J Korean Med Sci.  2024 Oct;39(40):e311. 10.3346/jkms.2024.39.e311.

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

• Lee YK
• Lih E
• Kim M
• Kim SY
• Nam KC
• Choi J
• Park IH
• Lee SK
• Tun SYY
• Phoo ESY
• Lee JW

• KMID: 2560665
• DOI: http://doi.org/10.3346/jkms.2024.39.e311

Abstract

Background
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.
Methods
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.
Results
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.
Conclusion
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.

Keyword

Clinical Intended Use; Clinical Unmet Need; Medical Device Development; Medical Device Innovation

Figure

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  Fig. 1 Healthcare Experts' Advisory Unit and Support matching process.KAMS = Korean Academy of Medical Sciences, KMDF = Korean Medical Device Development Fund.

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  Fig. 2 Mapping between HAUS checklist and STED.HAUS = Healthcare Experts’ Advisory Unit and Support, STED = Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (GHTF/SG1/N011:200818).

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  Fig. 3 Evolution of HAUS program and CLUE templates.HAUS = Healthcare Experts’ Advisory Unit and Support, STED = Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (GHTF/SG1/N011:200818), CLUE = Clinical Unmet Needs-based Intended Use Establishment, R&D = Research and Development, CLUE-MD = Clinical Unmet Needs-based Intended Use Establishment template for interventional medical devices, CLUE-Dx = Clinical Unmet Needs-based Intended Use Establishment template for diagnostic medical devices, CLUE-IVD = Clinical Unmet Needs-based Intended Use Establishment template for in vitro diagnostic medical devices, KMDF = Korean Medical Device Development Fund.

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  Fig. 4 Step-by-step CLUE process of developing the intended use based on clinical unmet needs using CLUE templates.CLUE = Clinical Unmet Needs-based Intended Use Establishment, CLUE-MD = Clinical Unmet Needs-based Intended Use Establishment process for interventional medical devices, CLUE-Dx = Clinical Unmet Needs-based Intended Use Establishment process for diagnostic medical devices, CLUE-IVD = Clinical Unmet Needs-based Intended Use Establishment process for in vitro diagnostic medical devices, IVD = in vitro diagnostic.

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