The global medical device complaint management market size was valued at USD 6.5 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 8.5% from 2022 to 2030. The growing adoption of digitalization in all phases and functionalities of the healthcare industry is promoting the market growth. Rapidly transforming systems from paper-based to digital solutions in managing complaints are supporting the market growth. The rising number of public and private partnerships and favorable government initiatives are boosting the adoption rates of automated, digital systems in complaint management processes.
The implementation of these automated software solutions supports enhanced documentation. By using a multi-page electronic form, complaint data and information are accurately and precisely captured and are reorganized by the software solution into a three-step program that comprises complaint processing, investigation, and resolution. Every step of this program is computerized and precisely documented. Furthermore, the complaint management system offers advanced analytical solutions incorporated with reporting tools, which could be used in augmented management oversight providing required transparency that enhances the decision-making processes.
Key participants are constantly focusing on devising innovative product development strategies to gain a competitive edge and cater to the growing demand in the market. For example, key players are developing innovative mobile application solutions to enhance customer complaints management. For instance, Intellect offers an integrated mobile application platform allowing customers to register complaints, escalate ticks, and generate queries. The Intellect mobile application is easily available on the App Store and the Google Play Store and can be downloaded as an Intellect application or a custom branded mobile application.
Post COVID Outlook
The medical device complaint management market decreased by 16.8% from 2019 to 2020.
The market is estimated to witness a y-o-y growth of 7.0% to 8.5% in the next 5 years.
The ongoing Covid-19 pandemic significantly impacted the normal functioning of healthcare systems and disrupted manufacturing cycles and supply and demand chains and led to numerous product defects and failures.
The fluctuating demand for medical devices across markets will lead to tight inventory management, slower reordering, and delayed product launches.
The U.S. FDA has approved several Emergency Use Authorizations (EUAs) for medical devices under section 564 of the Federal Food, Drug, and Cosmetic (FD&C) as a response to coronavirus.
Manufacturers need to follow reporting requirements as mentioned in the EUA letter for authorized devices and report any adverse events or product failures through an electronic medical device reporting (eMDR) system established by the U.S. FDA.
Favorable government initiatives are boosting the growth of the complaint management market. For instance, the U.S. FDA encourages patients, healthcare professionals, care providers, and consumers to voluntarily submit reports of product defects and/or adverse events to MedWatch, which is the U.S. FDA’s Safety Information and Adverse Event Reporting Program, or then by using MedWatcher, the mobile application. Moreover, adverse event reporting witnessed a surge in the number owing to the launch of the MedWatcher. The MedWatcher application simplifies and accelerates the complaint reporting process by offering customers an easy four-step form, which is to be electronically submitted to the U.S. FDA. Therefore, the development and launch of these innovative mobile applications in complaint management are expected to fuel the market growth.
The product surveillance and regulatory compliance segment dominated the market in 2021 and accounted for a revenue share of over 55.0%. Regulatory agencies and customers are growing less tolerant of adverse events, product defects, and medical device failures since it results in injury, harm, or death. Furthermore, regulatory agencies are constantly focusing on the importance of product surveillance to precisely track product performance and compliance.
Under the product surveillance segment, the medical device vigilance/ medical device reporting segment is expected to register the fastest growth rate over the forthcoming years. This lucrative growth is attributed to regulatory reforms undertaken by regulatory authorities such as the U.S. FDA. For instance, the U.S. FDA has made it compulsory for firms to report any complaints regarding adverse events or product malfunctions and failures related to medical devices directly to the U.S. FDA. Non-compliance with these mandatory regulatory reforms would result in hefty penalizations.
The complaint log/intake segment is expected to register the fastest growth rate over the forthcoming years. This segment is the pioneer stage of complaint management and portrays a gateway mechanism for preventive or corrective action and post-market activities. Complaint files are linked to the medical device reporting (MDR) event file since the complaint needs to be assessed and determined whether it is a reportable adverse event. Moreover, its compulsory for medical device manufacturers to capture and track complaints based on the quality system regulation (QSR), which has been defined in 21 CFR Part 820.
North America dominated the market for medical device complaint management in 2021 and accounted for a revenue share of over 40.0% due to the presence of stringent regulatory guidelines for complaint management. For instance, in the U.S., the regulatory guidelines for MDR include compulsory requirements for manufacturers, importers/exporters, and user facilities in reporting adverse events and product failures related to medical devices directly to the U.S. FDA.
Asia Pacific is anticipated to grow lucratively over the forthcoming years. The presence of renowned multinational companies such as Wipro and Tata Consultancy Services (TCS) spearheading the complaint management market in the Asia Pacific is expected to drive the market in Asia Pacific. The European market is anticipated to expand at a significant CAGR over the forecast period owing to the stringent regulations and mandatory requirements for medical device manufacturers to report adverse events and corresponding safety actions undertaken to the European regulatory authorities. Manufacturers and companies failing to comply with these mandatory requirements could face hefty penalizations.
Key players are constantly devising innovative product development strategies and revising their collaborations and mergers & acquisitions strategies to gain a competitive edge in the market and expand their business footprint. The majority of the medical device companies operating in the industry are thriving for efficient complaint management systems in order to attain all-around regulatory compliance. Thus, the manufacturers are focused on providing these companies with upgraded complaint management systems through innovation and offering inputs for improvements in designs, thereby resulting in a competitive edge on the account of improved product quality and minimum complaints.
Some prominent players in the global medical device complaint management market include:
Tata Consultancy Services (TCS)
Parexel International Corporation
Market size value in 2022
USD 7.0 billion
Revenue forecast in 2030
USD 13.4 billion
CAGR of 8.5% from 2022 to 2030
Base year for estimation
2016 - 2020
2022 - 2030
Revenue in USD million/billion and CAGR from 2022 to 2030
Revenue, company ranking, competitive landscape, growth factors, and trends
Service type, region
North America; Europe; Asia Pacific; Latin America; MEA
U.S.; Canada; Germany; U.K.; Spain; Italy; France; Japan; China; India; Australia; Brazil; Mexico; South Africa; Saudi Arabia
Key companies profiled
Tata Consulting Services (TCS); IQVIA; Biovia; Wipro; Sparta Systems; AssurX; Freyr; SAS; Parexel International Corporation; MasterControl
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This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2030. For the purpose of this study, Grand View Research, Inc. has segmented the global medical device complaint management market report based on service type and region:
Service Type Outlook (Revenue, USD Million, 2016 - 2030)
Complaints Log / Intake
Classify the Issue
Product Surveillance & Regulatory Compliance
Medical Device Vigilance/Medical Device Reporting
Returned/ Non-returned Product Analysis
Root Cause Analysis, Testing
Resolve & Closure
Customer Letter Creation
Regional Outlook (Revenue, USD Million, 2016 - 2030)
b. The global medical device complaint management market size was estimated at USD 6.5 billion in 2021 and is expected to reach USD 7.0 billion in 2022.
b. The global medical device complaint management market is expected to grow at a compound annual growth rate of 8.5% from 2022 to 2030 to reach USD 13.4 billion by 2030.
b. Product surveillance and regulatory compliance services dominated the medical device complaint management market with a share of 56.0% in 2021. This is attributable to the fact that the regulatory agencies and users of medical devices are becoming less tolerant with the failure of the medical devices as it results in the serious injury, death or potential harm to the users.
b. Some key players operating in the medical device complaint management market include Tata Consulting Services (TCS); IQVIA; Biovia; Wipro; Sparta Systems; AssurX; Freyr; SAS; Parexel International Corporation; MasterControl.
b. Key factors that are driving the medical device complaint management market growth include the increase in transition from paper-based to the digital system for tracking complaints, supportive government reforms along increasing demand for an automated systems for the process of complaint management.
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