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dk555 replied to the topic "Enabling Stakeholder Engagement in Clinical Trials" – 1 month, 1 week ago
Stakeholder engagement can make or break the success of clinical trials. I agree with the points made regarding proactive communication and structured feedback. There are some more targeted strategies that clinical project teams can use to maximize the value of… Read more»
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dk555 replied to the topic "Balancing Cost, Time, and Quality in Clinical Trials" – 1 month, 1 week ago
The project management triangle becomes particularly rigid in clinical research because quality is non-negotiable. Patient safety and regulatory compliance are foundational. While you can never optimize all three corners fully, there is a balance that can be struck by rebalancing… Read more»
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dk555 replied to the topic "What factors should be considered during selection a vendor?" – 1 month, 1 week ago
Cost and quality of the product are certainly major factors that should be considered when selecting a vendor, but there are many other considerations that can and should be considered as well. From my own personal experience, it can be… Read more»
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dk555 replied to the topic "Procurement Management and environmental/social policies" – 1 month, 2 weeks ago
In my opinion, using procurement to influence supplier behavior can be ethical, but only under certain circumstances. It must be approached with intentionality and equity. When large corporations use their purchasing power to push for reform, the impact can be… Read more»
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dk555 replied to the topic "Human Resource Management" – 1 month, 2 weeks ago
The suggestions regarding FMEA and RCA are great for safety-critical projects. Organizational planning for these types of projects should also use tools that bridge the gap between system-level safety management and resource coordination. Some techniques that can be used include… Read more»
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dk555 replied to the topic "Maximizing Quality Management" – 1 month, 2 weeks ago
While regulations are very important for baseline safety and efficacy, I think an overemphasis on regulatory compliance can limit the full potential of quality management. Regulations are designed to prevent failure, but in my opinion, don’t always push teams to… Read more»
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dk555 replied to the topic "Navigating the Risks of Post-Verification Changes" – 1 month, 3 weeks ago
To expand on the points above, I would like to add that decision-making in these high-pressure moments can benefit from a multi-criteria decision analysis (MCDA) approach. MCDA allows teams to compare multiple options by assigning weighted values to different criteria… Read more»
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dk555 replied to the topic "Making Design Reviews Work in Medical Devices" – 1 month, 3 weeks ago
To ensure a design review meeting is efficient and productive, preparation is key. In my opinion, following a structured guideline both prior to and during the meeting can help to ensure that all required documents and approvals are ready in… Read more»
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dk555 replied to the topic "Why Capturing Lessons Learned Matters" – 1 month, 3 weeks ago
I agree that closing a project without evaluating the lessons learned is a significant loss of opportunity. Documenting lessons learned is only valuable if the insights gained are accessible and embedded into future workflows. Finding the best format or platform… Read more»
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dk555 replied to the topic "Change Control in Project Management" – 2 months, 1 week ago
Striking the right balance between control and flexibility in change management comes down to how well change control processes are tiered, risk-based, and embedded in the project culture. There are many approaches that aim to strike this balance, one of… Read more»
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dk555 replied to the topic "How Many Project Update Meetings Are Necessary to Keep them Productive" – 2 months, 1 week ago
To keep weekly or bi-weekly meetings productive, following a standardized meeting format can help keep meeting attendees on track and focused. For example, you can break the meeting up into core sections:1. Quick Status Updates where each team provides a… Read more»
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dk555 replied to the topic "Managing Challenges in Metrics" – 2 months, 1 week ago
One additional way to ensure metric remain relevant and useful is by applying a goal-oriented metrics framework. One example of these is SMART Key Performance Indicators (KPIs) are tools used to measure the progress of a company toward its goals…. Read more»
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dk555 replied to the topic "Information Distribution For Project Success" – 2 months, 3 weeks ago
In order for project managers to strike the right balance between keeping stakeholders informed and avoiding overwhelming them, there are many strategies that can be employed. Customizing the information flow between stakeholders is a great start. Project managers can segment… Read more»
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dk555 replied to the topic "The Crucial Role of Regulatory Compliance in Medical Device Innovation" – 2 months, 3 weeks ago
Balancing innovation with regulatory compliance requires a proactive approach that integrates compliance into each stage of product development. By not addressing it early, companies set themselves up for delays, regulatory setbacks, and high costs. Implementing a Regulatory Affairs and Quality… Read more»
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dk555 replied to the topic "Optimizing Information Distribution" – 2 months, 3 weeks ago
Balancing effective communication and productive work time is very important in project management. Instead of looking at meetings and emails as opposing forces, I think project managers can implement tiered communication strategies. These would be based on different factors such… Read more»
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dk555 replied to the topic "Planning and Executing in Project Management" – 2 months, 4 weeks ago
In biomedical engineering, project managers need to strike a delicate balance between efficient execution, innovation, and regulatory compliance. Previous responses have brought up planning tools such as pilot studies and risk assessments, but another strategy that can be used is… Read more»
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dk555 replied to the topic "Considerations of Verification Protocols" – 2 months, 4 weeks ago
A strong verification protocol is absolutely essential for ensuring product reliability and regulatory compliance. One way to ensure a strong protocol is to implement a structured validation approach which includes acceptance criteria and traceability. There are many strategies that can… Read more»
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dk555 replied to the topic "Design Transfer Project Management" – 3 months ago
Both Design Transfer Project Managers and R&D Project Managers play important roles in the product lifecycle, but they approach risk management and process validation differently. R&D Managers focus on identifying technical problems and refining the product. Design Transfer Project Managers… Read more»
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dk555 replied to the topic "Task scheduling" – 3 months ago
Effective task scheduling is essential for making sure that project timelines remain on track and resources are used efficiently. A well structured schedule helps identify critical paths, manage dependencies, and prevent bottlenecks. One common approach is following the Critical Path… Read more»
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dk555 replied to the topic "Sustainable Business Models in Project Management" – 3 months ago
Long-term revenue streams in biotech and pharmaceutical industries often depend on chronic disease management rather than one time cures. From a project management perspective, the sustainability of gene therapies hinges on how well companies can adapt their business models to… Read more»
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