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

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 structurally evaluated. The use of the current SaMDs as highly concentrated in the medical image processing field, with emerging information and communication technology companies producing many products. The relationship between SaMDs and hardware-type medical devices varied with their use purpose, based on which an innovation regime map for SaMDs was constructed. Next, the differences in reimbursement systems in Japan, the U.S., and Europe were comparatively analyzed, considering the policy implications for high-uncertainty technologies, such as SaMD and orphan drugs. We specifically focused on the cost-effectiveness-oriented reimbursement decision in Europe, the approval-for-reimbursement structure in Japan, and the range of individual decisions by payers in the United States. We summarized the actual state of price setting and payment models in each region (e.g., performance-based payments, price caps, and rebates). A framework for risk allocation between manufacturers and insurers is required when the value of medical technology is uncertain, suggesting a need for flexible and data-linked evaluations in future system designs.