Medical Device Complaint Management Market Trends [2031]

Report Description

Medical Device Complaint Management Market Outlook 2031

The global medical device complaint management market size was USD 7 Billion in 2022 and is likely to reach USD 12.5 Billion by 2031, expanding at a CAGR of 8.6% during 2023–2031. The market growth is attributed to the high adoption of complaint management solutions in the healthcare industry.

Increasing adoption of compliant management solutions presents significant opportunities in the market. Complaint management solutions reduce human errors and enhance productivity, with automated processes. However, automation of the complaint management process helps categorize complaints and ensure they are addressed suitably.

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Rising number of adverse events associated with the use of medical devices influences the need to record these events, which is expected to drive the market. For instance, according to the report published by the National Institutes of Health (NIH) in 2023, in the US, approximately 250,000 patients who receive medical care experience medical device-related adverse events every year. Furthermore, more than 10,000 patients die every year during the care.

The market report finds that the COVID-19 pandemic fueled the medical device complaint management market, due to the increasing importance of effective complaint management in managing device-related issues and ensuring patient safety. The adoption of digital technologies in complaint management has increased during the pandemic, which boosted the market. However, disruption in the supply chain, strict government regulations, increased cybersecurity risks, and social distancing hampered the market.

Impact of Artificial Intelligence on the Medical Device Complaint Management Market

Artificial intelligence (AI) technologies are expected to boost the medical device complaint management market in the coming years. AI and digital technology are changing the way organizations manage quality processes. Customer satisfaction has become crucial, as industries move toward Industry 4.0 at an unprecedented speed. Thus, companies are moving to a proactive value-based customer approach by using AI and digital technology.

Implementing smart quality practices in complaint management reduces the overall cost of quality assurance. AI-embedded quality management systems transform the way companies manage complaints, with capabilities such as complaint risk classification, providing suggestions on reportability, type, and severity. However, it is important to quickly classify and triage quality incidents, due to increasing complexity and volume.

Medical Device Complaint Management Market Dynamics

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Major Drivers

Increasing focus on quality assurance is anticipated to drive the market during the forecast period. Quality assurance is an important aspect of medical device complaint management. Several companies are developing smart quality approaches to transform their quality assurance processes. They are redesigning key quality processes, involving automation and digitalization, and allowing design-thinking methodology and new analytics to offer deep insights into process efficiency and product performance.

Rising production and adoption of medical devices are significantly boosting the market. According to the US Food and Drug Administration annual report 2022, the Food and Drug Administration Center for Devices and Radiological Health (FDA CDRH) oversees more than 6700 medical device product categories and approximately 27000 facilities that are related to the production of medical devices throughout the globe.

Existing Restraints

Lack of standardization is expected to hamper the medical device complaint management market. The absence of coding standardization impedes the end-to-end traceability of medical products, which leads to inefficient handling of records. This causes issues in recognizing expired and damaged products, endangering patient safety. In addition, the FDA has established guidelines for medical device reporting (MDR) to ensure that medical device problems are reported and addressed promptly.

Emerging Opportunities

Increasing adoption of digitization and enhanced functionalities of the healthcare industry is expected to boost the market. The need for improved patient access and care; personalization, customization, and automation of healthcare delivery; and protection of patient data from cyber threats drives the adoption of digital technologies in healthcare.

The COVID-19 pandemic has accelerated the adoption of digital technologies in healthcare. However, increasing technological advancements are expected to create lucrative opportunities for the market players. Thus, several companies are focusing on developing advanced product development strategies to expand a competitive edge and meet the overall growing demand in the market.

Scope of Medical Device Complaint Management Market Report

The market report includes an assessment of the market trends, market segments, and regional markets. Overview and dynamics have also been included in the report.

Medical Device Complaint Management Market Segment Insights

Service Segment Analysis

Based on service, the medical device complaint management market is divided into product surveillance & regulatory compliance, complaints log/intake, resolve & closure, and returned/non-returned product analysis.

The product surveillance & regulatory compliance segment is further classified into medical device vigilance/medical device reporting, reportable/non-reportable, and field action.

The complaints log/intake segment is further segregated into classify the issue, receive complaints, and record issue. The resolve & closure segment is further divided into customer letter creation and complaint summary. The returned/non-returned product analysis segment is further segmented into root cause analysis, complaint investigation, and corrective/preventive action.

The product surveillance & regulatory compliance segment is expected to expand at a significant pace during the projection period, due to the increasing regulatory reforms being undertaken by regulatory authorities, such as the FDA. Adverse events, such as medical device failures and product defects, result in injury, death, and harm, which makes product surveillance crucial. Thus, regulatory agencies are continuously focusing on product surveillance to accurately track product compliance and performance, thereby propelling the segment.

The complaints log/intake segment is anticipated to hold a key share of the market in the coming years. The complaint log/intake process is the first stage of complaint management in the medical device industry. It serves as a gateway mechanism for preventive or corrective action activities.  Complaint files are allied to the MDR event files, as the complaint requires to be determined and evaluated if it is a reportable adverse event.

Application Segment Analysis

On the basis of application, the medical device complaint management market is segmented into large enterprises and small & medium enterprises. The small & medium enterprises segment is expected to register a robust growth rate during the forecast period.

Small & medium enterprises (SMEs) are often involved in the development and manufacturing of medical devices, and they are responsible for handling customer complaints.

Complaint management is a critical aspect of the medical device industry, as it helps to ensure that devices are safe and effective for patients. SMEs follow several practices to improve their complaint management processes, such as training employees, establishing complaint handling, investigating complaints thoroughly, monitoring complaint trends, and documenting complaints investigations.

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Regional Analysis

In terms of region, the global medical device complaint management market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the projection period, owing to the increasingly strict regulatory guidelines for complaint management.

The regional market growth is further attributed to the rising awareness among patients regarding product safety and growing incidents of malfunctioning and product recalls. In the US, the regulatory guidelines for MDR mandate manufacturers, importers and exporters, and users to report medical device-related adverse events and product failure to regulatory agencies.

The market in Asia Pacific is anticipated to expand at a rapid pace in the coming years, due to the increasing presence of several market players. The regional market growth is further attributed to the increasing investments in digitization in the medical sector and the rising collaborations between multinational companies with local companies to increase the demand for the products.

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