J Korean Med Sci.  2025 Apr;40(14):e137. 10.3346/jkms.2025.40.e137.

Translational Research Could Start From the ‘Translation’ of Unmet Medical Needs to the Intended Use

• Lee YK

• KMID: 2566825
• DOI: http://doi.org/10.3346/jkms.2025.40.e137

Reference

1. National Center for Advancing Translational Science (NCATS). About translational science. Updated 2025. Accessed February 10, 2025. https://ncats.nih.gov/about/about-translational-science .

2. Austin CP. Translating translation. Nat Rev Drug Discov. 2018; 17(7):455–456. PMID: 29674698.

3. European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. 2017, 1-175. Updated 2025. Accessed February 10, 2025. https://data.europa.eu/eli/reg/2017/745/oj .

4. International Organization for Standardization (ISO). ISO 14971:2019: medical devices—application of risk management to medical devices. Updated 2019. Accessed February 10, 2025. https://www.iso.org/standard/72704.html .

5. International Organization for Standardization (ISO). ISO 13485:2016: medical devices—quality management systems—requirements for regulatory purposes. Updated 2016. Accessed February 10, 2025. https://www.iso.org/standard/59752.html .

6. International Electrotechnical Commission (IEC). ISO/IEC 62366-1:2015: medical devices – part 1: application of usability engineering to medical devices. Updated 2020. Accessed February 10, 2025. https://www.iso.org/standard/63179.html .

7. International Medical Device Regulators Forum (IMDRF). IMDRF MDCE WG/N57FINAL:2019: clinical investigation. Updated 2019. Accessed February 10, 2025. https://www.imdrf.org/documents/clinical-investigation .

8. International Organization for Standardization (ISO). ISO 14155:2020: clinical investigation of medical devices for human subjects — good clinical practice. Accessed February 10, 2025. https://www.iso.org/standard/71690.html .

9. World Health Organization (WHO). Target product profiles. Accessed February 11, 2025. https://www.who.int/observatories/global-observatory-on-health-research-and-development/analyses-and-syntheses/target-product-profile/who-target-product-profiles .

10. Food and Drug Administration (US). Guidance for industry and review staff: target product profile — a strategic development process tool. Updated 2007. Accessed February 14, 2025. https://downloads.regulations.gov/FDA-2007-D-0256-0002/attachment_1.doc .

11. Lee YK, Lih E, Kim M, Kim SY, Nam KC, Choi J, et al. 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. J Korean Med Sci. 2024; 39(40):e311. PMID: 39435518.