The market is expanding as a result of the healthcare sector's increasing adoption of digitalization across all stages and functions. The market's expansion is being supported by the quick conversion of paper-based complaint management systems to digital ones. Increased adoption of automated, digital systems in complaint management procedures is being attributed to an increase in public-private partnerships and supportive government initiatives.
Covid 19 Impact and Market Status
The COVID - 19 pandemic dominated the year 2020, infecting nearly two million people. On the other hand, depending on the market, medical procedures have decreased by 50% to 60% while diagnostics, personal protective equipment, and essential medical supplies have seen unprecedented demand. As enterprises realign their resources to operate within the pandemic's constraints, each scenario shows how the market might recover. The cases take into account factors like consumer confidence, the economy's effect, and general industry recovery.
Product Surveillance and Regulatory Compliance to Emerge as the Most Lucrative Segment
The market is dominated by the product surveillance and regulatory compliance segment, which accounts for more than 55% of total revenue. Because adverse events, product defects, and medical device failures cause injury, harm, or death, regulatory agencies and customers are becoming less tolerant of them. Additionally, regulatory agencies continually emphasise the importance of product surveillance to precisely track product performance and compliance. In the upcoming years, it is anticipated that the product surveillance segment's medical device vigilance/medical device reporting segment will grow at the fastest rate. Regulators, such as the United States Food and Drug Administration, have implemented regulatory reforms that are to blame for this profitable growth. For instance, the US Food and Drug Administration has made it a requirement for businesses to submit to the FDA any complaints regarding unfavourable events, faulty products, and failures involving medical devices. Heavy fines would be imposed for failure to comply with these mandated regulatory reforms.
Over the upcoming years, Asia Pacific is anticipated to experience Profitable Growth
Due to well-known multinational companies like Wipro and Tata Consultancy Services (TCS) dominating the complaint management market in the region, the market in Asia Pacific is predicted to expand. Over the course of the forecast period, it is anticipated that the European market will expand at a noteworthy CAGR due to the stringent rules and regulations for medical device manufacturers to document adverse events and any associated safety actions to the European regulatory authorities. Manufacturers and businesses that fail to comply with these mandatory requirements may face significant penalties.
Strengthening medical device complaint management systems will help the nation maintain its position as a leader in the global healthcare industry. The country already has a strong healthcare sector, particularly in terms of infrastructure like hospital beds and trained staff.
The use of automated software solutions allows for better documentation. A multi-page electronic form is used to precisely and accurately collect the data and information needed to process complaints. The software solution then rearranges this data and information into a three-step process that includes processing complaints, conducting investigations, and resolving complaints. This program's every step is computerised and meticulously documented. Moreover, the complaint management system offers cutting-edge analyticals solutions incorporated with reporting tools that could be applied to enhance management oversight, bringing about necessary transparency, and enhancing decision-making procedures.
The complaint management system offers cutting-edge analytical solutions combined with analysis tools that can be used to support management oversight by bringing about the necessary transparency and enhancing decision-making procedures. Key players are constantly working to develop novel product development strategies to gain a competitive edge and meet the market's increasing demand. In the global market for medical device complaint management, innovation is what drives growth. In the post-pandemic era, the majority of Medical Device Complaint Management firms tend to work quickly and with a customer-centric approach. Attempts to reduce costs along different links in the value chain so that products can be sold for a profit.
The main factor influencing the medical device complaint management market is the shift from a paper-based to a digital structure for tracking complaints. The market for medical device complaint management is being driven by sympathetic government restructurings as well as rising demand for automatic arrangements for the procedure of management of complaints. The market for managing complaints about medical devices has the opportunity as software is increasingly used to support standard complaint management procedures.
The efficient management of customer complaints online using advanced analytics is known as medical device complaint management. Complaints can originate from anywhere. They cannot be eliminated, but they can be greatly reduced. They can be effectively dealt with even if they can't be stopped. Complaint handling in the medical device industry entails much more than simply placating dissatisfied customers. It is a legal requirement as well as a risk-reduction necessity. Medical device adoption has been prompted by an increase in healthcare spending, which also fuels market expansion over the forecast period.
The use of automated software solutions allows for better documentation. This program's every step is computerised and meticulously documented. The market for complaint management is expanding as a result of advantageous government initiatives. For example, the US Food and Drug Administration (FDA) encourages patients, medical professionals, caregivers, and consumers to report product flaws and/or adverse events voluntarily to MedWatch, the FDA's Safety Information and Adverse Event Reporting Program, or through the mobile application MedWatcher.
At a CAGR of 5.3% over the projected period, the global market for medical device complaints is anticipated to increase from USD 4.0 billion in 2019 to USD 5.8 billion by 2029.
The rise of this market can be attributable to an increase in product liability claims and medical device recalls. Additionally, this industry is expanding as a result of the rising need for postmarket surveillance services.
The strict requirements for product approvals, lack of knowledge regarding product surveillance and regulatory compliance services, and high prices connected with these services are some of the major factors limiting the growth of the medical device complaint market. The lengthy approval processes for innovative medical equipment are also a problem for market players. But in the upcoming years, it's anticipated that the growing use of risk-based postmarket surveillance programmes would open up fresh prospects for market expansion.
The competitive landscape of the medical device complaint management market has been shaped by strategic mergers and acquisitions and product innovation. Leaders are emphasising capacity enhancements and a wider global footprint to seize profitable opportunities in developing economies. The following are the key market players in the global medical device complaint market: IQVIA, Parexel, SAS Institute, Wipro Limited, Tata Consultancy Services, Sparta Systems Inc, and Freyr Solutions are among the companies represented.
Latest Innovations of the Global Body area network Market: a snapshot
IQVIA announced the addition of a new Grants and Funding Management module to its portfolio of Orchestrated Customer Engagement (OCE) solutions in November 2021. The life sciences sector anticipates that this initiative will give them a way to effectively manage and supervise their international strategic giving programmes.
A full-service contract research company (CRO) that specialises in the development of medical devices and combination products, NAMSA was purchased by IQVIA Holdings Inc. in January 2019. The company will be able to increase its global presence in the market for medical device compliance thanks to this purchase.
Medical Device Complaint Market Scope
Metrics | Details |
Base Year | 2023 |
Historic Data | 2018-2022 |
Forecast Period | 2024-2029 |
Study Period | 2018-2029 |
Forecast Unit | Value (USD) |
Revenue forecast in 2029 | USD 5.8 billion |
Growth Rate | CAGR of 5.3% during 2019-2029 |
Segment Covered | Service Type, Regions |
Regions Covered | North America, Europe, Asia Pacific, South America, Middle East and Africa |
Key Players Profiled | IQVIA, Parexel, SAS Institute, Wipro Limited, Tata Consultancy Services, Sparta Systems Inc, and Freyr Solutions are among |
Key Segments of the Global Medical Device Complaint Market
Service Type Overview (USD Billion)
- Product Surveillance and Regulatory Compliance
- Complaint Log/Intake
Regional Overview (USD Billion)
North America
- U.S
- Canada
Europe
- Germany
- France
- UK
- Rest of Europe
Asia Pacific
- China
- India
- Japan
- Rest of Asia Pacific
South America
- Mexico
- Brazil
- Rest of South America
Middle East and South Africa