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Reports from University of Twente Advance Knowledge in Health Technology (Medical Devices Early Assessment Methods: Systematic Literature Review)

July 21, 2014

By a News Reporter-Staff News Editor at Clinical Trials Week -- Investigators publish new report on Health and Medicine. According to news originating from Enschede, Netherlands, by NewsRx correspondents, research stated, "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. A systematic literature review was conducted in September 2013, using computerized databases (PubMed, Science Direct, and Scopus), and references list search."

Our news journalists obtained a quote from the research from the University of Twente, "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. 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. This study showed converging aims yet widely diverging methods for early assessment during medical device development."

According to the news editors, the research concluded: "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."

For more information on this research see: Medical Devices Early Assessment Methods: Systematic Literature Review. International Journal of Technology Assessment in Health Care, 2014;30(2):137-146. International Journal of Technology Assessment in Health Care can be contacted at: Cambridge Univ Press, 32 Avenue Of The Americas, New York, NY 10013-2473, USA. (Cambridge University Press -; International Journal of Technology Assessment in Health Care -

The news correspondents report that additional information may be obtained from K. Markiewicz, University of Twente, MIRA Inst Biomed Technol & Technical Med, NL-7500 AE Enschede, Netherlands. Additional authors for this research include J.A. van Til and M.J. IJzerman (see also Health and Medicine).

Keywords for this news article include: Europe, Enschede, Netherlands, Health and Medicine

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Source: Clinical Trials Week

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