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Domains and Methods of Medical Device Technology Evaluation: A Systematic Review.
Fotini Santos Toscas1, Daiana Laurenci Orth Blas2, Leidy Anne Alves Teixeira3
1Technology Center for SUS/SP, Institute of Health (CTS-IS), and Radiology Program, Faculty of Medicine, State University of São Paulo (USP), São Paulo, SP, Brazil.
This systematic review identifies key domains and methods for health technology assessment (HTA) of medical devices (MD). Findings suggest a need for tailored HTA approaches due to the diversity of MD, recommending technological characterization for standardization.
Area of Science:
- Health Services Research
- Medical Technology Assessment
- Health Economics
Background:
- Health technology assessment (HTA) is crucial for integrating medical devices (MD) into healthcare systems.
- Standardized methods for HTA of MD are needed to ensure effective and efficient adoption.
- The diversity of MD poses challenges for uniform HTA methodologies.
Purpose of the Study:
- To systematically review the main domains and methods for HTA of MD.
- To understand how to support the technological incorporation of MD into healthcare systems.
Main Methods:
- A systematic review was conducted using databases like MEDLINE, Embase, and Web of Science.
- Searches covered studies published between 2017 and May 2023.
- Rigorous selection, extraction, and quality assessment processes were employed by blinded reviewers.
Main Results:
- Out of 5,790 retrieved studies, 41 were included in the analysis.
- Identified criteria for MD evaluation were grouped into eight distinct domains.
- The review highlighted the necessity for specific HTA methods for MD.
Conclusions:
- A single methodological guideline for HTA of MD is insufficient due to device diversity.
- Clustering criteria based on technological characterization is proposed for a more standardized HTA process.
- Tailored HTA approaches are essential for effectively assessing medical devices.
