My first thought after reading this post is that a project manager could look to hire someone new to replace that person. However, hiring someone new can take longer than expected, especially with onboarding and training. Because of this, a…   Read more»

One way a project manager can handle an unknown budget is by setting aside a contingency reserve for risks and potential design changes. Even if the budget is unknown to the project manager, the PM would usually have rough estimates…   Read more»

I think the most important knowledge areas are scope, time, and cost management. Scope management is important because it defines the goals of the project and the work that must be done. If scope isn’t clearly defined, it can lead…   Read more»

Design verification focuses on testing if the device is built correctly according to design specifications and validation ensures that the “correct device” is built and meets the user needs or intended use. Most of the verification and validation activities take…   Read more»

There are many different factors that can impact schedule variance for a medical device project. For example, delays in regulatory approvals can add weeks or months to a schedule and lower earned value. Failing during verification or validation can cause…   Read more»

Since a lot of people have already shared many great companies on the East Coast, I wanted to share a few that I was particularly interested in when I was living in California. In Southern California there are a lot…   Read more»

I agree that returning to an earlier phase of a project does not necessarily mean the project is failing, however, in the case of medical device projects, this can be very costly and potentially derail a project. Because of this,…   Read more»

I think the most important phase in the project process is the planning phase because it establishes the foundation for the entire project. During planning, the project scope, timeline, and project team are clearly defined. For a medical device project,…   Read more»

I think that a project manager can be accommodating to their team members while also successfully managing a project through good communication and setting clear expectations. If team members understand project goals, the project timeline, and their responsibilities from the…   Read more»

I think that managers and stakeholders are both important to a project, however when it comes to completing a project promptly, managers play the more critical role. Investors provide the funding and resources needed to begin a project, while managers…   Read more»

Being prepared before a design review meeting is important to ensure the meeting runs smoothly and a decision about moving forward to the next phase of the design control process can be made. Before the meeting, I think it would…   Read more»

Balancing risk and reward is one of the biggest challenges in risk management. While minimizing risk is necessary, trying to eliminate every possible risk can slow down development and increase costs. It is best practice to focus on reducing risks…   Read more»

Slack is the amount of time a task can be delayed without delaying the project completion date. As others have stated, project slack is important because it gives a project manager flexibility. A project schedule without any slack would mean…   Read more»

Estimation failures in the planning phase of a medical device project can severely threaten the success of a project because cost, project timeline, and regulatory compliance are connected. If tasks in the work breakdown structure like verification testing or biocompatibility…   Read more»

Avoidance is most easily incorporated during the product design phase. During the design phase the device is still conceptual, and hazards can be eliminated before they are built into the product. In addition, design changes at this stage are less…   Read more»

I agree that it is important to remain impartial when dealing with conflicts between team members. However, this becomes much more challenging when the project manager and a team member are the ones experiencing issues. I have experienced this while…   Read more»

Detailed planning should definitely take place before the planning phase of the project management process concludes. However, I think it’s important that the project management plan should not be viewed as a document that is finalized and instead be treated…   Read more»

Hi everyone!
My name is Sarah Gildea, and I am pursuing a graduate certificate in Biomedical Device Development at NJIT. I look forward to connecting with all of you!
Here is my LinkedIn: https://www.linkedin.com/in/sarah-gildea1/

While I do not have direct experience in the medical device industry, I have experience working at a local retail store whose structure closely resembled a matrix organization. As a supervisor and department head of the toy department, I reported…   Read more»

After completing the simulation, I do not believe changing the Design Specification Document (DSD) is necessary to resolve the failed verification test. When I asked if there is a minimum or maximum temperature the product must remain at, Dr. Simon…   Read more»