Market Trends of Global Medical Device Testing And Certification Industry
Testing Services Segment is Expected to Witness Rapid Growth During the Forecast Period
Medical device testing evaluates medical devices' safety, efficacy, and performance. This thorough process encompasses a series of tests, experiments, and evaluations, ensuring that medical devices meet regulatory standards and function as intended. The medical device testing services segment is on the brink of substantial growth, fueled by the rising adoption of these services, the rollout of advanced testing options by industry leaders, and the enforcement of stringent regulatory mandates.
Various laboratories and key players are at the forefront of providing these testing services. For example, in December 2023, Impelsys, a leading global technology firm, launched a state-of-the-art medical device testing laboratory in Mangalore. This facility, dedicated to medical device testing, complements Impelsys's extensive healthcare offerings, which span data analytics, AI-driven platforms, cloud services, and educational solutions. Similarly, UL Solutions, a global leader in applied safety science, rolled out new medical device testing services at its Rochester Hills laboratory in Michigan, United States, in October 2023. These newly introduced services are poised to bolster the rapidly expanding medical device sector in the U.S., assisting manufacturers in elevating the safety, security, usability, and interoperability of their essential healthcare products.
Moreover, the surging demand for testing services, driven by stringent regulatory mandates, is anticipated to accelerate the market's growth in the foreseeable future. For instance, a June 2023 article in the Annals of Internal Medicine highlighted the European Union's revamped Medical Device Regulation (MDR), which has tightened oversight on medical devices. This regulation broadens the spectrum of devices subjected to intensified clinical trial testing before market approval. Additionally, the MDR enforces rigorous clinical surveillance on these devices, monitoring their benefits and potential risks throughout their lifecycle. Given these intensified regulations, the appetite for testing services is poised to escalate, propelling segment growth in the years ahead.
In conclusion, the surge in testing services, combined with stringent regulatory oversight on medical devices, is set to catalyze the segment's growth in the forecast period.
North America Dominates the Market and is Expected to do the Same over the Forecast Period
The geographical analysis of the medical device testing and certification market shows that North America holds a significant market share in the global market. The major factors attributing to the substantial market growth in the region are the increased focus on the quality of medical devices, the presence of many companies that serve the medical device industry, well-developed healthcare, and top multinational medical device companies.
For instance, an article published by UpCert in March 2023 stated that medical electrical devices in Canada must comply with safety standards, such as the CSA C22.2 No. 60601-1, which focuses on general safety requirements for medical electrical equipment. This standard, along with others like IEC 60601-1-2 (which deals with electromagnetic compatibility) and IEC 62366 (concerning usability engineering), ensures that devices function safely in medical environments without posing risks from electrical malfunctions or interference with other equipment. Therefore, this highlights the need for manufacturers to take responsibility for their testing processes and ensure compliance with safety standards like IEC 60601-1.
Furthermore, the United States Food and Drug Administration (FDA) has steadily increased its annual authorization of novel medical devices, fostering innovation and advancing healthcare solutions that will impact the medical testing and certification market. For instance, in 2023, the FDA rebounded from the challenges posed by the pandemic, approving 84 novel medical devices despite a heavy regulatory workload in 2022. A notable highlight of 2023 includes the rapid authorization of the first over-the-counter test for the detection of fentanyl in urine, which received clearance within 16 days. Similarly, the FDA granted marketing authorization to Owlet’s medical pulse oximeter, an innovative device designed to monitor infants’ oxygen levels. This demonstrates the agency’s commitment to bringing critical technologies to market swiftly and efficiently.
Thus, all the factors mentioned above, such as increasing demand for compliant and safe medical devices coupled with the continuous launch of new devices, are anticipated to drive the application of rigorous testing conducted by manufacturers to meet stringent safety and performance standards before marketing. It is envisioned to drive market growth in the North American region over the forecast period.
