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smitshah replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years, 8 months ago
FDA need to be rigid and strict in order to make sure that good quality products are launched which in any way does not harm people on use, because they are someone who are trusted by so many people with there life. I would also agree that the way FDA approval procedures are laid that is somethings that takes long for approval. If FDA tries to…[Read more]
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smitshah replied to the topic Ethics of Animal Testing in the forum Pre-clinical Device Development 7 years, 8 months ago
As far as science goes there is still no alternative to animal testing. There are animal model available and being currently developed but if you see the from bio chemical prospective which is a mystery in itself. If company develops a drug or bio-material than without animal testing its almost impossible to identify how would they react within…[Read more]
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smitshah replied to the topic Research for the Fututre or Now? in the forum Pre-clinical Device Development 7 years, 8 months ago
Research in advancement and exploration of the unknowns in the wild. There is no definitive path if in the path we have a urge to know there are thing for which we can’t give any reason for something which is left behind we may have to change our path to find the reason because it is something which may raise question on our topic in future. So I…[Read more]
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smitshah replied to the topic Academia vs. Industry Research in the forum Pre-clinical Device Development 7 years, 8 months ago
I work as a researcher in academia I would definitely tell that in academia we learn more thing than in industry because its basically application of what we know but where as in academia we learn new things more frequently at your own pace and even carry experiment at our space there is no hush for deadline to be chased. Even quality of results…[Read more]
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smitshah replied to the topic Milestones Missed: Failure or Success? in the forum Intro to Project Management 7 years, 8 months ago
If a milestone is missed I would consider it as failure on the initialization and planning stage of the project cycle. If a milestone is missed especially on the red path which THE most important path for the project cycle it would be a major back log and tough one to recover from in order to complete the project on life cycle.
This can be…[Read more] -
smitshah replied to the topic Obstacles while working on a project in the forum Intro to Project Management 7 years, 9 months ago
I had taken up a project during my final year of BE where in I created a member of four like minded people to work Functional Electric Muscle Stimulator. We had in total of one year to complete the project and had to to submit status report apart six months. While doing this project in order to prove its contribution and effectiveness in current…[Read more]
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smitshah replied to the topic Project Life Cycle in the forum Intro to Project Management 7 years, 9 months ago
I think in project life cycle there cannot be any single phase that can be more important than other because the end project would be a result of proper research and approach (i.e is initiation phase) well developed plan, thoughtful execution of the plan and timely monitoring and bringing changes when and the very end proper analysis of the whole…[Read more]
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smitshah replied to the topic Discussion Topic: Academia vs. Industry in the forum Introduction to Medical Device Development 7 years, 9 months ago
I have experience in both the fields,even though I worked in industry only for a limited time and lately I have been working as a research student in academia. I think working in academia as a researcher you can learns lots of things and in very very detailed way but I would also mention that this detail might not be really be important to many…[Read more]
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smitshah replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 7 years, 9 months ago
In order to achieve perfect balance between the two I think the length of the course should be increase or the course should be splitted in two semester where in in one semester basic theory and practical implication can be covered and in the advance course it should be more assignments and knowledge from industrial point of view. If the course is…[Read more]
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smitshah replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 7 years, 9 months ago
I believe that its neither practical nor informational courses which by itself can provide sufficient knowledge. Its always a right balance between the two which can impart great skills into a student. For example if we do litmus test experiment in chemistry without understanding what are acid and what are bases and how they regulate chemical…[Read more]
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smitshah became a registered member 7 years, 9 months ago