Healthcare Experts' Advisory Unit and Support (HAUS) Program for Medical Device Development in Korea: Introduction of...

Area of Science:

• Medical Device Development
• Clinical Engineering
• Healthcare Market Access

Background:

• Accurate definition of "intended use" is critical for medical device market entry.
• Effective collaboration between clinical and engineering experts is essential.
• A structured tool is needed for information gathering and decision-making in device development.

Purpose of the Study:

• To describe the implementation and outcomes of the Healthcare Experts' Advisory Unit and Support (HAUS) program.
• To introduce the Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates.
• To evaluate the effectiveness of the HAUS program in facilitating medical device development.

Main Methods:

• The Korean Academy of Medical Sciences implemented the HAUS program, matching clinical experts with device development projects.
• Collaborative academic conferences were held to promote the HAUS program.
• Consultation meetings utilized checklists, followed by satisfaction surveys and compilation of results into integrated documents.

Main Results:

• The HAUS program saw a significant increase in consultation sessions from 2021 to 2023.
• Development teams reported high satisfaction (91.4%-100%) with the HAUS program.
• The CLUE templates were developed to enhance communication and systematize the establishment of intended use through four stages.

Conclusions:

• The HAUS program effectively provided clinical expert opinions to development teams.
• The CLUE templates facilitate collaboration and the definition of robust clinical intended use for medical devices.