ArticleDigital health
Innovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products.
Article in Digital health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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4 authors.
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Abstract
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 ( 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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