Now that you have read about the phases of clinical research in drugs and the steps necessary to get medical devices approved you are in a position to analyze the development process in a little more detail.
The objective of this assignment is for you to prepare a short position paper by following the following steps:
1) Conduct a minimal amount of research about clinical research related to one of the options described in detail below. You will need to include at least three citations outside of the references included in this course for your paper as a minimum.
2) Develop a 3 pages position paper that addresses the assignment below. Your paper should contain an introductory paragraph which presents your thesis statement (your position). The next few paragraphs should clearly present your arguments; pro-arguments that support your thesis statement and con-(opposing) arguments. For pro-arguments, explain how each supports your thesis statement. For your con-arguments, explain why they do not support your premise and why you believe each is not strong enough to sway your perspective. After support your thesis statement with your evidence, close with a concluding paragraph which reiterates your thesis statement and the main reasons why briefly.
Demonstrate your ability to formulate a position, substantiate it with the evidence that you find in performing your research, integrate some of your own thinking in order to develop your arguments.
The length of the paper is between 3 pages, double spaced, 12 pt Times New Roman font, and one inch margins. Please include a title page with the title of your paper, your name, course no. and name, and running header of the title (by including a ‘header’ on each page), a separate reference list at the end, and include page numbers.
Medical Device Development
Based on Figure 2.9 on page 49 of your textbook, it is apparent that there are three classes of medical devices. Some medical devices pose no real threat to human beings while others may be considered ‘high-risk devices’ that directly affect the functioning of the body. Based on your research about medical device clinical research, why must all devices go through a regulatory approval process? Discuss the pros and cons of the U.S. regulatory process for device review and approval, and what the intended outcomes are for each step. In order to simplify the system, would it make sense to place all devices in a single category and run them through the same process? Discuss what arguments support your response. If your response does not follow Figure 2.9, p. 47 in your textbook, explain how you would modify Figure 2.9.
Your position statement should be along the lines of “It is appropriate for the FDA to classify investigational devices as Class I, II, or III which delineate the regulatory pathway for market approval” or “It is not appropriate for the FDA to combine certain or all devices into different Classes such as I, II or III.”
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