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eac25 replied to the topic "Discussion Topic: Realities of Planned Value" – 5 years, 11 months ago
One the biggest problems that can arise from an overestimated budget is of course layoffs. Not only will you lose employees who have been contributing to the project, the potential demoralizing effects on the rest of your employees will make… Read more»
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eac25 replied to the topic "Discussion Topic: The critical path" – 5 years, 11 months ago
When I was working with a 3D-printed foot orthosis project one of our side projects was testing out other possible materials to print it with. We had gotten all the way toward refining the final print design when we had… Read more»
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eac25 replied to the topic "General Wellness Product" – 5 years, 11 months ago
This may be a strange angle to take, but I think those “energy wristbands” that were a mild craze a while ago can be considered a general wellness product. These were ordinary bracelets that were advertised to give you more… Read more»
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eac25 replied to the topic "LifeVest Wearable Cardioverter Defibrillator" – 5 years, 11 months ago
For the mobile application, if the only function of the application was to show the heart rate I believe it still would be subject to FDA regulation. It certainly would have an easier time passing FDA hurdles than if there… Read more»
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eac25 replied to the topic "Simulations" – 5 years, 11 months ago
I believe having in-person meetings would definitely have made for a more efficient use of time. When you’re part of an online class where you may not necessarily be able to meet with your group members in person, it’s imperative… Read more»
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eac25 replied to the topic "Validation vs. Verification" – 5 years, 11 months ago
During one of my past internships I was part of a project where we had to program a website to monitor flooding. The verification of that project was essentially whether or not the website functioned. This consisted of learning the… Read more»
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eac25 replied to the topic "Tests for validation and verification phase" – 5 years, 11 months ago
For verification, it’s important to note that tests aren’t the only acceptable verification activities; a company can also utilize inspections and analyses for their requirements, which can sometimes be cheaper and/or less time-consuming than tests. Some examples of these alternate… Read more»
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eac25 replied to the topic "Thalidomide's Impact on Regulation and the FDA" – 5 years, 11 months ago
My follow up question is, do strict policies stunt medical innovation and economic growth? This is a really good follow up question to think about. I believe strict policies do stunt medical innovation and economic growth, but it is necessary…. Read more»
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eac25 replied to the topic "Mobile Medical Applications" – 5 years, 11 months ago
I find this point about the Fitbit app very interesting. I myself own a Fitbit and the associated app, and this app allows you to monitor various things such as sleep patterns, physical activity, and even heart rate (if your… Read more»
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eac25 replied to the topic "Meat without Murder" – 5 years, 11 months ago
I agree with gingeranderson, if we’re hypothetically talking about getting technology to the point where artificially grown organs are nearly indistinguishable from human organs, then it would fall under the responsibility of CBER to regulate these organs. However, I believe… Read more»
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eac25 replied to the topic "Discussion Topic: The 510k Process" – 5 years, 11 months ago
It seems that a recent lawsuit about power morcellators in 2014 has brought up this issue again. Dr. Amy Reed underwent surgery to remove uterine fibroids using laparoscopic power morcellation, an otherwise routine hysterectomy. In this process, a tool is… Read more»
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eac25 posted a new topic "Potential FDA Changes under Trump" – 5 years, 11 months ago
This concerns information we covered past in week 2 but I feel like this is a pretty relevant topic. Based on a recent executive order that Trump has made, it seems that Trump is trying to cut the amount of… Read more»
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eac25 replied to the topic Disconnect in rewarding motivation in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
This disconnect doesn’t really surprise me. It’s very easy for someone who didn’t spend much time working on a specific project (usually upper management) to take a quick look at some metrics they might have available (hours worked, number of lines coded, etc.) and quickly but inaccurately award people that may not have deserved it if they asked…[Read more]
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eac25 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
After becoming more familiar with managerial roles over this past semester, I can say that I don’t particularly want to become a manager anytime soon. I have a newfound understanding and appreciation for what managers do, but I think I’ll use that knowledge to be a better employee rather than become a manager. I think once I have more…[Read more]
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eac25 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
I think my biggest potential motivator is good coworkers. I’ve made some real lasting friendships through work that have carried on even after parting jobs. It’s interesting for me to learn more about people and it goes a long way towards building a stronger team for the job at hand. I also feel like strong social interactions help out in…[Read more]
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eac25 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
I think these reasons will definitely vary based on the kind of work people do. I think these numbers are pretty reasonable for a private sector engineering job, and generally within my expectations. When you get down to more part-time service or retail industry work however, that’s when I think money is the main motivator. That isn’t to say that…[Read more]
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eac25 replied to the topic Discussion Topic: Scope creep….when your project changes in the forum Project Management Knowledge Areas 7 years, 12 months ago
The first capstone project I was assigned to suffered from scope creep, or rather a lack of scope definition. When the professor was describing the project at first, it was rather vague and only described the subject that the project would be about; in this case, it was based around the 3D imaging software MIMICS. After our group had decided to…[Read more]
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eac25 replied to the topic Integration PM in the forum Project Management Knowledge Areas 7 years, 12 months ago
I could consider my one summer internship an integration of sorts. I was in charge of designing a website with Google Maps API, and eventually we would have to integrate it with external data coming in through another website. The biggest issue at the time was finding a programming language that would allow for both the processing of the external…[Read more]
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eac25 replied to the topic Procurement Management in the forum Project Management Knowledge Areas 7 years, 12 months ago
Although I haven’t had any direct experience with procurement myself, I’ve caught glimpses of the processes in some previous jobs. When I worked in a restaurant, I often had to go back into storage to refill our supply of cups, takeout bags, etc. When I went back there, I noticed that there was typically a huge amount of whatever I needed to get,…[Read more]
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eac25 replied to the topic Ideal PM Processes vs. Real life in the forum Project Management Process and Medical Device Development 8 years ago
I think in general IPEC is always the framework for projects. What I’ve been told is that this cycle is typically disrupted when other people (usually higher-ups) hand you unexpected challenges and force you to do something.Speaking as something who’s worked under a rather lax project manager, I can say that a project with a very short planning…[Read more]
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