MEDICAL DEVICE VIGILANCE MARKET ANALYSIS

Medical Device Vigilance Market Size and Trends

Global medical device vigilance market is estimated to be valued at USD 59.30 Bn in 2024 and is expected to reach USD 119.10 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 10.5% from 2024 to 2031. Strict regulations regarding medical device safety along with the increasing usage of electronic health records can drive the market growth.

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Global medical device vigilance market growth is driven by growing need for companies to comply with international regulations and standards set by regulatory bodies like the U.S. FDA and the EU's MDR. Rising awareness among end users about reporting device issues and malfunctions also contributes to increase in surveillance programs being adopted across the healthcare industry.  Demand for quality care by aging population and increasing expenditure on healthcare worldwide can also drive the market growth.

Rising incidence of chronic diseases

Chronic diseases like cancer, diabetes, cardiovascular diseases, and other  poses a serious health threat. There has been  increase in risk factors associated with these chronic diseases like sedentary lifestyle, smoking, obesity, stress, and others. This has led to growing incidence rates of chronic conditions. As per some estimates, chronic diseases now account for over 60% of all deaths globally. Managing these chronic illnesses requires prolonged use of medical devices like insulin pumps, pacemakers, implantable defibrillators, and others. This long term reliance on medical devices increases the chances of adverse events or device malfunctions. Device manufacturers are compelled to have robust vigilance systems to quickly detect, analyze and take corrective actions for any issues. Proactive post market surveillance allows companies to ensure patient safety and also protect their brand name.

Rise in incidence of medical device adverse events

Increase in occurrence of adverse events involving medical devices across healthcare facilities compels regulatory bodies to strengthen medical device vigilance practices globally. As per the data from World Health Organization, every year over 8 lakh people face serious issues including injuries or death due to faults in medical equipment. This is a matter of grave concern as devices are extensively used right from diagnosis to post-operative care. Stringent norms are being introduced to ensure continuous monitoring of performances of all devices. This has significantly boosted the need to establish robust surveillance systems for timely reporting, analysis and prevention of adverse incidents. Medical device manufacturers and healthcare providers are investing heavily in specialized vigilance software, trained workforce and setting up centralized databases. The complexity and variety of devices used also demand advanced IT tools that can efficiently process huge volumes of data.  According to United Nations Population Fund, over 25% of hospitals in developing nations still lack basic equipment to deal with accidents and detect flaws in critical care appliances. Building a full-proof vigilance infrastructure has become imperative to safeguard the lives of burgeoning patient population across the world. It is predicted that in the next five years, developing economies will spend over 50 billion dollars in upgrading their vigilance standards and matching international benchmarks.