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.

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 wer

SUBMITTER: Lee YK 

PROVIDER: S-EPMC11496563 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature