I believe most projects have more than one priority to focus on. Priorities can change as you progress through each stage of design control and project management. These priorities can include planning the specification, performing successful clinical trials, and choosing…   Read more»

In order to build a maintain a good relationship with a vendor, you should first establish the best way to communicate with each other. You should specify all your needs and expectations, while ensuring that the vendor’s demands are met…   Read more»

For everyone in the survey, it can be a mix of different motivators that cause the employees to stay. I believe my main motivators will change overtime. For the timing being, I am focused on finding a job that will…   Read more»

The PM definitely has an impact on the team’s motivation and productivity level. In order to successfully motivate the team, the PM must determine what motivates, demotivates, and keeps each member engaged. The PM should make an effort to understand…   Read more»

Developing the schedule and determining the budget are done during the planning phase, before initiation of the clinical trails. To develop the schedule, the PM would need to take into account the amount of resources, the amount of team members…   Read more»

While having a common communication management plan will save time, I believe it needs to be altered depending on the project. If the plan doesn’t help all participants clarify and voice their opinions effectively, delays would occur anyway. This could…   Read more»

The WBS is a crucial part of the scope management process, no matter how small the project may be. It is responsible for breaking down all the tasks, delegating work to each team member, and making sure everyone is referring…   Read more»

Specifications should be broader during the beginning of design control, but should narrow down during the later stages. The project team can also refer to previous similar projects and compare previous specs to their estimated ones. Products sensitive to failure…   Read more»

I believe it depends on how negative the SV is, and how close the team is to completing the project. If a negative SV was calculated closer to the beginning of the project, there is still enough time to speed…   Read more»

The project manager should discuss the amount of work and timeframe required for the project with potential members to make sure they can fully commit to the project. That timeframe should include vacation days, and additional days for unexpected emergencies….   Read more»

One main solution to staying on or ahead of schedule (positive schedule variance) is adequate and thorough planning during the initiating and planning phases. During weekly design review meetings, the group will discuss and agree on factors like estimated expenditure,…   Read more»

I believe that one of the most important aspects of the monitoring and controlling phase is the design review meeting. Any additional changes, metrics, variances, and updates can be discussed in these meetings. To ensure all members are on the…   Read more»

While I do not have any industry experience in design review meetings, I think it is crucial to finish the previous step before moving on to the next. Even if you are on a strict timeline, it is irrational to…   Read more»

The FDA is strict on ensuring all guidelines are met when audits are conducted. Works logs are one of the documents auditors must review and reference during their visit. If work logs aren’t properly recorded for all employees, it will…   Read more»

Since we are already at the validation phase, I would try to fix the issue with the primary vendor first. I would consult with the primary vendor about the amount of defeats in the packaging provided. Then, I would have…   Read more»

I would also follow the ISO requirements and guidelines regardless of enforcement. I feel that developing a medical device that causes users harm during testing and execution defeats the purpose of developing the device in the first place. Users put…   Read more»

Design validation is crucial, especially if verification fails during the executing phase. It is important to confirm that each numbered input meets the user’s needs, before it is tested in a clinical setting. The stakes are higher in clinical testing,…   Read more»

Delays are bound to happen, but steps can be taken ahead of time to minimize the magnitude of them. In Dr. Simon’s lecture, he mentioned building a shed as an example. The planning phase is crucial to decreasing potential delays…   Read more»

With a deadline fast approaching, it is important to set a strict deadline for the team to follow. As project manager, I would makes sure to designate roles to different members of the group and schedule weekly meetings. In these…   Read more»

Project managers hold an important role in encouraging group communication, overseeing any disputes, and setting a feasible timeline for each project. The manager needs to be able to clearly state his/her expectations for the project and team, while allowing members…   Read more»