Medical Devices Vigilance Global Market Report 2024

The medical devices vigilance market size has grown strongly in recent years. It will grow from $82.52 billion in 2023 to $90.26 billion in 2024 at a compound annual growth rate (CAGR) of 9.4%. The growth observed in the historical period can be attributed to several factors, including the increasing awareness regarding medical device vigilance, a growing understanding among physicians and patients about the benefits of such vigilance, mounting pressure on medical device manufacturers to ensure safety, a rise in the number of government initiatives promoting vigilance, and an overall increase in the usage of medical devices. These factors collectively contributed to the emphasis on monitoring and reporting adverse events or incidents related to medical devices for the enhancement of overall safety and effectiveness.

The medical devices vigilance market size is expected to see strong growth in the next few years. It will grow to $126.17 billion in 2028 at a compound annual growth rate (CAGR) of 8.7%. The anticipated growth in the forecast period can be attributed to various factors, including the increasing launch of recall systems for medical devices, a rising number of post-market surveillance programs, an uptick in reported adverse events, a growing demand for therapeutics and surgical procedures, and the increasing complexity related to patient safety regulations. Major trends in the forecast period include technological advancements, the adoption of the International Medical Device Regulators Forum (IMDRF) framework facilitating the exchange of safety information across borders, the development of remote patient monitoring devices, and the utilization of 3D printing and personalized devices in the medical device vigilance landscape.

The anticipated increase in the number of medical recalls is expected to drive the growth of the medical device vigilance market. Medical recalls involve actions taken by regulatory authorities, manufacturers, or distributors to remove or correct medical products posing risks to public health or non-compliance with regulatory standards. Medical device vigilance involves continuous monitoring of devices in the market, identifying adverse events, malfunctions, or safety concerns, which are reported to regulatory authorities for potential investigation and, if necessary, product recalls. In December 2022, the US Food and Drug Administration (FDA) observed a notable rise in medical device recalls, with 442 documented in 2022 compared to 331 in 2021, indicating an almost 10% increase. This increase in recalls is a significant factor driving the growth of the medical device vigilance market.

Prominent companies in the medical device vigilance market are actively developing innovative products, including quality management software (QMS), to enhance customer satisfaction. QMS is a formalized system documenting processes, procedures, and responsibilities to achieve quality policies and objectives. In December 2022, Greenlight Guru, a US-based company providing systems and software to medical device companies, launched QMS software designed to modernize processes, reduce time in clinical testing, and expedite the introduction of safer products to market. Pre-validated per FDA and ISO best practices, Greenlight Guru's software aids companies in complying with evolving standards and provides training and certifications to advance careers in product development, quality, and regulatory assurance.

In January 2024, GE Healthcare, a US-based medical technology company, successfully acquired MIM Software Inc. for an undisclosed amount. This strategic acquisition is aimed at reinforcing GE Healthcare's digital strategy and augmenting its imaging portfolio, particularly in the realm of medical device vigilance. MIM Software Inc., the acquired entity, specializes in medical imaging analysis and artificial intelligence (AI) solutions, offering services related to medical device surveillance. The acquisition aligns with GE Healthcare's commitment to advancing its capabilities in the rapidly evolving field of medical device vigilance.

Major companies operating in the medical devices vigilance market report are Johnson & Johnson, Intel Corporation, Oracle Corporation, Medtronic, Siemens Healthineers, RELX Group plc, MasterControl Inc., Laerdal Medical, Numerix, Smithers, Omnify Software Inc., Freyr, Sparta Systems, MDI Consultants Inc., Greenlight Guru, Jama Software, Sarjen Systems Pvt. Ltd, Arena Solutions Inc., Xybion Corporation, ZEINCRO Group, Extedo Gmbh, AssurX Inc., AB-Cube, Panacea Pharma Projects Limited, Qvigilance, General Electric (GE) Healthcare, Philips Healthcare, Baxter International, Stryker Corporation, Boston Scientific.

North America was the largest region in the medical devices vigilance market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the medical devices vigilance market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the medical devices vigilance market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Medical device vigilance involves the ongoing monitoring and reporting of adverse events or incidents associated with the use of medical devices. This process is a crucial element of post-market surveillance, aiming to ensure the continued safety and effectiveness of medical devices throughout their lifecycle. The purpose of medical device vigilance is to identify and address potential risks linked to the use of these devices, ultimately prioritizing patient safety and maintaining public trust in the healthcare system.

The primary delivery modes for medical device vigilance are on-demand and on-premise. On-demand medical device vigilance delivery mode refers to a system or approach where services related to medical device vigilance, such as monitoring, reporting, risk assessment, and communication regarding adverse events or incidents, are provided as needed or upon request by healthcare providers, manufacturers, or regulatory authorities. This delivery mode is utilized across various applications, including therapeutics, diagnostics, surgical procedures, research, and others. End-users of on-demand medical device vigilance services include original equipment manufacturers (OEMs), clinical research organizations (CROs), and business process outsourcing (BPO) firms.

The medical devices vigilance market research report is one of a series of new reports that provides medical devices vigilance market statistics, including medical devices vigilance industry global market size, regional shares, competitors with a medical devices vigilance market share, detailed medical devices vigilance market segments, market trends and opportunities, and any further data you may need to thrive in the medical devices vigilance industry. These medical devices vigilance market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The medical device vigilance market consists of revenues earned by entities by providing services such as adverse event reporting, post-market surveillance, risk management, quality management systems, and regulatory compliance. The market value includes the value of related goods sold by the service provider or included within the service offering. The medical device vigilance market also includes sales of data collection devices, communication devices, data storage and processing devices, medical imaging equipment, and wearable devices. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from goods and/or services sold within the specified market and geography through sales, grants, or donations in terms of currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values - that is, they are revenues generated by organizations in the specified geography within the specified market, irrespective of where they are produced. It does not include revenues from resales either further along the supply chain or as part of other products.


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