The FDA Medical Device Fellowship Program
In an effort to optimize the timeliness and quality of its evaluations, the FDA has initiated an innovative program.
The views and opinions in this article are those of the authors and do not necessarily reflect those of the US FDA, the US Department of Health and Human Services, or the Public Health Service.
To view the table related to this article, please refer to the print version of our May/June issue, page 59.
In order for a medical device to be studied or marketed in the US, the applicable laws must be followed. For most endovascular devices, this includes obtaining marketing clearance or approval by the FDA, or an approved investigational device exemptions (IDE) application if it is to be studied clinically. As described previously, this involves submission by a manufacturer or sponsor of documents containing the information necessary to support the marketing clearance or use in a study. These documents must be thoroughly evaluated by the review staff in the Office of Device Evaluation (ODE) in the Center for Devices and Radiological Health (CDRH) at the FDA. Following is a description of a new initiative to provide the ODE additional resources to optimize the timeliness and quality of their reviews of such documents.
From the ODE Annual Report for Fiscal Year 2002 (ie, September 2001 to October 2002), more than 10,000 documents are received per year for review. Fortunately, more than 10,000 are also completed, so the balance stays fairly constant, although those received are not necessarily the same as those completed (Table 1).
Last year, the Division of Cardiovascular Devices (DCD), responsible for review of endovascular and other vascular and cardiovascular devices in the ODE, reviewed almost 2,500 original IDEs and IDE supplements, more than 900 510(k) submissions, and approved around 10 new PMAs and almost 300 PMA supplements. With fewer than 50 reviewers on staff to evaluate these submissions, each reviewer has to assimilate and evaluate a vast amount of information in a limited period of time. It is not unusual for a staff member to be reviewing 10 or more submissions at once. Given the relatively heavy workload in this Division, as well as the critical nature of many of the devices reviewed, the Division’s need for additional resources is particularly acute.
USE OF OUTSIDE EXPERTS
One approach CDRH is taking to address this resource challenge is to make greater use of expertise from the outside medical and scientific communities. Although outside experts, including advisory committee members, have been consulted on device issues to a limited extent for many years, the Center is now taking this approach to a new level with the establishment of the CDRH Medical Device Fellowship Program (MDFP).
The MDFP is designed to expand the capacity of CDRH to evaluate a growing number of highly complex medical devices, as well as to help with some of the Center’s more routine work, by recruiting qualified individuals for short-term and/or part-time appointments. Most fellows spend an initial period of time—typically 3 months or more—at CDRH learning the medical device review process. At the end of this period, fellows may choose to maintain a consultative relationship with CDRH, either on-site or from an off-site location, return to their academic institutions for further training, or pursue related careers.
Beginning last August, one of the first MDFP participants, a third year medical resident, spent 6 months in DCD reviewing submissions in various phases of the approval process, and participating in collaborative discussions regarding clinical trial design challenges for specific medical devices. This individual has since chosen permanent employment with CDRH and at the same time will be maintaining a clinical appointment with his academic institution.
Another participant, a heart failure expert from Case Western Reserve University, devotes 20% of her time to Center work, telecommuting from her home in Ohio. A cardiothoracic surgeon from California devotes 100% of her time to CDRH review and consultation, working from her home state and traveling to CDRH headquarters in Maryland as needed.
Beginning in January 2003, CDRH piloted a Biomedical Engineering (BME) Co-op Program with a small number of university biomedical engineering departments. The co-op experience typically involves a 2-year commitment, with the student alternating semesters between CDRH and school. The BME Co-op Program, which brought in several exceptional students for the spring semester, has been expanded to include additional biomedical engineering programs.
One of several biomedical engineering students from Marquette University divides time between evaluating data alongside engineers in ODE and doing laboratory work at one of the labs in the Center’s Office of Science and Technology.
Currently, CDRH is working with hospitals, universities, and professional societies to establish on-going relationships that will help in identifying qualified candidates for the program.
Fellowship positions are made available based on the specific needs of the Center at any given time, and may include opportunities for physicians, engineers, statisticians, epidemiologists, nurses, microbiologists, physicists, and others. Participants in the program thus far have ranged from senior level physicians, engineers, and other scientists, to medical fellows and residents, to graduate and undergraduate students in a variety of disciplines. They have come from academia, healthcare organizations, or other government agencies. Some are current or former advisory committee members; these are often ideal candidates because they have some familiarity with the approval process and are known to CDRH staff. Others are retired CDRH employees seeking to renew their contributions to CDRH’s mission.
Within the Office of Device Evaluation, approximately 17 Medical Device Fellowships are currently slated for the fiscal year of 2003, and several more are under discussion. Eleven of these will be in the DCD. In the DCD, the participants have primarily been physicians and engineers.
Fellows participate in various aspects of the review process, in a capacity determined by their level of training and experience. Physicians are asked to provide input on clinical data and evaluations of clinical outcomes submitted by device companies. Engineers look at device designs as well as evaluate preclinical testing.
BENEFITS OF THE PROGRAM
From a CDRH perspective, the program brings in support for the Center’s in-house experts, helping staff keep up with a demanding workload. Outside experts may have experience with emerging device technology that helps the Center predict and prepare for future challenges. As technology changes, so do expertise needs. Using outside experts on an as-needed basis provides CDRH with a flexible workforce that can address new device questions as they arise. In addition, having students and professionals in the program on limited appointments provides a pool of potential recruits for CDRH to consider for future employment.
Program participants have the opportunity to learn about the medical device approval process. For many this may be a career enhancer, translating into marketability for future career paths. Many healthcare professionals view this program as an opportunity to contribute their knowledge and experience to public service, consulting with CDRH on complex questions and issues, and being part of the process of bringing safe and effective medical devices to market. For students, it is an opportunity to apply what they’ve been learning in school, work alongside professionals in their field of interest, and consider public service as a challenging and rewarding career.
The program is flexible in terms of time commitment and experts may have the opportunity to work in more than one office. A medical researcher in the program is an MD with over 15 years of research experience in basic electrophysiology and biomedical engineering. This person is scheduled to rotate through the various offices within CDRH during his 1-year appointment, enabling him to gain experience in device regulation and monitoring throughout a device’s total product life cycle. The rotation will begin with the review of preclinical data and end with monitoring approved devices that are being used regularly by healthcare professionals, patients, and consumers.
CONFLICT OF INTEREST
CDRH’s credibility is based, to a great extent, on its ability to provide objective and unbiased assessments of the products it regulates. Thus, avoiding potential conflicts of interest on the part of all CDRH employees, including fellows, is of paramount importance. Just as permanent FDA employees are screened, candidates for the fellowship program are carefully scrutinized for financial interests in regulated companies.
In addition, as employees of a regulatory body entrusted with protecting highly confidential information, CDRH staff, including fellows, are prohibited from disclosing any confidential or proprietary information during or after their service to the FDA.
As medical device technology becomes more sophisticated, the determination of device safety and efficacy by the FDA becomes increasingly challenging. The use of outside experts is one mechanism CDRH is using to augment the technical review of medical devices and to manage the ever-increasing workload the Center is facing. Universities, healthcare institutions, professional societies and individuals interested in learning more about this program may send inquiries to email@example.com or to:
Susan A. Homire, DVM
Senior Science Advisor
Office of the Center Director
Center for Devices and Radiological Health
9200 Corporate Blvd, HFZ-1
Rockville, MD 20850 n
Garrett Pilcher is currently an intern at the FDA.
Dorothy B. Abel is a Regulatory Review Scientist with the US FDA Center for Devices and Radiological Health in Rockville, Maryland; she is also a regular columnist for Endovascular Today. Ms. Abel may be reached at (301) 443-8262, ext. 165; firstname.lastname@example.org.
Susan A. Homire, DVM, is a Senior Science Advisor with the US FDA Center for Devices and Radiological Health in Rockville, Maryland. Dr. Homire may be reached at (301) 827-7994; email@example.com.