[Programmed Medical Device (SaMD) and Orphan Drug Innovation Processes and Industrial Systems].

Abstract

The innovation patterns and institutional environments of software as a medical device (SaMD) were empirically, comparatively, and institutionally analyzed as SaMD is attracting attention as innovative medical technology. Data were collected on SaMD products approved by the U.S. Food and Drug Administration (FDA) and medical providers (n=581 and 268, respectively). The relationships among SaMD use, the interaction of SaMD with existing medical devices, and company characteristics were structural