AUTHOR=Toscas Fotini Santos , Blas Daiana Laurenci Orth , Teixeira Leidy Anne Alves , Santos Marisa da Silva , Dias Eduardo Mario 

TITLE=Domains and Methods of Medical Device Technology Evaluation: A Systematic Review

JOURNAL=Public Health Reviews

VOLUME=Volume 45 - 2024

YEAR=2024

URL=https://www.ssph-journal.org/journals/public-health-reviews/articles/10.3389/phrs.2024.1606343

DOI=10.3389/phrs.2024.1606343

ISSN=2107-6952

ABSTRACT=The evaluation of Medical Devices (MD) still poses a major challenge for decision-making. The context and peculiarities need to be considered, along with organizational impact, the learning curve, dynamic pricing, and constant incremental innovation. Objectives: Identify the main domains that integrate technology assessment studies from the perspective of technological incorporation into healthcare systems. Methods: Performed structured searches in MEDLINE, Embase, BVS, Cochrane Library, and Web of Science for full studies published between 2017 and May 2023. Selection, extraction, and quality assessment were performed by two blinded reviewers, and discrepancies were resolved by a third reviewer. Results: A total of 5,790 studies were retrieved, of which 41 were included. We grouped the identified criteria into eight domains for the evaluations. Conclusion: Overall, studies discuss the need to establish specific methods for conducting HTA in MD. Due to the wide diversity of MD types, a single methodological guideline may not encompass all the specificities and intrinsic characteristics of the plurality of MD. Studies suggest using clustering criteria through technological characterization as a strategy to make the process as standardized as possible.