In reference to the first question, I believe an NDA is not a substitute for a patent, but rather a viable solution for circumstances in which a patent is not desirable or cannot be obtained. For example, an NDA may…   Read more»

In terms of paying for the spouse’s meal, I feel that most doctors today are probably already aware of such restrictions. Therefore, if they do bring their spouse to such a dinner than it should not come to them as…   Read more»

While forming a project team, the primary characteristic that I would look for in a potential member of the team is their ability to effectively and confidently express information they would like to share. Personally, I feel that communication is…   Read more»

If I were to start a medical device company, I would choose to instate a project- based setup in my company. For starters, a positive of this setup is that information is shared between the people from different departments that…   Read more»

From the three organizational setups discussed in the lecture, I would prefer to work with or manage the project-based organization followed by the matrix organization as a runner up. For starters, I believe these two are more suitable options over…   Read more»

For starters, I believe it is important to first verify that every individual at the meeting is on the same page about what the project is and a basic idea of what it will entail. Following this, as a project…   Read more»

In terms of the magnitude of company liabilities for risks associated with misuse of a product by a user, I believe is dependent on the situation at hand. For starters, I believe it is important that the company take the…   Read more»

For starters, I believe the inclusion of the non-descriptive statement of “As Far As Possible” is due to the fact that risks can vary greatly depending on the product. For example, any medical product used to make incisions will still…   Read more»

I believe the advantage of separating the two documents is that it helps break down the project and makes it easier to conceptualize. Since the DID is the first document following the PDF and DDP that goes more into listing…   Read more»

In terms of outsourcing the production of a biomedical device, I believe the type of product being made has a major influence on whether this could pose potential pros and cons. For example, if the product is something simple like…   Read more»

Personally, I believe the ultimate purpose of design controls is to make the project team think thoroughly about every minor to substantial aspect of the project. Through such an in-depth analysis, the benefit received is that it helps reduce the…   Read more»

The sources that help determine design inputs can come from a variety of different areas such as customer feedback or intended purpose of product. For example, if feedback gathered from target consumers show the need for a compact product, the…   Read more»

Verification is an important aspect of design controls that puts the claims and specifications defined by the project team to the test. In a general overview, verification helps assess a product meets both quality standards and performs as outlined prior…   Read more»

In my opinion, I believe the importance and usefulness of standardized design controls is that it necessitates the project team to question every detail of the project as well as document every aspect of it. In relation to questioning every…   Read more»

For starters, I believe a double blind study is definitely better for clinical trials that involve the testing of things like a new medicine or pill. The reason for this is that it removes any additional bias that could have…   Read more»

In my opinion, I believe it is very important for patients to be given the decision to determine whether data or samples pertaining to them can be used for research or other purposes. For starters, the creation of untold unknowns…   Read more»

As mentioned by Dr. Simon, a major factor involved in high level clinical tests is the ability to remove any bias that could impact the results of a test. In the case posed in the question here, the bias under…   Read more»

In my opinion, I believe that marketing can in some cases be manipulative and can coerce someone into buying something that they do not need. In a scenario such as this, I believe this is a form of marketing that…   Read more»

In my opinion, two of the most powerful advertisements that I have seen are both by the company Apple and aired before I was born. Nonetheless, I believe both advertisements are quite iconic and memorable to watch even to this…   Read more»

With the continuously increasing forms of entertainment platforms that one can choose from, it has become more crucial for companies to engage the attention of viewers and assure that their form of advertising is being watched. One form of participation…   Read more»