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f-dot replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
I would love to be a research/scientist for some time and work on projects. I have some leadership skills and wouldn’t mind going back to something like that. I agree with most of you in that I would stay where I was to get experience and then move into a manager position so that way I have that experience to help lead others. I wouldn’t want to…[Read more]
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f-dot replied to the topic Are you an X or Y? in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
I think it’s a little hard to determine what type of employee I am. When it is something I am interested in, then yes I am a Y. I am motivated to learn and get better because I do not always feel like I have the necessary skill. If there is something that I’m not interested in, and using the job as say a stepping stone, or thinking it as an…[Read more]
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f-dot replied to the topic Different PM techniques based on size in the forum Project Management Application: Clinical Trial 6 years, 12 months ago
Going through this course I think I have always pictured a big/established company; never really considering the workings of a smaller, start up one. I think it is definitely true that certain projects may be straight forward and predictable while other projects are more complex and risky, as ashley has already said. This in general would dictate…[Read more]
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f-dot replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial 6 years, 12 months ago
Hate to beat a dead horse, but I also agree a project manager’s motivation is helpful and needed in any project. I also think it’s beneficial to have a good understand of why were doing what were doing. I said in the other post that I’ve always believed I would be doing important and impactful work. Having someone believe in you and counting on…[Read more]
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f-dot replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial 6 years, 12 months ago
I can’t say I’m surprised, because I never really considered those aspects before, but I think it makes a lot of sense. When looking for a job, or any work, I’ve always looked most for exciting and challenging work. I love the expression “love what you do and you’ll never work a day in your life”.
The work that I want to be apart of is meaningful…[Read more] -
f-dot replied to the topic Specifications: A double edged sword? in the forum Project Management Knowledge Areas 7 years ago
I agree with andria93 and cs22 that specifications should be as accurate as you can to make sure all aspects are documented and followed correctly. The limits are an interesting aspect because there are times when there should be upper and lower, or just one, but overall I do think of them as a guideline for validation and testing. In this…[Read more]
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f-dot replied to the topic Deadlines and SOP's in the forum Project Management Knowledge Areas 7 years ago
Reactive management is not terrible if it can be used correctly. If the manager still applies himself and is able to keep the long term goals on track, and able to accomplish their own tasks at the same time (without being swamped in emails) then it is great. But this often doesn’t happen. The problem becomes when they put off the long term work…[Read more]
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f-dot replied to the topic Six Sigma and Project Management in the forum Project Management Knowledge Areas 7 years ago
The Six Sigma seems to be a very efficient way for business’s to secure a projects scope. The DMADV also seems like a great way to handle any major decision. Take away the product part and apply to problem solving and it works quite well. It’s no surprise that PMs use the tool to help increase organization and scheduling. I think for them to…[Read more]
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f-dot replied to the topic Importance of Metrics in the forum Project Management Process and Medical Device Development 7 years ago
I think we all agree there are different evaluations of the numbers and they all come in handy when determining the future of the company and product. As we know, Metrics are needed in order to show variances and thus help us compare to where we need to be. I agree with what ak977 said and what the professor, every metric that we utilised must be…[Read more]
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f-dot replied to the topic planned value vs actual costs in the forum Project Management Process and Medical Device Development 7 years ago
I think it’s little difficult to add a new statement to this conversation, as everyone here has made very good points, but here is my 2 cents.
The monitoring and controlling phase are seen throughout the project to evaluate risk, and lower cost. We know that the PV and AV along with the EV dictate either a positive or negative SV and CV. I t…[Read more] -
f-dot replied to the topic Medical Devices in the forum Project Management Process and Medical Device Development 7 years ago
I think that when it comes to failing with the vendor its important to ask why. Was the product not what they expected, and subsequently lost of interest? Or was the vendor disappointed entirely and pulled its funds. Losing a vendor is tricky if you are relying on it to stay afloat. Finding a new one can be challenging where as losing one of many…[Read more]
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f-dot replied to the topic In the Shoes of a Project Manager in the forum Project Management Process and Medical Device Development 7 years ago
As most of the posts above this are comparing the charts, I will chose to answer the second question to change it up. I think the bone drug delivery from the 2nd simulation would be classified as a Class II medical device. The injection would not stay in the body permanently as it is absorbable and designed to stimulate natural bone growth. It is…[Read more]
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f-dot replied to the topic Design Review Meeting Culture in the forum Project Management Process and Medical Device Development 7 years ago
I don’t have any experience working in the industry, so when I imagine the meeting I picture something like kindergarten and theres a talking stick. I think it should go around, but before its passed to the next group, the team in question should get a chance to respond (Or at least given their change to defend)
Overall, the project team in q…[Read more] -
f-dot replied to the topic Verification Testing Deviations and Failures in the forum Project Management Process and Medical Device Development 7 years ago
My colleagues above me make some great points. I agree that noticing any deviation earlier is better than after the validation. It would seem we also agree that verification should have as little deviations as possible. But I think srg36 makes a good point in that deviations are common in running new tests. I think this largely takes effect when…[Read more]
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f-dot replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 7 years ago
A medical device I would consider to have significant risk, are contact lenses. Everyday millions of people (guessing, don’t quote me), put contacts into their eyes instead of wearing glasses, but have you considered the risk they are taking? If the wearer fail to wash, clean/disinfect, or properly store their lenses, they risk infection. This…[Read more]
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f-dot replied to the topic Factors to look for while evaluating change request in the forum Project Management Process and Medical Device Development 7 years ago
Merzkrashed makes a lot of good points. I think something else we would need to consider is the stockholders/team and customers/venders. Will your team agree with the decisions? Do they agree on the change but not the plan of action? You should also consider the customers and the venders. Will your change get the product out sooner or later? Will…[Read more]
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f-dot replied to the topic Which of the following project would you say is better and why in the forum Project Management Process and Medical Device Development 7 years ago
I think cdj24 makes a really good point to think about the company. When thinking of how to answer, I was leaning more towards the idea of having a negative CV and a positive SV, as I think it would be better to be slightly over budget, yet ahead of schedule. Not that you would want to cut back on future costs, but it at least gives you the…[Read more]
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f-dot replied to the topic Change in PM in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
Hopefully the project does not have to start over (maybe the reason why the PM had to leave), in which case the new PM would start from the beginning like every other time – as long as they know the content. If the PM shifted during the middle of the project, I would agree with the “kick off” meeting that was previously mentioned by a few. I think…[Read more]
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f-dot replied to the topic Planning Phase in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
Where as it is obviously important for everyone involved to know the users needs, I also think it is important to consider what the user does not want. If we are given a list of things to include and given some creative liberty, then there may come a product that includes something undesired by the user, but never expressed to the designer. For…[Read more]
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f-dot replied to the topic task Scheduling :factors in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
Going off of what srg36 said in response to moniquet07, I think the project scheduling would need a “Clarification” or a “Agreement” step. This way all parties know what they are up against, and if something is not correct (either time wise or design wise), the PM can make adjustments. And with any schedule, you I also think it should include the…[Read more]
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