There has been a surge in academic and business interest in software as a medical device (SaMD). SaMD enables medical professionals to streamline existing medical practices and make innovative medical processes such as digital therapeutics a reality. Furthermore, SaMD is a billion-dollar market. However, SaMD is not clearly understood as a technological change and emerging industry.
This study aims to review the landscape of SaMD in response to increasing interest in SaMD within health systems and regulation. The objectives of the study are to (1) clarify the innovation process of SaMD, (2) identify the prevailing typology of such innovation, and (3) elucidate the underlying mechanisms driving the SaMD innovation process.
We collected product information on 581 US Food and Drug Administration-approved SaMDs from the OpenFDA website and 268 company profiles of the corresponding manufacturers from Crunchbase, Bloomberg, PichBook.com, and other company websites. In addition to assessing the metadata of SaMD, we used correspondence and business process analysis to assess the distribution of intended use and how SaMDs interact with other devices in the medical process.
The current SaMD industry is highly concentrated in medical image processing and radiological analysis. Incumbents in the medical device industry currently lead the market and focus on incremental innovation, whereas new entrants, particularly startups, produce more disruptive innovation. We found that hardware medical device functions as a complementary asset for SaMD, whereas how SaMD interacts with the complementary asset differs according to its intended use. Based on these findings, we propose a regime map that illustrates the SaMD innovation process.
SaMD, as an industry, is nascent and dominated by incremental innovation. The innovation process of the present SaMD industry is shaped by data accessibility, which is key to building disruptive innovation.

Analyzing the impact of a sustainability agenda in research and innovation on system transition is a critical research topic. This literature stream aims to examine how research and innovation can deal with wicked-problems at a dynamic system level to create more sustainable future systems. However, this study addresses two main issues in the current sustainability transition literature. First, the literature to date offers little insight into concrete implications for the management of innovation processes at the organizational level. Second, sustainability is often addressed as per se desirable. While the concept of Sustainable Innovation (SI) can valuably contribute in addressing the first issue by providing essential features to analyze business management procedures and their broader implications on socio-technical systems, it falls short in addressing the second issue. Essential aspects of sustainability, such as the responsibility for potential future trade-offs through innovation, are not strategically integrated into the current framework. This study argues that without strategic integration of responsibility, there is a risk of contributing to a partially-sustainable-\"irresponsible\"-socio-technical system change as a result of business innovation activities. Therefore, an extended innovation process model for sustainability to embed responsibility at the core of innovation activities is required. For this purpose, the framework of Responsible Research and Innovation (RRI) is utilized. This paper reports on findings from a systematic literature review of a representative sample of empirical studies from the SI and RRI literature. Thereby, the goal was to extend the understanding of management opportunities within innovation processes for sustainability through the implementation of RRI principles, in order to create sustainable socio-technical systems.