Regulatory Affairs on Health Technology Essay Discussion

December 2, 2022

Regulatory Affairs on Health Technology Essay Discussion

Order Number	636738393092
Type of Project	ESSAY
Writer Level	PHD VERIFIED
Format	APA
Academic Sources	10
Page Count	3-12 PAGES

Instructions/Descriptions

Regulatory Affairs on Health Technology Essay Discussion

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Question #1:

Your technology company, Orange Peel, would like to register its new smart watch with health
sensors, including a module that performs micro-sampling of the blood through tiny capillaries
that painlessly penetrate the upper layers of the skin of the wearer. Basic measurements of key
circulating metabolite levels can be measured with this device in real time, giving the wearer and
his/her health provider real-time performance measurements of kidney and liver function.
Orange Peel is preparing STED paperwork for submission to the Australian regulatory bodies.
What information does Orange Peel need to gather for this STED file?

Question #2: Following Orange Peel’s success with its watch in Australia, the company has
decided to diversify its portfolio of smart interconnected medical devices. It has created a line of
limb augmentation exoskeleton devices for the legs that give the wearer additional contraction
strength and support. The degree of support, the speed of contraction, and other metrics, can be
controlled by the synched Orange Peel watch, and synchronized to music, external inputs, etc.
Applications range from walking assistance for the injured, infirmed, and elderly, to standing
stamina improvement for factory and fulfillment center workers.
What procedures does Orange Peel need to follow to have its robo-pants approved as
medical devices on the Chinese market? Do they need to conduct clinical trials of the
devices if they have trial results from Australia?

Question #3:
As head of the Regulatory Affairs Division for Orange Peel Asia, you have been tasked with
developing a regulatory strategy for marketing approval for your robo-pants in all of China,
India, and Taiwan.
What is the framework of your strategy and the milestones you will have along the way?

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Question #4:
In conjunction with the Ministry of Public Heath in China, Orange Peel has developed a version
of its watch that detects the presence of common opioids in the blood of patients, via a
disposable add-on cartridge. The hope is to gain approval for medical use of this device to
monitor compliance in pain treatment, in order to control initial stages of potential opioid abuse.
What is the regulatory course to have the watch and disposable add-on cartridge approved
for sale on the Chinese market?

Regulatory Affairs on Health Technology Essay Discussion

RUBRIC

Excellent Quality

95-100%

Introduction

45-41 points

The context and relevance of the issue, as well as a clear description of the study aim, are presented. The history of searches is discussed.

Literature Support

91-84 points

The context and relevance of the issue, as well as a clear description of the study aim, are presented. The history of searches is discussed.

Methodology

58-53 points

With titles for each slide as well as bulleted sections to group relevant information as required, the content is well-organized. Excellent use of typeface, color, images, effects, and so on to improve readability and presenting content. The minimum length criterion of 10 slides/pages is reached.

Average Score

50-85%

40-38 points

More depth/information is required for the context and importance, otherwise the study detail will be unclear. There is no search history information supplied.

83-76 points

There is a review of important theoretical literature, however there is limited integration of research into problem-related ideas. The review is just partly focused and arranged. There is research that both supports and opposes. A summary of the material given is provided. The conclusion may or may not include a biblical integration.

52-49 points

The content is somewhat ordered, but there is no discernible organization. The use of typeface, color, graphics, effects, and so on may sometimes distract from the presenting substance. It is possible that the length criteria will not be reached.

Poor Quality

0-45%

37-1 points

The context and/or importance are lacking. There is no search history information supplied.

75-1 points

There has been an examination of relevant theoretical literature, but still no research concerning problem-related concepts has been synthesized. The review is just somewhat focused and organized. The provided overview of content does not include any supporting or opposing research. The conclusion has no scriptural references.

48-1 points

There is no logical or apparent organizational structure. There is no discernible logical sequence. The use of typeface, color, graphics, effects, and so on often detracts from the presenting substance. It is possible that the length criteria will not be reached.