OCTA: Seeking FDA Approval and impact on Medical provider

Description:
The paper is more related to Health Economics.

The overall goals of the paper are 1) seeking an understanding of the process that new medical devices have to undergo when attempting to obtain regulatory approval in the US; along with the role and level of involvement of academic institutions 2) evaluating the current market and status for OCTA, its use in ophthalmology, the stakeholders involved in OCTA, its advantages/disadvantages when compared to current “gold-standard” methods, and 3) performing a cost-benefit analysis to assess key financial performance metrics including - return on investment (ROI), net present value (NPV), internal rate of return (IRR), and payback period, to justify purchasing new, expensive equipment such as OCTA devices.
LENGTH: The written product is anticipated to be between 1500-3000 words (5-10 pages, double spaced, 1 inch margins), excluding references, tables and figures. Students are encouraged to consult with Instructions for Authors in a journal relevant to the field of study, or may find guidance from the Universal Requirements for Manuscripts (http://www.icmje.org/index.html) or for quality improvement work - http://squire-statement.org/guidelines. Submission for publication is NOT required.
For all projects, each of the categories of Glassick’s criteria must be fulfilled (see Grading Rubric)
Goals: The project goals must be clearly stated. The student may want to clearly identify this section of the written product, labeling it goals or hypothesis or aims.
Adequate preparation: Adequate background material, with references, must be included. Sufficient detail must be provided to allow the mentor/Pathway Director to understand the level of background preparation undertaken by the student, as well as the significance of and rationale for the project and the approach. This literature review is typically in an “Introduction” section of a paper.
Methodology: The methods required to complete the scholarly project must be described in enough detail that the reader clearly understands all important steps in the completion of the project. This may include selection, data collection, measurements used and analysis methods.
Results: The results derived from the methods must be clearly stated in such a manner that the meaning is understood by the student and the mentor/Pathway Director.
Reflective critique: The student must discuss both the strength and weaknesses of the project, its methodology, and its results. Future implications of this work need to be discussed. This is typically in the “Discussion” section of the paper, and may also require references.
Presentation and Creative and Original Thought: Both of these categories will be reviewed by the scholarly project mentor and Pathway Director. If the written product is unclear in communicating the information required, the student may be asked to rewrite all or a portion of the scholarly product.