The device should follow the safety norms provided by various regulatory bodies based on the device category. It is mandatory for the medical device to undergo a quality and clinical test before available for marketization. Medical device testing consists of end-to-end investigation, estimation, and valuation carried out to justify its safety and efficacy as prescribed and specification in compile with federal & regulatory bodies.
The emergence of strict regulatory guidelines for safety measures and the efficiency of the devices that become crucial for all medical device manufacturers to follow. Since it is essential for the commercialization of medical devices. The regulatory norms vary based on national and international measures. For instance, the various regulatory bodies include Food and Drug Administration (FDA) followed by the US, European Union guidelines designed by Europe, Health Canada Registration in Canada, and Central Drug Control Organization in India.
The regulatory body norms differ from country to country has made the process hectic for the manufacturer to figure out the guidelines specific to medical devices. This increased the demand for medical device testing service provider companies to configure the testing protocols and register medical devices under the respective country’s regulatory governance to receive approval for marketization.
The Medical Device Testing Market is established with the potential of $9.49 billion in 2022. This market was expected to grow from $10.21 billion in 2023 to $ 16.94 billion in 2030 with a CAGR of 7.5% in the forecast period of 2023-2030. The market of medical device testing has been segregated based on the service type involves testing, inspection, and certification, with respect to sourcing types such as In-house & outsourced, in relation to device types include Class I, Class II, and Class III, and by technology includes active implant medical device, Non-invasive medical device, In-vitro diagnostic medical device, ophthalmic medical device, orthopedic, and dental medical device. The potential companies providing medical device testing services are Eurofins Scientific, Institute for Testing and Certification Inc., BSI Group, SGS SA, and Intertek Group PLC.
The requirement for checking the quality, safety, and efficacy of the medical device is mandatory before anything else. It should compile with the terms of regulatory guidelines that drive the testing service segment to a larger extent compared to others in the existing market. A defined or approved quality medical device will have huge market acceptance since there is awareness emerged among customers left with the choice to pick the product which meets the quality standards. This significantly improves the growth of testing-type service provider companies.
Critical medical devices such as implantable pacemakers, pulse generators, alternative heart valves, and others listed in class III type need more attention based on safety usage and require approval from FDA for a sale. This established the demand for developing testing services for class III-type medical devices that support the growth of testing facilities in manufacturing industries as well as service-providing companies. Ultimately, drives the growth of the medical device testing market.
The prevalence of medical device testing centers, strict regulatory norms & guidelines, the presence of a huge number of medical device companies, and well-established healthcare technology are the major attributes that support the huge market growth of medical device testing in North America. Further, promoting awareness and developing industrial testing facilities by countries such as Canada and Asia-Pacific region is expected to show high growth in the forecast periods.
Medical devices are vital because they have a direct impact on patients’ health and well-being. As a result, medical device testing is crucial to verify that these devices work optimally while in use. The major obstacles, such as device compatibility, security flaws, and cloud adoption, can be overcome with the use of end-to-end testing. Any type of performance fault could be hazardous to the patient's health, even resulting in death. Thus, medical equipment testing services are required by the healthcare industry to guarantee the dependability, safety, and efficacy of the devices in use. It results in sustaining the market growth of medical device testing worldwide in the upcoming years.