Medical Devices

Because of the broad definition, estimates of medical device markets vary as any item from a nuclear camera, catheter to a latex glove can be considered a medical device. It is scattered marketplace in which hundreds of companies worldwide participate. Despite this, a couple scores of companies dominate the market for most segments.

The medical device market is not even half as large as the global pharmaceutical market, though it sees many more transactions.

This is due to pricing, because in volume terms more units sold and more patients are impacted by the device market. Although the largest component of the market is in the United States, the majority of sales are non-US, and growth is occurring in other markets.

Medical devices are typically classified into three classes: Class I, II and III based on the risk associated with them. These classifications signify the level of control required to ensure the safety and effectiveness of the device. Consequently, manufacturers of the different classes need to adhere to different levels of regulations and norms, i.e., stringent regulations for higher class of medical devices.

Class I is the least risk. This class includes medical devices that pose minimum risk to a patient and are simpler in design as compared to Class II and Class III medical devices This classification was originally provided by the US Food and Drug Administration (US FDA), and similar classifications are followed by major Asian countries such as Japan and China. Class III requires the highest level of safety and effectiveness assurance as the potential threat to the patient is highest in their case.