The medical device vigilance market is projected to garner noteworthy gains on account of increasing cases of medical device recalls. Growing prevalence of cases where patient’s health was adversely affected due to faulty medical devices could drive the demand for meddev vigilance solutions. Numerous hospitals and medical institutes are adopting advanced medical device vigilance systems to ensure optimum safety of patients. 

The main purpose of a medical device vigilance system is to enhance the safety and health of patients and healthcare professionals by minimizing medical device-related fatalities. Research organizations and business processes are looking to install these solutions for effective operation.

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Increasing imposition of stringent federal regulations promoting the practice of medical vigilance could massively benefit the business outlook. Regions like Europe have enforced strict guidelines to maintain patient safety. The European Medical Device Directive (MDD) has advised medical device manufacturers to report Field Safety Corrective Actions (FSCAs) and adverse incidents to the EU competent authorities. Firms that fail to accurately report these incidents might face severe repercussions.

The Europe medical device vigilance system market could thereby emerge as a lucrative avenue for prominent industry players. According to a research conducted by Global Market Insights, Inc., the global medical devices vigilance market is estimated to record USD 91.5 billion by the year 2025.

Growing number of research projects instigated across the world could boost the demand for medical devices vigilance solutions in clinical research organizations. Estimates suggest that the clinical research organization end-user segment could record growth at 7.7% within the forecasted timeframe.

Shifting efforts towards novel drug development for the treatment of several chronic illnesses and the need for medical vigilance software to manage regulatory affairs, quality assurance and clinical trial data could enhance the industry outlook in the years to come. 

Rapid development of modern healthcare IT solutions like vigilance systems and healthcare applications could drive the adoption of medical devices vigilance platforms across North America. Earlier in 2018, the regional market held over 33% of the overall revenue share, and is anticipated to showcase significant growth during the analysis period. 

Active participation from the federal agencies to curb medical device-related casualties might enhance product demand over the forthcoming years. Citing an instance, in February 2020, FDA issued a series of warning letters to medical device firms like CPAPNEA Medical Supply, Unetixs Vascular and Biomedix WAI after receiving an uptick in enforcement activity.

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Surging expansions projects conducted across research institutes in Asia Pacific could propel the demand for high-quality medical device vigilance software. Studies suggest that the Asia-Pacific medical devices vigilance industry could register a compound annual growth rate (CAGR) of more than 9% by the end of 2025. Escalating cases of medical device-related accidents across the region might broaden the business horizon for regional manufacturers.

Partial Chapter of the Table of Content

Chapter 3. Medical Devices Vigilance Industry Insights

3.1. Industry segmentation

3.2. Industry landscape, 2014 - 2025

3.3. Industry impact forces

3.3.1. Growth drivers

3.3.1.1. Increasing number of adverse events reported

3.3.1.2. Worldwide growing awareness regarding medical device vigilance

3.3.1.3. Government initiatives concerning adverse events reported

3.3.2. Industry pitfalls and challenges

3.3.2.1. Failure of certain manufacturing companies to ensure product safety

3.4. Growth potential analysis

3.4.1. By application

3.4.2. By delivery mode

3.4.3. By end-user

3.5. Regulatory landscape

3.6. Porter’s analysis

3.7. Competitive landscape, 2017

3.7.1. Strategy dashboard

3.8. PESTEL analysis

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