One approach that I have seen companies marketing their product is through partnerships with larger more recognized companies. This allows for the product to be seen by people who may already follow the growth of that larger company. In development the next stage is usually clinical trials, therefore having a recognized trusted company backing…[Read more]

In the industry there are indeed many products that can be discovered based on project needs. The Rees system is a product that is leaned about just by googling what is needed for monitoring equipment in validation programs, and the entire market for monitoring systems came up. The company I work for now currently use the Rees system to monitor…[Read more]

There are a lot of interesting points made above which made it hard to make a decision. But from my research I would go with an LLC. As a mid sized company you can start as an LLC and change it to a INC later. The common advantages of an INC and LLC are-
– Limited liability
– No double taxation
– Pass through of losses
Of course if this is a…[Read more]

Going through all the posts in this tread I agree with the majority of what everyone is saying- that I would not turn down a position based on the type of company. I would focus on the role and the kind of experience I can get from the role. The company’s stability would matter to me if I was being offered a partner or Chief position but otherwise…[Read more]

Public companies have shares that can be publicly traded in the stock market. Private companies do not have stock that can be publicly traded. One of the advantages of a private company is that Private companies are not required to file their annual financial statements with the Registrar of Companies, and so their annual financial statements are…[Read more]

I think that inmost departments that are impacted by quality there is usually not enough focus on the big picture. In most departments the main focus are the goals of the particular department. While the quality department would focus on keeping the entire company safe by following the rules set down by the FDA. Most other departments are…[Read more]

I currently work in manufacturing and everything we do is review by Quality. Our department has a good relationship with QA who reviews our batch records. This may just be so due to the fact that manufacturing doesn’t really get to have much say in the process. Our process is defined by process development, we simply manufacture the produce and a…[Read more]

The article I looked at stated that the IOM report on the 510(k) process contains broad recommendations that may have significant consequences and impacts on the medical device industry. Specifically, IOM concluded that the 510(k) process “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for c…[Read more]

I read an article about some rumors that Apple is trying to come up with a watch that continuously measures the blood glucose level. In the early 2000s, the FDA approved a device called the GlucoWatch. It used a low electrical current to draw glucose right out of the body, where it was measured by sensors on the back of a tight-fitting watch. The…[Read more]

Based on my research, the FDA started regulating tobacco in 2009 by the passage of the Family Smoking Prevention and Tobacco Control Act. What I found interesting is that the Family Smoking Prevention and Tobacco Control Act specifically states that FDA cannot ban an entire category of tobacco products, such as cigarettes. FDA’s regulatory role…[Read more]

I do not have any personal experience working with a company where the study itself was outsourced but I do have experience seeing a vital part of the company being outsourced. At my first job the Help desk was outsourced to India to save money. I can speak to that experience. Outsourcing the Helpdesk to India did hurt the company. Our clients…[Read more]

In the Industry research has a shorter time limit as there is time ticking and there is much more pressure on making it work as it has to be sold and make money otherwise the company is at a loss. In terms of time malmanagement there is always a deadline and if they realize the deadline cannot be met the plan is usually redone to compensate for…[Read more]

As mention, for testing in biocompatibility, the testing should follow ISO 10993. However, depending on the product there are various other testing that needs to be done before the procurement of any material that goes into a process and after the product is completed. This also have to go through the QC department, that will either do additional…[Read more]

I had worked in a research lab on TBI when we used a blast tube to collect data on pressure being applied to the brain. One of the issues that we experienced was the amount of pressure that were actually being applied to the mice, needing a buffer of sorts. The data showed that the intensity of the force was so great that it was difficult to get…[Read more]

The projects that is have worked on, the milestones were the body of the project. I think that missing milestones can result in failure of the project. At least in the projects that I have worked on all the milestones were extremely critical and were considered in the panning initiation and planning phase as critical. I do think that they can be…[Read more]

The projects that is have worked on, the milestones were the body of the project. I think that missing milestones can result in failure of the project. At least in the projects that I have worked on all the milestones were extremely critical and were considered in the panning initiation and planning phase as critical. I do think that they can be…[Read more]

I think the monitoring and control. In my experience, seldom I have been a part of a project and all phases ran it course smoothly without monitoring it and making sure that when the planning is being don’t that the deliverable that were determined in the initiation phase is meet. Or that the execution phase also insure the plan is carried our m…[Read more]

I worked on a project to validate some of our labs that were doing GxP work with non-GxP work. The idea was to make all the work GxP and have it follow GxP procedures. One of the biggest problem that we ran into was the requirements by Quality. We had to satisfy some requirements for the Change control that we had open to go into effect and…[Read more]

About 6 months ago when I worked in validation, mw group worked on a project where we did a media simulation in collaboration with the manufacturing department. There were one other group managing that project and it was the first time we were performing it with this group. In the initiation phase the group got together and determined what needed…[Read more]