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. Rhim is currently the Executive Director of Medical Device Consulting, at NSF International, where she provides strategic and hands-on consulting services to clients looking to introduce innovative medical devices to patients. She joined NSF International after nearly 10 years in the medical device and public health sectors, including over seven years with the U.S. Food and Drug Administration.
Tell us a little bit about your time at FDA.
I came to the FDA right out of graduate school, not knowing much about the Agency or appreciating the enormity of its charge in promoting and protecting public health. During my first years at FDA, I spent my time as a lead reviewer in the divisions of orthopedic and cardiovascular devices, and was responsible for the premarket review of a variety of different device types and submissions. Many times, these reviews involved coordinating a large team of experts who all weigh in on a device’s safety and effectiveness profile. More recently, I took a position as the chief of the Anterior Spine Devices Branch. In this role, I was able to lead a team of engineers and medical officers, who collectively assessed all premarket reviews for anterior spinal devices requesting US marketing clearance or approval. Additionally, there were opportunities to engage with industry counterparts as well as representatives from larger trade associations.
What past experience or trait do you think helped you be a successful reviewer and then branch chief?
Growing up, it was ingrained in me to always think about the team over myself. That collaborative nature has made the difference in considering all points of view, resolving disagreements, and keeping teams aligned to a common goal. Decisions at FDA, and even those in industry, are never made in a silo and always require functional collaboration. What has been critically important in this collaboration is the fundamental reliance on scientific evidence first.
What are you up to these days?
What some refer to as the “other side”, I now work with medical device manufacturers who are looking to get into the US market, as well as other global markets. I am using my intimate knowledge of the FDA review process to help tackle challenging regulatory scenarios and also guide clients to the most effective and efficient path to commercialization.
What's something that you learned from FDA that helped you in your current position?
Other than the regulations themselves and how reviews of submissions are conducted, I have gained an appreciation for the balance of scientific and regulatory perspective necessary for premarket review. From this, I have also learned that there are often a number of acceptable regulatory approaches, but all should have a sound scientific rationale.
What do you think is a common misconception about FDA and/or FDA reviewers?
One big misconception is that FDA wants to say “no”, which is far from the truth. There are a number of reasons that manufacturers are challenged, and these can range from an inadequate scientific rationale to an unaddressed risk to health. Other times, a particular device is questioned because FDA has evidence that points to a problem that had not come to light until recently about a certain technological feature or a certain use within a device family. Still, there are other situations where there may be a systemic issue raised by the medical community. FDA doesn’t always have the answers and very much appreciate a scientific discussion focused on how to mitigate your risks to health. If anything, FDA wants to see more devices on the market and in the hands of patients.
What is some advice you can give to a person interested in regulatory affairs?
First, don’t be afraid to jump in. While there is merit in becoming more acquainted with the regulations and reading through regulatory affairs blogs and books, nothing can really solidify any of that knowledge without the hands-on experience. Second, talk to others for perspective. The field of regulatory affairs is so broad and the scope of what that means in different product areas (i.e., drugs, devices, food, etc.) is starkly different, too. Take time to explore each of these and reach out to people on the front line. Also consider that regulatory affairs is not only about getting something on the market, as there is a whole other regulatory world after getting that FDA stamp. Finally, think globally. Just as companies are thinking about global marketing, begin to understand that there are separate regulatory paradigms for different parts of the world. You have to be versatile across these platforms to make yourself a regulatory expert.
More about Caroline Rhim, Ph.D.
Dr. Rhim received her doctorate degree in Biomedical Engineering from Duke University, and her Bachelor and Master of Science degrees in Materials Science and Engineering from M.I.T.
Prior to joining NSF International, Caroline served as an FDA Branch Chief for the Anterior Spine Devices Branch at the Center for Devices and Radiological Health (CDRH). Caroline also led the review of premarket submissions as a lead scientific reviewer in both the Division of Orthopedic Devices and Division of Cardiovascular Devices. During her tenure at FDA, she was involved in streamlining the premarket and postmarket review process, as well as the classification efforts for posterior cervical screw systems.
For more information about Caroline and her colleagues’ work at NSF International, please visit the following link: http://www.nsf.org/services/by-industry/medical-devices/