Medical Device Vigilance Market

Medical Device Vigilance Market is projected to driven by growing Medical Device Concerns


The Medical Device Vigilance Market comprises medical devices and software products that monitor adverse events related to medical devices post their approval. Medical device vigilance helps trace device failures and adverse reactions, thereby facilitating timely product recalls. With increasing recalls of implantable devices over manufacturing defects and technological obsolescence in recent years, medical device vigilance systems are witnessing significant traction globally.

The Global Medical Device Vigilance Market is estimated to be valued at US$ 103.36 Mn in 2024 and is expected to exhibit a CAGR of 9.0% over the forecast period 2024 to 2031.

Key Takeaways

Key players operating in the Medical Device Vigilance Market are BrainsWay, Magstim, Nexstim, Salience, MagVenture A/S, eNeura Inc. BrainsWay designs and sells deep TMS systems for the treatment of various neurological disorders. Meanwhile, Magstim developed NBS System 5 that allows clinicians to perform TMS therapy and research applications.

The growing demand for medical technologies and introduction of new sophisticated devices have increased the risks of device-related adverse events. This has propelled the need for continual post-market safety monitoring using vigilance software. The rising geriatric population susceptible to various medical conditions also augments Medical Device Vigilance Market Growth.

Major players are expanding their geographical presence through partnerships and collaborations with regional distributors. For instance, Nexstim tied up with exclusive sales representatives in Italy, the Nordics, and Australia to strengthen its international foothold. Similarly, BrainsWay partnered with Healthtronics to market its deep TMS products across the United States. This widens the customer reach in foreign markets.

Market Key Trends

One of the key trends in the Medical Device Vigilance Market is the shift from on-premise to cloud-based solutions. Cloud-based vigilance software is easier to maintain, cost-effective with guaranteed updates, and securely accessible from any location. The emerging cloud models promote collaboration in capturing adverse events. Cloud migration allows stakeholders to focus on their core competencies instead of IT infrastructure upkeep. This boosts the operational efficiency of medical device companies.

Porter’s Analysis

Threat of new entrants: The medical device vigilance market has moderate threat from new players due to highly regulated environment and required certifications. However, growing demand and technological advancements provide opportunities for upcoming players.

Bargaining power of buyers: Presence of several medical device manufacturers gives buyers moderate bargaining power in the global market. Buyers can negotiate on price and delivery terms.

Bargaining power of suppliers: The market has fewer raw material and component suppliers giving them high bargaining power. Suppliers also have threat to forward integrate.

Threat of new substitutes: Low threat as there are limited product substitutes for medical device vigilance process. It is regulated by regional authorities making switching difficult.

Competitive rivalry: Intense rivalry exists among leading players to gain market share through product innovation, quality improvement and strategic partnerships.

Geographical Regions

North America accounts for the largest share of the medical device vigilance market currently due to stringent regulatory environment and technological advancements. Europe is the second largest market driven by growing healthcare expenditure and expanding medical device industry. Asia Pacific is expected to be the fastest growing region during the forecast period owing to increasing investments from manufacturers and rising medical tourism.

Fastest growing region

Asia Pacific region is poised to grow at the fastest rate in the medical device vigilance market during the forecast period. This is attributed to improving healthcare infrastructure, rising healthcare expenditure, increasing penetration of health insurance and expanding medical device industry in emerging countries such as India, China and Japan. Government support for regional manufacturing will further aid market growth in Asia Pacific.

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