Posted by: @au45 Both matrix and project based organizations have their advantages and disadvantages as a project manager. As a project manager I feel a significant factor in finding success is being able to create a harmonious work environment where…   Read more»

The company I work for would probably fit best in a matrix organization category. We specialize in ion channel drug discovery, so most of our work is focused on identifying promising compounds in the pre clinical stage that we can…   Read more»

Posted by: @jk299 So the company I would like to be in is a matrix organization because a matrix organization is one that” brings together employees and managers from different departments to work toward accomplishing a goal” it is a…   Read more»

@jej7 I agree, lack of resources can lead to failures in risk assessment. I like the example that was given, with a poorly managed complaints department at a medical device company. This can be even further looked at from the…   Read more»

@zbw2 spoke on a good system to use when considering risks. They mention that during the brainstorming part of the process, priority should be put on risks associated with the most critical parts of the device that can’t be avoided,…   Read more»

@amandaally1029 well said. Risk assessment is a very important consideration. It puts into perspective the severity and harmful events that can be associated with the use of the device. Deciding whether the risks are low, severe, or moderate can help…   Read more»

@llefevre you did a good job highlighting regulations on medical devices in different areas across the globe. What stands out most to me is the information you provided from the World Health Organization on countries in African regions. With only…   Read more»

Posted by: @zbw2 China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA “revised [their]…   Read more»

Design controls are used to ensure that medical devices meet user needs, intended uses, and specified requirements. These controls usually apply to the design of the product, as well as associated manufacturing processes. Though they aren’t required for all medical…   Read more»

For the different roles in clinical research, I believe that having a clinical background would be a plus, but not necessarily a requirement. When considering positions like a statistician, you wouldn’t think that it would be too important to your…   Read more»

Posted by: @kc4310 @amd29, I think you’re suggesting the multi-billion dollar pharmaceutical industry has little value?  Which I would like to agree, but there is strong evidence to suggest otherwise.  Pharmaceuticals provide a host of benefits for disastrous conditions of…   Read more»

Clinical testing is an important part of the pharmaceutical drug development process. It helps researchers determine if a new treatment or medical device is safe and effective in people. Testing gives better insight into proper dosage, effects throughout the body,…   Read more»

Posted by: @dyc6 I think the best advertisements really know how to speak to their audience. I remember watching tv ads featuring McDonald’s Happy Meals as a kid, where they would show the different toys available in the meal, and…   Read more»

Unique, creative ideas that are entertaining usually works best when trying to get an audience’s attention. I personally can’t think of one of my favorite ads, but Nike has released a few commercials I like which draw a sense of…   Read more»

As many of you have noted, I don’t think that I have looked deep enough to understand the risk behind accepting a position based on company type. I think that the role and experience you’ll be obtaining from the role…   Read more»

Posted by: @mem42 I haven’t witnessed anything exceptional, but in my other classes, we had a lecture about ethics and we discussed about different situations. As for my personal experience, I think that when you work in the industry you…   Read more»

Quality management is a vital part of businesses, especially those that deliver products that could affect an individual’s health like those that come from the biotechnology industry. Medical devices and drug components all rely on the nature of QA and…   Read more»

@ronakmandaliya made some points that I agree with. Quality specialists and engineers are some of the most important contributors to a business. Research and development/discovery can bring about most of the issues that would require quality engineering oversight, though other…   Read more»

There are scientists who are developing and using animal-free methods that are actually shown to be relevant to human health for studying diseases and testing products. There is a variety of cell-based tests and tissue models that can be used…   Read more»

@puneet says it perfectly. Though animal testing can be a bit unethical depending on the perspective, it may be something that would be difficult to eliminate. Animals have been used for many years in research and with their use, there…   Read more»