Life Cycle of a Medical Device

Question: Describe about the Life Cycle of a Medical Device? Answer: Introduction This assignment consists of an analysis of life cycle of medical devices present in medical market. Life cycle of medical devices means the set of stages of a medical device in its activity cycle. There is a brief discussion on life cycle of medical device and comparison of development of drugs with medical device development (P Constantinides, 2014). Every medical device is different in complexity and application. In this assignment there is an explanation of difference between development cycle of medical device and medical drugs. Life cycle of Medical Device 1. Concept research Concept research is the first phase of life cycle of any medical device. In this step the company will first analyze the medical market. As per the analysis report medical devices are development (Lewis, 2013). The modification or innovation if required in any old medical device company can only do after analyzing the 2. Prototype Design Development Before development of main model prototype or rough model of the device is developed to check whether the device is working properly or not (Fries, 2001). Prototype model of medical device is developed to check working.3. Preclinical development-Pre-clinical development is the stage in which prototype model of device before tested on human being is tested on any other living being so that the defects can be identified and corrected in main model of medical device (El-Haik and Mekki, 2008). 4. Clinical Trials Testing-Clinical trial testing is the fourth stage in life cycle of medical device it is done after the pre clin ical development and pre clinical testing of the device. The main model of the medical device is tested in this step (Fleming and Ma, 2002). The main model which will be launched by company is only tested in this step. 5. FDA Approval Market Launch Food and Drug Administration department after analyzing the above process of medical device give approval to company for launching their device in market (Platero, 2009). FDA main focus is on protecting and promoting the public health with the help rules and regulations. Without approval of FDA no company can launch medical device in the market. Difference between Device development and drug development Device Development Life Cycle Concept Research- This is the initial step in the development life cycle of medical device. In this step company do basic research in medical market to identify the requirement of the market. The device developed by the company should be made as per the requirement of market or hospitals or the clinics. Prototype Design Development- In this step medical device development company initially develop a rough model as per the analysis report. The rough model is developed to check whether the device is suitable in present environment or not. Pre clinical Development- Pre clinical development is the process in which device is developed to test its working and sustainability. Pre clinical development is done to check whether the device is good for long term or not. After development the device has to undergo the test which is done to check whether the device is performing as per the needs or not. Clinical Trials Testing- Clinical trial testing is the process in which main model of the device is tested. The device is tested in this step on the object for which it is developed. This is the trial test so after this if any defects are found in device it has to be corrected. FDA Approval Market Launch- FDA stands for Food and Drug Administration. FDA main responsibility is to maintain the public health in relation to drugs and foods products developed for them. Drug Development Life Cycle The steps involved in Drug development life cycle are as follow: Discovery and research In this step research is done of the drug market so that the requirement can be identified (Rosier, Martens and Thomas, n.d.). Pre clinical Before development of main drugs sample is tested to check the affect and side affect of it (Weinger, Gardner-Bonneau and Wiklund, 2011). Development Testing or Validation- After pre clinical test of the drug development is done and after development is testing is done. Trial Test- Trail test is done to identify the defects after main development of drugs (Willson, Ison and Tabakov, 2013). FDA Approval To market- FDA approval is important for any drug development company for launching any drugs in market. Conclusion The development life cycle of medical device and drugs are different which is discussed above. The main body responsible for launching any device and drug in market is FDA. FDA before launching conduct different test of the device and drugs. References El-Haik, B. and Mekki, K. (2008). Medical Device Design for Six Sigma. Hoboken: John Wiley Sons. Fleming, E. and Ma, P. (2002). Drug life-cycle technologies. Nat Rev Drug Discov, 1(10), pp.751-752. Fries, R. (2001). Handbook of medical device design. New York: M. Dekker. Lewis, J. (2013). Drug-Induced Liver Injury Throughout the Drug Development Life Cycle: Where We Have Been, Where We are Now, and Where We are Headed. Perspectives of a Clinical Hepatologist. Pharm Med, 27(3), pp.165-191. P Constantinides, P. (2014). Enabling the development and life cycle management of oral poorly soluble drugs using lipid-based drug delivery systems. Pharmaceutica Analytica Acta, s1(01). Platero, J. (2009). Molecular pathology in drug discovery and development. Hoboken, N.J.: John Wiley Sons. Rosier, J., Martens, M. and Thomas, J. (n.d.). Global new drug development. Weinger, M., Gardner-Bonneau, D. and Wiklund, M. 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