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Bryan Xavier posted a new topic "Managing Change Fatigue" – 1 week, 3 days ago
In complex and highly regulated projects like medical device development, changes are bound to happen. Design updates, documentation revision, and process adjustments are required to ensure compliance and quality, but when changes become frequent, teams can experience change fatigue. This… Read more»
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Bryan Xavier replied to the topic "Importance of Lessons Learned in the Project Closing Phase" – 1 week, 3 days ago
As much as learning from mistakes is important for future projects, it should also be important to use the lessons learned in real-time for decision makings during the project, not just as something to review afterward. If certain patterns emerge… Read more»
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Bryan Xavier replied to the topic "Role of Monitoring & Controlling in Project Success" – 1 week, 3 days ago
You raise an interesting point, others have mentioned already that EV, PV, and AC only show the symptoms of a project failing and do not explain why. Another shortcoming of earned value management is that it assumes that everyone shares… Read more»
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Bryan Xavier replied to the topic "Significance of Team Development in Project Execution" – 3 weeks, 2 days ago
One common way to foster team and individual developments is through peer mentorship and knowledge-sharing sessions. Less experienced team members are usually paired with professionals, and shadow them to develop skills in real time while contributing to the project. Mentorship… Read more»
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Bryan Xavier replied to the topic "Optimizing Information Distribution" – 3 weeks, 2 days ago
Asynchronous communication offers an alternative for small weekly meetings where everyone meets up for a status update. Instead of having excessive meetings, projects teams use tools like Slack, Trello, or Asana, to provide status updates without needing real-time attendance, allowing… Read more»
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Bryan Xavier replied to the topic "Enhancing Quality Assurance: Lessons from the DePuy ASR Hip Recall" – 3 weeks, 2 days ago
One way to improve QA for medical devices is implementing patient-reported outcome measures (PROMs), which provides a direct pipeline for patients to communicate their experience and outcomes. PROMs allow for personalized insights into how a device performed for them, and… Read more»
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Bryan Xavier replied to the topic "Role of Stakeholder Management in Project Success" – 1 month ago
Using Adaptive project governance can help with maintaining a balance between control and flexibility. Instead of every step being micromanaged, a leadership team can set the overall goals and milestones for a project, while the teams doing the day-by-day work… Read more»
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Bryan Xavier replied to the topic "Importance of Cross-Functional Collaboration" – 1 month ago
implementing cross-team training programs to promote communication between teams can allow for teams to have a understanding of each groups priorities, and make it less likely that there will be a delay due to miscommunications As for stakeholders, setting up… Read more»
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Bryan Xavier replied to the topic "Importance of Adaptive Project Planning" – 1 month ago
Using a extreme project management (XPM) framework is one possible solution. It provides a highly adaptive framework that uses rapid iterations and short term dynamics cycles where elements of the project can change based on data and continuous stakeholder input…. Read more»
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Bryan Xavier replied to the topic "Importance of Work Breakdown Structure" – 1 month ago
One approach that some projects use to manage scope creep and task delays is the Event Chain Methodology or ECM. ECM identifies potential event chains that can kickstart due to unexpected events and comes up with contingencies for these event… Read more»
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Bryan Xavier replied to the topic "Identifying the Critical Path – Preventing Project Delays" – 1 month ago
Instead of having one fixed critical path over the entire project, breaking the work into smaller pieces and having multiple critical paths for each phase allows for some leeway to reassess the next critical path once the current one is… Read more»
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Bryan Xavier replied to the topic "Significance of Scheduling in the Planning Phase" – 1 month ago
The estimation methods you presented provide a fixed schedule of expected task durations. Another approach that should be considered is dynamic scheduling through real-time data integration. By considering ongoing performance data using project tracking tools, scheduling can be continuously updated… Read more»
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Bryan Xavier replied to the topic "Risk Management in Project Planning" – 1 month, 2 weeks ago
One thing to consider with medical devices is that they don’t all carry the same level of risks, hence the classification. Implementing different risk-adaptive techniques for different classifications can speed up the process for Class I medical devices, as they… Read more»
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Bryan Xavier replied to the topic "Role of Enterprise Environmental Factors in Project Initiation" – 1 month, 2 weeks ago
Some responses already mention ways to increase innovation during a project by using software to communicate throughout the project team effectively or having a change in project structure. Another important factor that can affect the project is the psychological state… Read more»
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Bryan Xavier replied to the topic "Making connections between people and schools" – 1 month, 2 weeks ago
Hello everyone! My name is Bryan Xavier, and I’m an undergraduate at NJIT pursuing a BS and MS at NJIT. I can’t wait to connect with everyone! Connect with me here:http://www.linkedin.com/in/bryan-xavier-a680b429a
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Bryan Xavier replied to the topic "Addressing Verification Failures" – 1 month, 3 weeks ago
@amm7 To add on to your potential test, it may be better to test if the label does better on a flat surface or a curved surface. If the testing is done on a curved surface, it may cause problems… Read more»
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Bryan Xavier replied to the topic "Managing Scope and Stakeholder Expectations" – 1 month, 3 weeks ago
@ms3548 Adding to your point, its important to have the project teams and stakeholder have multiple ways to determine how to stay in scope with the project. Stuff like a simple cost-benefit analysis to decide whether a feature should be… Read more»
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Bryan Xavier replied to the topic "Risk Mitigation and Continuous Improvement" – 1 month, 3 weeks ago
One thing that may help when considering changing test parameters or even mitigating failures can be consulting experts in fields that deal with the potential failure that are trying to avoided. For example, with the case of label adhesion failure… Read more»
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Bryan Xavier replied to the topic "Critical Role of Design Controls in Medical Device Projects" – 1 month, 4 weeks ago
@pd493 To add upon your bringing up focusing on high-risk areas, rather than just focusing on one area at a time, they can split up the product in parts. Parts of the product that require strict guidelines can be focused… Read more»
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Bryan Xavier replied to the topic "Optimizing the Design Development Plan (DDP) for More Efficient Product Development" – 1 month, 4 weeks ago
All the methods listed in this forum are great ways to have flexibility on a DDP, however implementing risk strategies, such as a Risk Register. In a Risk Register, you can lay out all potential project risks from multiple team… Read more»
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