Supporting Medical Device Commercialization to Establish Core Research and Clinical Bases in the Medical Industry
[Asia Economy Yeongnam Reporting Headquarters Reporter Park Saeyan] Gyeongsangnam-do announced on the 21st that it has selected eight medical device companies this year through the Medical Device Translational Clinical Trial Support Center at Yangsan Pusan National University Hospital and will support non-clinical and clinical trials as well as usability evaluations.
The Medical Device Translational Clinical Trial Support Center project is a project with a total budget of 7.3 billion KRW, established according to the Ministry of Health and Welfare's plan to build medical device infrastructure support projects.
By establishing a medical device usability evaluation center, it has provided support for non-clinical and clinical trials and usability evaluations to 35 medical device companies from 2018 to last year.
The medical device industry has a greater impact on the human body, making the commercialization process more complex compared to general consumer products.
It goes through several stages including research and development, prototype production, non-clinical and clinical trials, approval, mass production, product improvement, and sales. In particular, the non-clinical and clinical trial stages are complicated in procedures and methods, causing significant difficulties.
The Medical Device Translational Clinical Trial Support Center at Yangsan Pusan National University Hospital focuses on supporting these difficulties faced by companies.
It provides meticulous consultation support from document preparation required for non-clinical and clinical trials to trial procedures and methods.
Additionally, it helps test potential problems expected when using medical devices in a virtual environment, evaluate usability, and make improvements.
Especially since July last year, when it was introduced as a mandatory evaluation procedure, the demand from companies wishing to receive support is expected to gradually increase.
The province plans to establish a demonstration support center based on the operational achievements once the Medical Device Translational Clinical Trial Support Center project ends in May next year.
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