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

Area of Science:

• Medical Technology Innovation
• Health Economics
• Regulatory Science

Background:

• Software as a Medical Device (SaMD) is emerging as a key area of medical technology innovation.
• Understanding SaMD's innovation patterns and institutional environments is crucial for its development and adoption.
• Existing research often overlooks the comparative analysis of SaMD innovation and global reimbursement landscapes.

Purpose of the Study:

• To empirically analyze the innovation patterns and institutional environments of SaMD.
• To comparatively evaluate reimbursement systems for SaMD in Japan, the U.S., and Europe.
• To construct an innovation regime map for SaMD and propose policy implications for high-uncertainty technologies.

Main Methods:

• Empirical and comparative analysis of SaMD products approved by the U.S. Food and Drug Administration (FDA) and medical providers.
• Structural evaluation of SaMD use, interaction with existing medical devices, and company characteristics.
• Comparative analysis of reimbursement systems in Japan, the U.S., and Europe, focusing on price setting and payment models.

Main Results:

• SaMD use is concentrated in medical image processing, with information and communication technology companies being major producers.
• The relationship between SaMDs and hardware medical devices varies by use purpose, leading to the construction of an innovation regime map.
• Significant differences exist in reimbursement systems, including cost-effectiveness focus in Europe, approval-for-reimbursement in Japan, and payer discretion in the U.S.

Conclusions:

• A flexible, data-linked evaluation framework is needed for uncertain medical technologies like SaMD.
• Risk allocation between manufacturers and insurers is essential for navigating the uncertainties in SaMD value.
• Comparative analysis of global reimbursement systems highlights the need for tailored policy approaches to foster SaMD innovation.