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mh746 posted a new topic "How Frequent Design Reviews Can Improve Medical Device Quality and Reduce Failures" – 7 months ago
One of the biggest challenges in medical device development is ensuring that design flaws are caught early enough to prevent costly rework or safety risks. When design reviews are conducted too infrequently or treated as a formality, small errors can… Read more»
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mh746 posted a new topic "Managing Design Change Requests Effectively Without Disrupting Development" – 7 months ago
One of the biggest challenges in medical device development is handling design change requests without causing delays, confusion, or regulatory issues. Design changes can come from new regulatory requirements, safety concerns, user feedback, or manufacturing improvements, and while they are… Read more»
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mh746 replied to the topic "Humanitarian Device Exemption" – 7 months ago
One major challenge with the Humanitarian Device Exemption (HDE) is the balance between access and safety. Since these devices don’t have to meet the same level of clinical effectiveness as other Class III medical devices, there’s a risk that patients… Read more»
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mh746 posted a new topic "Optimizing the Design Development Plan (DDP) for More Efficient Product Development" – 7 months ago
A common challenge in medical device development is creating a Design Development Plan (DDP) that is both comprehensive and flexible. The DDP serves as the foundation for the entire project, outlining scope, timelines, team roles, and regulatory requirements. However, some… Read more»
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mh746 posted a new topic "The Importance of the Design History File (DHF) in Regulatory Compliance" – 7 months ago
A major challenge in medical device development is ensuring that all design decisions, changes, and testing results are well-documented to meet regulatory requirements. The Design History File (DHF) serves as the ultimate record of a device’s design process, helping companies… Read more»
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mh746 replied to the topic "The PDCA Cycle – An Important Framework for Medical Device Projects" – 7 months ago
Organizations can make PDCA an ongoing process by making small, frequent improvements instead of treating it as a one-time checklist. One way to do this is by incorporating PDCA into regular team meetings where issues are identified, solutions are tested,… Read more»
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mh746 replied to the topic "Critical Role of Design Controls in Medical Device Projects" – 7 months ago
Organizations can balance regulatory compliance and innovation by embedding Design Controls into their everyday workflow rather than treating them as a separate burden. Instead of waiting until the final stages to check for compliance, teams can conduct small, frequent verification… Read more»
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mh746 posted a new topic "The Role of Regulatory Strategy in Combination Product Development" – 7 months, 1 week ago
Developing combination products—such as drug-eluting stents, growth factor-releasing bone void fillers, or cell-seeded scaffolds—poses unique challenges because these products involve both medical device and drug/biologic regulations. Unlike standalone medical devices, combination products require careful coordination between different reg…[Read more]
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mh746 replied to the topic "Balancing time, cost and scope in project management" – 7 months, 1 week ago
In medical device project management, balancing time, cost, and scope is a constant challenge. While all three are interconnected, I believe time is the hardest to control. Delays can happen due to regulatory hurdles, unexpected design issues, or supply chain… Read more»
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mh746 replied to the topic "Importance of Regulatory Strategy in Medical Device Project Management" – 7 months, 1 week ago
A good regulatory strategy is important in medical device project management because it helps companies follow the rules, avoid delays, and get their products approved faster. Planning for regulations from the beginning makes it easier to choose the right approval… Read more»
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mh746 replied to the topic "Caution with Medical Devices that Require a PMA" – 7 months, 1 week ago
Avoiding PMA in medical device development can slow down innovation. Since PMA takes a long time and costs a lot, many companies choose to improve existing devices instead of creating entirely new ones. This helps them get products to market… Read more»
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mh746 replied to the topic "Role of risk management in medical device projects" – 7 months, 1 week ago
I believe that technical risks are a major concern in medical device projects because they can lead to serious delays and additional costs if not addressed early. These risks include design flaws, material failures, manufacturing issues, and unexpected performance problems… Read more»
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mh746 replied to the topic "Managing Risks from External Dependencies" – 7 months, 1 week ago
Managing risks from outside factors like supplier delays and supply chain problems is very important. Plans like having backup suppliers, keeping extra stock, and tracking progress regularly are helpful. However, using technology and data can also play a big role… Read more»
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mh746 replied to the topic "Balancing Stakeholder and Customer Values" – 7 months, 1 week ago
Balancing the needs of stakeholders and customers can be challenging, but project managers need to find a way to meet both sides while keeping the company’s goals in mind. Each project is different, so the right approach depends on the… Read more»
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mh746 replied to the topic "Project Success and Scope Creep" – 7 months, 1 week ago
A project manager can keep project goals flexible while avoiding scope creep by focusing on prioritization and structured change management. It’s important to regularly check in with stakeholders to make sure the project goals still match the business needs,… Read more»
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mh746 replied to the topic "How to communicate effectively between team mates in project team ?" – 7 months, 1 week ago
I think effective communication within a project team is key to ensuring smooth collaboration and avoiding misunderstandings. While regular meetings and clear goal-setting are important, establishing a structured communication plan can significantly improve how information flows within the team. One… Read more»
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mh746 posted a new topic "Handling Conflicts Among Team Members Effectively" – 7 months, 1 week ago
