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Medical Device Vigilance Market Insights

Medical device vigilance includes post market surveillance, adverse reactions, incidents and recalls of medical devices. The main purpose of medical device vigilance is to improve health and safety of patients by reducing reoccurrence of incidences related to use of medical devices. Adverse reactions can occur due to use of medical devices and can have severe consequences.

The global medical device vigilance market was valued at US$ 53.4 billion in 2018, and is expected to witness a CAGR of 8.1% during the forecast period (2019 – 2026).

Figure 1. Global Medical Device Vigilance Market Value Analysis (US$ Mn) and Y-o-Y Growth (%)

Medical Device Vigilance  | Coherent Market Insights

Source: Coherent Market Insights Analysis (2019)

Increasing launches of recall systems for medical devices is expected to drive the medical device vigilance market growth

Increasing number of recall systems is one of the major factors driving the market growth. For instance, in April 2017, the South Korean Ministry of Food and Drug Safety (MFDS) launched a new recall system called ‘Harmful Medical Device Distribution Shutdown System’, for medical devices. Examples of medical devices recalled under this system are thermometers, pregnancy test kits, and electronic blood pressure monitors.

Furthermore, increasing number of post market surveillance programs for medical devices is expected to propel growth of the medical device vigilance market. For instance, in April 2015, Lombard Medical, Inc. launched a post market surveillance program for Aorfix. Aorfix is a medical device, used for the treatment of patients with aortic neck angulations up to 90 degrees.

Medical Device Vigilance Market- Regional Analysis

Regional segmentation of the global medical device vigilance market includes North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

North America medical device vigilance market is expected to account for the largest market share, owing to increasing number of national registries for medical implant devices in this region. For instance, in June 2018, The Veterans Affairs launched the national medical registry for medical implant devices. The purpose of this registry is to monitor device safety, track quality metrics, and ensure optimal care of patients.

Moreover, Europe is also projected to witness significant market growth owing to launch of medical device market surveillance projects in this region. For instance, in November 2016, the Medicines and Healthcare Regulatory Agency (MHRA) launched a new market surveillance project (joint action on market surveillance of medical devices) in Europe. The main aim of this project is to support market surveillance systems for medical devices by improving and developing coordination activities. This includes surveillance of various medical devices such as sticking plasters, hip replacements, contact lenses, personal oxygen tanks, and implemented pacemakers.

Asia Pacific is also expected to contribute significant share in the global medical device vigilance market over the forecast period, owing to increasing launches of medical device surveillance programs in this region. For instance, in May 2015, the Government of India launched a nationwide safety and surveillance program named ‘Materio-vigilance Programme of India’ for medical devices. This program is designed to monitor medical device related adverse drug reactions and to determine the safety of medical devices.

Figure 2: Global Medical Device Vigilance Market Value (US$ Mn), By Region

Medical Device Vigilance  | Coherent Market Insights

Source: Coherent Market Insights Analysis (2019)

Medical Device Vigilance Market - Competitive Landscape

Key players operating in the global medical device vigilance market include, ZEINCRO, AssurX, Inc., Sparta Systems, Oracle Corporation, Xybion Corporation, Sarjen Systems Pvt. Ltd., MDI Consultants, Inc., AB-Cube, Laerdal Medical, and Omnify Software, Inc.

Post market surveillance is mainly focused on reporting adverse events such as device malfunctioning, patient injuries, product returns, modifications, exchange, and recall after launch. These activities are designed to characterize accurate performance of medical devices, clinical outcomes, and quick identification of low performance medical devices. Post market surveillance is conducted by various institutions and organizations including pharmaceutical manufacturers, universities, government agencies, contract research organizations (CROs), business process outsourcing (BPOs), and original equipment manufacturer (OEMs).

Market Dynamics

Increasing number of post market surveillance studies for medical devices is expected to drive the growth of the medical device vigilance market. For instance, in July 2017, LifeTech Scientific Corporation launched a post market surveillance study for its LAmbre Left Atrial Appendage (LAA) Closure System which is used for treatment of atrial fibrillation. The post market surveillance study maintains the clinical safety records of LAmbre Left Atrial Appendage (LAA) Closure System.

Furthermore, rising government initiatives regarding medical device safety and recall is expected to boost the medical device vigilance market growth. For instance, in August 2018, Drug Regulatory Authority of India announced to launch a mobile app (Medical Device Reporting) which will provide information regarding safety and recall notices of products. This app will send a message to users and report injuries and problems related to medical devices. The app is a post market surveillance tool which is used by the Central Drug Standards Controller Organization.

Key features of the study:

  • This report provides an in-depth analysis of the medical device vigilance market size (US$ Mn), and cumulative annual growth rate (CAGR (%) for the forecast period: 2018 – 2026, considering 2017, as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approvals, market trends, regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global medical device vigilance market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies
  • Key players covered as a part of this study include, ZEINCRO, AssurX, Inc., Sparta Systems, Oracle Corporation, Xybion Corporation, Sarjen Systems Pvt. Ltd., MDI Consultants, Inc., AB-Cube, Laerdal Medical, and Omnify Software, Inc.
  •  Insights from this report would allow marketers and management authorities of companies to make informed decisions with respect to their future product launches, governmental initiatives, technological up-gradation, market expansion, and marketing tactics
  • The global medical device vigilance market report caters to various stakeholders in the industry, including investors, product manufacturers, distributors and suppliers for anesthesia device market, research and consulting firms, new entrants, and financial analysts

Detailed Segmentation:

  • Global Medical Device Vigilance Market, By Delivery Mode:
    • On-Demand
    • On-Premise
  • Global Medical Device Vigilance Market, By Application:
    • Therapeutics
    • Diagnostics
    • Surgical
    • Research
  • Global Medical Device Vigilance Market, By End User Type:
    • Contract Research Organization (CRO)
    • Business Process Outsourcing (BPO)
    • Original Equipment Manufacturers (OEM)
    • Others
  • Global Medical Device Vigilance Market, By Region:
    • North America
      • By Country:
        • U.S.
        • Canada
      • By Delivery Mode:
        • On-Demand
        • On-Premise
      • By Application:
        • Therapeutics
        • Diagnostics
        • Surgical
        • Research
      • By End User:
        • Contract Research Organization (CRO)
        • Business Process Outsourcing (BPO)
        • Original Equipment Manufacturers (OEM)
        • Others
    • Europe
      • By Country:
        • U.K.
        • Germany
        • Italy
        • Spain
        • France
        • Russia
        • Rest of Europe
      • By Delivery Mode:
        • On-Demand
        • On-Premise
      • By Application:
        • Therapeutics
        • Diagnostics
        • Surgical
        • Research
      • By End User:
        • Contract Research Organization (CRO)
        • Business Process Outsourcing (BPO)
        • Original Equipment Manufacturers (OEM)
        • Others
    • Asia Pacific
      • By Country:
        • Australia
        • India
        • China
        • Japan
        • ASEAN
        • South Korea
        • Rest of Asia Pacific
      • By Delivery Mode:
        • On-Demand
        • On-Premise
      • By Application:
        • Therapeutics
        • Diagnostics
        • Surgical
        • Research
      • By End User:
        • Contract Research Organization (CRO)
        • Business Process Outsourcing (BPO)
        • Original Equipment Manufacturers (OEM)
        • Others
    • Latin America
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
      • By Delivery Mode:
        • On-Demand
        • On-Premise
      • By Application:
        • Therapeutics
        • Diagnostics
        • Surgical
        • Research
      • By End User:
        • Contract Research Organization (CRO)
        • Business Process Outsourcing (BPO)
        • Original Equipment Manufacturers (OEM)
        • Others
    • Africa
      • By Country:
        • South Africa
        • Central Africa
        • North Africa
      • By Delivery Mode:
        • On-Demand
        • On-Premise
      • By Application:
        • Therapeutics
        • Diagnostics
        • Surgical
        • Research
      • By End User:
        • Contract Research Organization (CRO)
        • Business Process Outsourcing (BPO)
        • Original Equipment Manufacturers (OEM)
        • Others
  • Company Profiles
    • ZEINCRO,*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Recent Highlights
      • Strategies
    • AssurX, Inc.
    • Sparta Systems
    • Oracle Corporation
    • Xybion Corporation
    • Sarjen Systems Pvt. Ltd.
    • MDI Consultants, Inc.
    • AB-Cube
    • Laerdal Medical
    • Omnify Software, Inc.

 “*” marked represents similar segmentation in other categories in the respective section.

FAQ

Frequently Asked Questions

The global medical device vigilance market is estimated to surpass US$ 99.2 Billion by 2026.
Major players operating in the global medical device vigilance market include ZEINCRO, AssurX, Inc., Sparta Systems, Oracle Corporation, Xybion Corporation, Sarjen Systems Pvt. Ltd., MDI Consultants, Inc., AB-Cube, Laerdal Medical, and Omnify Software, Inc.
Medical device vigilance includes post market surveillance, adverse reactions, incidents and recalls of medical devices. The main purpose of medical device vigilance is to improve health and safety of patients by reducing reoccurrence of incidences related to use of medical devices, globally.
Increasing number of recall systems, coupled with increasing number of post market surveillance programs for medical devices are some of the major factors that are expected to propel growth of the market over the forecast period.
The global medical device vigilance market is estimated to exhibit a CAGR of 8.1% over the forecast period.
Among regions, North America is expected to hold dominant position in the medical device vigilance market during the forecast period.
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