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mh746 replied to the topic "Maximizing Quality Management" – 1 day, 16 hours ago
I think it’s true that focusing too much on just meeting regulatory requirements can limit the full potential of quality management. Regulations are important for safety and consistency, but they’re only the starting point. A good example is the Johnson… Read more»
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mh746 posted a new topic "Allergan's BIOCELL Breast Implant Recall: A Case Study in Quality and Risk Management" – 4 days, 14 hours ago
I recently came across the 2019 recall of Allergan’s BIOCELL textured breast implants. The FDA requested this recall after data linked these implants to a rare cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Out of 573 reported cases… Read more»
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mh746 replied to the topic "Critical Path, PERT, and Managing Time Under Uncertainty" – 5 days, 12 hours ago
Effectively communicating the trade-offs between time compression methods like crashing and fast tracking, and the risks they pose to cost and qualit, requires project managers to be both strategic and practical in their communication approach. One clear example comes from… Read more»
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mh746 replied to the topic "Procurement Management and environmental/social policies" – 5 days, 12 hours ago
Using procurement as leverage to encourage suppliers to adopt environmental and social policies can be ethical and effective when handled responsibly. The key is balance, ensuring transparency, fairness, and providing adequate support so suppliers can realistically achieve these expectations.For example,… Read more»
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mh746 replied to the topic "Tools and techniques in project management" – 5 days, 12 hours ago
Project management software significantly simplifies and enhances the accuracy of project planning and execution. While these tools do not fully automate setting dates and budgets without human oversight, they substantially ease this process by handling calculations, resource allocation, and forecasting.For… Read more»
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mh746 posted a new topic "Lessons from Medtronic’s 2015 Consent Decree – Why Robust Change Control is Critical" – 1 week, 3 days ago
In 2015, Medtronic encountered major regulatory trouble over its SynchroMed II Implantable Infusion Pump. After nearly a decade of inspection findings, the FDA concluded that Medtronic repeatedly failed to address manufacturing violations, including inadequate procedures for identifying and correcting quality… Read more»
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mh746 posted a new topic "Challenges of Using SV and CV in Medical Device Project Management" – 1 week, 3 days ago
When managing medical device projects, understanding where our project stands in terms of schedule and budget is important. This is where Schedule Variance (SV) and Cost Variance (CV) come into play, both of which are key components of Earned Value… Read more»
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mh746 posted a new topic "The Impact of Earned Value Management (EVM) on Project Budgeting" – 1 week, 3 days ago
Hello everyone, in the complex world of project management, staying on budget while effectively tracking performance is paramount. Earned Value Management (EVM) is a powerful tool that addresses these challenges by integrating measurements of project scope, schedule, and cost into… Read more»
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mh746 replied to the topic "What’s the Most Effective Form of Communication in Medical Device Projects?" – 1 week, 3 days ago
In medical device projects, where precision and clarity are paramount, combining formal and informal communication methods often proves most effective. A strategic mix of these methods can address the fast-paced and intricate demands of such projects. For instance, structured weekly… Read more»
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mh746 replied to the topic "How Many Project Update Meetings Are Necessary to Keep them Productive" – 3 weeks, 5 days ago
To determine the ideal number of project update meetings, it’s important to consider the project’s scope and the team’s communication needs. A practical approach might be to use a flexible scheduling system that adjusts based on the project’s phase. For… Read more»
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mh746 replied to the topic "Change in Scope Due to Customer Requests" – 3 weeks, 5 days ago
When a customer requests changes after project execution has begun, a proactive and collaborative approach can effectively manage these changes while minimizing disruption. Firstly, I would suggest implementing a rapid prototyping session with the customer to explore the requested changes… Read more»
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mh746 replied to the topic "Role of Monitoring & Controlling in Project Success" – 3 weeks, 5 days ago
Monitoring and controlling are important in running a project towards success, making sure it adheres to planned objectives related to scope, timeline, budget, and quality. While tools like earned value management (EVM) provide quantitative data on project health, focusing solely… Read more»
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mh746 replied to the topic "Importance of Lessons Learned in the Project Closing Phase" – 3 weeks, 5 days ago
At the end of a project, having a “reflection session” can be very useful. In this session, the team can sit together in a relaxed setting and share what they think went well and what didn’t. For instance, if a… Read more»
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mh746 replied to the topic "Optimizing Information Distribution" – 1 month, 1 week ago
Effective information distribution is a critical component of project management, particularly in how it influences productivity and clarity within a team. Striking the right balance between communication and actual task execution can significantly impact a project’s success. In practice, too… Read more»
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mh746 posted a new topic "The Crucial Role of Regulatory Compliance in Medical Device Innovation" – 1 month, 1 week ago
Navigating regulatory requirements is a critical challenge for companies in the medical device industry. These regulations are essential for ensuring that new devices are safe and effective before they reach the market. However, meeting these standards can be a complex… Read more»
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mh746 posted a new topic "Enhancing Quality Assurance: Lessons from the DePuy ASR Hip Recall" – 1 month, 1 week ago
In 2010, the medical device community faced a significant setback when DePuy Orthopaedics, a subsidiary of Johnson & Johnson, had to recall its ASR hip replacement system. The recall was prompted by a higher-than-expected failure rate, where the metal-on-metal bearing… Read more»
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mh746 replied to the topic "Company collaboration" – 1 month, 1 week ago
In the context of business collaborations like the one between BoneFix and FactoSet, companies often choose to collaborate when they lack the necessary capabilities or resources to develop a product independently, or when partnering can accelerate product development and reduce… Read more»
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mh746 replied to the topic "PMI Talent triangle" – 1 month, 1 week ago
Strategic and business management skills are increasingly vital for project managers in navigating complex project landscapes and aligning project goals with broader organizational strategies. These skills empower project managers to transcend traditional project boundaries, allowing them to contribute more meaningfully… Read more»
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mh746 replied to the topic "Scope vs Design Controls verification" – 1 month, 1 week ago
Scope verification and design controls verification serve distinct purposes within project and product management, particularly in fields where precision and adherence to regulations are crucial, such as medical device manufacturing. Scope verification is primarily concerned with ensuring that the project… Read more»
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mh746 replied to the topic "Role of Stakeholder Management in Project Success" – 1 month, 1 week ago
Effective stakeholder management in projects such as the Injectable bone growth factor syringes between BoneFix and FactoSet hinges on proactive engagement and strategic foresight. One innovative approach that could significantly enhance the alignment and cooperation between all parties involved is… Read more»
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