The idea of the Early Feasibility Studies (EFS) program was first published in 2011 as a FDA draft guidance. Historically, innovation was paramount to the advancement of medical therapy in the US, but over time innovation moved out of the US to less regulated countries. The FDA created this regulatory pathway to facilitate the study of novel medical devices in a U.S. clinical setting. Groups such as MDIC have been tracking key performance metrics of this program and documenting the value to US patients. From an engineering perspective, the EFS process adds rigor to the early phases of development where critical clinical effectiveness questions need to be answered. These questions can only be answered in the human clinical condition, not on the bench and not in animals.
Early feasibility studies engender more risk than confirmatory studies because of their place in the development process. In particular, they can serve to develop and assess user skills (e.g., deployment techniques), as well as testing the performance of the device itself. Developing an effective engineering test plan for this type of clinical study takes experience and understanding of the medical device development process.
Close collaboration between physician investigators, engineers and study scientists is required for all clinical studies, but the EFS emphasis on user technique and device performance makes it critically important in that setting. We understand what it takes to succeed, and can help in this important part of the process.
Developing appropriate device evaluation strategies (DES) as opposed to a full risk analysis takes a unique understanding of the clinical risk situation and how the device will perform under unknown clinical conditions. The DES should identify and appropriately mitigate all known risks while properly identifying what will be controlled and mitigated within the study.
Contact us for more information about writing flexible device evaluation strategies suitable for EFS, navigating the EFS pathway with FDA, and conducting a study that allows feedback to flow amongst the stakeholders so your novel device may be clinically tested in the most efficient way.
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