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…   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…   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…   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…   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…   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….   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….   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…   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…   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…   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…   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…   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…   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…   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…   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…   Read more»

In today’s fast paced, media centric, society most technology giants spend most of their money only on the initial marketing of a product. This means that once it is given the initial push, they rely on the consumers to spread…   Read more»

As can be predicted by its name, a sole proprietorship has one owner who is fully responsible for the operation of the company. The owner makes decision that will affect the overall growth of the business. Its not possible for…   Read more»

First its important to identify the difference between an incorporation and a limited liability company. An LLC is the United States’ version of a private limited company. An LLC’s business structure combines the taxation of a partnernship with the limited…   Read more»

When we observe the hierarchy of the government it is clear that a system of checks and balances keeps the three branches running in agreement. However, this is not always the case in an industrial setting where various departments influence…   Read more»