Start off by giving us some more detail about your time at FDA.
I spent three years at FDA. For the first nine months, I was an American Institute for Medical and Biological Engineering (AIMBE) Scholar, working on strategic projects for the Center for Devices and Radiological Health (CDRH). Afterward, I became a premarket device reviewer for CDRH. My titles included “Biomedical Engineer” and “Staff Fellow”, and my roles included Lead Reviewer and Biocompatibility Consulting Reviewer for the Division of Cardiovascular Devices (now referred to as DHT2B), Vascular Surgery Devices Branch (now known as the Vascular and Endovascular Devices Team).
Tell us a little more about being an American Institute for Medical and Biological Engineering (AIMBE) Scholar. Can you briefly describe the program and talk about your responsibilities in that role?
The AIMBE Scholars program is an opportunity for early career PhDs in biomedical engineering or related fields to serve as expert advisors to policy makers at CDRH. The first cohort of AIMBE Scholars started at FDA in 2014. To date, AIMBE Scholars have worked on a wide range of projects aimed at improving the review process, providing tools to support regulatory decision-making, and developing policies to promote innovation and public safety. More information on the program can be found at https://aimbe.org/scholars-program/.
My AIMBE Scholar appointment was with the Office of Device Evaluation (now known as the Office of Product Evaluation and Quality, or OPEQ), where I assisted with efforts to reclassify a large number of medical devices. Reclassification is a process that impacts the regulatory requirements for each reclassified device. It is a complex process involving multiple teams across CDRH. To coordinate this process, I needed to learn the details of the process, then guide each team through it. This involved project management and lots of internal written and verbal communication. Throughout the process I worked with upper management, middle management, and individual premarket reviewers.
In addition to our FDA projects, AIMBE Scholars also attended site visits to current and potential industry sponsors. We also presented our projects at the AIMBE Annual Meeting to academic and industry members of AIMBE. These were great opportunities to network and hone our regulatory communication skills.
What about your experience as an AIMBE scholar made it clear to you that you wanted to spend more time at FDA?
Two things: the public health impact of FDA’s work, and the people at FDA. Regarding public health impact, it was fulfilling to work on projects where the immediate goal was to benefit public health. Prior to this work, I was a graduate student developing early-stage technologies that might one day help patients. While such research could be important in the long-term, it takes many years to prove a new technology, and many more years to develop a medical product and obtain regulatory approval/clearance. In contrast, the work I did at FDA changed the regulatory requirements for each reclassified device, which directly impacts the speed and cost to develop and market new products in that device category. It was thrilling to be able to see how my work could have a positive impact on patients in the short term.
Regarding people, I really enjoyed working with FDA reviewers and managers. You might think that FDA employees are focused on just rules and red tape, however, people there are very passionate about public health, and creative in getting things done that benefit patients within the framework of rules and regulations.
You worked as a lead reviewer in the Vascular Surgery Devices Branch. Before your time at FDA, what was your experience with blood-contacting cardiovascular devices?
Prior to FDA, I helped develop a resorbable vascular graft, which is a blood-contacting permanent implant. This was part of my dissertation work as a graduate student at the University of Pittsburgh, under the mentorship of Dr. Yadong Wang. That work helped me to understand how device materials interact with blood. I also learned about the design requirements for implants that need to withstand and maintain blood pressure, and the various failure modes to watch for.
While this experience was certainly helpful to my work as a lead reviewer, it was not a prerequisite for the job. After starting as a reviewer, I learned that FDA considers a wide range of backgrounds for lead reviewers, though they are most commonly engineers or scientists. Additionally, most of what I needed to know I learned on the job. FDA review teams have a wealth of collective experience and scientific knowledge about their devices. Coming in as a fresh Ph.D., I certainly did not know even 10% of what it takes to review a device. But the review team did and they got me up to speed quickly.
What was your favorite thing about working with a review team on a premarket notification (510(k)) or premarket approval (PMA) submission?
I enjoyed “standing on the shoulders of giants”, so to speak. I had the privilege of working with seasoned scientists, engineers, medical officers, and veterinary officers. I learned so much from these FDA veterans over the course of my premarket reviews. Much of their insight comes uniquely from experience reviewing devices, so it felt like I was learning things I couldn’t learn anywhere else.
What does it mean to be a biocompatibility reviewer?
Here is my personal take on what a biocompatibility reviewer does: Biocompatibility reviewers focus on reviewing the potential biological response that a patient can have to a medical device. Practically speaking, this means that biocompatibility reviewers review a combination of in vitro and in vivo testing, risk assessments, and rationales for why testing is not needed. These tests, risk assessments, and rationales focus on the impact of the device, or chemicals that can leach out of the device; on the patient’s cells/tissues, blood, and organ systems.
Biocompatibility review is just one of many roles that a premarket device reviewer can play at FDA. For example, I served as both a lead reviewer and a biocompatibility reviewer for premarket device submissions.
What past experience or trait do you think helped you be a successful reviewer during your tenure at FDA?
When I started review work, I thought that my technical expertise would be my most valuable asset for day-to-day work. While it certainly came in handy, the skills that helped me most were actually my communication and consensus building skills. Review teams often include multiple experts with a range of technical backgrounds and communication styles. To complete a review efficiently, we all needed to find common ground regarding priorities, action items, and ultimately, the safety and effectiveness of the device.
What were your favorite FDA submissions to work on and why?
I enjoyed reviewing 30-Day Notices for manufacturing changes. In reviewing these submissions I got to see some of the manufacturing steps for the device, then evaluate and/or question the thought process behind each manufacturing change. This was fun because I got to see how devices are made; there are a wide range of manufacturing techniques out there, and some of them are fascinating. For the techniques that I already knew well from graduate school, it felt satisfying to leverage my existing knowledge to expedite a review.
What are you up to now and how does your current role incorporate your regulatory experience?
I currently work as a Senior Associate within the Regulatory Affairs team at MCRA. MCRA is a leading advisory firm and Contract Research Organization (CRO) for the medical device industry, with a range of services including regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. As a Regulatory Affairs Senior Associate at MCRA, I help our US and international clients to write and submit regulatory submissions to achieve and maintain market approval/clearance. These submissions include US FDA submissions, such as 510(k)s, Investigation Device Exemptions (IDE), and Premarket Approvals (PMA). They also include international submissions such as Clinical Evaluation Reports (CER). We also help our clients to develop and execute long-term regulatory strategies.
My FDA experience translates well to my work as a regulatory consultant. I am constantly using my firsthand knowledge of FDA’s regulatory expectations when I write premarket submissions for MCRA’s industry clients. The translation is direct for cardiovascular devices and biocompatibility evaluations, since I worked on those two specific things at FDA. For other device types and different types of testing, I can extrapolate from what I know, while also leveraging the experience of other MCRA employees. One of the great things about working at MCRA is the depth of experience that MCRA has in a range of product areas. For example, if I’m working on an orthopedic device submission, I can ask any of our 5 former FDA orthopedic device reviewers for their firsthand knowledge. I can also borrow the experience of MCRA’s other seasoned regulatory consultants who have a long track record of developing successful orthopedic device submissions.
How is working in industry similar and/or different than working at FDA?
As a regulatory consultant, I’m writing rather than reviewing device submissions. However, the process of writing submissions is very similar to that of FDA review. For example, as a consultant I still think about things like technological characteristics, benefit/risk, and the appropriateness of predicate devices. I also frequently reference FDA Guidances and regulations, just as I did at FDA. In addition, I often change hats and “review” my draft submissions from the perspective of an FDA reviewer; this helps me to anticipate FDA questions and thereby strengthen the overall submission. So overall, writing a submission doesn’t feel too different from reviewing one.
Of course, there are some differences in consulting vs. FDA review. As a consultant at MCRA, I work on a larger range of project types than I did as an FDA reviewer. This includes both the types of devices and the types of work products. For example, at FDA, I worked only on cardiovascular devices without electrical components, also known as the “plumbing” devices. As a consultant with six months experience at MCRA, I have already worked on a larger range of technologies than I did at FDA, including cardiovascular, orthopedic, and wound care devices. Similarly, at FDA I mainly worked on US premarket reviews. As a consultant at MCRA, I do write US premarket submissions, but I also work on international submissions as well as developing overall regulatory strategy recommendations for clients, which consider not just the technology but also the regulatory time and costs of each potential pathway. I like the variety that comes with working as a consultant!