Medical Device Vigilance Market Size, Share, By Device, Delivery Mode, Application, End-User, and Region - Trends, Analysis, and Forecast till 2035

• The medical device vigilance market size is anticipated to grow at a rate of USD 164.6 billion by 2035.
• The market was projected to be valued at USD 64.6 billion in 2024.
• The target market is growing at a CAGR of 10.8%.

Medical device vigilance is the continuous observation and reporting of unfavorable incidents related to the use of medical devices in order to spot possible issues and guarantee the devices' efficacy and safety. Further, the strict Medical Device Reporting (MDR) rules set forth by the FDA and EMA specify how adverse events and occurrences involving medical devices must be reported. The information that needs to be reported, the deadlines for reporting, and the reporting procedures are all outlined in these regulations. The target market is projected to grow significantly owing to the increasing awareness of device safety among healthcare professionals and patients.

For instance, in September 2024, FDA aimed to launch ‘active’ monitoring system to improve medical device safety.  The new system targets to detect potential safety issues nearly in real time by monitoring data, such as electronic health records and billing claims. That data is sometimes called real-world evidence (RWE).

Key Takeaways:

• North America held the largest share of the market in 2024 due to the strong demand for sustainable energy solutions across the region.
• By product, rigid core LVT is expected to account for the largest share of the medical device vigilance market in the upcoming years as these films are widely utilized for their durability, cost-effectiveness, and ability to effectively protect solar cells.

Key Drivers of Target Market:

Rising Technological Advancements is Expected to Accelerate Market Expansion

Constant improvements in technology enhance the capabilities of vigilance systems, allowing for better monitoring, data analysis, and reporting of adverse events associated with medical devices. Further, this factor accelerates demand for more advanced vigilance solutions.  

• For instance, In July 2024, the World Health Organization (WHO) has introduced an online platform called MeDevIS (Medical Devices Information System), the first global open access clearing house for information on medical devices. It is designed to support governments, regulators, and users in their decision-making on selection, procurement and use of medical devices for diagnostics, testing, and treatment of diseases and health conditions. WHO will be continuously improving the MeDevIS platform, engaging multiple stakeholders and partners, and expanding it with additional technologies and devices used in various health areas, including pandemic and emergency settings.

Aesthetic Versatility Can Potentially Speed Up Market Growth

Growing emphasis on patient safety and the need for effective monitoring of medical devices contribute to the demand for vigilance services. Additionally, healthcare providers are increasingly prioritizing systems that ensure device efficacy and safety, which benefits the medical device vigilance market growth. 

• For instance, in September 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a new three-year Strategy for Improving Safety Communications, which aims to transform the way we provide information about the risks and safety of medicines, medical devices and healthcare products in the U.K. to support effective implementation of new safety measures.

Restraints:

Growth of the Target Market is Limited due to Complexity of Regulations

Navigating the complex regulatory landscape can be challenging for manufacturers, potentially slowing down the implementation of necessary vigilance measures.

• For instance, in August 2024, a U.S. government audit found problems in the Food and Drug Administration’s oversight of medical devices and cited the results of a data analysis by the International Consortium of Investigative Journalists of device-related injuries and deaths. The audit report by the Government Accountability Office said that FDA officials were struggling to implement an “active” surveillance program mandated by law 12 years ago due to a lack of information that would allow them to identify devices used by patients and detect potential safety issues.

• Counterbalance Statements: Although producers faces difficulties due to the complex regulatory environment, creativity is also stimulated by it. Tighter laws push manufacturers to create safer and more efficient medical equipment, which eventually benefits patients and healthcare professionals by guaranteeing greater safety and effectiveness requirements.   

Opportunities & Market Trends:

Major Opportunity for Target Market is Increased Patient Awareness: 

• Growing awareness among patients regarding their rights to report adverse events creates opportunities for companies to develop user-friendly reporting systems. Empowering patients to participate in vigilance initiatives can enhance data collection and improve overall device safety. 
• For instance, in May 2023, the government of India issued the National Medical Device Policy. The policy is based on India’s vision to promote growth and development of the Indian medical devices sector, to make it more competitive globally by achieving 10-12% global market share over the next 25 years and to reduce India’s import reliance.

The medical device vigilance market is classified into device type, delivery mode, application, end user, and region.

Device Type:

Device type in the medical device vigilance industry are divided into diagnostic devices, therapeutic devices, monitoring devices, surgical devices, and others. The therapeutic devices segment is expected to dominate the medical device vigilance market share over the forecast period as this segment includes a variety of devices used for treatment purposes, and it plays a significant role in the overall vigilance landscape due to the critical nature of these devices in patient care and safety monitoring.

Delivery Mode:

By delivery mode, the aimed market is classified in on premise and cloud based. The focused market share is dominated by the cloud based category as these systems allow organizations to scale their vigilance operations seamlessly, adapting to varying workloads without substantial infrastructure investments. Also, cloud providers often built compliance features, which assists organization in adhering to strict regulatory requirements.

• For instance, in October 2024, Click Therapeutics, Inc., a leader in Digital Therapeutics as prescription medical treatments, announced the launch of Software-Enhanced Drug therapies, part of a new product offering called Click SE. With this launch, Click Therapeutics is pioneering a new prescription digital therapeutic product category in response to increasing interest in the U.S. Food and Drug Administration (FDA) draft guidance on Prescription Drug-Use Related Software (PDURS).

Application:

Based on application, the target market is separated into four segments including risk management, adverse event reporting, post-market surveillance, and other applications. The post-market surveillance segment dominates the medical device vigilance market share. The segment’s growth is attributed to the increasing consumer preferences for durable and aesthetically appealing flooring options in homes. The demand for LVT in residential applications has grown significantly as homeowners prioritize high-quality, low-maintenance flooring solutions that emulate the appearance of natural materials like wood and stone.

• For instance, in July 2023, the U.K. government recently released the text of a new draft statutory instrument (SI), which will update the post-market surveillance (PMS) rules for medical devices in Great Britain. The draft SI became public as a result of its notification to the World Trade Organization (WTO) and can be found on the WTO's website. U.K. is introducing these new rules on PMS in the context of an ongoing revamp of the U.K.'s medical device regulatory framework following its exit from the European Union. 

End-User:

By end-user, the market is segmented into clinical research organizations (CROs), business process outsourcing (BPO), original equipment manufacturers (OEM), and others. The clinical research organizations (CROs) segment dominates the focused market as it provide specialized services, such as device safety monitoring, adverse event reporting, and regulatory compliance, making them essential components of vigilance procedures. Their ability to deliver comprehensive and scalable solutions aligns with the growing demand for stringent monitoring of medical devices.

Region:

Geographically, the market is studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America: This region has strict regulations enforced by agencies, including FDA, which mandates comprehensive post market surveillance and vigilance systems and for this major factor this region is considered to hold the largest market share for the focused market. This regulatory framework drives manufacturers to adopt robust vigilance practices to ensure compliance and enhance patient safety.

Asia Pacific: This region claims a vast and varied patient population, which increases the demand for medical devices and necessitates effective vigilance systems to monitor their safety and efficacy across different demographics.

• For instance, in October 2023, the Central Drugs Standard Control Organization (CDSCO) has released a new version of the Medical Device Adverse Event Reporting Form under the Materiovigilance Program of India (MvPI), version 1.2, which is a national program for monitoring and reporting adverse events associated with medical devices.

Medical Device Vigilance Market Report Scope:

Segmentation:

By Type:

• Diagnostic Devices
• Therapeutic Devices
• Monitoring Devices
• Surgical Devices
• Others

By Delivery Mode:

• On Premise
• Cloud Based

By Application:

• Post-Market Surveillance
• Adverse Event Reporting
• Risk Management
• Other Applications

By End User:

• Clinical Research Organizations (CROs)
• Business Process Outsourcing (BPO)
• Original Equipment Manufacturers (OEM)
• Others

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Russia
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • Indonesia
  • Malaysia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The target market includes Abbott Laboratories, Johnson & Johnson MedTech, Medtronic, and other significant businesses. The competitive landscape of the target market is shaped by major companies which focuses on technological advancements and compliance with regulatory requirements while navigating someof the challenges.

For instance, in March 2024, Fresenius Medical Care (FME), the world’s leading provider of products and services for individuals with renal diseases, launches a new “Augmented Reality” (AR) application to make learning easier for nursing staff in Kidney Replacement Therapy in Intensive Care Units. The AR glasses, in combination with digital learning modules, allow nursing staff to learn how to use acute dialysis machines on site within the intensive care wards. The glasses stream visual and acoustic recordings as users interact with the dialysis machine, providing professionals with an immersive learning experience.

List of Key Players in the Market:

• Medtronic
• Johnson & Johnson MedTech
• Abbott Laboratories
• Siemens Healthineers
• Medline Industries
• Koninklijke Philips N.V.
• GE Healthcare
• Baxter International Inc.
• Boston Scientific Corporation
• Stryker Corporation
• Thermo Fisher Scientific Inc.
• Cardinal Health, Inc.
• Zimmer Biomet Holdings, Inc.
• Hologic, Inc.
• Fresenius Medical Care AG

• In August 2024, Fisher & Paykel Healthcare Corp announced the launch of the F&P my820 System in the U.S. It is designed specifically to perform in home environments where temperatures can fluctuate, the F&P my820 System automatically adapts to environmental temperature changes using a built-in sensor. This sensor works to mitigate circuit condensate while also reducing device-wire clutter and providing patients with a simplified set-up process.
• In May 2024, the Drugs Controller General of India (DCGI) has called for timely reporting of adverse events related to medical devices and directed all medical device license holders and manufacturers to report any adverse events related to life-saving medical equipment on the government’s Materiovigilance Programme of India (MvPI) platform stating that the move is vital to mitigate risks and safeguard public health. 

Analyst View:

The target market is expected to accelerate in coming years due to an increase in the number of medical device recalls, rising incidences of adverse events, and the growing adoption of medical device vigilance software.

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