The global medical device complaint management market size was worth around USD 6.9 Billion in 2022 and is predicted to grow to around USD 12.4 Billion by 2030 with a compound annual growth rate (CAGR) of roughly 7.5% between 2023 and 2030.
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➤ The market is expanding due to the increasing number of safety incidents that are linked to the use of medical devices.
The US Food and Drug Administration (FDA) reported a substantial increase in the number of medical device reports received between 2017 and 2019. The FDA received approximately 1,463,210 medical devices in 2019, a 19.6% increase from the 1,225,110 devices received in 2017. This increase is the result of the increasing awareness of patient safety and the necessity to document any events that involve the use of medical equipment. This, in turn, is expected to increase the demand for medical device complaint management on a global scale.
➤ The market growth is impeded by the incorrect classification of medical device complaints.
Improperly categorizing complaints may lead to an interminable cycle of escalating issues. It causes distortions in monitoring, trending, and w. Regulators systematically monitor for it (and frequently issue observations for it) as it has the potential to result in MDRs not being lodged at the appropriate time. Improper classification can exacerbate the challenge of clearing backlogs by necessitating the time-consuming process of re-opening and re-investigating closed files, in addition to causing them.
➤ A lucrative opportunity is presented by the main player’s innovative product launch.
In order to meet the market’s growing demand and gain a competitive advantage, the primary participants in the medical device complaint management market are consistently striving to develop innovative product development strategies. For example, prominent organizations are developing innovative mobile application solutions to enhance the administration of client complaints. For example, Intellect offers a platform for mobile applications that are integrated and can be used by users to submit complaints, escalate issues, and generate queries. The Intellect mobile app is readily accessible on the App Store and Google Play Store, where it can be downloaded as either an Intellect app or a mobile app under a different brand.
➤ Risk assignment and ranking are significantly hindered by inadequate training.
Rate the severity of each complaint, and prioritize it accordingly. Nevertheless, a significant number of complaint managers are unable to perform the necessary level of analysis for this position due to a lack of training. In order to designate risk numbers in a consistent and effective manner, it is frequently necessary to have a product engineer who possesses a comprehensive understanding of the software and the factors that the program considers when determining its response. Consequently, the medical device complaint management market is anticipated to encounter a significant obstacle in the form of inadequate training for risk assignment and ranking during the forecast period.
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The Global Medical Device Complaint Management Market is segmented based on product, application and region
Global Medical Device Complaint Management Market: Product Segment Analysis
● Complaints Log/Intake
● Product Surveillance & Regulatory Compliance
● Returned/Non-Returned Product Analysis
● Resolve & Closure
Global Medical Device Complaint Management Market: Application Segment Analysis
● Small & Medium Enterprise
● Large Enterprise
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The global Medical Device Complaint Management market profiles key players such as:
● Freyr
● Tata Consultancy Services Limited.
● Biovia
● IQVIA
● Wipro
● AssurX
● Sparta Systems
● SAS
● Parexel International Corporation
● Master Control
● HCL Technologies Limited
● UserWise Inc.
● Cognizant
● Interneer Inc.
● Oracle
● Zendesk
● Thryv Inc
● BizzMine
● PTC
● Orcanos
???? Recent Developments:
• According to a news release from Sparta Systems, a Honeywell company, InfectoPharm Arzneimittel und Consilium GmbH, the leading pediatric pharmaceutical manufacturer in Germany, has selected TrackWise Digital® as its next-generation quality management platform for end-to-end operations.
• In November 2021, a new module of IQVIA’s Orchestrated Customer Engagement (OCE) products, Grants and funding administration, was made available. It is anticipated that this initiative will provide the life sciences sector with a method to effectively manage and superintend their international strategic giving programs.
➤ The market is anticipated to be dominated by North America during the forecast period.
The global medical device complaint management market is anticipated to be dominated by North America during the forecast period. The region’s expansion is ascribed to the presence of stringent regulatory standards for the resolution of complaints. For example, the U.S. MDR regulatory guidelines mandate that manufacturers, importers/exporters, and user facilities report adverse events and product defects related to medical devices to the U.S. FDA on a mandatory basis.
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