Department of Laboratory Medicine and Genetics, Soonchunhyang University College of Medicine, Bucheon, Korea.
Research Center, Korean Academy of Medical Sciences (KAMS), Seoul, Korea.
J Korean Med Sci. 2024 Oct 21;39(40):e311. doi: 10.3346/jkms.2024.39.e311.
A 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.
The 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.
The 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.
The 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.
在开发新医疗器械时，明确和精确地定义“预期用途”可以决定其进入医疗保健市场的成败。为此，临床和工程专家之间需要进行实际合作，并且需要一个适当的工具来在该过程中有效收集信息和做出决策。
韩国医学科学院与韩国医疗器械开发基金合作，实施了医疗保健专家咨询小组和支持（HAUS）计划，以在医疗器械开发项目中匹配咨询临床专家。2022 年和 2023 年共举办了三次和五次合作学术会议，以提高对 HAUS 计划的认识。在咨询会议中，使用清单来促进沟通，并在会后进行满意度调查。然后，将咨询会议的结果汇编成一份综合文件。
HAUS 计划的咨询会议数量逐渐增加，从 2021 年的 31 次增加到 2023 年的 128 次。与顾问（临床专家）相比（78.6%至 100%），医疗器械开发团队（开发团队）对各个调查项目的满意度（91.4%至 100%）更高。根据 HAUS 咨询会议的经验和观察，开发了“基于临床未满足需求的预期用途建立（CLUE）模板”，旨在提高沟通效率并支持建立预期用途的系统方法。CLUE 过程包括四个主要处理阶段：阶段 1，初始概念；阶段 2，专家咨询；阶段 3，决策；和阶段 4，预期用途。
HAUS 计划似乎通过提供临床专家的意见为开发团队提供了帮助。并且，所产生的产品 CLUE 模板已被提议用于促进开发团队和顾问之间的合作，并定义强大的临床预期用途。
