The Medical Device Vigilance Market comprises products and services that help medical device manufacturers and importers comply with regulatory obligations regarding gathering and reporting of adverse events/incidents that may occur with the use of their medical devices. Vigilance of medical devices is important ensure the safety, quality and performance of medical devices. It helps identify potential issues early on and take corrective actions to address them.

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:

Regulatory agencies are emphasizing on improving post-market surveillance to ensure safety, effectiveness and quality of medical devices. For instance, in Europe the Medical Devices Regulations 2017 places greater responsibility on manufacturers for monitoring and reporting incidents involving medical devices across the product lifecycle. Similarly, under the U.S. FDA’s Unique Device Identification (UDI) system, manufacturers are required to report any issues with their medical devices. The growing regulatory oversight is augmenting demand for medical device vigilance solutions.

Porter’s Analysis
Threat of new entrants: The medical device vigilance market has high switching barriers for new entrants mainly due to stringent regulatory requirements related to medical device safety monitoring. This acts as an entry barrier for new players.

Bargaining power of buyers: The bargaining power of buyers is moderately high due to the fragmented nature of the market and availability of substitutes. However, customized services from existing players reduce buyer bargaining power.

Bargaining power of suppliers: Suppliers have moderate bargaining power due to the availability of substitute solutions. However, niche capabilities required for specific client requirements reduce their bargaining power.

Threat of new substitutes: Low threat from substitutes exists as medical device vigilance revolves around regulatory compliance and safety monitoring requiring specialized knowledge and infrastructure.

Competitive rivalry: High due to the presence of numerous global and regional players competing on capabilities, expertise, partnerships and collaborations.

SWOT Analysis
Strength: Presence of specialized knowledge and infrastructure for medical device safety monitoring compliance.
Ability to provide end-to-end drug vigilance services leveraging expertise.

Weakness: High initial investment and operating costs associated with medical device vigilance infrastructure and resources.
Reliance on partnerships/tie-ups for regional/local expertise.

Opportunity: Increasing regulatory stringency and monitoring requirements driving market demand.
Growing medical devices market introducing novel devices requiring vigilance.

Threats: Economic slowdowns reducing vigilant spending of clients across regions.
Technology disruption through alternate monitoring approaches/platforms.

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 oversight on medical device safety and monitoring.

Regionally, North America dominates the medical device vigilance market currently owing to robust regulatory policies and presence of major players. Asia Pacific is expected to grow at the fastest rate over the forecast period due to rapidly growing medical devices market and increasing investments in healthcare infrastructure in countries like China and India.

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. These players are focused on providing customized end-to-end solutions and leveraging partnerships for regional/local capabilities.

Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it