Empirical insights into the innovation process and industrial system of the Software as a Medical Device (SaMD)

A paper based on a project report research by Yu Jiakan of Sengoku Laboratory, Professional Master's Degree Program of School of Environment and Society has been published in the Journal of Medical Internet Research (h-Index=178, IF=7.4), one of the top journals in the field of health informatics.

The study empirically elucidated the innovation process and industrial system structure of the Software as a Medical Device (SaMD), which represents the digital transformation of the medical and healthcare sectors, and discussed future prospects.

Product information on 581 SaMDs approved by the US Food and Drug Administration (FDA) was collected from the OpenFDA and company profiles of the 268 manufacturers offering these products from commercially available databases and publicly available company information. Descriptive statistics, correspondence analysis and business process analysis were applied to this dataset to assess the distribution of SaMD products based on their intended use and the relationship between SaMD and other medical devices and others in the product and service system.

The results confirmed that the SaMD industry is currently highly concentrated in the processing of medical imaging data and the interpretation of radiological imaging data. In terms of company trends, it was confirmed that existing medical device manufacturers, who are leading the market formation, are focusing on incremental innovations, while new entrants, including start-ups, are more inclined towards disruptive innovations. With regard to product and service systems, it was found that hardware medical devices act as complementary assets for SaMD, but how they interact varies across SaMD product distribution groups. Finally, based on these findings, the SaMD innovation process was organised as a regime map based on the level of innovativeness in intended use and the level of integration with complementary devices (Figure).

Although SaMD is attracting attention as a centre of excellence in digital health, the industry is still in the early stage and is dominated by incremental innovation. The entry of new companies from transdisciplinary sectors and the accessibility to medical and healthcare data will be key to driving disruptive innovation.

• Link to the paper