Innovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products.

BACKGROUND: Digital health innovation is reshaping healthcare, with Software as a Medical Device (SaMD) as a critical frontier. However, little is known about how enterprises evolve portfolios within this regulated market. OBJECTIVES: This study uses enterprise-level SaMD product portfolio data to characterize innovation trajectories in SaMD development and assess heterogeneity in these trajectories across enterprise characteristics. METHODS: We identify 578 FDA-approved products from 289 enterprises (2012-2022) using the OpenFDA database. A multi-state model tracked innovation dynamics across 4 states: (1) one initial approval, (2) multiple approvals in identical area, (3) expansion into 2 areas, and (4) diversification into 3 or more areas. We apply Kaplan-Meier survival analysis with log-rank tests, Competing-risk cumulative incidence analysis, and Cox proportional hazards regression to examine how enterprise size and industry classification influenced portfolio expansion, with right-censoring at the observation end date. RESULTS: The analysis reveals stagnating innovation trajectories. 67% (n=193) of enterprises made only a single FDA submission. Kaplan-Meier estimation yielded a median time to first portfolio expansion of 8.41 years over a 10-year observation window, with large enterprises transitioning significantly faster than micro enterprises ( p <0.001). Neither industry nor entry timing showed significant differences. Cumulative incidence functions show that the five-year cumulative incidence of focused expansion (33.6%) was five times that of diversification (6.4%). Cox proportional hazards regression confirms enterprise size as the dominant predictor (micro vs. large HR=0.19, p <0.005). Software enterprises show a significantly higher expansion hazard (HR=2.15, p =0.04), while other industry types showed no significant effect. CONCLUSIONS: Innovation of SaMD follows structurally constrained trajectories. We propose that this is caused by resource barrier that hinders smaller enterprises. Overcoming this barrier requires innovation systems that facilitate integration of complementary assets. Sustainable innovation depends on shifting from isolated product development to coordinated, multi-domain ecosystems.

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Authors

Yu J; Zhang J; Miyashita S; Sengoku S

Published

Jan 1, 2026

Journal or venue

Digital health

DOI

10.1177/20552076261464265

Paper type

journal article

Source

Pubmed