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Dkonara921 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 6 years, 5 months ago
My biggest source of motivation would be the goals that I wish to achieve in life. I believe that the work you do every day has to lead to some ultimate achievement. Having life goals is something that allows me to find encouragement and motivation in everything I do. It can be a source of willpower, which is need in order to succeed in life.…[Read more]
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Dkonara921 replied to the topic Six Sigma and Project Management in the forum Project Management Knowledge Areas 6 years, 5 months ago
Project managers cannot simply integrate aspects of Six Sigma into their projects because the organization that they are working for may not be familiar with the methodology. If Six Sigma isn’t adopted as part of the organization’s culture, then it’s nearly impossible to just integrate it into your project, even though it’s a great approach to…[Read more]
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Dkonara921 replied to the topic Specifications: A double edged sword? in the forum Project Management Knowledge Areas 6 years, 5 months ago
The way that I think about this issue is that having a wider range of specification is good for many reasons. First of all, it gives a lot of leeway in terms of manufacturing the product and using the product. If there is not a strict limitation into the device, then the errors producing during manufacturing wouldn’t be as frequent as producing a…[Read more]
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Dkonara921 replied to the topic Changining staff in the forum Project Management Knowledge Areas 6 years, 5 months ago
The easiest solution would be to consult the heads of your department which is where you received your former team member from and ask if you could get a replacement. This would seem like the best solution because obviously there are other individuals in the company who have the required set of skills for the job. Another potential solution would…[Read more]
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Dkonara921 replied to the topic planned value vs actual costs in the forum Project Management Process and Medical Device Development 6 years, 6 months ago
Both planned value and actual costs matter during this phase because, unlike the other phases, the monitoring and controlling phase takes place for the duration of the entire project. It’s important for actual costs to be kept as minimal as possible for this phase since there is potential for costs to rise during a longer phase rather than a short…[Read more]
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Dkonara921 replied to the topic Factors affect schedule variance (SV) in the forum Project Management Process and Medical Device Development 6 years, 6 months ago
Schedule variance is defined as the difference between earned value and planned value. Some of the factors that can affect schedule variance are mostly contingencies such as: a worker can become ill or severely injured from the project, a vendor that you are relying on has made a delayed shipment, issues with management. If a worker is injured or…[Read more]
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Dkonara921 replied to the topic Lessons Learned in the forum Project Management Process and Medical Device Development 6 years, 6 months ago
Requiring a project team to report on the lessons learned is very important for many different reasons. Firstly, it’s essential for project teams to learn from their experiences so that members can perform better in future projects. Future projects will only run more efficiently if individuals on a project team learn from their mistakes and find…[Read more]
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Dkonara921 replied to the topic Design validation in the forum Project Management Process and Medical Device Development 6 years, 6 months ago
Design validation is important because this is the step where you have to essentially prove that your project was successful. The fundamental purpose behind your project is to develop a product or service that will fulfill a need to a customer, whether it be management or consumers. In the design validation, you have to show that all of your…[Read more]
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Dkonara921 replied to the topic Executing Process in the forum Project Management Process and Medical Device Development 6 years, 6 months ago
I do agree with this statement because the aspects listed are crucial because of their significance. Information distribution is very important because project team members or at least those who should know something must know it. Lack of awareness of something by one person can cripple the entire project execution phase depending on what the…[Read more]
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Dkonara921 replied to the topic Design Validation in the forum Project Management Process and Medical Device Development 6 years, 6 months ago
The way I see it is that the design inputs that you write in must meet the needs of the customer because that is the ultimate purpose of this project. You are doing this project to produce something (e.g. a product or service) that will fulfill the needs of the customer, because he/she is the source of your revenue that your business depends on.…[Read more]
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Dkonara921 replied to the topic Challenges PM face in the forum Project Management Process and Medical Device Development 6 years, 7 months ago
One particular challenge that project managers face is time management. As the leader of the entire team who is responsible for the entire project, time management can be something that is particularly difficult because there is a lot of work that must be done in a finite amount of time. Another reason why time management can be difficult is…[Read more]
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Dkonara921 replied to the topic Factors to look for while evaluating change request in the forum Project Management Process and Medical Device Development 6 years, 7 months ago
There are many factors that must be considered when evaluating a project change request. One such factor would be if the change would alter the business requirements. In other words, does the project try to produce results that the business or company requires? In addition, if the project change would require additional funding that cannot be…[Read more]
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Dkonara921 replied to the topic Unexpected Time Delays – miniSim in the forum Project Management Process and Medical Device Development 6 years, 7 months ago
If the discussion doesn’t produce a solution, then it should be tried again and again until it does because the project team is responsible for everything about the project. It’s important for them to have efficient communication with each other. If there are arguments and tensions between members, then it must be resolved by reminding people that…[Read more]
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Dkonara921 replied to the topic Definition of Risk/Benefit Ratio ? in the forum Project Management Process and Medical Device Development 6 years, 7 months ago
The Risk/Benefit Ratio is a way of comparing the risks of an action to the benefits that will come if that action is taken. If the benefits are relatively high compared to the risks, then it’s mostly worth taking the action because the benefits will outweigh the potential negative consequences that may arise. Also, it gives an indication if it’s…[Read more]
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Dkonara921 replied to the topic Estimating Project Timeline in the forum Project Management Process and Medical Device Development 6 years, 7 months ago
One way to think about solving this problem is to brainstorm any potential risks that may arise while doing the actual project. I think that getting input from people who’ve had experience in doing the tasks similar to the ones that must be done for this project is essential. Input should be taken from not only the team members, but the project…[Read more]
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Dkonara921 replied to the topic Are Missed Milestones really Bad? in the forum Project Management Process and Medical Device Development 6 years, 7 months ago
In my opinion, I think that it really depends on the milestone that you missed and what the results would’ve been had you not missed the milestone. Missing a milestone could make the project run easier because you are focusing on less things and it will most definitely save more money since resources are diverted to other parts of the project.…[Read more]
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Dkonara921 replied to the topic Sucess Factors in the forum Project Management Process and Medical Device Development 6 years, 7 months ago
Agreeing on the project goals is important because the team needs to understand the purpose behind the project and what is expected to come out of their efforts. If every team members understands what the project goals are, they will better understand what is expected of them and what their roles are in the project. Furthermore, it helps keep…[Read more]
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Dkonara921 replied to the topic Planning Phase in the forum Project Management Process and Medical Device Development 6 years, 7 months ago
Another important measure that is important when considering the medical device is how frequently the device will be used by the user or how long the device will last. For instance, if the device is an electronic device, important questions to ask would be: 1) how long will the battery last? 2) Is the device expected to be used daily or weekly?…[Read more]
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Dkonara921 replied to the topic Inputs for Design Input Document in the forum Project Management Process and Medical Device Development 6 years, 7 months ago
Input from any different department (e.g. Marketing, Regulatory, Engineering) can only help in improving the efficiency of the device. There many be someone who doesn’t offer a feasible specification but it can always be rejected. Asking for input from any individual from any other department will allow the project team to address concerns and…[Read more]
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Dkonara921 replied to the topic Unapproved Device in the forum Introduction to Project Management 6 years, 7 months ago
In case of an emergency, an unapproved medical device could be used if there is some enough that is has created positive results and has been tested in trials. As someone previously stated, there are about 4,000 patients each year that the FDA allows physicians to try unapproved devices or procedures. However, this is reserved for people who are…[Read more]
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