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

Area of Science:

• Digital Health
• Health Informatics
• Medical Device Innovation

Background:

• Software as a Medical Device (SaMD) is a key area in digital health innovation.
• Understanding enterprise portfolio evolution in the regulated SaMD market is limited.

Purpose of the Study:

• Characterize SaMD innovation trajectories using enterprise-level portfolio data.
• Assess how enterprise characteristics influence these trajectories.

Main Methods:

• Analyzed 578 FDA-approved SaMD products from 289 enterprises (2012-2022) via OpenFDA.
• Employed a multi-state model to track innovation from initial approval to diversification.
• Utilized survival analysis (Kaplan-Meier, competing-risks, Cox regression) to examine enterprise size and industry effects.

Main Results:

• 67% of enterprises had only one FDA submission; innovation trajectories are largely stagnating.
• Median time to first portfolio expansion is 8.41 years; large enterprises expand significantly faster than micro enterprises.
• Focused expansion is five times more common than diversification; enterprise size is the dominant predictor of expansion.

Conclusions:

• SaMD innovation follows constrained trajectories, likely due to resource barriers for smaller enterprises.
• Innovation systems need to facilitate integration of complementary assets for sustainable growth.
• A shift towards coordinated, multi-domain ecosystems is crucial for SaMD innovation.