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Shachi 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 the project manager for this week’s simulation, first and foremost
1. I would have come up with a game plan for the simulations by defining the timelines that can be achieved realistically.
2. Afterwards, I would have assigned the work to the team members by applying work breakdown structure(WBS) on the simulation.
3. Next step would…[Read more] -
Shachi replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
I came across an article on implant dentistry, where the dental claims related to implants often have a high degree of severity. And there were several reasons illustrated for these high claim severity. One, implant dentistry is reallu expensive and costs patients anywhere from $5,000 to $40,000. Second, the patients usually have high functional…[Read more]
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Shachi replied to the topic Work Breakdown Structure in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
I agree with everyone regarding working in the team and using the Work Breakdown Structure(WBS) for assigning the work to the team members. There are few more points i would like to add to the discussion:
1.To successfully use a WBS, the project manager needs to prepare a ‘to do list’ for the project which is very similar to a grocery list one…[Read more] -
Shachi 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
The DMAIC process of Six Sigma involves defining and quantifying a problem, collecting the data and clarifying the problem, tools are used to resolve the problem from the root, and finally, the improved operations are used as control to prevent recurrence of the problem. The toolkit of Six Sigma includes a variety of techniques, such as…[Read more]
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Shachi 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
The DMAIC process of Six Sigma involves defining and quantifying a problem, collecting the data and clarifying the problem, tools are used to resolve the problem from the root, and finally, the improved operations are used as control to prevent recurrence of the problem. The toolkit of Six Sigma includes a variety of techniques, such as…[Read more]
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Shachi replied to the topic Discussion Topic: Design and Process Verification in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
The Execution Phase of any project plan is to make sure all the activities of the project that were planned are carried out in an effective and efficient way.The verification test designed for the execution phase depends heavily on the plans developed in the Planning Phase. Though the rule of following the verification design protocol in the…[Read more]
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Shachi replied to the topic Discussion Topic: Realities of Planned Value in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
In every company the project is planned based on the resources available. If the budget is bigger, more people can be roped in to finish the project more quickly and deliver more. Therefore, no project planning is complete until you come up with a budget. It doesn’t matter whether the project is big or small, or how many resources are available or…[Read more]
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Shachi replied to the topic Simulations in the forum Introduction to Project Management 8 years, 1 month ago
One major difference between a virtual team over real industry team is that the team members can pitch in at their own comfortable timings. So usually its the two or three members at a time who will be discussing the new ideas instead of all of them present at the same time and trying to be audible to each other as it happens in the face to face…[Read more]
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Shachi replied to the topic Simulations in the forum Introduction to Project Management 8 years, 1 month ago
One major difference between a virtual team over real industry team is that the team members can pitch in at their own comfortable timings. So usually its the two or three members at a time who will be discussing the new ideas instead of all of them present at the same time and trying to be audible to each other as it happens in the face to face…[Read more]
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Shachi replied to the topic Ideal project team in the forum Introduction to Project Management 8 years, 1 month ago
I totally agree with Robert and jvv6 regarding the ideal project team. Apart from that all the team members should be open to new ideas. Its always better to have people from different fields in a team which brings about a diversity in the work culture. As a heterogeneous team generates the best ideas. At the same time the team members must…[Read more]
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Shachi replied to the topic LifeVest Wearable Cardioverter Defibrillator in the forum Introduction to Project Management 8 years, 1 month ago
I agree with bb252 that it is definitely a Class III device as it poses high risk to the patients. But this device is generally used under the condition where the patient has a weak heart and implanting ICD is not an option and is likely to benefit from its usage. Apart from that it overcomes some of the limitations of ICD’s with respect to…[Read more]
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Shachi replied to the topic How to initiate project successfully in the forum Introduction to Project Management 8 years, 2 months ago
For any project to be launched successfully and get a sponsorship, it should follow the following six steps:
Step 1: Create a detailed business case for everyone to know what the exact the business requirements are. It will be the foundation of the project.
Step 2: Do a Feasibility Study to determine the solutions for the business requirement.…[Read more] -
Shachi replied to the topic Toxic Medicine in the forum Introduction to Project Management 8 years, 2 months ago
The homeopathic medicine has been practiced for more than 200 years and is based on the principle where
pharmacologically-active agents are administered to treat the symptoms of a disease. Homeopathic products
come under the category of over-the-counter (OTC) or prescription medicines as compared to allopathy medicines as they are considered to…[Read more] -
Shachi replied to the topic Potential FDA Changes under Trump in the forum Introduction to Project Management 8 years, 2 months ago
It’s indeed a very interesting topic to debate upon. According to the latest data on time taken by FDA on the product approval varies from 6 to 10 months. Relaxing the regulation a bit would definitely expedite the whole process. But at the same time, we don’t want another thalidomide episode. Its going to be a big challenge to find an…[Read more]
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Shachi replied to the topic Human Factors study in combination products in the forum Introduction to Project Management 8 years, 2 months ago
Human factors is the study of the interaction of people and technology to ensure that a good compatability exists between the human beings and the device,manufactured to address a disorder or a condition. In addition to that, it provides safety and efficacy to that interaction which includes the user interface, instructions,and training programs…[Read more]
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Shachi replied to the topic Difference in the forum Introduction to Project Management 8 years, 2 months ago
A project manager is a person who is responsible for the successful planning, design, execution,
monitoring, controlling and closure of a project. Their main role is to come up with solutions or approaches that facilitate the commercialization of that particular brand or product. This job title is present in many different industries such as…[Read more] -
Shachi replied to the topic Discussion Topic: To trial or not to trial in the forum Introduction to Project Management 8 years, 2 months ago
Any Design Validation procedure comprises of the tests required to demonstrate the functions of the medical device as expected and it should meet the needs of the user. It incorporates inspection and analyses as part of validation in addition to testing.
Any given medical device includes the label, the instructions for use, the packaging, and…[Read more]
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Shachi became a registered member 8 years, 2 months ago