Medical device testing is the process of transforming an innovative equipment design into a reliable and marketable product. It combines expert knowledge with an advanced infrastructure of accredited laboratories and research centers. Medical device testing puts it through a comprehensive assessment and helps demonstrate compliance with standards and regulations. The testing can range from prototype testing to Certification Body (C.B.) Scheme and lab tests for ergonomics, electrical, mechanical, and functional safety assessments, and software testing.
Medical devices are highly regulated by multiple regulations by government bodies and compliances. Additionally, there is a growing demand for exceptional performance, effectiveness, and safety from the devices. This is compelling the medical device manufacturers to define and implement effective medical device testing strategies throughout the development cycle.
An effective testing strategy includes compliance processes and technical testing for better performance and reliability of medical devices. A medical device manufacturer needs to test each function of the medical device right from the start. If an error is detected in the later phases of testing, it will be very costly and time-consuming to go back to the design phase and rectify the issues. This is why testing and certification is an important segment in the development of the medical device in the healthcare industry.
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
Consumers continuously expect outstanding performance, effectiveness, and safety from medical devices. This has increased the demand for validation and verification of medical devices. Therefore, it is mandatory for the manufacturers to properly define and test medical devices for the confirmation of quality. Several sets of test requirements, component selection, and the final assembly of a medical device are anticipated to augment the overall growth of the market. Furthermore, global companies are investing in automation, which has surged the need for automated quality assurance. The demand is further elevated due to the COVID-19 outbreak as a human intervention has reduced in the process.
Excessive regulations, both national and international, can become barriers to the innovation of local medical devices. Incorporating new technologies in the licensing procedure of these devices can be lengthy and expensive, posing a potential hindrance to the market growth. Lengthy procedures also incur huge amounts of money to the manufacturers due to the prolonged delays and additional equipment costs. This is significantly challenging for low-income countries that have a lack of infrastructure and budget constraints.
Due to large scale globalization, import and export of products, the exchange of goods and services can be time-consuming. Acceptance of products in international markets is a challenge that companies face due to the long lead time required for overseas qualification tests. This increases the risk of losing valuable customers, product quality, and costs additional time and money. With the growth in international trade, the lead time for overseas qualification tests is increasing, marking it a critical challenge for the medical device testing market.
Technological advancement is taking over the healthcare industry at a rapid pace. The medical device testing market is witnessing a series of developments in the field of drug-device combination, personalized medicine, and the advent of portable and wearable medical devices. Medical equipment is now implemented with IoT and A.I., which is serving as a key growth factor for market growth. Key companies in the developed, as well as some of the developing economies, are heavily investing in these technologies as they are going to rule for a longer period of time. They are also focusing on complying with the stringent regulations of these technologies in the healthcare industry.
The growing demands of Testing, Inspection, and Certification (TIC) services, along with good quality and standard products, is a prime factor driving the segment growth. TIC services ensure that the products have met the required quality, safety, and performance regulatory standards. This includes electro-medical device testing, biocompatibility testing, and clinical research services that are assessed in the final stage of the testing.
This is done to investigate the faulty material and test the performance of the devices. Therefore, it will increase the demand for testing services manifold in the upcoming years. Manufacturers require assistance in improving the marketability of their medical devices and in lowering costs, which is bolstering the market growth. This will help the certification services segment, specifically, to grow with a higher CAGR during the forecast period.
At a time like the COVID-19 crisis, it is difficult for manufacturers to gather funds for the infrastructure to conduct in-house tests of medical devices. Therefore, many large firms are increasingly outsourcing medical device testing services to help reduce overall testing costs. There is a growing trend to outsource TIC services to third-party vendors if the testing requires the implementation of complex technologies. The in-house sourcing type segment held the largest share of the medical device testing market in 2019 and is expected to witness the fastest-growth with some limitations this year.
Asia-Pacific dominates the medical device testing market, owing to the rising disposable income and advancements in the healthcare infrastructure in China, South Korea, and Japan. Growing awareness regarding healthcare devices in India, especially after the pandemic, has compelled the government to invest in research and development of new portable and accurate equipment. Rising consumer awareness has also increased the importance of testing and certification in the region, which is bolstering the market growth
Strict regulations have been established by the North American and European governments to maintain quality and safety standards in the pharmaceutical and healthcare industries. The market growth can further be attributed to the increasing R&D activities, early adoption of new technologies, and the growing demand for long-term therapy by patients. North America accounts for the largest number of the geriatric population globally, which is accelerating the growth of the medical devices market in the region. Contract Research Organizations (CROs) are investing heavily in this region due to lower costs and easy availability of skilled labor.