Lab Med Online.  2023 Apr;13(2):65-71. 10.47429/lmo.2023.13.2.65.

Current Status and Perspectives for in vitro Medical Devices for Infectious Disease Diagnosis - Survey of Product Development and Clinical Trials

• Kim S
• Lee S
• Kim S

• KMID: 2552727
• DOI: http://doi.org/10.47429/lmo.2023.13.2.65

Abstract

Background
The in vitro diagnostic (IVD) medical device industry has experienced remarkable growth during the COVID-19 pandemic. We here survey the existing difficulties in addressing various processes, including IVD development, clinical trials, domestic and overseas licensing, and areas in which improvement efforts and support should be focused.
Methods
A survey of companies registered in the Korea in vitro Diagnostic Association between November and December 2021was conducted using a Google questionnaire. In addition to basic questions about IVD development for infectious diseases and clinical trials, participants were asked for feedback regarding targeted infectious agents and hurdles faced in clinical trials. Twenty-three (52.3%) of 44 companies responded to our survey. For scoring, we either used the Likert scale or calculated the percentage of multiple answers.
Results
Matching with a clinical trial agency was the most difficult aspect of clinical trials, and delays in review and approval by the Korean Ministry of Food and Drug Safety (KMFDS) was a major challenge facing domestic licensing. Currently, the most actively targeted IVD development arena is COVID-19 (42.7%) followed by influenza (23.5%). The major purpose of clinical trials is to obtain KMFDS approval (91.3%), followed by European IVDR (in vitro Diagnostic Regulation) approval (60.9%).
Conclusions
The survey revealed that matching with well-prepared clinical trial institutions with sufficient stored clinical samples, accurate clinical performance analysis, and a rapid KMFDS review and approval process are necessary to enhance competitiveness and export.

Keyword

Infectious diseases; in vitro diagnostic medical device; Medical device legislation; Reagent kits

Figure

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  Fig. 1 Difficulties facing developers of in vitro diagnostic medical devices for infectious diseases. Responses were averaged after scoring on the Likert 5-point scale (1, very easy; 5, very difficult).

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  Fig. 2 Challenges in conducting domestic clinical trials of in vitro diagnostic medical devices for infectious disease detection (1, very easy; 5, very difficult). Abbreviation: IRB, institutional review board.

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  Fig. 3 Challenges faced by those applying for permission to manufacture and import in vitro diagnostic medical devices for infectious disease diagnosis (1, very easy; 5, very difficult).

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