The medical device vigilance market deals with monitoring and reporting the adverse incidents associated with medical devices. Medical device vigilance helps ensure the safe and effective use of medical devices through a structured post-marketing surveillance program. It enables timely reporting and evaluation of events and enables corrective and preventive actions.
The global Medical Device Vigilance Market is estimated to be valued at US$ 89.72 Bn in 2023 and is expected to exhibit a CAGR of 4.9% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market key trends:
One of the key trends in the medical device vigilance market is the growing preference for cloud-based medical device vigilance solutions. Cloud-based solutions offer benefits such as easy access, reduced IT costs, automatic software updates, and scalability. They allow storing and accessing data from remote locations through internet connectivity. This provides flexibility to users and enables real-time collaboration. The growing adoption of bring your own device culture in healthcare is also expected to support the demand for cloud-based medical device vigilance solutions.
SWOT Analysis
Strength: The medical device vigilance market is growing rapidly due to strict regulations for product safety and efficacy. Manufacturers are mandated to monitor device performance post-approval and implementation of vigilance systems allows real-time risk monitoring and regulatory compliance.
Weakness: High costs associated with implementing a full-fledged vigilance system and integrating it with other legacy systems. Lack of skilled professionals for data analysis can also impact the vigilance program.
Opportunity: Increasing demand for cloud-based vigilance solutions provide opportunities for software vendors to develop advanced tools for easy report submission and data integration across the product lifecycle. Emerging markets offer lucrative growth opportunities.
Threats: Consolidation of markets makes it difficult for smaller players to compete. Delayed approvals and changes in regulatory guidelines also introduce uncertainties.
Key Takeaways
The Global Medical Device Vigilance Market Size is expected to witness high growth, exhibiting CAGR of 4.9% over the forecast period, due to increasing regulatory requirements for improved post-market safety oversight.
Regional analysis
North America dominates the medical device vigilance market currently due to stringent regulatory environment and presence of majority key players. However, Asia Pacific is expected to exhibit the fastest growth over the next few years led by growing medical technology industry in China, India and other developing Asian countries coupled with increasing investments by players to strengthen regional presence.
Key players
Key players operating in the medical device vigilance market are AB-Cube, AssurX, Oracle, Sarjen Systems, Sparta Systems, Xybion, ZEINCRO, Omnify Software, INTEL, MDI Consultants, Numerix. The market is concentrated owing to presence of few major players controlling major market share. However, small players are focusing on partnerships and product innovations to strengthen product portfolio and gain greater market share.
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