Medical Devices Vigilance Market Scope
The selection, assessment, documentation, quality check, and identification of the condition of medical devices as a result of their use is known as medical device vigilance. Medical device vigilance seeks to protect patients, healthcare facilities that use medical devices, and others by avoiding or eliminating accidents that result in dangerous injuries and adverse effects. Medical device vigilance monitors the identification of technological problems and possible adverse effects associated with medical devices. Because of their broad variety and vital significance for clinical treatment and patient care, it is becoming increasingly important to control the manufacturing, operating, and distribution processes to ensure their consistency, safety, and efficient operation. The rates of adverse events related to medical devices, increasing numbers of medical recalls, the adoption of medical device vigilance software by business process outsourcing firms, the pressure on medical device manufacturers to produce patient-safe medical equipment, and tightening of safety regulations for medical device manufacturers prior to and after commercialization
Attributes | Details |
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Study Period | 2018-2030 |
Base Year | 2023 |
Unit | Value (USD Million) |
Key Companies Profiled | AB-Cube (France), AssurX, Inc. (United States), Oracle Corporation (United States), Sarjen Systems Pvt. Ltd (India), Sparta Systems, Inc. (United States), Xybion Corporation (United States), ZEINCRO Group (Greece), Intel (United States), Omnify Software (United States) and MdiConsultants (United States) |
CAGR | 8.1% |
The key manufacturers are targeting the innovations of the products with better quality, and better technical characteristics, and also assist in providing and humanizing the after-sale service to the consumers. The key players are probable to keep a stronghold on the market over the anticipated period. The key players are accepting strategic decisions and are thinking about mergers and acquisitions to maintain their presence in the market. Research Analyst at AMA estimates that United States Players will contribute to the maximum growth of Global Medical Devices Vigilance market throughout the predicted period.
AB-Cube (France), AssurX, Inc. (United States), Oracle Corporation (United States), Sarjen Systems Pvt. Ltd (India), Sparta Systems, Inc. (United States), Xybion Corporation (United States), ZEINCRO Group (Greece), Intel (United States), Omnify Software (United States) and MdiConsultants (United States) are some of the key players that are part of study coverage.
About Approach
The research aims to propose a patent-based approach in searching for potential technology partners as a supporting tool for enabling open innovation. The study also proposes a systematic searching process of technology partners as a preliminary step to select the emerging and key players that are involved in implementing market estimations. While patent analysis is employed to overcome the aforementioned data- and process-related limitations, as expenses occurred in that technology allows us to estimate the market size by evolving segments as target market from the total available market.
Segmentation Overview
The study have segmented the market of Global Medical Devices Vigilance market by Type , by Application (Diagnostic Application, Therapeutic Application, Surgical Application, Research Application and Other) and Region with country level break-up.
On the basis of geography, the market of Medical Devices Vigilance has been segmented into South America (Brazil, Argentina, Rest of South America), Asia Pacific (China, Japan, India, South Korea, Taiwan, Australia, Rest of Asia-Pacific), Europe (Germany, France, Italy, United Kingdom, Netherlands, Rest of Europe), MEA (Middle East, Africa), North America (United States, Canada, Mexico).
region held largest market share in the year 2023.
Market Leaders and their expansionary development strategies
In January 2022, Johnson & Johnson Medical Devices Companies announced a strategic partnership with Microsoft to enable its digital surgery solutions for medical devices.
October 2020 – Taiwan regulator releases draft guidances for medical device vigilance reporting. The Taiwan Food and Drug Administration (TFDA) published two draft guidance documents for public consultation on October 8, offering updated information on post-market surveillance and reporting procedures.
Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Influencing Trend:
Rise in the Number of Medical Devices due to an Increase in the Number of Clinics
Market Growth Drivers:
Growth in the Number of Medical Devices Recalls due to Technical Defects and Increasing Number of Post Market Surveillance Programs
Challenges:
lack of Skilled Professionals in Under Developed and Developing Countries
Restraints:
Negligence of Manufacturing Companies Towards Product Safety
Opportunities:
Rising Adoption of Medical Devices Surveillance Systems and Growing Awareness Regarding the Safety Regulatory Guidelines
Key Target Audience
Manufacturers of Medical Device, Suppliers of Medical Device, Wholesalers, Distributors and Retailers of Medical Device, Healthcare Industry and Regulatory Bodies