Development Pattern of Medical Device Technology and Regulatory Evolution of Cataract Treatment.

Healthcare (Basel)

Graduate School of Public Health and Healthcare Management, The Catholic University of Korea, Banpo-daero 222, Secho-gu, Seoul 06591, Republic of Korea.

Published: February 2023

To prevent regulation from becoming an obstacle to healthcare technological innovation, regulation should evolve as new healthcare technologies are developed. Although regulation is closely related to healthcare technology development, there are few studies that view healthcare technological advances from the multi-layered perspective of papers, patents, and clinical research and link this with regulatory evolution. Therefore, this study tried to develop a new method from a multi-layer perspective and draw regulatory implications based on it. This study applied this method to intraocular lens (IOLs) for cataract treatment and detected four major healthcare technologies and two recent healthcare technologies. Moreover, it discussed how current regulations evaluate these technologies. The findings provide implications for healthcare technological advances and the evolutionary direction of regulation through the example of IOLs for cataract treatment. This study contributes to the development of theoretical methods for co-evolution with regulations based on healthcare technology innovation.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9957356PMC
http://dx.doi.org/10.3390/healthcare11040453DOI Listing

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