@sameer-rana I agree that the project and matrix functional structures can be better suited for most companies. In a project-based organizational structure, planning and execution are carried out as a team. There are individuals that are heads of the project,…   Read more»

@shereenmurrah I have worked in a functional organization structure mostly and I see the many benefits of this setup. This functional structure describes the common structure of a company with a position of power that directs the needs of others….   Read more»

It is hard to pinpoint which functional structure would be the best because of many different factors. Each structure comes with benefits and risks, and certain companies might find this useful. In the functional structure, there are levels of command…   Read more»

@ao242  Looking at patient preference is important in understanding how the risk-benefit assessment impacts patients. Certain patient information is more favorable in testing for the success of the medical device. To better understand if the risks outweigh the benefits certain…   Read more»

@k-faulk  Looking throughout the thread to identify common risk management errors is a good idea. These mistakes are major and impact how long the product will be on the market. Each of these major mistakes can lead to the downfall…   Read more»

It is understandable that certain companies are not using the risk management processes correctly. Each part of the risk management process plays an import role for proper execution. The risk management process can requires a team outside the project management…   Read more»

@mrlee5 You described the necessary use of Design Controls in other countries very well. Design controls are a series of processes that ensure a device is safe, it works and meets the needs of the market. In the US the…   Read more»

@niya-j  I agree that the purpose of Design Controls goes far past just planning for a medical device to make it to market. Design Controls provides an extensive series of steps and documents that check the safety and function of…   Read more»

Design controls are a series of processes that ensure a device is safe, works, and meets the needs of the market. The US design control regulation falls under FDA 21 CFR Part 820 and ISO 13485:2016. The FDA 21 CFR…   Read more»

@niya-j I agree that both sides of the argument have a complicated choice when it comes to what is ethically correct. An Informed Consent form is necessary for obtaining proper documentation of patient agreement. The cells of Henrietta Lacks have…   Read more»

@kc4310 I agree that once patient consent is given, they should be able to proceed with the test treatment that is being offered. There are other issues that could arise as a result of this decision. The negative impacts of…   Read more»

There are many ethical issues behind initial clinical studies in small groups of volunteers for the study. Initial study groups are small in order to test initial impacts on the human body. It is important that these volunteer clinical trial…   Read more»

@carrissap10 I agree that blue is a popular color used in businesses to promote different things. Blue is a calming color that seeks to create peace. In most medical settings the color blue is used for the patients. Hospitals and…   Read more»

@mrlee5 I agree that certain products like Nike are easier to promote based on popularity. Their commercials enhance and showcase the products that they already have in store. They do have good commercials that incorporate celebrities. That will appeal to…   Read more»

Anytime there is a catchy song, phrase, and good-looking product; there will be an increase in sales. There are many commercials that consumers can point out by background music or beats. For example, “Nationwide is on your side” is a…   Read more»

@dsk35 Communication is one of the most important issues that arise between QA and other departments. Especially when there are multiple departments that need oversight by QA, certain things are not shared correctly. It is important to have uniform work…   Read more»

@delany   QA/QC plays an important part in ensuring the correct product makes it to market for consumers. I agree that this carries high importance similar to the planning phase of a project. The imperfections in production may be discovered…   Read more»

The QA/QC field and positions within a company shape the success of a product on the market. This field has always been described to me as the lazy role in the company that gets paid to stand around and do…   Read more»

@niya-j I agree that keeping a strong and constant level of communication will assist in having a better understanding between animal researchers and animal activist groups. Discussion panels can be a safe space for sharing different ideas and solutions. Adverse…   Read more»

@shereenmurrah You made important mentions for both academic and industry research. Neither academic nor industry research is guaranteed to yield the results that are wanted. Industry research does put their projects first to test them in a reasonable amount of…   Read more»