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 (%)
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
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).
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:
“*” marked represents similar segmentation in other categories in the respective section.
Table of Contents
*Browse 23 market data tables and 19 figures on “Medical Device Vigilance Market” - Global forecast to 2026”.
Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:
In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.
Coherent Market Insights desk research is based on a principle set of research techniques:
Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:
Preliminary Data Mining
The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.
Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.
Coherent Statistical model
We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:
Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.
This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:
The primary research is conducted with the ecosystem players including, but not limited to:
Finding it difficult to find the research that would cater to your business demands? Give us a chance to help you. One of our Research Consultants will connect to provide a customized solution.
Talk to our research consultant to design an exclusive report as per your research needs.
We aim to fulfil client's research demands with tailored research solutions.
We aim to provide research studies in quickest turnaround time and in a much cost effective manner.
We cover each industry from supply and demand side with an aim to provide a most holistic research study.
We strive to provide most accurate and reliable research findings in our research reports.