This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at firstname.lastname@example.org.
Dr. Nagaraja received his Doctorate and Master of Science degrees in Mechanical Engineering from the Georgia Institute of Technology, following a Bachelor of Science degree in Mechanical Engineering from the University of Michigan. In his role at FDA, Srinidhi acted as a senior consultant for mechanical safety of premarket medical device submissions, including IDE, PMA and 510(k) applications. He also analyzed post market mechanical failures, with expertise in cardiovascular and orthopedic devices. Concurrent with his time at FDA, Srinidhi was an affiliate faculty member at the University of Maryland, and developed an active research program improving assessment and studying the integrity of cardiovascular and spinal devices.
Tell us a little bit about your time at FDA.
I spent 10 years at the FDA’s Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH). Not many in industry are aware that CDRH has facilities to perform device research and testing. During my time at FDA, my responsibilities spanned both the regulatory and science based mission of CDRH. For example, I was a technical consultant to the review teams in the Office of Device Evaluation (ODE) for various regulatory submissions. My area of expertise was mechanical safety and performance of medical devices. In particular, I was involved in evaluating the durability, corrosion resistance, and mechanics of various medical devices. I was also a principal investigator for research studies focused in areas such as spinal biomechanics, nitinol durability, and corrosion susceptibility of implants. These studies were performed to help ensure that CDRH was ready to evaluate emerging and innovative medical technologies. In addition, the research aided in the development of appropriate testing standards (e.g. ASTM or ISO standards) or acceptance criteria for use by the medical device community during design verification activities.
How did your research in OSEL inform your work as a reviewer?
One example of how my research informed regulatory review was a study to better understand in vivo corrosion resistance of nitinol implants. This was an important topic within the implant community as there was considerable debate regarding suitable acceptance criteria during an FDA workshop that I co-organized in 2012. We conducted an animal study to address the issues raised and provide scientific data to help determine acceptable limits for the corrosion of implants. The papers published on this topic have helped clients I work with in my current position as part of design verification testing activities, and also have been referenced by FDA during regulatory review.
What was your favorite thing about working with a review team on a premarket notification or approval submission?
While working on a premarket approval (PMA) submission, I always enjoyed the diversity in skills and expertise within the team. It was a great opportunity to listen to and learn from medical officers, toxicologists, and veterinarians, and better understand their perspective of the risks and benefits of a particular device. I also was fortunate to work on PMAs in many different product areas, especially in those where the use of nitinol was increasing. This really made the day-to-day work fun, as I needed to think critically about how to apply mechanics principals to various significant risk devices.
While at FDA, you were also affiliate faculty at the University of Maryland. How did you swing that sweet gig? What was it like having that joint appointment?
It was great having a faculty appointment at the University of Maryland while at FDA. The connection was beneficial for both FDA and the university’s Bioengineering Department. As a result of the joint appointment, I was able to advise PhD candidates and participate in seminars and collaborate on research studies at the university. My dual position also created opportunities for University of Maryland students to gain experiences in regulatory science and device approval process as FDA interns. Overall it was a wonderful experience, and allowed me to mentor undergraduates and graduate students pursuing biomedical engineering degrees.
What are you up to these days?
I left FDA over a year ago and started at G. Rau Inc., which is an independent medical device testing laboratory in the Bay Area. Our company provides standard and custom mechanical testing (e.g., durability, corrosion) and technical consulting to medical device companies. My role at G. Rau Inc. is to support device companies seeking approval/clearance of their device. In particular, we help establish testing strategies, conduct testing to characterize device safety and performance, and address FDA deficiencies during the approval/clearance process.
How does your current role incorporate or benefit from your regulatory experience?
I think there is a direct benefit to having regulatory experience. I apply my previous FDA regulatory and research experiences to help device companies with design verification testing and other scientific matters in order to demonstrate the mechanical safety and performance of their device. For example, my reviews of devices at FDA were focused on analyzing testing plans, reviewing mechanical test reports, and providing technical recommendations to device companies. Now, I use those experiences to help companies outline an approach to successfully establish safety and performance of their device.
What do you think is a common misconception about your current company?
One misconception is that our company provides testing and technical consulting solely for nitinol-based products. However, our testing capabilities and expertise are fairly broad, allowing for testing of devices manufactured from other materials (e.g. titanium spinal components).