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amm7 replied to the topic "Keeping Clinical Research Teams Motivated During Long Timelines" – 23 hours, 39 minutes ago
I think one effective strategy could be tying milestones directly to patient outcomes or study impact, such as sharing anonymous patient stories or early findings that hint at real-world benefits. It humanizes the data and reconnects teams to the “why.”… Read more»
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amm7 replied to the topic "Creating Realistic Schedules in Clinical Trials" – 23 hours, 41 minutes ago
Clinical trials face several unique challenges that can disrupt timelines, including patient recruitment difficulties, variability in site activation speed, changes in regulatory requirements, drug supply chain issues, and unexpected adverse events. Patient dropouts, protocol amendments, or changes in the standard… Read more»
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amm7 replied to the topic "Protocol Deviations vs. Violations in Clinical Trials" – 23 hours, 43 minutes ago
Clinical trial teams can ensure protocol compliance while prioritizing patient safety by implementing a risk-based monitoring approach that emphasizes critical data and processes, supported by comprehensive training for site staff on both the protocol and ethical considerations. Clear definitions and… Read more»
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amm7 replied to the topic "Nine Knowledge Areas" – 1 week, 5 days ago
In my opinion, time, risk, and cost are the three most important knowledge areas in project management. Time is crucial because managing the project schedule ensures that tasks are completed on time, avoiding delays and maintaining stakeholder satisfaction. Risk management… Read more»
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amm7 replied to the topic "Bottom-Up vs Analogous Estimations – Project Cost Management" – 1 week, 6 days ago
I think it would be more effective to use Bottom-Up estimations in most cases. Using analogous estimations can be extremely dangerous for a large, complex, and costly project. An incorrect estimation can sink a project, so it is best to… Read more»
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amm7 replied to the topic "Necessity of Quality Management" – 1 week, 6 days ago
I agree that the top reason that smaller companies may lack a formal QMS is lack of resources.This can also be attributed to budget constraints and a company-wide focus on immediate deliverables over long-term process optimization. Without dedicated QM processes,… Read more»
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amm7 replied to the topic "Implementing Change Without Disrupting Production" – 2 weeks, 3 days ago
I agree that this would be quite a significant change, particularly because it affects a critical process that could alter the device’s biocompatibility, functionality, or performance. To implement the change without interrupting current production, I would second that the company… Read more»
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amm7 replied to the topic "Going back to a previous phase" – 2 weeks, 3 days ago
This topic is explored in Simulation 3, as a problem with cytotoxicity will force a return to the verification phase. This is costly and generally avoided unless absolutely necessary. Thus, such a step is warranted only when critical errors or… Read more»
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amm7 replied to the topic "Impact of Testing Variability on Product Risk" – 2 weeks, 3 days ago
To build confidence in testing outcomes, teams should proactively engage in interlaboratory comparisons early in development to identify variability across labs and adjust accordingly. Establishing internal benchmarks using worst-case or most stringent test conditions can help ensure robustness against methodological… Read more»
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amm7 replied to the topic "Change Control in Project Management" – 4 weeks ago
Organizations can balance control and flexibility by implementing a structured yet adaptive change management process. This involves clear criteria for categorizing changes based on risk and impact, ensuring that low-risk modifications undergo a streamlined approval process while high-impact changes receive… Read more»
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amm7 replied to the topic "Scope vs Design Controls verification" – 4 weeks ago
Though both are types of verification, scope and design controls verification are quite different. They take place in different project phases and address different things. Scope verification ensures that the project’s defined deliverables meet stakeholder expectations and requirements, confirming formal… Read more»
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amm7 replied to the topic "Importance of Lessons Learned in the Project Closing Phase" – 4 weeks ago
In order to ensure that past project insights lead to real improvements, it is important to continuously track and categorize lessons learned. Tracking this throughout a project rather than leaving it until the very end would reduce the chance that… Read more»
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amm7 replied to the topic "Company collaboration" – 1 month, 1 week ago
As mentioned above, collaborations between companies become necessary when one company lacks money, resources, time, or experience to complete a project on its own. What hasn’t been mentioned, however, is how this decision is almost purely a financial one. To… Read more»
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amm7 replied to the topic "Significance of Team Development in Project Execution" – 1 month, 1 week ago
I think an important motivator for team success is the satisfaction of reaching goals along the way. Thus, a good method for team development during execution is actually done during the planning phase. The project could be set up as… Read more»
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amm7 replied to the topic "Information Distribution For Project Success" – 1 month, 1 week ago
I think it is very important to find the balance between providing enough information to keep stakeholders informed without overwhelming them with excessive updates. To do so, I agree that summarizing updates could be effective. To expand on this point,… Read more»
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amm7 replied to the topic "Role of initiation process in medical device project" – 1 month, 3 weeks ago
During the initiation phase of medical device project management, key inputs include the Project Charter, feasibility data, market analysis, regulatory requirements, and stakeholder expectations. These inputs help define the Project Proposal, Scope Statement, and high-level risk assessment, which guide the… Read more»
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amm7 replied to the topic "Email Communication" – 1 month, 3 weeks ago
I agree with some of the previous entries that Microsoft Teams can be more efficient than email chains for shorter communication that does not have to be documented. More official, documented messaging across a larger group of people is likely… Read more»
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amm7 replied to the topic "Importance of Cross-Functional Collaboration" – 1 month, 3 weeks ago
I think this is a great point because the biomedical industry is highly cross-functional as you’ve mentioned. To ensure alignment among stakeholders in a partnership, project managers need to establish clear communication channels, set shared milestones, and create cross-functional teams…. Read more»
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amm7 replied to the topic "Significance of Scheduling in the Planning Phase" – 1 month, 3 weeks ago
Having slack in a project schedule is quite important to ensure that projects have built-in time for unexpected delays without derailing the entire schedule. I think that consulting the experts is the most important method to ensure that the project… Read more»
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amm7 replied to the topic "Different Types of Risks in a Project" – 1 month, 3 weeks ago
I agree that schedule risks are often the most prevalent and common in medical device projects, but financial risks are the most devastating. As stated earlier, financial risks are very serious and, if things go wrong, could lead to the… Read more»
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