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vthampi posted a new topic "Enabling Stakeholder Engagement in Clinical Trials" – 11 months, 3 weeks ago
Stakeholder engagement is a critical aspect of clinical trial project management, influencing everything in how a project progresses. However, maintaining effective communication and collaboration among stakeholders can be challenging. How can project teams use stakeholder feedback and insights to enhance… Read more»
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vthampi posted a new topic "Outsourcing Clinical Trials" – 11 months, 3 weeks ago
Clinical trials are projects to provide relevant data to show the safety and efficacy of a Class I or Class III device. They’re necessary for these devices to be on the market. What are the most prevalent reasons that a… Read more»
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vthampi replied to the topic "Clinical Trials" – 11 months, 3 weeks ago
Clinical trials are a decisive method to evaluate the safety and efficacy of a device before they hit the market. “Substantial data” to me is more than just the quantity of tests run, but the quality of the tests and… Read more»
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vthampi posted a new topic "Team Development at a Low Budget" – 12 months ago
Human resource management contains strategies to help develop the project team. This includes team building activities, reward systems, trainings, and more. However, all of these things cost money and may likely not be upper management’s priority during a project. What… Read more»
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vthampi posted a new topic "Necessity of Quality Management" – 12 months ago
Quality Management is about ensuring that the project meets its goals and meets standards set by regulatory bodies. It includes three main processes: quality planning, quality assurance, and quality control. Quality planning establishes the standards that need to be met… Read more»
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vthampi posted a new topic "Scope Management Optimization Strategies" – 12 months ago
Establishing project scope is one of the most vital steps of project initiation. However, it can be incredibly difficult because projects need to have boundaries as to what it encompasses, but it also needs to be flexible enough to be… Read more»
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vthampi replied to the topic "Risk Management in Medical Device Development" – 1 year ago
Balancing product innovation and patient safety is only possible with rigorous quality standards and a strict adherence to them. First, performing comprehensive risk assessments on the device during every phase of the project is essential in creating an updated risk… Read more»
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vthampi replied to the topic "Key Questions in Root Cause Analysis" – 1 year ago
All of the questions above are excellent and I would like to add a few other important ones. “How frequently does the problem occur?” and “Are there any variations between instances?” can help gauge the broader impact of the problem…. Read more»
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vthampi replied to the topic "Monitoring and Controlling in a Project" – 1 year ago
In a medical device project, a robust monitoring and controlling process is crucial in clinical trials. These trials essentially determine the safety and efficacy of your product, so it is critical that their progress is monitored closely. Unexpected developments during… Read more»
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vthampi posted a new topic "Changes to Products in Production" – 1 year ago
Once a project closes and it is ready for production, all documents necessary for making the product are handed over to manufacturing and the product goes into production. However, does this mean that the project manager and project team has… Read more»
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vthampi posted a new topic "Strategies to Counteract Negative Schedule Variance" – 1 year ago
Schedule Variance (SV) is the quantification of the monetary difference between where the project is (by percent completed and the total budget, not the actual cost) and where the project originally planned to be at that point in time. A… Read more»
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vthampi posted a new topic "Leaders of Change Control" – 1 year ago
Change control is critical in any medical device company, considering the products that are sold are directly affecting the lives of patients. For this reason, any changes made to these products must go through vigorous review and approval processes via… Read more»
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vthampi replied to the topic "PM in External Partnerships" – 1 year, 1 month ago
Managing internal and external expectations can get really complex. In addition to having clear communication with everyone, critical decisions need to be made with key stakeholders from both the internal and external sponsors being in the same meeting so that… Read more»
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vthampi posted a new topic "Compromises in Conflict" – 1 year, 1 month ago
In this week’s mini-sim, the first hurdle to overcome was a management-dictated timeline being ultimately unreasonable without a significant increase in project risk. The preferred outcome to this was to put management and a technical expert in the same room… Read more»
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vthampi posted a new topic "Instances of Multiple PMs" – 1 year, 1 month ago
After this week’s lecture, it’s not hard to imagine that managing a project can get extremely overwhelming for one person. Especially during the execution of the project, the PM has so many responsibilities including, but not limited to: distributing information… Read more»
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vthampi replied to the topic "Monitoring and Controlling Planned Value" – 1 year, 1 month ago
There are a few techniques to regularly maintain the planned value during the monitoring phase: consistently tracking project progress, analyzing the root causes of variances that come up, and keeping up with risk management strategies. Regularly monitoring during the monitoring… Read more»
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vthampi replied to the topic "What is the difference between project management process and design control?" – 1 year, 1 month ago
Design controls are what is required to complete a project. Project Management is what’s required for it to go SMOOTHLY. To be more specific, design controls (if done correctly) are a surefire way to meet regulatory standards and thoroughly document… Read more»
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vthampi replied to the topic "Feasibility Research vs Marketing Research" – 1 year, 1 month ago
The pre-feasibility/feasibility dataset and BAM are both critical in initiating projects. The pre-feasibility/feasibility dataset feeds into the BAM by making an assessment on the economic, operational, and technical viability of the project. Without this data, it would be significantly more… Read more»
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vthampi replied to the topic "Project Charter" – 1 year, 1 month ago
As you said, market and technical research is incredibly important for stakeholders’ consideration. If the idea is really that “grand,” then the market research should reflect that. Business presentation is also a factor, having done extensive research is absolutely necessary… Read more»
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vthampi posted a new topic "Keeping Finances a Secret from the PM" – 1 year, 1 month ago
In the lectures for this week, the professor mentioned that the managers sometimes keep project finances a secret from Project Managers. Can anyone provide insight as to why this may be? What benefits are derived from not disclosing the budget… Read more»
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