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jvv6 replied to the topic Engineering change order in the forum Project Management Process and Medical Device Development 8 years ago
I definitely agree with the posts above about the whole process of Engineering Change Orders and how beneficial they can be to a specific design of a project. They are used to track any major changes to a design based on efficiently they can improve the design or if it’s to simply fix a mistake. Another benefit I would like to add is because of…[Read more]
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jvv6 replied to the topic Engineering change order in the forum Project Management Process and Medical Device Development 8 years ago
I definitely agree with the posts above about the whole process of Engineering Change Orders and how beneficial they can be to a specific design of a project. They are used to track any major changes to a design based on efficiently they can improve the design or if it’s to simply fix a mistake. Another benefit I would like to add is because of…[Read more]
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jvv6 replied to the topic Challenges PM face in the forum Project Management Process and Medical Device Development 8 years ago
While these are all challenges project managers most likely face on a regular basis I would like to add on specifically to gingeranderson’s input on the lack of people with right skills to do a job. I definitely agree that either resolving this issue internally or outsourcing talent from outside the company then this brings in other conflicts such…[Read more]
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jvv6 replied to the topic PM: Handling Team Issues in the forum Project Management Process and Medical Device Development 8 years ago
Project managers should take the time during the actual development phase of forming the project team could in order to deal with real world issues such as absences, vacations, and obligations to other teams. This is such a critical time to plan ahead of time for these types of occurrences. When forming a project team, it is indeed best to have…[Read more]
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jvv6 replied to the topic Source Selection in Executing Process in the forum Project Management Process and Medical Device Development 8 years ago
I believe that the actual purchasing of raw materials or even contacting with prospective vendors is best carried out while under the execution phase of a project. However, I can see as to why some may feel that it’s best carried out while under the planning phase. Source selection during the planning phase does have its pros as it does pull the…[Read more]
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jvv6 replied to the topic Are Missed Milestones really Bad? in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
We can’t underestimate the setbacks and repercussions missing milestones can cause when it comes to a project. As others have already stated, it costs management time and money. Money may be negligible depending on the dollar amount, but time is something you do not get back. It looks bad on the company’s end to the customers that their are delays…[Read more]
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jvv6 replied to the topic In the Shoes of a Project Manager in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
If I were to play the role as the Project Manager for this week’s simulation, then I would push for everyone to start researching the day the simulation comes out. Since the span of this simulation is only a week’s worth, time management is crucial just like others have already stated in this thread. So as soon as everyone has absorbed all the…[Read more]
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jvv6 replied to the topic Benefits of this course in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
The beauty of this course is that it’s more practical than it is theoretical and really gives students an idea of what’s going on in the real world. Even if you may not be a Project manager and just a regular design engineer, it still gives you a grasp on what goes on behind the scenes while your career path may be focused more on Research &…[Read more]
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jvv6 replied to the topic Missing a Milestone Experience in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
For my senior project, my group members and I were building an adapter for the iron-gym. The scope of it was just a commercialized product to be used in conjunction with another product. The target audience was really suited towards athletes and fitness minded individuals. Our project is meant to undergo a lot of stress and so testing for failure…[Read more]
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jvv6 replied to the topic Discussion Topic: The critical path in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
I also have had an issue in the past with my senior project when it came to the Critical Path. During my senior project a lot of the group members thought we knew how to run simulations and so we accounted for it only taking up maybe three days at most. However, when we finally came to this step, we didn’t realize how complex the geometry of…[Read more]
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jvv6 replied to the topic Revising a Gantt Chart in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
As others have already stated, a lot of the time and effort into Research & Development and modifications on test protocols and exploration on how to fix this issue will be necessary. One thing I would like to bring up is if this type of occurrence was already accounted for, then it would have been considered project slack. Depending on how much…[Read more]
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jvv6 replied to the topic Discussion Topic: The proper time for Project Initiation in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
How much information is needed in order to begin a formal project is solely dependent on what is already known about the the technologies surrounding the prospective project. Like in the above example you provided, the biomaterial that’s been in development for nearly a decade will probably not need as much research regarding the pros and cons of…[Read more]
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jvv6 replied to the topic how the PM handles budget cut? in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
I agree with the above and believe the budget cuts will indefinitely have some marginal affect on cost estimation. It really is up to the project manager, and the project team on how the project can still be carried out and turn out to be a success with a new budget they’re working with. Cost estimations will be skewed with the newly reduced…[Read more]
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jvv6 replied to the topic Discussion Topic: Integrating Six Sigma into Project Planning in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
I am not too familiar with the Six Sigma tool, but I understand that it’s very beneficial to have within an industry that mass produces. When it comes to the Project Planning Process, the Six Sigma tool without a doubt would be integrated with Risk Management. From the lecture Risk Management is done in rounds, and the first round is done in the…[Read more]
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jvv6 replied to the topic General Wellness Product in the forum Introduction to Project Management 8 years, 1 month ago
Another product that I believe could be classified a general wellness product would be the opposite of dehumidifiers, humidifiers. Unlike their counterpart they’re mostly used in the winter time. I remember during undergrad I would have those weird roommates who’d keep the window slightly open and it actually made sleeping really uncomfortable…[Read more]
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jvv6 replied to the topic General Wellness Product in the forum Introduction to Project Management 8 years, 1 month ago
In the summer, whenever it was one of those hot summer days sometimes a dehumidifier is used to reduce the humidity levels of your household. Dehumidifiers are basic household appliance that I believe can be classified as a general wellness product because of its uses. Since they reduce household humidity levels, this reduces the likelihood of…[Read more]
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jvv6 replied to the topic Ideal project team in the forum Introduction to Project Management 8 years, 1 month ago
When it comes to an ideal project team, it’s all subjective in the sense of what industry it’s in or what product/service the company is trying to provide. So depending on the industry or product, I’d want team members with prior experience in that respective industry. So if I’m in the medical device field, I’d want marketing and engineering team…[Read more]
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jvv6 replied to the topic Mobile Medical Applications in the forum Introduction to Project Management 8 years, 2 months ago
I agree and believe your senior project would be classified as a “mobile medical app.” As you stated, the FDA did claim that “mobile medical apps” are intended to be “used as an accessory to a regulated medical device. Your app seems to do just that. Hearing aides are indeed FDA regulated medical devices and your app is being used in conjunction…[Read more]
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jvv6 replied to the topic Mobile Medical Applications in the forum Introduction to Project Management 8 years, 2 months ago
I agree and believe your senior project would be classified as a “mobile medical app.” As you stated, the FDA did claim that “mobile medical apps” are intended to be “used as an accessory to a regulated medical device. Your app seems to do just that. Hearing aides are indeed FDA regulated medical devices and your app is being used in conjunction…[Read more]
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jvv6 replied to the topic Combination Products in the forum Introduction to Project Management 8 years, 2 months ago
The necessary steps to take in order for a combination product to get FDA approval is to first find out what is the main purpose of the product itself. I just want to highlight how important it is for a product to identify its main functional requirement. There were a couple of examples from lecture of how there can be a different combination of…[Read more]
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