MEDICAL DEVICE VIGILANCE MARKET ANALYSIS

The high operation costs associated with medical device vigilance can hamper the global medical device vigilance market growth. Vigilance of medical devices requires robust compliance with regulations and mandatory reporting of adverse incidents related to devices. This involves a comprehensive process of collecting and analyzing data from multiple sources to identify potential safety issues. Maintaining such a stringent vigilance system entails significant financial resources. Vigilance operations include setting up an entire IT infrastructure for collecting reports from various stakeholders including hospitals, physicians, and patients. This IT system needs to be constantly monitored and updated according to evolving regulatory guidelines. Staff needs to be trained extensively to handle the reporting, investigation and reporting of adverse incidents. Large workforce of medical experts is also required to clinically review each case and determine if the adverse event is indeed linked to deficiencies in device design or manufacturing. Such rigorous oversight requires round-the-clock monitoring and management of the vigilance system. All these activities associated with medical device vigilance such as IT infrastructure maintenance, staff training and clinician engagement have considerable price tags attached to them. The ongoing expenditure on operations and personnel erodes gross margins that companies generate from device sales. This deters multinational corporations from making extra investments in small market regions. According to the data published by WHO in 2021, 54 low and lower-middle income countries accounted for only 9.2% share of the global medical device market due to high costs overriding revenue prospects.

Market Opportunities: Integration of AI and cloud based technologies

The integration of artificial intelligence and cloud-based technologies provides immense opportunities for global medical device vigilance market growth. With AI and cloud, medical device manufacturers can continuously monitor patient data across distributed locations in real-time. This allows for more efficient adverse event detection and quicker response. AI algorithms can be trained on massive volumes of historical patient data compiled on the cloud. These can then recognize patterns indicating potential issues and alert clinicians. This level of ongoing remote surveillance will improve the post-market vigilance of medical devices. Cloud infrastructure also makes it easier for manufacturers and regulators to access consolidated data sources. Any concerning signals can be investigated from a centralized interface instead of retrieving paper records from multiple file rooms. Data analytics tools on the cloud can generate insights into how specific device models are faring with diverse patient populations over time. Manufacturers may identify design elements or deployment settings that need optimizing based on such real-world evidence gathered through AI and cloud. Regulatory bodies too can leverage linked data on the cloud to monitor the performance of high-risk devices more attentively. According to the report on medical device safety by World Health Organization in 2021,  adopting digital health solutions is critical for improving post-market surveillance systems around the world. The cloud offers a unified platform to evaluate vigilant processes, coordinate international recalls if needed, and aid knowledge-sharing between regulatory networks. When combined with automation via AI, it can help overcome resource and infrastructure limitations that previously hindered robust vigilance.