I think Quality risk would be the most present in a project. I strongly believe quality risk is the most devastating risk. After all the planning and project management, if we manufacture a product of poor quality, it will not…   Read more»

I believe the question depends on what you mean by “valid.” There is no doubt that the Google PMP certification (Google Project Management Professional Certificate) serves as a strong entry-level qualification. This is especially true for individuals who are new…   Read more»

@mirna-cheikhali I understand the argument that schedule risk is common, but I would actually argue that financial risk is truly the primary concern in many industries. Delays are certainly an issue, yet in many situations, they can be handled. Teams…   Read more»

@sn64 Hi sn64! I agree with you- keeping abreast of regulatory trends is an evolving and complex endeavor. A noteworthy aspect to reflect on is the growing importance of AI and machine learning in regulatory intelligence. My company that I…   Read more»

Below are the parameters to determine the right level of WBS. 1.Project Complexity For simple straightforward projects, a high level WBS is needed. In complex projects more complicated and detailed WBS is necessary. 2. Size of the Team For small…   Read more»

Accurate estimation requires a combination of historical data, expert judgment, and quantitative tools. In project management, accurately estimating activity durations is a cornerstone of planning and execution. It serves as the basis for resource allocation, cost management, and timeline adherence,…   Read more»

The critical path method, a cornerstone of project management, may initially seem daunting due to the extensive processing required to align input and output. However, understanding its importance can help project managers and team members appreciate its value. One way…   Read more»

I have worked on a project before that faced some major scheduling complications. In my case, we noticed very late in the project that a manufacturing device we had used early in the project had been malfunctioning. Consequently, we had…   Read more»

I totally agree with the points you made in your post. It is crucial to develop both an effective and realistic schedule. As you briefly mentioned, a great way to do this is by using Gantt charts. While I have…   Read more»

Hi everyone. My name is Kelsi, and I am a BME PhD student at Rutgers. I would love to connect with you all on LinkedIn:
http://www.linkedin.com/in/kelsi-petrillo
Thanks!

I believe financial risk is one of the most present and impactful risks in a project. A project can have a great schedule, the right resources, and high-quality output, but if it runs out of funding, everything stops. Within financial…   Read more»

Breaking down work into structured sections helps teams stay organized and ensures each task is clearly defined. If tasks are too broad, important steps might be overlooked, causing delays and miscommunication. On the other hand, excessive detail can make the…   Read more»

Cost estimation in medical device projects is challenging because many factors can change unexpectedly. A major issue is estimating costs before fully defining tasks, which can lead to missing key expenses. For example, if a team assumes only one round…   Read more»

Medical device projects definitely should utilize cost estimation effectively and efficiently. A way to do that is investigating a project that was highly similar to the current project you are working on. Medical device projects deal with FDA regulation procedures…   Read more»

A Work Breakdown Structure (WBS) is crucial in project management for medical device development as it organizes tasks into manageable components. It helps define the project’s scope by breaking down complex processes into smaller, structured tasks, ensuring clarity and focus….   Read more»

Cost estimation in the planning phase of a medical device project presents several challenges. Regulatory compliance costs can be difficult to predict due to evolving standards and potential delays in obtaining approvals. Uncertain development timelines may lead to unforeseen expenses,…   Read more»

In project management, especially in medical device development, various types of risks can impact the project’s success. Technical risks arise from challenges in designing, developing, or integrating new technologies, which may lead to performance failures. Regulatory risks involve non-compliance with…   Read more»

A Work Breakdown Structure (WBS) is definitely a useful tool in a project, especially when it comes to medical devices. Most of what I am about to say definitely depends on the size of the project since the complexities of…   Read more»