Medical Device Testing Market

Market Overview

The global medical device testing market size was valued at USD 7.8 billion in 2023 and is projected to reach USD 11.6 billion by 2032, registering a CAGR of 4.5% during the forecast period (2024-2032). The Medical Device Testing market growth is being shaped by factors such as increased device complexity, technological developments in testing, strict regulatory requirements, and a focus on patient safety, among others. 

Medical device testing is a series of examinations and assessments to guarantee the safety, efficacy, and quality of medical equipment used in healthcare facilities. These tests are critical for ensuring that medical devices meet regulatory criteria and work as intended. Medical device testing includes various activities, such as biocompatibility testing to assess the device's interaction with biological systems, sterility testing to ensure the absence of viable microorganisms, performance evaluations to evaluate device functionality and durability, and usability testing to assess user interface and human factors.

The global medical device testing market is an essential area of the healthcare industry, providing a wide range of services and solutions to ensure medical devices' safety, dependability, and regulatory compliance. Medical device producers must meet demanding regulatory and quality criteria with the increasing complexity of medical technologies and the increased emphasis on patient safety. Advancements in testing methods and technologies, combined with an expanding regulatory framework and a demand for breakthrough medical technology, are driving market expansion. 

Highlights

• Testing Services accounts for the largest market share by service type.
• Chemical/Biological Testing holds the maximum share of the market by testing type.
• The clinical phase influenced the market growth by phase.
• In-house generates the highest revenue share by sourcing type.
• Active implant medical Devices dominate the market through technology.

Market Dynamics

Global Medical Device Testing Market Drivers:

Stringent Government Regulation

The medical device sector is strictly regulated around the world. Regulatory authorities such as the FDA in the United States, the European Medicines Agency (EMA) in Europe, and the National Medical Products Administration (NMPA) in China impose strict requirements to assure medical device safety, efficacy, and quality. Compliance with these rules needs rigorous testing throughout the equipment's lifecycle, resulting in increased demand for medical device testing services. The Food and Drug Administration (FDA) of the United States maintains strict laws governing the safety and efficacy of medical devices. For example, the FDA's Quality System Regulation (QSR), as stated in 21 CFR Part 820, requires medical device makers to design and maintain quality management systems to assure regulatory compliance. 

Additionally, the FDA requires premarket approval (PMA) or clearance through the 510(k) process for most medical devices marketed in the United States. These regulatory restrictions involve extensive testing to establish medical devices' safety, effectiveness, and quality before they are allowed for commercial distribution. Thus, strict regulatory requirements, as represented by the FDA's QSR and ISO standards, fuel global demand for medical device testing services. Compliance with these rules is required for market entry and maintains the safety, efficacy, and quality of medical devices, which supports the medical device testing market trend.

Global Medical Device Testing Market Restraints:

Complexity of Testing Requirements

The fast growth of medical device technologies and changing regulatory standards complicate testing requirements, necessitating ongoing adaptation and investment in testing capabilities. For example, introducing new materials into medical device manufacture, such as biodegradable polymers and nanomaterials, necessitates specialized testing procedures to evaluate their biocompatibility, degradation kinetics, and long-term safety profiles. 

Furthermore, excessive national and international regulations can act as a barrier to local medical device innovation. Incorporating new technology into these devices' licensing procedures can take time and effort, impeding market expansion. Lengthy procedures cost manufacturers a lot of money because of the delays and additional equipment costs. Low-income countries have considerable challenges due to a lack of infrastructure and budget constraints.

Additionally, the Medical Device Innovation Consortium (MDIC), a public-private partnership dedicated to enhancing regulatory science for medical devices, works with industry stakeholders to create and evaluate novel testing procedures and standards. MDIC's programs address the problems provided by complicated testing standards to streamline testing processes, increase productivity, and improve regulatory predictability for medical device manufacturers.

Global Medical Device Testing Market Opportunity:

Technological Advancement in Testing Methods

Incorporating sophisticated technologies such as artificial intelligence (AI), machine learning, and automation into medical device testing creates numerous prospects for innovation and efficiency. For example, AI systems may evaluate enormous datasets created during testing processes to uncover trends, abnormalities, and insights that human analysts may miss. Machine learning algorithms can use past data to refine testing protocols, identify failure modes, and improve testing accuracy. Automation technologies like robotics and robotic process automation (RPA) can improve testing operations by reducing manual errors and increasing throughput. 

Similarly, companies that use these technologies to provide sophisticated testing solutions can improve the speed, accuracy, and cost-effectiveness of medical device testing, satisfying the growing need for thorough and efficient testing services. UL Solutions has announced new medical device testing services at its Rochester Hills, Michigan laboratory. UL Solutions' expanded offers and capabilities will support Michigan's booming medical device industry and assist manufacturers in improving the safety, security, usability, and interoperability of critical healthcare goods.

Furthermore, automation technologies, such as robotic testing systems, are rapidly used in testing laboratories to automate repetitive operations, standardize testing methods, and boost testing throughput. For example, Intertek, a prominent testing and certification business, uses robotic testing platforms to perform mechanical, electrical, and durability testing on medical devices, increasing productivity and dependability while lowering testing costs and cycle times.

Regional Analysis

The global medical device testing market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global medical device testing market shareholder and is estimated to grow at a CAGR of 4.8% over the forecast period. Some factors driving market growth in the North American region include a greater emphasis on medical device quality, many companies that serve the medical device industry, well-developed healthcare, and top multinational medical device companies. The Center for Devices and Radiological Health (CDRH) is an FDA division. Class II devices require exceptional controls for 'labeling, guidance, tracking, plan, performance criteria, and post-market observation,' the majority require premarket notification 510(k) to assess substantial equivalence to a lawfully sold device. US healthcare spending is expected to rise by 5% between 2023 and 2024, reaching USD 4.9 trillion. According to the estimate, healthcare spending in the United States will account for 20% of GDP by 2024. Furthermore, as medical devices are increasingly approved in the region, demand for medical device testing services is expected to rise, thereby driving market expansion. 

Furthermore, many Original Equipment Manufacturers (OEMs) have focused on electronics manufacturing service providers to properly handle the growing quantities of electronic components in modern medical devices. This has increased demand for medical device testing activities for efficient healthcare in the region, and it is projected to be one of the primary drivers driving medical device testing market growth.

Asia-Pacific is anticipated to exhibit a CAGR of 5.0% over the forecast period, with a 30% revenue share. Rapid developments in healthcare infrastructure and increased regulatory oversight are propelling the region's position in the worldwide medical device testing services market. Furthermore, the expanding demand for various medical device testing methods, favorable pricing models, and the emergence of local manufacturing hubs drive the demand for high-quality testing services, supporting innovation and technological knowledge in the region. Furthermore, cost-effective testing services and the availability of a competent workforce are essential drivers of regional revenue growth.

Additionally, medical device clinical trials in India are driven by increased government financing for R&D to accelerate new product development, making the country a preferred destination for manufacturing services. Outsourcing medical device testing services to emerging countries and increasing clinical trials are expected to drive the worldwide medical device testing services market throughout the forecast period.

The European medical device testing market includes a wide range of testing services and solutions designed to ensure the safety, efficacy, and regulatory compliance of medical devices used in healthcare settings throughout the area. The European Union's Medical Device Regulation (MDR), which went into effect in May 2021, is one of the regulatory requirements driving the European medical device testing industry. The MDR imposes stricter regulations on medical device manufacturers, including increased inspection of clinical evidence, post-market surveillance, and conformity assessment procedures. 

Segmental Analysis

The global medical device testing market is segmented based on service, testing, phase, sourcing, and technology.

The market by service type is further segmented into Testing Services, Inspection Services, and Certification Services.

Testing services include a thorough review and analysis of medical devices to ensure their safety, efficacy, and compliance with regulatory requirements. These services include a variety of testing procedures, such as biocompatibility testing, sterility testing, performance testing, usability testing, and electrical safety testing, among others. Testing laboratories use specialized equipment, instrumentation, and processes to thoroughly evaluate medical devices, producing data and test results that indicate regulatory compliance. Testing services are critical in guaranteeing the quality and dependability of medical devices throughout their entire lifecycle, from initial development and validation to post-market surveillance and regulatory submissions.

Inspection services include the physical examination and evaluation of medical equipment to ensure they meet specified standards, specifications, and quality criteria. Visual inspections, dimensional measurements, and functional checks are standard services to identify faults, discrepancies, or non-conformities in device design, production, or labeling. Inspection services assist manufacturers in ensuring product integrity, uniformity, and compliance with regulatory requirements, lowering the risk of product recalls, safety accidents, and regulatory punishments. Inspections can occur at several points of the product lifecycle, such as raw material inbound inspection, in-process inspection during manufacturing, and final inspection before product release.

The market can be further bifurcated by testing type into Physical Testing, Chemical/Biological Testing, Cybersecurity Testing, Microbiology, and Sterility Testing.

Chemical and biological testing evaluates medical devices for potential dangers from chemical compounds, biological pollutants, and interactions with biological systems. This includes biocompatibility, cytotoxicity, sensitization, and irritation studies to determine the device's compatibility with living tissues and biological fluids. Chemical testing may also include detecting dangerous substances such as heavy metals, phthalates, and volatile organic compounds (VOCs) to verify product safety and regulatory compliance.

Physical testing evaluates medical devices' mechanical, structural, and material aspects to determine their performance, durability, and safety. This comprises tensile strength, compression testing, impact resistance, wear testing, and dimensional analysis. Physical testing determines the mechanical integrity of medical equipment, ensuring it can survive the pressures and strains during operation. It also ensures that device design, material selection, and manufacturing procedures adhere to specifications and standards.

Based on the phases, the market is fragmented into preclinical and clinical.

The clinical sector had the most significant medical device testing market share in 2023. The segment's growth is attributed to an increase in the product pipeline and the constant upgrading of regulatory criteria. Clinical testing examines medical devices in human subjects to determine their safety, effectiveness, and performance in real-world conditions. Clinical trials are carried out in stages, including early feasibility studies, pivotal trials, and post-market surveillance studies, to show the safety and efficacy of medical devices for their intended clinical applications. The growing emphasis on clinical evidence for new device approvals drives the demand for reliable testing services during clinical trials. Furthermore, the increasing desire of market participants who provide innovative testing procedures at a low cost and with a short turnaround time for a wide range of clinical investigations will likely boost segment expansion.

The preclinical market accounted for 35% in 2023. Preclinical testing studies medical devices in laboratory and animal research to determine safety, effectiveness, and performance before human clinical trials. Preclinical testing collects preliminary data on device operation, biocompatibility, and potential dangers to help design and improve medical devices for human use. Preclinical testing is critical in developing and evaluating medical devices before their approval for human use. The tests are intended to determine the devices' efficacy, safety, and performance to reduce potential dangers and improve patient outcomes in preclinical studies with small and large animals. 

By sourcing type, the market is sub-segmented into In-house and outsourced.

In-house testing is the practice of carrying out testing activities within the premises of a medical device maker or sponsor organization. In-house testing gives businesses complete control over testing methodologies, quality assurance, and data management. It frequently entails the development of separate testing facilities, complete with specialized equipment, apparatus, and workers skilled in testing procedures. In-house testing provides benefits such as greater control over deadlines, confidentiality of sensitive information, and the ability to modify testing methodologies based on internal requirements. However, establishing and maintaining in-house testing capabilities necessitates significant investment in infrastructure, experience, and regulation compliance.

Outsourced testing is outsourcing activities to third-party testing laboratories, contract research organizations (CROs), or specialized service providers other than the medical device maker. Outsourcing testing services provides various benefits, including access to specialist expertise, cutting-edge facilities, and regulatory compliance support without requiring internal investment in testing infrastructure.

Based on technology, the market for medical device testing is classified into Active Implant Medical Devices, Active Medical Devices, Non-Active Medical Devices, In-vitro Diagnostic Medical Devices, Ophthalmic Medical Devices, Orthopedic and Dental Medical Devices, and Vascular Medical Devices.

Active implantable medical devices are intended to be inserted into the body and powered by a power source, such as a battery or an external power supply. Pacemakers, ICDs, neurostimulators, and cochlear implants are a few examples. Active implantable medical devices are tested for electrical safety, biocompatibility, performance, and lifespan. Specialized testing techniques, including accelerated life testing and electromagnetic compatibility testing, are frequently required to assure the safety and reliability of these devices.

Active medical devices run on an energy source, such as electricity, and are utilized for diagnostic, monitoring, or therapeutic reasons. Examples include infusion pumps, ventilators, ECG monitors, and blood glucose meters. Active medical equipment is tested for electrical safety, accuracy, reliability, and functionality. Performance testing, calibration, and verification of device settings are required to ensure accurate and consistent measurement or delivery of therapeutic interventions.

Impact of covid-19

With the surging number of cases for the novel coronavirus pandemic across the globe, governments are scrambling to contain its spread. As a result, healthcare systems are overwhelmed in determining the effective delivery of medical care systems to the affected. The pandemic has disrupted the medical device manufacturing and testing industry.

Medical device manufacturers rely heavily on healthcare facilities for their clinical data collection. Pre and post clinical trials help manufacturers to obtain certificates for market approval. The medical device companies are finding it difficult during the pandemic to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty

Recent Developments

• February 2024- Bureau Veritas announced the acquisition of the Conformity Assessment company from ANCE Estándares S.C.: "ANCE S.A de C.V." (Asociación de Normalización y Certificación), Mexico's leader in testing and certification services for electrical and electronic equipment.
• March 2024- Intertek collaborated with Hicomply to provide end-to-end technology and certification information security solutions.