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jad73 replied to the topic "Types of Corporations" – 5 years, 10 months ago
If I were to be an owner of a business, I would want to own a piece of an LLC. A LLC can have multiple owners including corporations. Therefore, the possibilities are endless in addition to being able to sell… Read more»
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jad73 replied to the topic "R&D vs Quality" – 5 years, 10 months ago
Sounding off to the previous posts. I think that R&D and Quality Assurance/Compliance conflicts in most cases due to the differences in the role they play and the overall objective they need to meet. Quality assurance/compliance dictates whether each or… Read more»
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jad73 replied to the topic "Quality Control and Quality Assurance + Ethics" – 5 years, 10 months ago
Echoing on what dh239 posted; This is what happened in the Ford Pinto case. The company knew that there was a flaw in the design and they did the risk analysis and calculated the amount that would be needed to… Read more»
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jad73 replied to the topic "Discussion Topic: The cost of Quality" – 5 years, 10 months ago
Although quality can be burdensome due to several factors mentioned in majority of the posts here; I think that its worthwhile for companies to implement it, especially for companies in the medical/healthcare space. Quality Assurance/Control makes sure that the processes… Read more»
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jad73 replied to the topic "Ethics of Animal Testing" – 5 years, 10 months ago
As of now, animal testing is the closest we can get when it comes to testing new medicines, vaccines or medical devices on a living subject before moving on to actual human subjects. This is due to the limitations in… Read more»
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jad73 replied to the topic "Approaches to Research" – 5 years, 10 months ago
In the industry research is done by scientists or engineers as oppose to grad-students or post-docs in academia. I think that researchers in the industry setting is a better approach since you have a wider selection of candidates that will… Read more»
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jad73 replied to the topic "Research for the Fututre or Now?" – 5 years, 10 months ago
I think research that will yield results to be used for now can lead to research ideas that can be improved upon; which will then pave the way to a research study that will be used for future generation or… Read more»
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jad73 replied to the topic "Milestones Missed: Failure or Success?" – 5 years, 10 months ago
In Capstone I and II, there are several milestones set to ensure completion of the project at the end of the 2 semester course. Here, if milestones were met its marked completed but if it is missed; a team must… Read more»
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jad73 replied to the topic "Manager Vs Engineering" – 5 years, 10 months ago
Managers and engineers play completely different roles in projects, which can cause ethical dilemmas that has no clear answer(s). Managers are mostly concerned with the end results where they must meet certain deadlines, budget and etc. to make a profit… Read more»
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jad73 replied to the topic "Discussion Topic: Project Management in a medical device setting" – 5 years, 10 months ago
I think that the main challenge project management for medical devices face is the lengthy time of certain projects. This is mainly due to the rigorous protocols and strict regulations enforced by the FDA or other regulatory agencies alike. Since… Read more»
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jad73 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics 7 years, 4 months ago
I think this class is truly an eye opener because the materials that were covered here weren’t really discussed in the undergraduate level; there were mentions here and there but never really discussed thoroughly. This class has shown me another aspect of device development, outside of R&D and theory; which also showed me more career options…[Read more]
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jad73 replied to the topic Non Compete Agreement in the forum Consultants and Legal Basics 7 years, 4 months ago
I think that its not fair to have a non-compete agreement that will last a long time, e.g. 6+ months, especially for the newly graduated people because its not as if the company is gonna sustain you when you leave or get fired. You are basically on your own and not having a job for that long can be rough. It’ll also affect one’s chances of getting…[Read more]
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jad73 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 7 years, 4 months ago
Written agreements are definitely much better than verbal agreement. As most of the participants mentioned here, that written agreements are easier to defend in court because you have a document that is legally binding which is easier to use in court if things went awry. This is also the main reason why documentation is stressed a lot not just in…[Read more]
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jad73 replied to the topic Collaboration projects in the forum Organizational Development in Device Companies 7 years, 4 months ago
I agree with @tilak‘s post. I think that the matrix organization will allow for a more open communication between staffs of each company which will result in a clearer, defined goals in which everyone involved will be on the same page all throughout the completion of the project. I also agree that there will be an indirect system of checks and…[Read more]
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jad73 replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies 7 years, 4 months ago
I think I can do both. I’m more suited starting out in a middle management role then transitioning to upper management. It goes in line with what @Scott said where upper managers would be best if they spent some time with the company as a middle manager. I think that being able to complete/fulfill a task on a daily/weekly basis is a fulfilling…[Read more]
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jad73 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies 7 years, 4 months ago
From personal experience, I think that its better to work with people who you don’t personally know but knowledgeable in the role they’re playing on a project. For Capstone I and II, I worked with people whom I’ve never met from previous classes but they were knowledgeable of the things that they’re supposed to do. The team dynamics were somewhat…[Read more]
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jad73 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I think that its only fair that getting a hold of these standards for regulations because these standards are what can possibly save a company from a lawsuit. However, sometimes regulatory standards are not enough measure to prevent injuries. I remember from one of my classes where the issues with the design on the Ford Pinto had caused the car to…[Read more]
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jad73 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
This phrase does pose a difficult situation because gauging “As Far As Possible” is pretty much relative. However, I think that thorough assessment of risks involved ,whether it be severe or minor, and providing solutions to either avoid or mitigate these risks is best. This would also tie into another discussion topic regarding risk management…[Read more]
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jad73 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I completely agree with the notion that risk management documentation should be considered a living document. I think that updating risk management documentation based off of feedback and complaints after its out on the market is important to improve processes as well as the quality of the product. This can also help identify products that needs…[Read more]
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jad73 replied to the topic Why VERIFICATION is important? and Your ideas to improve Verification process ? in the forum Introduction to Design Controls 7 years, 4 months ago
Verification is important because this ensures that the product meets the requirements for the design of the product. This is verified by executing a test plan to verify that it’s within the accepted tolerance described in the requirements document. Verification makes sure that the product would not cause any harmful side effects due to a faulty…[Read more]
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