This was such an awesome course! Taking this class parallel to my internship really helped. It helped me understand more about my company (and other medical device companies), its structure, and departmental functions, as a lot of topics covered, I…   Read more»

To be honest, I think these laws are necessary and I don’t really think they are too restricted. Yes it does make situations awkward (like when the doctor brings his wife and her meal can’t be payed for). But usually…   Read more»

I think we need to first understand that both verbal and written agreements are recorded in some manner or the other. So both can be used and defended with. The difference is that verbal agreement usually isn’t as detailed as…   Read more»

Building a strong team is crucial to working better. I believe that a strong team is made of people with a mixture of skills. For example, they must have certain knowledge in their field, must be motivated to be on…   Read more»

For collaboration process, I think matrix type organization is the best option. A matrix type organization allows people to move around based on projects and their talents. I think this is a good option because a project manager can pick…   Read more»

I work in a functional based organization. I work for a specific department and my manager is the department supervisor. I haven’t been a part of a project, but I work on tasks that is required within my department. If…   Read more»

When it comes to Off-The-Shelf (OTS) products, I think the quality department knows that consumers don’t really read the labels and instructions that warn them about risks, and try their best to make them as safe as possible. OTS products…   Read more»

This is a great question! For high level risks, I would try my best to go with avoidance, I do not want to put the patient and the company at risk, given that we know the failure occurs frequently and…   Read more»

Although severity and number of occurrence are the main large categories that must be looked at for risk management, there should be more evaluation and discussion of other categories such as user’s age, quality of life after product failure, cost…   Read more»

In the company that I work for, we interchange the term “Design Control” and “Document Control” because everything in design control is detained in documents called Standard Operating Procedures (SOPs). So when design control fails, it means we have taken…   Read more»

As many of the students stated, design inputs so usually come from research and other investigational ideas. I would like to add that some also come from doctors and other medical companies. Hospitals and companies contract other companies to provide…   Read more»

I think the need or the advantage of the DID and DSD is that they serve two different audience. DID, which contains the broad specifications, is great for the customers, the ones who are actually interested in buying the product….   Read more»

From my experience in research, we did also document a lot and were very specific. But we didn’t have anyone inspecting us or our documents, we did it for the sake of honest data that was needed for publication. When…   Read more»

When I used to work at a research lab on campus, I didn’t really pay much attention to the meeting minutes sent to me. This is because it had the information (tasks and decisions) for all the members in that…   Read more»

Informed consent in very very important and I’m happy to say that now a days, it is taken very seriously. Back in Henrietta’s case, I don’t even think she was given a consent form, she just went for cancer treatment…   Read more»

As many students above stated, having a clinical background depends on the role. There are some roles like the PI that require clinical background, this is because the role is usually critical and can’t allow much mistakes. Having clinical background…   Read more»

Double blind studies much better than a single blind study, mainly to avoid mental bias. Thinking that drug will make someone better alters the mind to feel like it has actually worked. This is true for both the patient and…   Read more»

Emotional Intelligence (EI) is the ability to recognize one’s own emotions and feelings and of those around them. One will know if they have EI based on how they are able to cope with their own emotions and control their…   Read more»

SWOT analysis for Becton Dickenson (BD) Strengths: – Strong Free Cash Flow – Highly successful at Go To Market strategies for its products. – Good Returns on Capital Expenditure – Highly skilled workforce through successful training and learning programs. -…   Read more»

Marketing has changed over time. Gone are times when advertising was honest and to the point, now more tactics such as emotional intelligence and manipulation is used to lure people to buy the products. I think that the main reason…   Read more»