Forum Replies Created
RE: Enabling Stakeholder Engagement in Clinical Trials 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... |
2 months ago | |
RE: Balancing Cost, Time, and Quality in Clinical Trials 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 optimi... |
2 months ago | |
RE: What factors should be considered during selection a vendor? 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 m... |
2 months ago | |
RE: Procurement Management and environmental/social policies 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 ... |
In forum Project Management Knowledge Areas |
2 months ago |
RE: Human Resource Management 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... |
In forum Project Management Knowledge Areas |
2 months ago |
RE: Maximizing Quality Management 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 ... |
In forum Project Management Knowledge Areas |
2 months ago |
RE: Navigating the Risks of Post-Verification Changes 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... |
In forum Project Management Process and Medical Device Development |
3 months ago |
RE: Making Design Reviews Work in Medical Devices 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 requ... |
In forum Project Management Process and Medical Device Development |
3 months ago |
RE: Why Capturing Lessons Learned Matters 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 embed... |
In forum Project Management Process and Medical Device Development |
3 months ago |
RE: Change Control in Project Management 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 m... |
In forum Project Management Process and Medical Device Development |
3 months ago |
RE: How Many Project Update Meetings Are Necessary to Keep them Productive 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 secti... |
In forum Project Management Process and Medical Device Development |
3 months ago |
RE: Managing Challenges in Metrics 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 measu... |
In forum Project Management Process and Medical Device Development |
3 months ago |
RE: Information Distribution For Project Success 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 informat... |
In forum Project Management Process and Medical Device Development |
4 months ago |
RE: The Crucial Role of Regulatory Compliance in Medical Device Innovation 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... |
In forum Project Management Process and Medical Device Development |
4 months ago |
RE: Optimizing Information Distribution 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... |
In forum Project Management Process and Medical Device Development |
4 months ago |