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Life Cycle Of Medical Device Add in library

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Question:

Describe about the Life cycle of medical device and distinction between drug development and device development?
 
 

Answer:

Introduction:

Generally every device has an estimated life for its best performance. Medical devices are also described as one of the very essential devices of the society and they are used to go through certain stages during their estimated life. Each and every medical device is used in various places with numerous objectives; such as a medical device may be used for clinic purpose, the same device is also used in hospital or operational purpose. A medical device goes through several phrases during its life.

One of the most important difference and vital component of any plan control that describes a product existence cycle is that it may play a crucial role through a medical device review for representative design-control fulfillment. Developing a product existence cycle in tandem along with a good product development process (PDP), it specifies the necessary articles for whole design-control and the management of the device as to its compliance (Ulmer and Ulmer, 2006).

Life cycle of medical device and distinction between drug development and device development:

The first phase of the life cycle of a medical device is the concept research, Here the main concept of the medical device as to its research deals with the function and utilization of the device. The estimated life of the medical device is also very much important as to its implementation (Ulmer and Ulmer, 2006). The major perception is also very much required whilst determining the adequate competency of the medical device. The life of the device estimated depending upon its utilization and the method of depreciation based upon which the device is to be working. The next phase of the life of a medical device is the design development of the prototype of the medical device. The design is the foremost aptitude of any medical device, it has to be recognized on such a way that it can made more out of the product (Field and Tilson, 2006).  

A general medical device’s cycle of life comprise research, production, development, and end of life. These can surely be prolonged as required to deal with a exact device design or developed procedure of the device, and the device class, category, and classification. There may be sub phases at some stage in product enlargement, like prototype, engineering, build, alpha, beta, and archive, but the major apprehension is to identify the existence cycle that most excellently gather the general intention as it follow different medical products and editions of medical products from side to side development, the market, and archival subsequent to the discontinuation that is the companionship have to hold up those goods in the market even while their promotion cycles have finished (Prutchi and Norris, 2005).

Drug development is the procedure of fetch a new pharmaceutical drug to the marketplace on one occasion a direct composite has been recognized throughout the procedure of drug discovery (Chorghade, 2007). It consists of pre-clinical investigate (microbes and animals) and clinical tests (on humans beings) and might comprise the stride to get hold of the regulatory sanction to souk the drug (Rogge and Taft, 2005).

Several characteristic of drug development are concentrated on fulfilling the regulatory needs of the drug licensing establishments. These usually compose a numeral of tests premeditated to decide the chief toxicities of a great compound before the first use in human beings (Rogge and Taft, 2005). It is an officially permitted prerequisite that an appraisal of key organ toxicity be complete, that consequence on the liver and digestive system, heart and lungs, kidney, brain, etc (Kasper and Harrison, 2005). In addition to consequence on supplementary fractions of the body that may be exaggerated by the drug (for example, the skin if the newly introduced drugs is to be distribute throughout the skin). whilst, more and more, these examinations may be completed by means of in vitro methods (for example, with secluded cells), a lot of tests may only be made by using investigational animals, while it is merely in an integral organism so as to the complex interaction of metabolism and drug revelation upon toxicity can be tested (Baguley and Kerr, 2002).

Conclusion:

Device management and drug management can be concluded as two different factors as to the medical field. While medical devices are the articles of the medical phenomena and drug management are the contentions as to the production and development of the newly introduced medicines. Device in medical fields are generally used for the purpose of checking but drug development leads to the level of improvement as to the medicines. Though they are quite dissimilar as to each other but they are the two wings of the medical science.

 

References

Baguley, B. and Kerr, D. (2002). Anticancer drug development. San Diego: Academic Press.

Baguley, B. and Kerr, D. (2002). Anticancer drug development. San Diego: Academic Press.

Chorghade, M. (2007). Drug development. Hoboken, N. J. [u.a.]: Wiley-Interscience.

Field, M. and Tilson, H. (2006). Safe medical devices for children. Washington, DC: National Academies Press.

Goldstein, E. (1992). Medical science. Boca Raton, Fla.: Social Issues Resources Series.

Kasper, D. and Harrison, T. (2005). Harrison's principles of internal medicine. New York: McGraw-Hill, Medical Pub. Division.

Prutchi, D. and Norris, M. (2005). Design and development of medical electronic instrumentation. Hoboken, N.J.: Wiley-Interscience.

Rogge, M. and Taft, D. (2005). Preclinical drug development. Boca Raton: Taylor & Francis.

Ulmer, G. and Ulmer, C. (2006). Medical science. [Waco, Tex.]: CORD Communications

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