I agree that written agreements are preferred over verbal agreements, especially when it comes to legal disputes in court. However, possible advantages to verbal agreements include ease, convenience, and flexibility. For small agreements without much risk, verbal agreements may be…   Read more»

An example of a recent kickback is in October 2020, when Medtronic agreed to pay neurosurgeon Dr. Wilson Asfora for social events at a restaurant which he owned. Dr. Asfora would also have social gatherings at his restaurant in which…   Read more»

I really liked the practicality of the information taught in this class. For those wanting to work in the medical device industry (or already do), this course teaches each step of medical device development very clearly and gives practical advice…   Read more»

Upper management and middle management also differ in their vision, with the former being more long-term focused and the latter being more short-term focused. Both share effective leadership qualities, but have different tasks. Upper management sets the goals for the…   Read more»

I don’t think there is one best and most effective organizational structure for a company, but there is a particular organizational structure that works best for an employee at the company. Some may argue that a matrix organization is the…   Read more»

I would like to work in a matrix type organization, because it seems to be highly efficient, i.e. there are no departmental silos nor are there redundant resources, and knowledge transfers well from project to project and between departments. Although…   Read more»

Another factor contributing to risk values is the percentage of false-positives or false negatives, particularly for diagnostic devices. For example, if a patient is scanned (with X-ray, MRI, ultrasound, etc.) and the result is actually a false positive, then the…   Read more»

A Risk Matrix can also be used to assess risk and see whether or not the risk should be accepted. For a medical device with high severity of risk, it may be acceptable if the occurrence is occasional, since that…   Read more»

Another risk management method is Root Cause Analysis (RCA), which gets to the main reason for risk. It identifies the fundamental risks involved in a project, usually after the problem has come up. RCA asks questions such as: “what happened?…   Read more»

This might sound a bit silly, but I think one factor to consider is whether one needs a Gantt Chart in the first place. For my capstone project, we used a simple project timeline along with weekly to-do lists, which…   Read more»

In a research lab setting, we commonly look at previous studies that would be similar to our proposed study and calculate the effect size for that study (which is sometimes directly stated in the research paper). First, it is important…   Read more»

Meeting minutes are especially important for those working on multiple projects, since each project has its own set of tasks and someone may easily confuse or forget those tasks. It also helps the team stay organized, which is important for…   Read more»

It is difficult to exactly pinpoint the issues that arise from insufficient design controls, since the process of design controls has 9 parts within it: planning, input, output, review, verification, validation, transfer, design changes, and design history file. If a…   Read more»

A risk vs. benefit analysis can also be done to decide whether one should outsource or perform in-house production. With in-house production, one may face risks with money, especially for smaller companies which may not have the best equipment to…   Read more»

Another way to choose which test to perform is to look at previous studies’ design specifications and question how they obtained those specifications. For my senior capstone project, we did a lot of research into the design specifications listed for…   Read more»

I believe placebo-controlled trials are necessary and can be done ethically, since previous studies have shown the placebo-effect to be apparent in a wide range of fields. The mechanism behind the placebo-effect is still not quite fully understood, but multiple…   Read more»

I think having a clinical background is not necessary, since people can learn while interacting with the patients on the spot, however, there are many benefits to having a clinical background. Since having a clinical background is a plus, it…   Read more»

I believe it is acceptable to expose a few human subjects to risk of harm for the benefit of future patients, since those few human subjects are told of all the risks and benefits of the clinical trial and make…   Read more»

I think the best advertisements really know how to speak to their audience. I remember watching tv ads featuring McDonald’s Happy Meals as a kid, where they would show the different toys available in the meal, and would really grab…   Read more»

Although color in branding is very important in catching one’s eye, there may be individual differences in interpreting the colors as well. For example, some people have a preference for one color over the other. Different cultural backgrounds can also…   Read more»