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 of my previous employer. They were a niche medical device company, with a relatively…[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. It is unethical and a source of a potential conflict of interest if gifts are given to a physician who is being asked to participate…[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 a good amount of overlap in the contents of both courses, the project management course used…[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 and in which direction to start can prove invaluable. As the project gets underway, in addition to subject matter…[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 moving into upper management from middle management requires time and experience. Time and experience, over a variety of…[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 functional groups. It works well for the large company that I work for as it allows for…[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 the requirement being met, but just barely. I believe the concept of as far as possible is meant to be a challenge and a charge 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 to the best of their ability. So when it comes to things like intraoperative surgical equipment, reps from the company should train…[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. However, these regulations are a necessary part of the cost of business as they provide guidance for the…[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 on the market to fulfill the given need/function. Secondly, customer needs were taken into…[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. The second function of the Gantt chart is to outline the dependance of a specific task relative to another.…[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 sort of narrative of the ebbs and flows of a project. In my own personal experience, meeting minutes…[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 in order to achieve a state of informed consent. But, I believe that when an individual decides to enroll in a clinical trial…[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 need of treatment. It simply means that where an investigational intervention may be…[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 the human body (anatomy, physiology, pathology, immunology, pathophysiology) allow for a more…[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 entities are preferable for their ability to generate capital investments via shares without surrendering…[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. However, when starting out on a career path, getting experience is the most important thing to keep in mind. If the…[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 P/E Ration: 31.06

From the data gathered, it would appear that Pfizer is holding steady in a maintenance…[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 go from proposal/experimental phase to pilot phase, the QA department works with all project leads and…[Read more]