What does this research mean for the field?

Evidence integration methodologies, such as Bayesian synthesis and real-world data integration, are increasingly vital for evaluating innovative medical devices when randomized trials are infeasible, though significant challenges remain regarding evidence heterogeneity, bias, and a lack of standardized regulatory guidance. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

August 31, 2026Frontiers in MedicineOpen Access

Evidence integration and bridging methodologies for high-risk and innovative medical devices and in vitro diagnostic medical devices: a scoping review

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Authors

NBNensi BralićUniversity of Split RBRužica BandićUniversity of Split MVMiro VukovićUniversity of Split

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Implication

Scoping review maps evidence integration and bridging methodologies for high-risk medical devices, highlighting the need for harmonized regulatory standards.

Key Points

To map evidence integration and bridging study methodologies for high-risk and innovative medical devices and in vitro diagnostics, and to identify primary methodological and regulatory challenges.
Conducted a scoping review following Joanna Briggs Institute guidance across bibliographic databases, industry resources, and preprint platforms for literature published from 2017 onward.
Identified methods for comparing or integrating medical device evidence using artificial-intelligence-assisted data extraction and synthesis alongside human verification.
Included 19 studies outlining methods such as Bayesian evidence synthesis, adaptive trial designs, indirect comparisons, propensity score methods, real-world data integration, linked evidence frameworks, in silico approaches, and bridging studies.
Identified critical implementation challenges consisting of evidence heterogeneity, methodological bias, lack of standardized practices, and inconsistent regulatory acceptance across digital health and in vitro diagnostic technologies.

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Bralić et al. (2026) studied this question.

synapsesocial.com/papers/6a9541eaf20e493292a741b2 https://doi.org/10.3389/fmed.2026.1917208

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Implication

Scoping review maps evidence integration and bridging methodologies for high-risk medical devices, highlighting the need for harmonized regulatory standards.

Evidence integration and bridging methodologies for high-risk and innovative medical devices and in vitro diagnostic medical devices: a scoping review

Discussion

Member takes

Implication

Key Points

Cite This Study

Evidence integration and bridging methodologies for high-risk and innovative medical devices and in vitro diagnostic medical devices: a scoping review

Discussion

Member takes

Implication

Key Points

Cite This Study

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