This course really opened my eyes to how the world of medical devices really operates. As a biomedical engineering student, most of my education was focused on theoretical design and processes of medical devices and instruments. However, this course taught me a lot about how these devices are put out into society and what it takes for a product to…[Read more]

In its simplest form, an NDA (Non Disclosure Agreement) is a legally binding contract that creates a confidential relationship between persons holding an idea or invention and persons to whom this information will be revealed. NDAs help to protect sensitive information. More specifically, NDAs also outline what information is considered private…[Read more]

Although it is possible to begin a project based on a verbal agreements, it is still a very informal method of commitment and is not effectively reinforced. Written agreements are physical evidence of a contract between two or more parties that can efficiently motivate the successful completion of the project. In most cases, there are no…[Read more]

The main goal in this type of situation is to find an organizational structure that both parties can agree on for the duration of the collaboration. Communication is the most important factor for such a task to be successful. The type of structure that best fits this scenario is a matrix organization.
Matrix organization allows for multiple…[Read more]

My workplace consists of a matrix organization in which resources are split based on project priorities. Project managers are able to share the skills of employees across projects and departments. Project managers in the research and development team lead projects within specialized departments with the help of junior scientists and researchers. I…[Read more]

In a company setting, it is easy to work with people that we have cordial relationships with since everyones goals are aligned. After that, its a matter of selecting people that can provide a versatile set of skills and abilities. It is essential for each member to have comprehensive knowledge of their department. The most common problem in…[Read more]

I don’t agree with this reason. For an effective product design, I believe risk management and design controls should occur in parallel to one another. That way risks can be identified in each step of a design and fixed immediately. The second reason is true. The reason most companies fail to effectively assess risk is because it is approached a…[Read more]

Strict regulations allow for enforcement agencies such as the FDA to filter out companies that are dedicated in meeting regulatory standards along with creating an effective product. Purchasing these standards shows how committed companies are in advancing their agenda. It also helps companies to maintain their safety standards throughout all…[Read more]

Depending on the situation or the environment in which a medical device or drug is used, its cautionary labels may not always work effectively. As Dr. Simon mentioned, in highly dynamic environments, such as an operation theatre or in an ambulance, its highly unlikely that the user will stop and read the instructions or labels. After putting it…[Read more]

The largest source of design input is market research. Understanding the market gap for your product can help to understand what services need to be fulfilled by your product. From this market research, an outline of customer needs can be developed. The way to meet each of these needs will require detailed technical research that will outline the…[Read more]

DDPs as a whole are very crucial in the timeline of the project. The gantt chart helps to outline each segment as it is approached. The project manager must effectively build a DDP to outline all the different departments of the project. With this in mind, the communication management plan can thus be argued as one of the most important parts in…[Read more]

Although I’ve never attended a design review meeting, I think it’s safe to say these meetings are crucial to get every member of the team and even sponsors and consumers on the same page. It would be the perfect platform for outlining the details of the design and receiving constructive criticism and approval on the various design phases. These…[Read more]

Placebo controlled trials are a great way of helping scientists understand why a new medical treatment is more useful and effective than no treatment at all. Due to the “Placebo effect”, some patients may progress and get better without receiving any treatment at all, therefore lowering the accuracy of these trials. Nevertheless, because of this…[Read more]

In most cases, double blind studies are an effective way of performing a research study and learning new information about a drug or new treatments. Double blind studies are also a way of removing bias from the testing of these drugs. Any previous knowledge that an investigator may have can affect on the outcome of how the new drug is analyzed. In…[Read more]

A background in clinical studies should be required depending on the profession and work environment. For example, a Principal Investigator (PI) is the “primary individual responsible for the preparation, conduct, and administration of a research grant or other sponsored project in compliance with applicable laws and regulations” and for this…[Read more]

Currently I work as a clinical research intern at Colgate-Palmolive Co. Their mission statement is as follows:

“As a Company that strives to be the best truly global consumer products company, we are committed to doing business with integrity and respect for all people and for the world around us. and Continuous Improvement will continue to drive…[Read more]