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MEDICAL DEVICES EARLY ASSESSMENT METHODS: SYSTEMATIC LITERATURE REVIEW

Part of: Special Collection - Methods

Published online by Cambridge University Press:  07 May 2014

Katarzyna Markiewicz ,
Janine A. van Til  and
Maarten J. IJzerman
Katarzyna Markiewicz
Affiliation:
University of Twente, Health Technology and Services Research, MIRA Institute for Biomedical Technology and Technical Medicine
Janine A. van Til
Affiliation:
University of Twente, Health Technology and Services Research, MIRA Institute for Biomedical Technology and Technical Medicine
Maarten J. IJzerman
Affiliation:
University of Twente, Health Technology and Services Research, MIRA Institute for Biomedical Technology and Technical Medicine
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Abstract

Objectives: The aim of this study was to get an overview of current theory and practice in early assessments of medical devices, and to identify aims and uses of early assessment methods used in practice.

Methods: A systematic literature review was conducted in September 2013, using computerized databases (PubMed, Science Direct, and Scopus), and references list search. Selected articles were categorized based on their type, objective, and main target audience. The methods used in the application studies were extracted and mapped throughout the early stages of development and for their particular aims.

Results: Of 1,961 articles identified, eighty-three studies passed the inclusion criteria, and thirty were included by searching reference lists. There were thirty-one theoretical papers, and eighty-two application papers included. Most studies investigated potential applications/possible improvement of medical devices, developed early assessment framework or included stakeholder perspective in early development stages. Among multiple qualitative and quantitative methods identified, only few were used more than once. The methods aim to inform strategic considerations (e.g., literature review), economic evaluation (e.g., cost-effectiveness analysis), and clinical effectiveness (e.g., clinical trials). Medical devices were often in the prototype product development stage, and the results were usually aimed at informing manufacturers.

Conclusions: This study showed converging aims yet widely diverging methods for early assessment during medical device development. For early assessment to become an integral part of activities in the development of medical devices, methods need to be clarified and standardized, and the aims and value of assessment itself must be demonstrated to the main stakeholders for assuring effective and efficient medical device development.

Keywords

Health technology assessmentMedical devicesHealthcare economics and organizationsCost-effectivenessTranslational research
Type
Methods
Information
International Journal of Technology Assessment in Health Care , Volume 30 , Issue 2 , April 2014 , pp. 137 - 146
Copyright
Copyright © Cambridge University Press 2014 

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