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 lead to potential career growth and development, which is also linked to challenging work that will keep me engaged. My end goal is to…[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 what matters most to each individual since it can vary from person to person. For example,…[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 performing the trials, the budget, and time designated for each task. A WBS will help create the Gantt…[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 be due to the group misconstruing what stakeholders expect, the group failing to report their…[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 to the same guide. One of the pitfalls, is not knowing when to stop. Tasks should be broken down to reasonable sizes,…[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 and/or will require in vivo testing should have smaller spec widths. It should also…[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 up the process and catch up. It will be concerning however, if the SV was very negative near the end of the project with the deadline…[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. After the team is formed, members will need to log in their expected absences on a…[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, amount of materials needed, timeline/deadline, and spec. If the values are…[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 right track and pace, they should be held on a weekly basis. After the team reviews the previous design…[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 move onto the next step if you aren’t fully prepared for it. For example, if the planning process is rushed, the team can grossly…[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 hinder the auditor’s assessment. As a result, high debilitating fines can be handed to the company. In more…[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 the vendor visit the site to survey the amount of damage and poor quality, or take pictures for the vendor to evaluate. We will…[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 their trust into the claims made by the medical device companies and it is their responsibility to…[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, so all the risks and user requirements should be clearly stated before we reach that stage. It…[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 by properly accounting for the amount of required materials, strict time required for certain steps (like glue/adhesive…[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 meetings, the team members can report their progress and discuss how to minimize the time required for each step…[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 to contribute their thoughts/opinions on them. This can be accomplished by holding…[Read more]

I think it depends on the frequency of the missed milestones, how novel the company is, and the companies’ ability to financially support these “failures.” While it is true that each failure brings the company valuable experience on what doesn’t work, there is a limit to the magnitude of loss profits and time. For companies that are new to the…[Read more]

In order to set a reasonable timeline for project completion, all members of the group should meet up and discuss their time estimations for each step and why. If there is any trouble agreeing on a timeline, the team can reference previous projects that were similar to the current one. They can talk about the changes they could have made that…[Read more]