ReviewJournal of Korean medical science2024
Healthcare Experts' Advisory Unit and Support (HAUS) Program for Medical Device Development in Korea: Introduction of Clinical Unmet Needs-Based Intended Use Establishment (CLUE) Templates.
Review in Journal of Korean medical science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Antimicrobial Peptides in Preventive Medicine: Current Perspectives on Coating Strategies.ACS infectious diseases · 2026Review
- Translational Research Could Start From the 'Translation' of Unmet Medical Needs to the Intended Use.Journal of Korean medical science · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
backgroundA clear and precise definition of the "intended use" in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process.
methodsThe Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts' Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document.
resultsThe HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the "Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates" were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing: Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use.
conclusionThe HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use.
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Registered trials
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