ReviewJournal of medical Internet research2023
Innovation Process and Industrial System of US Food and Drug Administration-Approved Software as a Medical Device: Review and Content Analysis.
Review in Journal of medical Internet research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 14 citations in OpenAlex.
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- Anticipating Moral and Economic Considerations, Opportunities, and Potential Frictions for AI in Medical Imaging: Multistakeholder Cocreation Study.Journal of medical Internet research · 2026Article
- United States Food and Drug Administration Regulation of Clinical Software in the Era of Artificial Intelligence and Machine Learning.Mayo Clinic proceedings. Digital health · 2025Review
- A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study.Journal of medical Internet research · 2025Article
- Facilitators and Barriers to the Implementation of Digital Health Technologies in Hospital Settings in Lower- and Middle-Income Countries Since the Onset of the COVID-19 Pandemic: Scoping Review.Journal of medical Internet research · 2025Article
- Integration of wearable devices and artificial intelligence in Alzheimer's disease: A scoping review protocol.PloS one · 2025Article
- Driving Innovation Through Regulatory Design and Corporate Behaviour: A Case Study of Functional Food Industry in Japan.Foods (Basel, Switzerland) · 2024Article
- Innovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products.Digital healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere has been a surge in academic and business interest in software as a medical device (SaMD). SaMD enables medical professionals to streamline existing medical practices and make innovative medical processes such as digital therapeutics a reality. Furthermore, SaMD is a billion-dollar market. However, SaMD is not clearly understood as a technological change and emerging industry.
objectiveThis study aims to review the landscape of SaMD in response to increasing interest in SaMD within health systems and regulation. The objectives of the study are to (1) clarify the innovation process of SaMD, (2) identify the prevailing typology of such innovation, and (3) elucidate the underlying mechanisms driving the SaMD innovation process.
methodsWe collected product information on 581 US Food and Drug Administration-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 of SaMD, we used correspondence and business process analysis to assess the distribution of intended use and how SaMDs interact with other devices in the medical process.
resultsThe 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.
conclusionsSaMD, 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.