Consequence of failed medical device

 

The report should include the following headings:
– Name of Failed medical device and Description
– Classification
– Stakeholders
– Impact of a failed medical device in society
– Evaluate design, development and testing strategies/processes
– Medical device regulatory process

Sample Solution

Consequence of failed medical device

Medical error has been estimated to be one of the leading causes of death in the US, accounting for over 250,000 deaths annually. This is only exceeded by the two big killers, heart disease and cancer. Medical devices are intended to sustain and improve quality of life. Unfortunately, there is inevitably a risk that failure of these products or the associated procedure can result in injury, disability, threats to life or even death. A pacemaker is an example of a medical device. It is placed in the chest to help control abnormal heart rhythms by using electrical pulses to prompt the heart to beat at a normal rate. When something goes wrong with the sinoatrial node, you may develop a consistently slow heartbeat or the normal pacemaker activity may stop entirely.

he two main issues at hand are quite contrary to one another, but they ultimately come down to Paakkanen’s work style and how she runs Marimekko. While Paakkanen has generated extreme success with her persistence as a control quadrant leader and her clear objectives for the company, she’s at a fork in the road. She must choose between staying with Marimekko and expanding the company internationally or starting to train a successor to take over her management role in the company so she can retire (Mitchell 11). Kirsti is dependable and reliable, a perfect control quadrant leader. But due to her micromanaging she doesn’t necessarily teach her workers. She informs her workers of what they’re supposed to do and is helpful (CVA). But, no one knows how to run the company or organize the different aspects of the product making like Paakkanen due to her lack of hands-on training of her employees. So, at this point in her career, she does not have a successor, who she would be comfortable leaving the company with, so she feels that she should not retire (Mitchell 11). This is completely fine since she has worked so hard to optimize the company and wants to continue to do so, but if something were to happen to her, she has no one to fill her shoes due to her control personality.
On the other hand, if she chooses to stay and expand, she faces a few challenges. The company has a strong sense of their Finnish brand image, which could potentially be lost by expanding internationally. Plus, Paakkanen would not have as much control over the branches internationally, which is not how she tends to work. She loses control over aspects such as distribution or manufacturing (Mitchell 10). This could cause conflict among different subsidiaries internationally, which would hurt the company. Also, there may be a lack of demand for this type of unique design that Marimekko offers (Mitchell 10). If they expand internationally, people may not understand or appreciate the company’s designs and the market could fall short. Lastly, if she continues to stay and expand with the company, she is still the only one in charge. Yes, she brings success, but others must lear

This question has been answered.

Get Answer
WeCreativez WhatsApp Support
Our customer support team is here to answer your questions. Ask us anything!
👋 Hi, Welcome to Compliant Papers.