Tuesday, October, 15, 2019 03:52:16

The global medical devices vigilance market is experiencing a transformational shift in dynamics in the recent times, courtesy – the numerous adversities taking place pertaining to medical devices. Medical device vigilance systems are lately being vigorously adopted for ensuring safety of patients, healthcare professionals, along with other users. Moreover, strict government regulations for the manufacturers for developing highly efficient and safe devices would drive the demand for medical devices vigilance market in the years to come.

Medical devices vigilance market size was valued at USD 52.8 billion in 2018 and is expected to witness 8.2% CAGR from 2019 to 2025.

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Companies in the medical devices vigilance market have been focusing on improvising the existing medical devices vigilance software. Rising investments in R&D by major industry players for developing technologically advanced vigilance systems will also propel the industry landscape. Moreover, increasing awareness and availability of vigilance software among patients will augment the market demand. Patient access towards adverse event reporting which further enables handling daily medical device vigilance requirements, publishing regulatory reports and exporting of files would favor the growth of medical devices vigilance market.

The United States is anticipated to be an extremely lucrative revenue ground for the medical devices vigilance market. The regional expansion can be aptly attributed to the increasing number of adverse events occurring in the nation, pertaining to medical devices. According to the Food and Drug Administration, over 1 million adverse events regarding medical devices were reported in the country in 2015. This would consequently lead to the escalating adoption of medical device vigilance systems, thereby impelling the industry growth.

As a matter of fact, the United States was the dominant region in the North America medical devices vigilance market in the year 2018. Apparently, the region held an astounding 89% of the revenue share in the same year and is estimated to retain a majority of industry share in the years to come as well.

Prominent firms partaking in medical device vigilance market share have apparently retained focus on strategic initiatives as well as software development to strengthen their market position. However, partnerships, acquisitions and collaborations have also been among their strategies to stay ahead of the competition. A gist of the contribution by some of the major companies in the medical devices vigilance market is mentioned below:


As a part of its exponential growth tactics, Genpact, in the year 2017, has unveiled its Pharmacovigilance Artificial Intelligence (PVAI) solution. Apparently, the solution aims for transforming drug safety data management and reporting. PVAI is the first fully-integrated processing solution in the life sciences industry, which covers all stages of adverse event (AE).

This solution leverages intelligent automation to significantly lower the effort for processing adverse events, along with providing Artificial Intelligence (AI) driven level of actionable insight as well as real-time predictive analytics, which was previously not possible. Product advancements like these by key industry players, are estimated to boost the commercialization landscape of the medical devices vigilance market in the upcoming years.

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A few months ago, leading clinical research organization (CRO), Quanticate, has introduced QVigilance for delivering a dedicated pharmacovigilance and risk management services. The service is with a focus to establish compliant PV systems and support small and mid-size ventures that are in transition from clinical trials to post-marketing.

The previous year, the company had also invested in the implementation of the leading pharmacovigilance, Oracle Argus, a fully validated E2B (R3) compliant safety database. Quanticate’s initiatives are likely to encourage the company’s peers to take on newer projects and propel the commercialization graph of the medical devices vigilance industry forward.

Enumerating the aforementioned efforts undertaken by key industry players, it is overt that the medical devices vigilance market would showcase remarkable growth in the coming years. The competitive spectrum of this industry is quite varied, and consists of acclaimed companies like Numerix, Omnify Software, INTEL, MDI Consultants, ZEINCRO, Sarjen Systems, Xybion, Sparta Systems, AB-Cube, Oracle and AssurX.

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