The medical device market is vast and everything from a large imaging system to a disposable item can be classified as a type of medical device. Throughout the past decade, Kalorama has covered many device markets in detail. Certain areas such as infusion pumps, patient monitoring and catheters have shown promising growth. Others have solid market leaders earning stable revenue. What are the best markets for medical devices? Who are the main participants and what have been their recent competitive moves? What can makers of medical devices and those making investments in the market expect from device companies for the next five years? How has the industry fared in the recent global recession?
This Kalorama Information report, The Global Market for Medical Devices answers these questions and examines the global medical device industry and the key competitors participating in it. As part of its coverage, the report includes:
Two trends are at odds in any assessment of the global medical device industry. One is the aging of the world’s population, and especially in key healthcare markets such as the US and Japan. The other trend is the global recession, and its impact on healthcare spending. To some the device industry was considered “recession-proof.” As of early 2009 it looked like the medical device industry did not see the kind of drastic cash crunches and layoffs seen in other industries. But nonetheless growth if not revenue was down at many companies in the industry forefront and the decreased hospital spending particularly in the United States was featured in many annual reports. The US represents the largest medical device market and hospitals represent the largest customers in that market. According to the American Hospital Association in its recent Economic Crisis report: 77 percent of hospitals reported overall reduced capital spending. 14 percent of hospitals reported stopping projects that were already in process.
There are problems in international hospital markets as well. The National Health System in the UK is considering cuts to healthcare spending, Japanese hospitals seeking to control costs have to ration care and some are looking into medical tourism activities to bring in revenue. However in emerging markets such as India and China, healthcare spending is expected to increase.
Medical Device Classification
Class I: 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. Class I devices are classified in the ‘general controls’ category, as specified by the US FDA, and include devices such as tongue depressors, bedpans, elastic bandages, examination gloves, hand-held surgical instruments and X-ray film. The manufacturing and distribution of medical device products in this class generally requires: Registration, Marketing license, Pre-market approval is not required
Class II: According to the US FDA, Class III devices are subject to ‘special controls’ in addition to ‘general controls’. These devices require a higher level of safety assurance in terms of potential injury or other harm to the patient. Devices in this class include X-ray machines, powered wheelchairs, infusion pumps, surgical drapes and ultrasonic diagnostic devices. In addition to Class I requirements, themanufacturing and distribution of medical device products in this class generally entails the following: Special labeling requirements Compliance with performance standards Post-market surveillance Pre-market approval may be required
Class III: Devices in this class require the highest level of safety and effectiveness assurance as the potential threat to the patient is highest in their case. Information availability regarding the safety aspect of these devices is generally limited as compared to Class I and Class II devices; and these, therefore, require additional safety measures after ‘general controls’ and ‘special controls’. Medical devices in this category include life-supporting or life-sustaining devices, such as replacement heart valves, implanted cerebellar stimulators, implantable pacemaker pulse generators, endosseous (intra-bone) implants, etc. In addition to Class I and Class II requirements, the manufacture and supply of these devices entails the following: A scientific review to ensure the safety and effectiveness of a device Pre-market approval (mandatory) In some countries, a device-tracking system to maintain and update information about the recipients of the device is necessary for certain Class III devices such as implantable pacemakers.
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