The global medical device industry is estimated to be between U.S. $ 220 and 250 x 109 in value. This industry continues to show a healthy growth rate overcoming many economic slowdowns. It is projected to grow from about U.S. $ 100 billion to almost U.S. $ 300 x 109in 2015. Figure 1.1 shows the growth from 2000 projected to 2013.‖
The U S has about 40% of the global market share, followed by Europe, Japan, and the rest of the world (Figure 1.2). Germany is the largest market in Europe followed by France, Italy, and the United Kingdom. Japan is the second largest country by market share next to the U. S. The rest of the world comprises regions like China, India, and Latin America. These regions are seeing 10-15% annual growth rates in the medical device market. One of the reasons for this growth is the population increases in these regions compared to the United States and Europe. The demand for health care and medical devices as a result continues to increase for these regions and globally as well.‖ 4
Global medical device market share by region
Medical devices range from simple devices like tongue depressors, syringes, and bandages to highly sophisticated imaging machines and long term surgical implants. Medical devices include surgical instruments, catheters, tubing‘s, coronary stents, pacemakers, MRI machines, X-ray machines, prosthetic limbs, artificial hips, knees, surgical gloves, and bandages. Medical device as defined by the U.S. FDA is anything used for therapeutic and/or diagnostic purposes in humans or animals, which is not a drug. In the European Medical Device Directive a medical device is defined as a product with a medical intended purpose, whether for diagnosis, treatment, or alleviation of a medical condition in humans and is not a drug.
Devices are classified into three classes: Class I, Class II, and Class III depending upon their risk and criticality. Examples of Class I devices are tongue depressors, bandages, gloves, and simple surgical devices. Class II devices are wheel-chairs, X-ray machines, MRI machines, surgical needles, catheters, and diagnostic equipment. Class III devices are used inside the body. Most implants are Class III devices. Examples include heart valves, stents, implanted pacemakers, silicone implants, and hip and bone implants.‖
