Whenever I think of the reasons as to why I work a 9 – 5 job, my top motivators are: exciting work at my company and having a supportive manager. I believe just these two motivators go hand-in-hand with career…   Read more»

@ih37 In response to your question regarding if tunnel vision and scope creep fall under the same category, I would say yes, they do fall under the same category. Both actions ultimately deviate from completing the overall project and put…   Read more»

Like many have said, the project manager’s level of motivation is critical to a team’s productivity. The project manager’s overall motivation can be a contributing factor in the overall success of a project. One thing I would do to keep…   Read more»

One way to tackle a loss of an employee in a project is to delegate that task to other employees who may have performed a similar task in the past, until a replacement is found. Transferring an employee’s workload to…   Read more»

Retaining top performers in a company can really make or break a company, specifically a medical device company. I have seen a risk management department fall apart due to the Human Resource department not focusing on retention of top performers….   Read more»

Over my time of working in the medical device industry and working in the Quality Department, I also feel that communication is imperative to the success of a project. Although it may sound very trivial, communicating potential barriers to a…   Read more»

I believe that it is worth shortening the time frame of a project depending on the risk being taken. When it comes to research, I believe the risk is very high, and the full suggested time needed for the research…   Read more»

At work, we had an issue of not knowing what devices were evaluated and which devices were under evaluation of another employee. It was getting to a point where this issue started to escalate and devices that needed to be…   Read more»

  There could be many reasons a project fails. The major reason why a project fails is due to a project not meeting the customers needs. It can pass the verification, verification, and design of the product, but if the…   Read more»

As many of my classmates have mentioned, to avoid scope creep is to set a very particular/ specific objective that narrows down the scope of the task. I have also noticed that setting tight schedules with set deliverables can allow…   Read more»

I agree and disagree with the statement made. I agree that solicitation and source selection and managing vendor relations are one of the more important parts of a project, as if you don’t have the materials needed from your vendors,…   Read more»

Verification and Validation can be lumped together as V&V activities, however there is a key difference between the two stages. Verification is concerned with if the company designed the device right, while validation is concerned with if the company designed…   Read more»

Great question Mark! When it comes to failures in a project, I agree that testing out all parameters can be a waste of time and money for a company. One thing I learned from working in a medical device company,…   Read more»

I believe that returning to activities to an earlier phase is not necessarily a bad thing.  @srg36 mentioned, changes can happen due to unforeseeable events and I have seen that in the workplace. Returning to a previous state such as…   Read more»

So far, I feel that the information from this course has really allowed me to understand the behind-the-scenes activities in a medical device company, as well as the rules and regulation of the FDA. Prior to taking this course, I…   Read more»

I believe that verification should really take place during the Execution phase of the project, but it does not necessarily need to be a rigid rule.As seen in the first simulation, there were gaps in the verification protocol and changes…   Read more»

I have had a specific work experience where a my team was assigned to completed an investigation write-up for a CAPA. The day it was due, our boss had reviewed it and decided the investigation did not address the problem…   Read more»

When creating a timeline for a project, using timelines of similar tasks may aid in estimating a timeline for a project. However, one thing that I have seen that helps with timelines is having weekly meetings where each team member…   Read more»

Having worked in the complaints department, we work with risk documents very frequently. Risk management data used in the risk management documents are compiled from historical complaints data as well as anticipated failure rates that come from many many tests…   Read more»

From seeing how well my boss handled my team as a supervisor, especially during the COVID-19 Pandemic, there were a few key lessons I have learned that I would like to apply to when I become a project manager. One…   Read more»