Medical device

A medical device is any instrument, apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application—intended by the manufacturer to be used for human beings for the purpose of:

·Diagnosis, prevention, monitoring, treatment, or alleviation of disease;

·Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or handicap;

·Investigation, replacement, or modification of the anatomy or of a physiological process;

·Control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means

Medical devices vary according to their intended use and indications. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of mechanical engineering.

The global medical device market reached roughly $209 billion in 2006.

Medical device manufacturing requires a level of process control according to the classification of the device. Higher risk; more controls. These days, with the aid of CAD or modelling platforms, the work is now much faster, and this can act also as a tool for strategic design generation as well as a marketing tool.

Failure to meet cost targets will lead to substantial losses for an organisation. In addition, with global competition, the R&D of new devices is not just a necessity, it is an imperative for medical device manufacturers. The realisation of a new design can be very costly, especially with the shorter product life cycle. As technology advances, there is typically a level of quality, safety and reliability that increases exponentially with time.

For example, initial models of the artificial cardiac pacemaker were external support devices that transmits pulses of electricity to the heart muscles via electrode leads on the chest. The electrodes contact the heart directly through the chest, allowing stimulation pulses to pass through the body. Recipients of this typically suffered infection at the entrance of the electrodes, which led to the subsequent trial of the first internal pacemaker, with electrodes attached to the myocardium by thoracotomy. Future developments led to the isotope-power source that would last for the lifespan of the patient.

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Wikipedia