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pi29 replied to the topic Avoiding Tunnel Vision in the forum Project Management Application: Clinical Trial 6 years, 1 month ago
I think that sharing ideas with others in your group definitely helps. Everyone has a unique way of seeing things and can shine light on certain details you might have missed. During the first simulation I had a bit of tunnel vision happen to me and by sharing ideas we were able to come to a conclusion. Communication is the way to avoid focusing…[Read more]
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pi29 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 6 years, 1 month ago
I would choose a project management position but only after working as an engineer for a couple of years. I think having that technical background and actually knowing the process and work the engineers go throughout validate and create processes is very valuable and will make you a better project management. At work I’ve seen the engineers work…[Read more]
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pi29 replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial 6 years, 1 month ago
I found that a lot of what was mentioned in this class helped me fill in the gaps in my industry knowledge. I have been working as a quality engineering intern for a couple months now and though I have been involved in project meetings, taking this class certainly helped understand the documents that were being discussed and the way the problems…[Read more]
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pi29 replied to the topic QA vs QC in the forum Project Management Knowledge Areas 6 years, 1 month ago
QA or Quality Assurance makes sure that the project is meeting all industry regulations. For example if you want to set new storage conditions for one of your devices, you consult the quality assurance specialist to make sure that this is 1) meeting industry regulations and 2) all labels and customer letter and product inserts are updated to…[Read more]
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pi29 replied to the topic Overlapping activities in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
In your example I think that if possible those critical team members should have notified of their availability for the dates needed. The project manager should have asked if she/he did not if there were any vacation days coming up or critical project deadlines around the time of implementation. I feel like it would be rare for all critical…[Read more]
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pi29 replied to the topic Sucess Factors in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
I agree with these factors for the following reasons:
It’s important for everyone on the team to be on the same page and therefor agree with the project goals. If a team member doesn’t agree or has concerns it’s important to bring this up because it could be something crucial others overlooked. Proper communication comes into play so that no…[Read more]
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pi29 replied to the topic planned value vs actual costs in the forum Project Management Process and Medical Device Development 6 years, 2 months ago
The planned value and actual cost serve as points of comparison throughout the project to monitor what the current value of the project is to what the planned value is. And the actual cost helps determine how much it will actually cost and if your budget is realistic. Being able to track this throughout the project is important rather than waiting…[Read more]
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pi29 replied to the topic Factors affect schedule variance (SV) in the forum Project Management Process and Medical Device Development 6 years, 2 months ago
Schedule variance is keeping track of the project progress by comparing the current money worth of it to the planned worth it should have. If at month 6 the earned value is closer to the planned value than you predicted than that should mean that you’ve made considerable progress in the project and are ahead of schedule. Some things that could…[Read more]
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pi29 replied to the topic Lessons Learned in the forum Project Management Process and Medical Device Development 6 years, 2 months ago
I think it’s important to keep track of all lessons learned throughout the project by each individual team member who has a role in this project. If one of the team members leaves the company, their log can be a useful transition document for the person taking over the role. For other projects, this document can help avoid similar mistakes already…[Read more]
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pi29 started the topic Problem with the Vendors in the forum Project Management Process and Medical Device Development 6 years, 2 months ago
Hi Everyone,
I wanted your opinion on what you think would happen/should happen if you start getting a lot of problems with a certain vendor right in the middle of a validation. For example, you are currently validating your packaging and want to know if your packaging passes a visual inspection upon arrival to make sure there are no pinholes,…[Read more]
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pi29 replied to the topic It's the Right Thing To Do in the forum Project Management Process and Medical Device Development 6 years, 2 months ago
I would follow ISO:9001, the standards that specify quality management. Quality is an important part of the entire project and these guidelines help make sure that industry standards are met while meeting the demands of the customer. These processes can help with organization and efficiency of the project as well as to detect possible areas of…[Read more]
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pi29 replied to the topic Unexpected Time Delays – miniSim in the forum Project Management Process and Medical Device Development 6 years, 2 months ago
In the case of the MiniSim, passing results were obtained after shortening the length of the animal experiment. This resulted in an increased risk and reduction in quality of the results. I think some ethical points should also be considered and it should be kept in mind that these devices are going into people’s bodies. If shortening the time of…[Read more]
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pi29 replied to the topic Most Important Phase in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
I would say establishing a DDP and requirements would be the most important. If this document is properly outlined it sets the foundation for making plans and executing the project. If things go wrong, the DDP is referenced and it’s a guide to the flow of the entire project.
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pi29 replied to the topic Overlapping activities in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
“By failing to prepare you are preparing to fail”. The planning phase is the most important phase for any project. Thorough planning takes into account the possibility of staff leaving or not being available. There will always be something that can go wrong and a project manager that allots for this during the planning phase is preparing for a…[Read more]
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pi29 replied to the topic Importance of Logging Work in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
Logging my work has helped in many occasions. I think it’s come the most handy in research settings. I’ve been a research assistant for about 2.5 years now and have been working on the same project which is now being written into a paper. In order to put the paper together I need the details of all the experiments that were done, and the results.…[Read more]
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pi29 replied to the topic Scope Creep in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
I would say the longer that the scope remains unfinalized, the higher the chances of there being scope creep. The needs of the customer should be specified earlier on, and communication between both parties should express understanding that the design and needs of the customer are being properly understood, as well as the intentions of the…[Read more]
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pi29 replied to the topic PM: Handling Team Issues in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
I agree with Manolo^ that policies should be in place regarding vacation days, PTO, etc. Additionally, I think it’s important for the project manager to encourage communication between himself and the members of the team. Being able to trust your project manager and teammates can go a long way in planning. I think in terms of vacation days, these…[Read more]
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pi29 replied to the topic Revising a Gantt Chart in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
This entire scenario would pose a huge mess because since the failure is vital to the product’s intended use. I think that the possibility of this failure or a failure occurring and setting back the project should have been accounted for in the project timeline/gantt chart to avoid missing milestones. However since it’s already missed a dec…[Read more]
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pi29 replied to the topic Points to look for while out sourcing in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
Before outsourcing, the project manager should do a cost analysis to determine if doing this inhouse would save time, money, and man power. If not then before outsourcing the project manager should ensure that the company they plan on using has the resources to accomplish the task as well as meets all industry standards. An ISO certification is…[Read more]
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pi29 replied to the topic Inputs for Design Input Document in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
As mentioned in the lecture, it’s easier to address changes at the beginning stages of the project. In order to meet all customer needs, I believe marketing, engineering, manufacturing, and representatives from other departments should be present when determining design inputs. Input from all these disciplines will provide transparency as to the…[Read more]
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