JMIR Publications

ABSTRACT

Background:

There has been a surge in academic and business interest in software for medical devices (SaMD). SaMD enables medical professionals to streamline existing medical practices and make innovative medical processes such as digital therapeutics a reality. Furthermore, SaMD created a billion-dollar market. However, SaMD is not clearly understood as a technological change and emerging industry.

Objective:

This review explores how SaMD develops as an industry, which kinds of products dominate, and the underlying mechanisms that lead to the innovation process of SaMD.

Methods:

We collected product information on 581 FDA-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 SaMD, we used correspondence and business process analyses to assess the distribution of intended use and how SaMDs interact with other devices during the medical process.

Results:

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.

Conclusions:

The findings of this study suggest that 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. Clinical Trial: Not applicable to the present study