Medical Device Validation & Verification Market Size, Share, Growth, and Industry Growth by Type (Diagnostics, Therapeutic, and Implants), By Application (Cardiovascular, Dermatology, Orthopedics, Nephrology, Respiratory, Neurology, Oncology, ENT, and Others), and Regional Forecast From 2023 To 2028

Updated On: 01 April 2024

MEDICAL DEVICE VALIDATION & VERIFICATION MARKET REPORT OVERVIEW

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The global medical device validation & verification market size is estimated to be USD 626.6 million in 2022 and the market is projected to touch USD 1021.7 million by 2028, exhibiting a CAGR of 8.5% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with medical device validation & verification experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels.

Medical device verification and validation (V&V) are crucial steps in the medical device development process. To adhere to laws and provide a high-quality product that has fewer errors, higher repeatability, reduced production costs, and a quicker time to market, verification and validation are required. Although verification and validation are both steps in the testing process for medical devices, they serve quite different but equally crucial purposes.

The FDA defines design verification as “confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” Verification, in other terms, examines the correspondence between your design inputs and outputs. Validation is defined by the FDA as the process of “establishing by objective evidence that device specifications conform with user needs and intended use(s).” On the other side, validation is the testing procedure that demonstrates the gadget you designed functions as intended for the user.

COVID-19 IMPACT : Increasing Medical Devices Boosted Product Demand Significantly

COVID-19 had a life changing impact globally. The global medical device validation & verification market was significantly affected. The virus had various impacts on different markets. Lockdowns were imposed in several nations. This erratic pandemic caused disruptions on all sorts of businesses. Restrictions tightened during the pandemic due to increasing number of cases. Numerous Industries were affected. However, the market for medical device validation & verification experienced a hike in demand.

As the COVID-19 virus spread out across the globe, it increased the number of patients. This led to massive numbers in hospitalization across the globe. Due to unavailability of beds in hospitals, there were several individual health centers set up across the globe. To cope with the testing of the mass population diagnosed with COVID-19, there were several devices made for the same. This increased the need for medical device validation & verification in order to make sure all results provided by the devices were accurate at the very least.

However, with the contagious virus spreading through minimal contact, there was a rise in the need for hygienic and sterilized equipment. However, when it came to medical devices, those which came in contact with COVID-19 patients had to be disposed. This led to a rise in the manufacturing of multiple medical devices. Hence in order to verify these products, there was a rise in the medical device validation & verification.

LATEST TREND

"Scientific Advancement to Strengthen Market Outlook"

According to Toltec Ventures, the whole manufacturing process and the approval procedure have been streamlined as a result of the increased standardization of medical device validation & verification activities. Automated testing, as well as strong diagnostic and data collection tools, significantly improve medical device validation & verification. Companies that manufacture medical devices often adhere to a systematic development process with clear deliverables at each stage. Every specification requires proof of validation or verification.

The methods used to increase efficiency and results will keep evolving. As the regulatory environment keeps changing, new medical device validation & verification techniques, automated testing tools, and documentation tools will definitely become available.

MEDICAL DEVICE VALIDATION & VERIFICATION MARKET SEGMENTATION

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• By Type

Based on type, the market is divided into Diagnostics, Therapeutic, and Implants.

Diagnostics holds a major share of the global market.

• By Application

Based on application, the market is bifurcated into Cardiovascular, Dermatology, Orthopedics, Nephrology, Respiratory, Neurology, Oncology, ENT, and Others.

Cardiovascular as application holds a major share of the global market.

DRIVING FACTOR

"Inclusion of Software to Boost Market Share "

The inclusion of software into medical equipment has led to an increase in their complexity. Previously, turning on and off the equipment and displaying information were done manually using the software in medical devices. The medical device software has become significantly more sophisticated as a result of the complexity of the requirements and customer requests, which has increased the need for validation and verification. This development is expected to drive the global medical device validation & verification market share.

"Growing Patient Numbers to Boost Market Size"

The majority of medical device businesses are concentrating on developing cutting-edge technologies due to the increasing frequency of cancer and accompanying mortality. The Organization for Economic Co-operation and Development (OECD) estimates that cancer caused the deaths of around 4.5 million persons in the Asia Pacific region. The market is anticipated to be driven by rising cancer treatment awareness and a rise in medical device companies' outsourcing of their cancer device development operations. This is anticipated to hike the global medical device validation & verification market size.

RESTRAINING FACTOR

"Tedious Procedure to Pose as Market Constraint "

Each medical device that undergoes medical device validation & verification needs to wait a long time to receive a decision on its approval status. This is caused due to the delicate procedure that is being undertaken. There have not been ground breaking developments in the field of medical device validation & verification. There is also a need for specialized personnel to undertake these tests. Hence the requirement of training people for testing these devices adds on to the tediousness of the overall procedure of medical device validation & verification. Hence these factors are expected to restrain the global medical device validation & verification market growth.

MEDICAL DEVICE VALIDATION & VERIFICATION MARKET REGIONAL INSIGHTS

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"North America Dominates the Market as Major Developer "

North American countries are the largest market shareholder for medical device validation & verification. This is built upon factors such as huge investments from companies in this region. A contributing factor is the recent technological advancements in medical devices and increasing complexity in product design. Moreover, medical device manufacturers are focusing on North America due to the booming healthcare industry in the region. APAC is the second major shareholder of the global medical device validation & verification market.

KEY INDUSTRY PLAYERS

"Market Players Focus on New Product Launches to Strengthen Market Position"

Leading players in the market are adopting various strategies to expand their presence in the market. These include R&D investments and launch of new, technologically-advanced products in the market. Some companies are also adopting strategies such as partnerships, mergers, and acquisitions to strengthen their market position.   

List of Market Players Profiled

• SGS S.A. [Switzerland]
• Quest Global [Singapore]
• Intertek [U.K.]
• Element Materials Technology [U.K.]
• TÜV SÜD [Germany]
• North American Science Associates, Inc. [U.S.]
• Eurofins Scientific SE [Luxemburg]
• Charles River [U.S.]
• Sterling Medical Devices [U.S.]
• Pacific Biolabs [U.S.]
• Toxikon Corporation [U.S.]
• Steris Laboratories [U.S.]

REPORT COVERAGE

This research profiles a report with extensive studies that take into description of the firms that exist in the market affecting the forecasting period. With detailed studies done, it also offers a comprehensive analysis by inspecting the factors like segmentation, opportunities, industrial developments, trends, growth, size, share, restraints, etc. This analysis is subject to alteration if the key players and probable analysis of market dynamics changes.