For me, goals are what keep me motivated. When what I am doing aligns with my short term and long term goals, it makes me passionate about the work I do because it is helping me get to the places…   Read more»

I think that an interesting thing to add to this thread is that while many people put in extra hours to increase productivity, research shows that it can actually make you less productive. There are a lot of different studies…   Read more»

Every project and team is unique. For example, certain projects may be straight forward and predictable while other projects are more complex and risky. These two different types of projects would have to be managed differently because of this. Likewise,…   Read more»

While an outline of a communication management plan documented as a SOP can be beneficial to keeping the entire company on the same page, I think it is also important to give the project manager leeway. The project manager should…   Read more»

A WBS should be a break down of every project task and deliverable defined by the project scope. If the WBS is poorly constructed the following can occur: missed deadlines, going over budget, scope creep, confused project team members, project…   Read more»

I think another thing that is important to address in a supplier contract is to clearly define responsibilities. For example, if something goes wrong with the product, is it the company or supplier’s fault? According to the FDA, the device…   Read more»

I think it is important to have some buffers in the schedule to account for any unexpected delays for any reason. The time frame and budget is set when a project is approved. It is better to overestimate the time…   Read more»

One important component of closing is creating a project closure report. This project closure report lists every activity that is required in order to close the project. This report enables the project manager and the team to make sure they…   Read more»

This semester I am in part 2 of my capstone project. We have all of our protocols written to begin construction and testing but we are missing one key component of the device. The materials got delivered about a month…   Read more»

I think one of the main issues lies in increased customer demands. When the design team first hands off the project to the manufacturing team, a certain plan is made based on the expected demand. Once the product becomes more…   Read more»

I agree with everything that is said above. In addition, I think there should be a re-evaluation step which happens once the project has started to make sure that the way everything was planned is working out and that nothing…   Read more»

If a problem in the planning is identified mid-scope it should be reassessed with the entire team present, taking into account resources and timing. Pushing forward with flaws in the scope can cause bigger issues down the line. Using a…   Read more»

While I think all of the above are important, I think it is important to assess the situation. While a team member that is not good at communicating and keeping other team members up to date can certainly make a…   Read more»

I am currently working on a capstone project. We won a $3000 URI grant to design and fabricate our device. This grant must be used only for this project. As a result, we based our entire budget around this $3000,…   Read more»

In my experience, at design review meetings, everyone attending the meeting reads the document beforehand. The meeting starts by everyone saying their initials one by one and how long it took them to review the document. The people who wrote…   Read more»

I think that it is certainly sometimes crucial to go back to the planning phase in order to ensure the success of a project. Regardless of how well a project is planned out, sometimes obstacles and setbacks are unforeseeable. However,…   Read more»

While it is important to manage risk, it is also important to encourage creativity and risk taking within a company. Risks are what lead to breakthroughs and great medical products that can advance the company. If everything is over prioritized…   Read more»

In addition to what ak977 said, the main mission of medical device companies is to improve healthcare. Cutting corners just to increase profit or prevent the company from losing money is unethical and could result in people having issues with…   Read more»

I think an important thing to add to this discussion is how to adjust things when out of scope – whether it be due to budget or time. An example is in capstone, whenever something takes more time than our…   Read more»

I think that an additional topic to add to this discussion is while large corporations experience this issue with class II and class III devices, sometimes going the less creative or risky route with their devices to get it approved…   Read more»