this past summer at an internship with the Food and Drug Administration headquarters in Silver Spring, Maryland under the mentorship of Pitt alumna, Jill Marion. 

Julie was hired through the FDA’s ORISE research fellowship program to work on the Medical Product Safety Network (MedSun) team within the Office of Surveillance and Biometrics. The MedSun program works with hospitals to identify and solve problems with the use of medical devices in their facilities.

Julie answered a few questions about her experience in the program.

Can you tell us more about the program and your research?
My focus was on the research of medical device data analytics. The FDA is looking for ways to improve the way they deal with inconsistent hospital device data that is reported through MedSun, so my goal was to research and recommend possible analytics platforms to be integrated into their system to make the reporting system more accurate and efficient. I would have weekly meetings with my mentor for updates on my research and guidance, as well as biweekly meetings with the division to learn about any updates to include in my research. 

In between this research, I also worked with the survey team in the division to create questions to send to hospitals about the quality of their device reporting systems, such as CMMS (Computerized Maintenance Management System). I was basically working 9 am to 5 pm accumulating research from library sources like PubMed as well as notes from hospital phone calls that I conducted to get first-hand information about their current analytics platforms. After this research was done, I put it all together into a formal paper which I submitted at the end of my term and presented to the division. 

How did you get assigned to this research project?
Although I wasn’t sure exactly which project I would be working on until I started, I was able to pick the department I wanted to work in. Since the FDA is very branched and includes a lot of different fields of expertise, I was able to choose to apply to a division that most closely aligned with my interests. This was the Center of Devices and Radiological Health (CDRH), specifically in the Office of Surveillance and Biometrics (OSB).

What was your favorite part about your summer research experience?
I found the most rewarding part of this internship was gaining real “work” experience and seeing a first-hand, real-world application of bioengineering. About 80% of the people I worked with were bioengineers, so talking to them about their undergrad experiences and how they got to their current position was really helpful for me.

Do you have any advice for those looking to work for the FDA?
For those looking to work for the FDA, I would first recommend applying really early because the government takes forever to process paperwork. I would also recommend looking into the different offices and departments at the FDA and applying to a department that really interests you since your research will focus on the work they do in that specific department.