The consultant does violate the NDA or CDA by copying the template from the previous company. Each company should follow their own template when completing contracts. Although companies are similar in their products and goals, that still doesn’t mean that…   Read more»

When signing an NDA there are many factors to consider before accepting the contract. As mentioned above, it is very important to pay attention to what is written in the agreement and the time period for which it stands. Another…   Read more»

When determining which organizational structure is best for a company, it is important to take the company’s size into consideration. The organizational structure essentially determines the communication between the departments, which will determine the success of a project. Of the…   Read more»

It is healthy to have a little competition within a company, especially when it is friendly competition. However, if it becomes more than that, it can result in hurting the company’s work and its success. When there is negative competition…   Read more»

When two or more companies come together and decide on collaborating on a project, it is very important that the project is ran smoothly. There are issues that arise within a company when working on a project let alone collaborating…   Read more»

The regulations are highly important in ensuring that the product follows the correct standards and is safe to use in the medical device market. It does seem a little unfair that the company has to pay for the regulations, but…   Read more»

Project Risk Management works to manage the possible risks a project may have and how to fix it. With Project Risk Management, projects are planned to have fewer risks. With Risk Identification, the risks that could affect the project are…   Read more»

As stated previously, the risk-benefit analysis is an important, when determining the benefits and risks that need to be considered for a product. One of the factors that is considered in the analysis is postmarket data. When the product is…   Read more»

Validation is always an important step in the Design Controls. However, it is not necessarily always needed if there are no changes like you mentioned. Although that might be the case, I feel that a human factors evaluation should still…   Read more»

Syringes are commonly used in medical care, such as for intravenous injection in hospitals. Syringes need to be tested and verified before even being used. Some of the tests used to determine the performance of the injector include ANSI, AAMI,…   Read more»

The Verification step is a very important factor when understanding Design Controls. If the design does not pass the Verification Test, there could be a high risk factor. Although I have not personally encountered an incident when the design does…   Read more»

When determining design inputs it is very important to consider physical and performance traits. These two aspects will determine the used when designing the device. For instance, when considering the customer needs and having portable as one, that means the…   Read more»

A Gantt chart gives a detailed schedule in order to complete a project successfully. A major factor in the Gantt chart is the critical path. The critical path ensures that specific steps of the project were completed on time in…   Read more»

Taking minutes in meetings and reviewing them after are very important. They often provide when certain projects are due and what is needed to be completed. If you miss something in a meeting or forget what might have been said,…   Read more»

Clinical research allows for the growth of the research being done. Essentially, it includes humans as subjects to determine the effectiveness of the product. One major aspect that needs to be considered is the risk factor. If something goes on…   Read more»

I do agree that the Lacks family should receive some sort of compensation or acknowledgment for the amount research that has been completed and is still being completed using the HeLa cells. It is ethically wrong for the medical research…   Read more»

The Placebo-controlled trials are very beneficial in determining the efficiency of a product. With the Placebo trials, one group of subjects receives the real product, while the other group receives the imitation one. As a result neither group knowing which…   Read more»

Costco Wholesale is a company that does not use television advertisement, and has been very successful. There are four ways of promoting that the company uses to best market their products, which are sales promotion, direct marketing, personal selling, and…   Read more»

The medical device company I chose to look at is Johnson & Johnson. Johnson & Johnson is a major global healthcare company that has many different divisions, which include consumer products, medical devices, and pharmaceutical products. The company’s main goal…   Read more»

There are major differences as to whether a company is public or private. When a company is public, it has numerous shareholders involved, and trades stock publicly. In addition, a public company has to maintain their financial information. As a…   Read more»