A critical thing to note about a verbal agreement is that it often comes with a paper trail and can have many forms of evidence to back it up, despite it being “verbal” in nature. Verbal here simply means that there was no formal contract written for the agreement.
For example, there can be a verbal agreement to sell a house for a certain amount…[Read more]

Stark law restricts the physician from referring patient to a designated place where he or his family members has a financial relationship unless an exception is met. It is intended to eliminate financial motivation for a physicians to refer a patient to a lab or hospitals for unnecessary tests or treatment in order just to get money.The…[Read more]

NDA only gives you protection from the individual in the contract, in which they promise to keep the idea confidential. A patent grants you proof of ownership and full protection for your idea. The main difference can be shown by an example – let’s say you have an idea to develop something and you share that idea with person A and sign an NDA with…[Read more]

Being a project manager for a matrix organization can be a lot more challenging and requires more communication and organizational skills, but ultimately it can be more rewarding. There is another project manager who the employees have to report to, and who the project manager has to coordinate with. It is kind of like checks and balances in the…[Read more]

I think that even in a project based organization, they can still make efforts to collaborate between departments. For example, there can be monthly presentations given by a member of one team to all the different teams and this way departments can share knowledge with each other and this meeting also allows for people to become acquianted. In the…[Read more]

My ideal type of company to work for would be a matrix organization. I think it is beneficial to the company’s productivity that departments communicate with each other and can transfer knowledge about the project with other departments. This would seem to make a company run more smoothly and effectively. I think to successfully run a project…[Read more]

A Gantt chart is essential for staying on track and getting the project done in a timely manner. I can tell you from experience that working with companies that don’t set out a timeline or set clear goals, work is slow and not very productive. It is also essential to come up with a “contingency plan” in order to be able to complete the task on tim…[Read more]

When design controls are not set up properly, it results in a failed medical device as stated by those examples above. In the case of recalled medical devices, it would be interesting to study and review their design controls and analyze errors and what could have been done differently. It would also be interesting to study what those companies…[Read more]

From my experience in clinical research, one such document required by the FDA is an IRB, Institutional Review Board. This document is necessary to protect the welfare and rights of human subjects by ensuring that your experiment will not harm those involved. This is the very first step in running an experiment and needs to be approved before you…[Read more]

Design transfer involves transitioning the design from planning stages to production. This is a critical trade-off that requires a few things in order to go smoothly. One is communication between departments, which is essential. Another is a multitude of technical factors, such as proper funds and vendors to work with the company in creating the…[Read more]

Yes I agree that design control is an integral process and its failure can have a wide effect. If not done properly, the company will have to make recalls on the product which results in a large loss of money and time. Even worse, if it is a medical device and there is a flaw in its design that is not caught by design controls, it can harm a human…[Read more]

I think it is very complicated to get IRB approval for a clinical trial where the outcome is unknown. The IRB wants to make sure that a device will offer no potential harm to any subjects, and this is a case where the outcome is unknown and the researcher can’t be sure that no harm will be done. Thus this is not a likely area for students to…[Read more]

I think it depends on the study matter and double blind is not always necessary. Yet there are certain cases where double blind would be preferable. It is used to prevent research outcomes from being influenced by the placebo effect or observer bias. If a researcher knows that certain patients are getting the actual drug (lets say for Alzheimers),…[Read more]