The thing with project management techniques is that they MUST differ from not only company to company, but also project to project. Depending on the size, culture, and type of company, most places usually have a baseline of rules and regulations they follow in terms of their management style. However, depending on what the project is, things can…[Read more]

As stated above, CROs should be used when necessary. If a company has the time and money for it, then a reputable CRO would not be an issue if it was utilised. In addition, some small companies could possibly benefit from the use of a CRO, especially if they’re new in the game and do not have the resources to run clinical trials…[Read more]

I would prefer to have an employee who is a Y personality simply because motivation is more important than prior knowledge most of the time. If I want an employee who only does the bare minimum, I might take far longer to complete any sort of work or make any progress. Innovation comes from doing the maximum, not the minimum.

However, someone…[Read more]

There’s a few reasons I have left jobs in the past but the main has always been a better opportunity. However, there are jobs that I have regretted leaving and others I have not. The ones I have not regretted were ones with either hostile environments or ones which were simply, as the professor had said, unfulfilling in terms of praise and…[Read more]

I agree with srg36 — I believe that its primarily due to peer pressure. Americans are vastly overworked. According for the Center for Progress, Americans are overworked in several ways:
1. We have no maximum work hour limit. Although this might be beneficial to a point, it also does not punish companies that overwork their employees.
2. In the…[Read more]

As ala26 stated, it would be good to have some groundwork that is created as an SOP for the entire company and then allow the project manager to tailor it as needed. For example, some people communicate better in person, some respond through text, and others are strictly email senders. Therefore, in order to create proper documentation and track…[Read more]

As we’ve previously discussed in this class, communication is key in any project, especially for a manager. HR is meant to help employees improve their engagement and this is also the case in engaging with on another, even across departments. We’ve also discussed how, when communication is stressed, companies are able to save money, time, and…[Read more]

As you both discussed, you prefer Bottom Up Estimation. I am inclined to agree with you on most projects. However, there might be instances, such as small, fast projects, that might require Analogous Cost Estimating because they simply don’t cost enough to put in the effort to create an entire Bottom Up Estimation.

For example, if my boss were to…[Read more]

I also think that there should be an emphasis on the performance of the work, as previously stated. Project managers must ensure that their team is doing more than the bare minimum just to meet standards. A reasonably higher level of performance must be expected in order to ensure that the project is not only done but also done well.

There are several types of changes within the Monitoring and Controlling Phase of a project:
1. Non-Essential Design Change (NDC): Change to a design control document while product is still in design control
2. Design Change Number (DNC): Major change to device’s Bill of Materials or other manufacturing document while device is still in design…[Read more]

I do believe that communication is key to the success of any project. However, one thing that I really liked, which you highlighted, was Number 3: Develop clearly defined plans with assigned responsibilities.
I think that goes absolutely hand-in-hand with communication. One of the worst ways that a project can fail is when everything but each…[Read more]

As the above posters have said, I agree with them. There can be instances where one or the other being positive can workout for the benefit of the company. However, making that choice without knowing company culture, project projection, the budgets, the timelines, what the product is, etc., can be a tough choice to make.
For instance, if I was in…[Read more]

As we’ve learned, the planned value (PV) of a project is the estimated cost of the project’s activities which have been planned as of the reporting date. On the other hand, the actual value (AV) of the project is how much actual money has been spent on a project on the reporting date. The two numbers are very important to keep track of because as…[Read more]

As the professor discussed, every metric that we utilise must be measurable, actionable, and visually understandable. The last is especially important because we can use dashboards to keep track of them. Keeping track of the metrics that were discussed is especially crucial because essentially, the end goal is always to make sure that the value of…[Read more]

In this simulation, there were a few paths you could take to complete the mini simulation. The first one I took, which seemed the simplest, was to have Patty and Dr. M sit together and figure out the issue. I think, overall, that is usually the best case scenario because it allows people to come together and hash things out. The reason this was…[Read more]

Design Verification entails that the product you put out is what was actually requested and what the FDA has said is acceptable.
Let’s say that the customer wants a product that addresses issues A, B, C, and D. In addition, the FDA says that it MUST align with Rules 1, 2, and 3. Then, when you create the product but miss issue B and rule 2 because…[Read more]

Scope creep mainly occurs when the interference comes from upper management. They see that a product is capable of A and B and then they ask if C is possible and push for it.
I think that a better way of preventing scope creep is possibly to turn the new ideas into their own projects, instead of just adding them onto the first ones. However, one…[Read more]

Although I have no medical device industry experience, I have worked on team projects in other fields. As a supervising teacher, I have had lead on several projects that have been implemented with varying degrees of success. I believe that those with higher degrees of success were the ones which were most often started with more planning. The best…[Read more]