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rjs84 replied to the topic "Determining project priority" – 5 years, 10 months ago
I think the definition for a project and the experiences you have listed actually complement one another. What I mean by this is that in the beginning a project created with the criteria listed as having a defined beginning and… Read more»
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rjs84 replied to the topic "Program Management" – 5 years, 10 months ago
I think we can all agree that all those responsible for a project, ranging from the upper management all the way down to “lowest level” employee needs to be on the same page requiring transparency and harmonization as previously mentioned…. Read more»
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rjs84 posted a new topic "Executing Process" – 5 years, 10 months ago
Part of the executing process involves information distribution, solicitation, source selection, and managing vendor relations. Most of the time and money of the project go into its execution. I would argue that the parts of the executing process I mentioned… Read more»
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rjs84 posted a new topic "Flaw in the design process" – 5 years, 10 months ago
After last week’s focuses on the phases of a project and design controls. This combined with FDA regulations lays out a very strict process for which a medical device is to be created. This week’s forum involved one post about… Read more»
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rjs84 posted a new topic "Interpersonal skills vs technical knowledge" – 5 years, 10 months ago
According to Daniel Goleman, success can be broken down to be 70% interpersonal skills and 30% technical knowledge. The idea of this balance being in favor of interpersonal skills is not what I am questioning. A Forbes article titled “Intelligence… Read more»
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rjs84 replied to the topic Optimizing Clinical Trials Using Technology in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
The medical field has seen great advancement in creating digital networks for patient information. I think a similar system can be put in place for project management. Many components of a project are now outsorced including clinical trials. Keeping digital documentation would be easier to transfer each part of the project from one source to…[Read more]
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rjs84 replied to the topic What is retention ? in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
In theory, there should be a direct correlation between talent of an employee and his or her performance. If this were the case, it would make sense to retain the most talented employees at all costs. In reality, the relationship between performance and talent involves other variables. Motivation is one such variable. A lack of motivation can…[Read more]
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rjs84 replied to the topic Factors to look for while preparing schedule and budget for Clinical Trial in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
When preparing the budget for a clinical trial, it needs to be flexible. If the trial goes over-budget, the sponsor must cover the cost. Budget items can be categorized in one of two ways: 1) fixed and upfront costs which are needed for study conduct and are incurred whether or not a subject is enrolled and 2) costs related to subject visits.…[Read more]
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rjs84 replied to the topic Deadlines and SOP's in the forum Project Management Knowledge Areas 6 years, 11 months ago
Preventative management is ideal. In a sense, reactive management leads to more of the documentation and other factors that you mentioned can lead to delays in progress. Preventative management is the best way to keep to a time and cost budget. However, it is possible to go through an entire project without needing any reactive management.…[Read more]
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rjs84 replied to the topic Discussion Topic: Risk Analysis methods in the forum Project Management Knowledge Areas 6 years, 11 months ago
The Monte Carlo Simulation can be used to model uncertainty in inputs or any problem having a probabilistic interpretation. It can be used to create prices for assets based on an average of hundreds to thousands of hypothetical scenarios.
Because this analysis is ultimately a statistical test, many of its drawbacks come from the assumptions that…[Read more]
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rjs84 replied to the topic QA vs QC in the forum Project Management Knowledge Areas 6 years, 11 months ago
The easiest way to categorize these two is to say that quality assurance deals with verification while quality control deals with validation. QA looks to prevent quality problems through planned and systematic activities. Their main goal is to improve development and test processes so that defects do not arise when the product is being…[Read more]
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rjs84 started the topic Executing Process in the forum Project Management Process and Medical Device Development 7 years ago
Part of the executing process involves information distribution, solicitation, source selection, and managing vendor relations. Most of the time and money of the project go into its execution. I would argue that the parts of the executing process I mentioned at the start of this post are actually the most important parts of the project and…[Read more]
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rjs84 replied to the topic Medical Devices in the forum Project Management Process and Medical Device Development 7 years ago
I think each situation has different repercussions. Failing of experiments is something that should be accounted for during planning. Excessive failure of experiments may show that the project is not as feasible as was thought and should be terminated. I think the other situations listed are slightly less predictable. We saw a similar situation…[Read more]
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rjs84 replied to the topic Work Breakdown Structure in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
One experience that I had with this was in my undergraduate research. The research I was doing was in collaboration with another lab on campus. The other group with electrospin PLLA based fibers and then I they would send them to me to mechanically characterize them. Doing a collaboration between two groups like this comes with a number of…[Read more]
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rjs84 replied to the topic Communication and Responsiveness in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
This was something that was a very common issue when I took capstone. First of all our capstone group of 5 people had many individual commitments that made it very difficult to meet at the same time. One way that we addressed this was to break up into even smaller groups that could all meet at the same time and would focus on specific parts of…[Read more]
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rjs84 replied to the topic Missing a Milestone Experience in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
Similar too many other people who responded, I also experienced some setbacks during my capstone project. The project was to design an adhesive that would be applied to a graft intended to block a cerebral spinal fluid leak. Our initial timeline involved having nearly 2 months to test our prototype. Unfortunately the materials we purchased took…[Read more]
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rjs84 replied to the topic Project Scope: When the timeline you have doesn't work in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
I don’t think that a company can authorize any of the unethical examples you just suggested. If a new regulation was established, designing a placebo study to circumvent this regulation would not only be unethical but most likely illegal. The first option in this scenario would be to attempt to reevaluate the schedule and see if it is still p…[Read more]
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rjs84 replied to the topic Change in PM in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
This is a great question but I think it needs to be specified why the change in PM occurred. If it was due to that person leaving your company to take another job or personal reasons… etc. I believe the new PM should more or less ensure tasks are completed in the manner they were originally prescribed. However, this person will also be…[Read more]
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rjs84 replied to the topic The best strategy in running Risk Management Meeting in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
As a project manager the first thing I would do is brainstorm with my team all of the possible project and product risks in the initial risk management meeting. For future meetings I think it would be important to balance both a macroscopic and microscopic view of related risks. The major risks involved always need to be considered but time…[Read more]
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rjs84 replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 7 years, 1 month ago
I believe your post actually involves two different questions. You originally talked about project risks but then asked for an example of a product risk. Product risks refer to potential defects within the product itself. This could be something like designing a software that will need to continue to be updated after the product is initially…[Read more]
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