국내 의료기기로 등록된 정형용교정장치 제품의 특성과 성능 분석을 통한 개선 방안 연구

초록

Demand for spinal medical devices is increasing due to the increase in the number of patients with spinal diseases, aging, and incorrect posture due to increased use of computers and smart-phones. Accordingly, non-surgical spinal medical devices that are preventative rather than treatment-oriented are emerging. Orthopedic correction devices, a representative item of non-surgical spinal medical devices, are in the process of being commercialized, which is very difficult, and it is difficult to prioritize important matters due to the various interests of medical professionals, developers, sellers, manufacturers, and quality managers when using the product. Therefore, in this study, we seek to find solutions for improvement factors in non-surgical spine medical devices. As a research method, we conducted a survey on the characteristics of orthopedic correction devices used in the non-surgical spine medical device market, and a survey and analysis of related patent literature and related papers. In particular, based on the approval data for orthopedic correction devices registered as grade 2 in Korea, we analyzed the operating factors according to product performance, spinal traction program, and improvement factor scale to derive improvement plans. A survey was conducted among those involved in medical devices regarding the direction of improvement plans. It is expected that this study will provide evidence that can provide strategic insight to various stakeholder in the field of non-surgical spine medical device development.

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