We will refine and select device concepts, which will be used to assess feasibility. A clear and simple statement will be generated based on the clinical problem to define concept success (e.g., the device should be able to grab and hold the walls of a femoral artery). The selected and refined concepts will be translated into solid computer models. 

We will generate prototype designs with enough detail to assess their functionality. Prototypes are fabricated using a combination of off-the-shelf and custom components. They will be tested using models with the actual biology or the most realistic alternative. Feasibility testing can be accomplished through bench testing, animal testing, and analysis. We will compare the results against metrics in a technical review or a formal design review and summarize the results in a report. 

During the Concept Development phase, we will compile all documentation into a project file, including background information, engineering drawings for prototype fabrication, memos, and reports. Together with clients, we will identify and record key metrics that will be used as objective measures for feasibility testing. At the end of the phase, we will provide a proposal and draft plan for future work to develop the concept into a full device design.