Stakeholder Perspectives on Incorporating Patient Preference Information into Drug and Medical Device Regulatory Decision-Making in Korea.

Purpose: This study aimed to examine multi-stakeholder perceptions regarding the integration of patient input and patient preference information (PPI) across the medical product lifecycle and to identify priority areas and regulatory prerequisites for its effective incorporation in South Korea. Patients and Methods: A cross-sectional online survey recruited a non-probability sample of volunteers from patient organizations, regulatory agencies, academia, and medical device and pharmaceutical companies through open announcements on stakeholder organization websites. The survey evaluated three domains: 1) Gap between necessity and current incorporation, 2) priority areas and application scope, and 3) barriers and improvements. Paired Results: Among 183 respondents, perceived necessity of incorporating patient input was high, whereas current incorporation was rated substantially lower, indicating a clear gap between stakeholder expectations and current practice (p < 0.001). On average across lifecycle stages, respondents from patient organizations reported higher perceived necessity (4.20) than respondents from pharmaceutical (3.39; p < 0.001) and medical device companies (3.62; p = 0.004). Across priority areas, necessity ratings were highest for products requiring direct patient use (4.14) and lowest for contexts involving uncertainty in efficacy or safety (3.42). For uncertainty in efficacy or safety, the medical device company group reported significantly higher ratings than the pharmaceutical company group (3.61 vs 2.91; p = 0.029). Conclusion: While Korean stakeholders broadly supported the incorporation of patient perspectives into regulatory decision-making, divergent views across stakeholder groups highlight the need for consensus-building toward a patient-centered approach. Further evaluation, including priority mapping and structured pilot programs, may help assess the feasibility and regulatory utility of PPI in regulatory decision-making.