First in Man


There are two main paths for clinical studies in the United States for medical devices. The first is the most common, called a traditional study. This approach follows a U.S. Food and Drug Administration (FDA) design process including agency testing, pre-clinical trials, and then first-in-man trials. The second, which is called an early feasibility study, can be just as important but is used much less often. First-in-man trials accomplished in an early feasibility study can be extremely important for innovative concepts with poor preclinical models. Done correctly, it can facilitate efficient use of capital, and companies understanding this process and innovating multiple designs can dramatically increase their odds of success. A traditional feasibility study is a clinical study where safety and effectiveness data is gathered on a near-final or final device design. Because this takes place later in development, the FDA expects to see more preclinical data in an investigational device exemption (IDE) application. This preclinical data can be a result of mathematical modeling and simulation, bench, in-vitro, animal, or cadaver testing. Later, this clinical study becomes part of an FDA submission. Read the rest of the Steve's latest MPO article here: MPO March 7, 2017

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