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 medi...

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 inf...

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...

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...

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. Pro...

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 versatil...

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...

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 ...

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, ...

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 researc...

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 ...

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 ...

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...

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 bia...

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 preparat...