At the previous company for which I worked, I was required to sign a non-compete agreement. While I generally believe that very restrictive non-compete agreements are very unfair to employees, especially recent graduates, I did understand it from the perspective…   Read more»

As has been mentioned in previous posts, there needs to be a clear line between work and family. But I do not believe that is the primary issue. The primary issue is a matter of ethics and conflicts of interest….   Read more»

This is my second course with you, Dr. Simon. I previously took your Project Management for Medical Devices course. This course was good, but I felt the project management course was superior in content, delivery, and structure. While there is…   Read more»

I believe that when forming a project team, one must always start with subject matter experts. Technical knowledge is critical in the early phases of a project. Even if the knowledge is not complete, at least knowing where to look…   Read more»

I believe that I am better suited for a role in middle management with my current skill set. I have a fair amount of technical expertise which would allow me to think about logistics much more naturally. I believe that…   Read more»

I work for a company that follows a functional organization. Functional heads operate with a large degree of power governing day to day operations as well as project development. Groups are also organized around projects with little cross talk between…   Read more»

I believe the concept of as far as possible is meant to be vague. It isn’t defined as a certain level of safety or risk mitigation. Because by defining the point at which risk is “adequately” mitigated would lead to…   Read more»

Risk mitigation begins with end user training and education, in my opinion. After a company has done all it can to make a safe and efficacious device or product, it is up to them to educate the end user population…   Read more»

The companies that I have worked for that operate under any sort of regulation either purchase the standards or opt to use a subscription service. There are many regulations, and as has been mentioned, they are very expensive to purchase….   Read more»

In our senior design capstone project for BME, the design inputs were developed from two sources: market research and customer needs. In order to develop design inputs, market research was conducted in order to understand what products and devices exist…   Read more»

Gantt charts provide two critical functions: timing and dependence. The overall view of the Gantt chart allows all the tasks and deadlines of a project to be looked at. These timelines can be further detailed with macro and micro tasks….   Read more»

Meeting minutes, we can all agree, are useful in retracing and revisiting topics covered during meetings. As has been mentioned above, meeting minutes can help track some of the thought processes and logic that lead to decisions. Acting as a…   Read more»

I believe that every individual has the right to know what is going to be done to them in any sort of clinical setting. I believe that the passage of knowledge to a patient and their understanding is absolutely critical…   Read more»

Placebo-controlled trials are very important in establishing efficacy and statistical significance during the development of a medical device or drug. It should also be noted that a placebo doesn’t necessarily mean that no treatment is given to an individual in…   Read more»

A clinical background is a very valuable trait when considering the field of clinical research. While engineers and technical experts are capable of working in this field, and successfully so, having a greater depth of knowledge in the intricacies of…   Read more»

When starting a small business, an LLC is a great model to set up the business. As has been mentioned above, it provides liability protection and more control over the business and its operations. However, as the business grows, corporate…   Read more»

When deciding which company to work for, either the company has to be a reputable/well-known one, or the position/work has to be in line with the goals/desires of the individual. Ideally, you have a job that meets both of these….   Read more»

I did some research on Pfizer. Here are my findings: Current Stock Price: $36.37 Market Cap: $216.13 Billion Revenue per employee: $542.46k (I would like to see a larger fraction of this) Total Asset Turnover: 0.31 Net Margin: 13.63 Current…   Read more»

The company I currently work for has a good relationship with its QA/QC departments. The reason for this is integration. All projects that are proposed and piloted are done so while consulting with the QA department. Before a project can…   Read more»

Quality departments are often seen as standing in the way of innovation or creativity. However, their primary directive is protection. Protecting the company from FDA/NGO intervention. Protecting the company from releasing bad products. Protecting the business in general. But as…   Read more»