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.
Keywords: healthcare technology innovation; intraocular lens; medical device; regulatory evolution.