In terms of the Henrietta Lacks case, I do believe that it was immoral for what they did, and even gave their family no compensation when they asked. However, since the rise of informed consent, I do believe that people should be explained the use of certain procedures that may help advance medicine. However, this may influence their answer to…[Read more]

I believe that clinical studies are necessary in order to determine the best possible treatment for a disease or other pathology. There are some advantages to the participant as well, being monetary compensation and follow up check-ups for a potential treatment that may help their disease. It may also be an advantage to some since they are…[Read more]

Placebo-controlled trials have been around in clinical testing for a long time. Placebos mainly act as a control procedure that needs to be done in order to keep all the variables the same, except for the actual drug. It can also shed light on the psychological effects that occur such as the placebo effect. It can show that just “thinking” that a…[Read more]

Many newly medical device companies usually showcase their new medical devices by attending conferences and expos. They also advertise through email and websites, detailing their products and why it is a good fit for many customers. The marketing strategy for these new companies should be heavily invested, especially for a new product or a…[Read more]

Manipulation and persuasion both describe the same thing but have different methods of achieving the same result. Manipulation deliberately markets certains aspects of a device or feature to a target audience, leaving out crucial details of the product. On the other hand, persuasion can present a number of facts and “fluff” up the words to mak…[Read more]

Siemens Healthcare is a global medical device company which undertakes the design, development, manufacture, and distribution of medical devices and technologies for diagnostic markets. Siemens offers various imaging equipment, healthcare information systems, management consulting and support services. It is a huge corporation, conductive…[Read more]

A medical device company that has 50 people and $10 million in revenue, there has to be a comparison between an Inc corporation and an LLC corporation in order to maximize all the benefits. An advantages of an LLC is that they are only taxed once and there is no personal liability. This would protect the company from any lawsuits. There is also…[Read more]

The main difference between a public and a private corporation is that the public corporation have shares that can be traded and enlisted in the stock market. There are also differences in the management between the two. Public corporations are usually ran by a board of directors. Thus these companies are usually run by professionals that…[Read more]

There are several reasons that a court can use in order to pierce the corporate veil. As thuytienlecao listed above, more than one reason can exist in order for a court to hold off on being liable and hold a corporation’s shareholders or directors liable. I believe that one of the main reasons that a court decides to do this is because the…[Read more]

I agree with a lot of akshayakirthy’s points when it comes to involving the employees in quality control. It is highly important to have written guidelines and rules in order for all the employees to follow. When it comes to product development, the product should meet the requirements in order to pass the inspection and be used by others.…[Read more]

Although I have not been exposed to a major ethical issue regarding quality control, I still know that it occurs, especially when it deals with hospital equipment. When I was shadowing a phlebotomist (a person who draws blood from patients) for my training period, I saw him drop a needle on the ground. Although the cap was still on, my first…[Read more]

Working in a laboratory in a hospital, there are many quality control departments that come to inspect the area. The specific company is known as CAPS (College of American Pathologists) which accredits the entire spectrum of laboratory test disciplines using a customized checklist requirements. Recently, I went into work and a lot of the staff…[Read more]

I believe that the FDA’s strict rules are necessary to protect the public and what they consume on a daily basis. Although there is a long process that needs to be taken in order to get a drug on the market, it definitely has it benefits, making sure that the drug or device has gone through clinical trials and it has produced enough data that it…[Read more]

A collagen coated vascular prosthesis is considered a combination product. The product is used as a vascular graft and considered non-porous by coating it with a layer of collagen, taken from young calf skin. These grafts were implemented in the thoracic aorta and did not require special preparation time before implementation. I believe this type…[Read more]

One product that was on recall by the FDA was the Insulin Corporation Omnipod Insulin Management System. This product is basically a small pod that you fill with insulin, attach to any part of the body that will receive the injection, and press start for it to be delivered. However, there was a huge recall on the product because the needle may…[Read more]

E-cigarettes are currently regulated by the FDA, as said by their website. Since e-cigarettes use electronic nicotine delivery systems, it is regulated by the FDA. Although not all e-cigarettes contain nicotine, they are still regulated by the FDA because they may contain other products, such as vegetable glycerin, propylene glycol, flavoring, and…[Read more]

Although both types of research are important, I do believe that research for the future is more important than research for now. Companies make research important for the current generation in order to remain relevant to the public and in order to remain profitable for their discoveries. However, the future research still has the utmost…[Read more]

I have assisted in many pre-clinical and clinical research opportunities to know a lot of the ways that it can go wrong. I specifically worked with rats and performing surgery to remove their brain and basically freeze them in a certain preservative in order to transfer them to other places or just store them for future use. However, a lot of the…[Read more]

Research in academia and industry both has its advantages and disadvantages. I have only been exposed to the academia portion of research as a student at NJIT. However, as mentioned in the lecture, there is little pay. However, there is a lot more freedom when deciding what research project should be done. It can lead to great results, such as a…[Read more]

Project management for medical devices and building a school or skyscraper are very different projects which require different planning and execution phases. Medical devices should be planned in a way to ensure that the device will work and not cause harm to the consumer. It should be tested a lot in the execution phase to ensure a product that…[Read more]