by The medical device vigilance market consists of software and services focused on complying with regulatory requirements for collecting and reporting adverse events involving medical devices. Strict requirements by regulators necessitate timely reporting of device performance issues, malfunctions and serious adverse incidents. This has driven significant demand for software solutions that help streamline the end-to-end vigilance process from event detection to regulatory filing.
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 Dynamics:
Non-compliance can attract hefty penalties, driving demand for automated vigilance software. Additionally, the increasing complexity of medical devices has increased the risk of malfunctions and adverse effects, necessitating robust vigilance systems. Major players have leveraged this opportunity through continuous innovation and addition of new features to their existing solutions such as AI-powered event detection and analytics tools for risk assessment. However, budgetary restrictions for small & medium enterprises continue to restrain market potential to some extent.
SWOT Analysis
Strength: The Medical Device Vigilance Market has strong growth potential due to the increasing demand for safety of medical devices. Strict regulations are forcing manufacturers to adopt vigilance software. Vigilance solutions help in timely reporting of device issues and ensure patient safety.
Weakness: High implementation cost of vigilance software is a challenge for small companies and startups. Lack of skilled professionals hampers the effective use of these solutions.
Opportunity: Growing medical tourism industry in developing nations creates lucrative opportunities. Rising investments by governments in healthcare infrastructure boosts market growth.
Threats: Reluctance among manufacturers to share critical device information. Lack of harmonization among global regulatory guidelines.
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 patient safety concerns. Strict regulations regarding urgent field safety notices and post-market surveillance are driving the adoption of vigilance software.
Regional analysis: North America dominates the global medical device vigilance market due to strict regulatory environment and presence of major market players. Europe accounts for the second largest market share owing to rising healthcare expenditure and growing medical tourism industry in the region. Asia Pacific exhibits the fastest growth rate in the forecast period attributed to increasing investments in healthcare sector by developing countries like India and China.
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. Key players are focused on innovations and adopting organic strategies like partnerships and agreements to expand their market reach.
Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
