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tn58 replied to the topic Product Failure in the forum Product Life Cycle and Product Management 8 years ago
As Viraj and Luisa gave examples of recalling of products. I will add that companies face a lot of financial troubles when the device is being recalled. As any industry has competitors, it gives your competitors a chance to copy your idea and make it more secure. Not only this, but it creates a hype in the public and the shares or investors start…[Read more]
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tn58 started the topic Go or Kill in the forum Product Life Cycle and Product Management 8 years ago
As this week’s lecture talks about “killing a project” or “go” with the project.
As mentioned in the notes, you would typically “GO” with a project if marketplace is attractive, concept aligns with corporate strategy, and resources are available.
My question to all of you is, is it possible that a project was put in the “GO” category and…[Read more]
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tn58 replied to the topic Discussion Topic: Managing the Product Life Cycle in the forum Product Life Cycle and Product Management 8 years ago
Product Introduction is also very important as it follows after Planning and Development. Some of the key aspects in Product Introduction are reviewing project at regular intervals and begin establishing connections to customers. Keeping track of the project during the intervals will be critical in order to make sure that the timeline is being…[Read more]
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tn58 replied to the topic Design Review Meeting in the forum Project Management Process and Medical Device Development 8 years ago
One of my graduate courses I took at NJIT, our final project was to make a product which isn’t on the market and sell the product to your classmates (who were investors, private companies etc).
My partner and I came up with a bandage idea which had healing properties. We provided the materials needed, equipment needed, cutting, production time,…[Read more]
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tn58 replied to the topic Importance of Logging Work in the forum Project Management Process and Medical Device Development 8 years ago
Keeping a log for my current positions is critical. Each meeting, each dollar spent, each appointment, and summary of the nature of the appointments must be submitted to the Director of the EOP program. As a Project Coordinator, I am responsible for making sure that each tutor knows the rules and regulations of NJIT as well as the standards for…[Read more]
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tn58 replied to the topic Cost Analysis of Project in the forum Project Management Process and Medical Device Development 8 years ago
I currently work as a Project Coordinator for NJIT in which I am coordinating an entire project from training to payroll, to dealing with students and tutors. Initially, it was planned each tutor can make up to $700 per semester and the hours/tasks will be documented as the program continues throughout the semester. As I am currently in the last…[Read more]
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tn58 replied to the topic PM: Quality Assurance Process in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
As Betty explained the tasks needed to be performed by the PM to obtain accurate assessment of quality assurance of the project. To add to the next step, I would say that executing process, design verification and validation are where time management really kicks in. Everything is planned prior to that but this is where the PM actually needs to…[Read more]
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tn58 replied to the topic Challenges PM face in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
Agreeing with Betty, another challenge a project manager faces is budget information. Often times, budget information is not distributed to project managers and they are unable to time their projects. And often times when the project is almost finished but the company can no longer afford to keep the team members or contracts expiring, this is…[Read more]
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tn58 replied to the topic PM: Handling Team Issues in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
First of, I would talk to the individual team member to make sure everything is going well. As a project manager, it is your duty to make sure each member of the team is in the right mind when coming to work. As far as taking absences or vacations, when you get hired you are a lotted a certain paid time off and I would make sure I speak to each…[Read more]
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tn58 replied to the topic Validation Expiration in the forum Process Validation and Process Risk 8 years, 1 month ago
In my opinion, it would depend on the company. Original validation would expire because changes are made within equipment and those changes need to be validated to assure that the equipment will produce accurate results. It would be a on a case to case bases. For example, a mass spec used in a major product would not need to be re-validated.…[Read more]
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tn58 started the topic Comparing Knowledge of FDA, EU, etc before and after this course in the forum Process Validation and Process Risk 8 years, 1 month ago
I wanted to ask everyone taking this course, how much has this course helped you? Has your understanding of how companies follow and operate under FDA, EU, and other regulations enhanced?
I personally have benefited a lot from taking Dr. Simon’s courses, I was able to understand how a product is thought out from step one. Not only doing these…[Read more]
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tn58 started the topic Comparing Knowledge of FDA, EU, etc before and after this course in the forum Process Validation and Process Risk 8 years, 1 month ago
I wanted to ask everyone taking this course, how much has this course helped you? Has your understanding of how companies follow and operate under FDA, EU, and other regulations enhanced?
I personally have benefited a lot from taking Dr. Simon’s courses, I was able to understanding how a product is thought out from step one. Not only doing these…[Read more]
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tn58 started the topic Comparing Knowledge of FDA, EU, etc before and after this course in the forum Process Validation and Process Risk 8 years, 1 month ago
I wanted to ask everything taking this course, how much has this course helped you? Has your understanding of how companies follow and operate under FDA, EU, and other regulations enhanced?
I personally have benefited a lot from taking Dr. Simon’s courses, I was able to understanding how a product is thought out from step one. Not only doing…[Read more]
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tn58 started the topic Simulation in the forum Process Validation and Process Risk 8 years, 1 month ago
Looking at this week’s simulation,
if you were the customer Arugalo Medical how would you modify your timeline if the component you need from a vendor will be delayed for an unknown time period. Since it is critical component what action will you take to make sure this never happens again.
My answer to this question would be to make sure my…[Read more]
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tn58 started the topic Benefits of this course in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
Hi Guys,
So I know we all have been posting discussion questions regarding simulations and all the lectures each week. However, I wanted to get your input on what you think so far about this course?
My personal experience, I took medical device development with Dr. Simon two semester ago and currently my last semester at NJIT, I am enrolled in…[Read more]
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tn58 started the topic Benefits of this course in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
Hi Guys,
So I know we all have been posting things regarding simulations and all the lectures each week. However, I wanted to get your input on what you think so far about this course?
My personal experience, I took medical device development with Dr. Simon two semester ago and currently my last semester at NJIT, I am enrolled in both of Dr.…[Read more]
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tn58 replied to the topic Are Missed Milestones really Bad? in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
I’m not sure exactly what your question is asking. But in my personal opinion I do not think missing a milestone is a link to future success for a company in the long run. For example, when you miss a milestone, you most likely are compromising on understanding your product better and you are taking a risk when you rush through the timeline. When…[Read more]
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tn58 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 was a project manager for this week’s simulation in a real life situation. I would get in contact with everyone from day 1 so there is no falling behind. I would make a WBS and assign parts of the simulation to each person in the team. For example, every single person would be asked to do their own research and bring their findings to the…[Read more]
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tn58 replied to the topic Process Revalidation in the forum Process Validation and Process Risk 8 years, 1 month ago
I do not think the processes have to be revalidated because of multiple locations. However, I will add that the quality team may have argued this if they saw that each location would impact the equipment in someway which may change the end results. That is the only way I see the quality team arguing this. If the location influences the end result,…[Read more]
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tn58 started the topic FDA vs. ISO in the forum Device Documentation 8 years, 1 month ago
According to the lectures,
Process Validation according to the FDA is defined as “results of a process cannot be fully verified by subsequent inspection and test.”
And process validation according to ISO is defined as “processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or…[Read more]
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