In accordance with the results of the analysis of the current status of the medical industry in Russia, the methodical approach to the assessment of the feasibility of medical device creation project has been developed based on the calculation of the potential socio-economic impact of the implementation of medical devices by the cost of illness method, which includes the model and evaluation methodology and allows to make formalized quantitative assessment of the positive effect of the implementation of medical devices, to compare the potential impacts of the implementation of different medical devices being developed with the costs of the creation of medical device, as well as to prioritize medical device creation projects in the portfolio. © 2018 IEEE.