Global Medical Device Technologies Market - Segmented by Type, End User, and Geography - Growth, Trends, and Forecast (2018 - 2023)
The global medical device technologies market is expected to register a CAGR of 7% during the forecast period of 2018–2023. Medical device manufacturing is a long process requiring robust SOPs and strict guidelines to be followed. Nowadays, the design and production have become easier with the help of new modeling platforms. The new devices are dedicated to a consumer-driven model that includes wearable devices, wireless internet linked systems, etc. Technologies, such as RFID and motion sensing are being used in monitoring devices. The medical device companies are searching for ways of implementing technology by understanding the needs of the customers and ensuring that the devices work round the clock.
Rise in Number of Chronic Diseases
Globally, the disease burden is shifting from infectious diseases to chronic conditions, with a corresponding escalation in incidence rates of cancer. Chronic diseases, such as heart disease, cancer, diabetes, stroke, and arthritis are long lasting in their effects. Cancer and cardiovascular diseases are the two most common causes of mortality. Globally, chronic diseases kill more than 38 million people each year. Cardiovascular diseases account for most of the chronic diseases related deaths (17.5 million people annually), followed by cancers (8.2 million), respiratory diseases (4 million), and diabetes (1.5 million). These four groups account for 82% of all chronic disorder deaths. The rise in incidences of chronic diseases has increased the demand for medical devices. The other factors such as investment in R&D and the need for preventive healthcare are driving the medical device technologies market.
Strict FDA Regulations
Strict FDA regulations are bound to be present in the field of healthcare. The regulatory framework for medical devices is not standardized in many countries across the globe. FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who design, manufacture, repackage, relabel, and import medical devices into the United States. In addition, CDRH regulates radiation-emitting electronic products, such as lasers, X-ray systems and ultrasound equipment. The Food and Drug Administration (FDA) strictly regulates the approval of medical devices depending on their class. Class I devices can be self-registered, but class II devices require a premarket notification, i.e., 510(k) submission to FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device. Whereas, approval for the class III device, i.e., premarket approval (PMA) is the most stringent type of device marketing application that is required by the FDA.
FDA has strict regulations to approve marketing devices, due of which many manufactures prefer outsourcing their devices to other countries. The rules also pose several barriers to technological innovation, which might hamper the improvement of prevention, diagnosis, and treatment of disease. When the FDA delays the approval process, companies lose profits. New medical device technologies need more time to be tested, as the FDA is responsible for the safety and reduction of risks to a minimum. The strict FDA regulations are hindering the growth of the medical device technologies market. The other factors such as uncertainty in reimbursement and increase in the cost of services are also hindering the growth of the market.
United States Leads the Market in North America
In 2017, the United States medical device technologies market held the largest market share in the North America region due to the presence of a large number of companies located in the country. R&D investment in the companies has increased drastically, which has, in turn, led to the invention of new technologies.
Key Developments in the Market