Rising incidence of chronic diseases and increasing emphasis on patient safety can boost demand for medical device vigilance across the world. Various regulatory bodies have implemented stringent norms and guidelines to ensure vigilance over medical devices post approval and marketing. With increasing complexity of medical devices, it is imperative for manufacturers to have robust vigilance systems for risk assessment, malfunction reporting and incident analysis. However, lack of harmonization and variation in regulatory framework across different regions can hamper the market growth. Ongoing research and development of innovative vigilance solutions can offer growth opportunities for market players in the near future.
Market Dynamics:
Growing burden of chronic diseases such as cancer, diabetes, and cardiovascular disorders globally has boosted demand for various types of medical devices. At the same time, numerous incidents related to device malfunctions, errors, and failures have emphasized the need for an effective post-market surveillance system. Stringent regulatory guidelines mandating implementation of vigilance procedures by manufacturers can drive the market growth. However, high costs associated with setting up and maintaining vigilance processes throughout the device lifecycle can hamper the market growth. Ongoing innovation in digital health technologies can offer new opportunities with integration of artificial intelligence and cloud computing in medical device vigilance solutions.
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