By Eric Distad
As a global CRO providing services within the landscape of Medical Device and Diagnostics, we are approached by companies of all shapes and sizes with devices at various stages of the development process. Some of the most interesting opportunities involve smaller medical device companies that are at the point of designing their clinical strategy and making the leap to feasibility/First-in-Man (FIM) trials. While not always a required step prior to the pivotal study, these studies can play a critical role in the final design of the device and/or trial.
As discussed in recent Syneos Health white papers on regulatory changes in Europe and China, changing regulations in key geographic markets are leading to longer regulatory processes, making it crucial to have a solid understanding of the real world device use and confidence in the trial design prior to starting the pivotal study. Feasibility/FIM studies can assist in building this confidence.
I have recently had the opportunity to present at various conferences on FIM and feasibility device studies. Discussions during the presentations often involve questions about geographic preference for the conduct of these studies. Historically, these early phase device studies have been run outside the United States, primarily in Europe and APAC countries, such as Australia.
While these are still common and practical geographies in which to run these studies from regulatory, timeline, and cost perspectives, it is important to consider your patient population, regional health standards/standard of care, and medical devices regulatory requirements as part of your overall early phase clinical strategy. For example, it might be quicker and cheaper to run a feasibility study on a facial filler in APAC. However, if the ultimate targeted patient population will be those located in other global regions, the data obtained from the APAC study may not be entirely applicable. Likewise, due to different treatment algorithms and societal differences, it may not be applicable to run a feasibility study in a socialized healthcare system when the U.S. market is the primary target.
This trend of running early phase studies outside of the U.S., and the subsequent questionable data quality and applicability, is something the FDA has been working to address. In 2011, the FDA released a guidance document reflecting a shift towards easing expectations for these studies. [1] Steps were taken, such as expanding changes that can be made under the five-day notification, decreasing pre-clinical data requirements, and being able to make design changes without FDA review, in order to make these often fluid and quick-turnaround studies more viable for conduct in the U.S. In addition, an enhanced review process for these studies has the potential to decrease the approval timeline to make it more comparable to those of European and APAC countries.
As the above examples demonstrate, although small in size, the impact FIM and feasibility studies can have on your product development may be significant. As such, it is critical to carefully evaluate the best clinical strategy early in your medical device development cycle and planning in order to conduct studies that are not only timeline and budget friendly, but that provide data that are ultimately applicable to the long-range clinical plans for the device.
Read more about our Medical Devices Development experience here.
[1] https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103
About the Author
Eric Distad has been in the clinical research industry for 20 years, with various roles that have culminated in project management. The majority of his experience is with Class III medical devices supporting cardiovascular (coronary, peripheral, and carotid stents; AAA and TAA stent grafts; CHF/mitral valve insufficiency) and orthopedic (prosthetics and joint fusion) IDE studies, with additional work in diagnostics, human factors, and combination devices studies. He also has experience in urology, muscular dystrophy and rheumatoid arthritis trials. Eric has worked for both sponsor and CRO companies large and small, and has been involved in projects from protocol development through successful PMA submission. Throughout his career, he’s prided himself on open communication and building strong relationships with customers and team members, resulting in clinical programs that are not only completed successfully, but are a positive experience for all involved.
