In Capstone, we had to formulate test plans in order verify our design. Should one of our tests fail, we were taught to reassess our design and change the specifications and tolerance in our document in order to assure that the product will pass the test the next time it is tested. Based on the other’s responses, this is also the case in industry…[Read more]

I personally don’t have any experience in industry; however, we’ve had design reviews for our capstone project at NJIT. The way these meetings go is that each team has their requirement documents or test plan reviewed in front of all the other teams and every other team has to pick apart nuances in the document for the purpose of helping the…[Read more]

It is true that the engineer is supposed to “make up a test”; however, the test needs to reflect the section of the design requirements that the test will be verifying. In the Capstone class in NJIT, when we were designing our test plan, we had to specify which requirements in our requirements document the test was aiming to satisfy. Numerous…[Read more]

Although it may hinder the product a bit in a business sense, I feel as though a medical device meant to work with humans should require validation even if it already passed the verification phase. This is due to the fact that it may not behave consistently across a vast amount of human subjects and these tests need to be in place in order to…[Read more]

I don’t have an work experience; however, for Capstone my senior year we had to develop a project schedule that was essentially a Gantt Chart. As such, you can think of a Gantt Chart as a detailed project schedule with clearly outlined goals/ milestones and tasks that need to be performed to achieve these project goals. For this, you should…[Read more]

From the deliverables Dr. Simon requested for this class I noticed a lot of similarities between them and the deliverables we had to submit for the undergraduate capstone project. In capstone, we were required to submit a lengthy and extremely detailed requirements document and a test plan. My professor for capstone described that the requirements…[Read more]

In the past, consent was not used since medical regulation was still young and not widely enforced. In the case of Henrietta Lacks, the doctor did not give her the option to use her valuable cells for research, but as you said, that cell culture lead to mass scientific advancements in cancer research. Had Lacks checked “no” on a consent form when…[Read more]

In a single blind study, only the investigator knows what is to be used on the subject, this has its advantages since the investigator in this case has complete control over what is given; however, this can also induce some bias from either the investigator him/herself or the subject should the investigator do a poor job in hiding the contents of…[Read more]

I personally feel as though placebos are necessary for studies and clinical trials. When doing statistical analysis, you’ll have a controlled-group that’ll receive the drug or device in question for actual treatment and perhaps another group that’ll receive a type of “sugar pill” or something else that won’t treat the illness or condition, but the…[Read more]

EI can easily turn into manipulation as the sales pitch has to be tailored to certain demographics. Dr. Simon mentions in his lecture that people may not even know they want something until they heard of it, but I think its also important to consider how the consumer hears about the product since this can affect their investment into product. This…[Read more]

Participation has become the fifth “P” of marketing since consumers these days have the ability to block unwanted ads and such unlike before where ads on TV or the radio couldn’t really be avoided. With this, companies had to focus more on interaction and customer relationships in order to gauge attention. The most popular way companies engage…[Read more]

Emotional Intelligence (EI) is the ability for an individual to identify and utilize emotional factors when it comes to either themselves or other people. Essentially, an emotional intelligent person will be able to tell how another person is feeling simply by looking at a few factors such as body language, speech, etc. EI could be utilized in…[Read more]

I may the pessimist here, but I don’t believe I personally would turn down a job simply based on the type of company it labels itself as. In this day and age, especially for people fresh out of college, landing a job in any field, even engineering, is taxing. This is made even more difficult if students never undertook any internships, co-ops,…[Read more]

There a few things to consider when deciding to make a business either an LLC (limited liability company) or an incorporated company (S-corp or C-corp). With an LLC, business owners are personally protected from the risks that involve a lawsuit or other legal actions that involve the company. This way, the individual’s assets are protected unless…[Read more]

The reason a business owner may choose to form a corporation or limited liability company (LLC) is so that should the company find itself unable to pay its debts to its creditors, the owners, shareholders, etc. won’t have to be held liable; however, the courts could “pierce the corporate veil” and hold these people accountable in certain cases.…[Read more]

Document control of a QA department is meant to assure that all documentation for a project is in order so when the FDA or some other organization comes for an audit, for example, the company team is prepared to show they are abiding by their standards. With that being said, perhaps one thing that can be improved in order to make documentation…[Read more]

I feel as though both sides have valid concerns in how a project should proceed. On the R&D hand, you have legitimate data and statistic to prove that the project is good to continue. Quality on the other hand have standards that they have assure the project meets; otherwise, it can spell trouble for the company early on. As mentioned in other…[Read more]

To those who say quality is a burden I can see where they’re coming from. With QA/QC in place, a lot of money has to thrown into a process that hinders the launch of a product, but it is a necessary burden. Spending ~$500k on QA/QC is astronomically better than losing +$1Mil to lawsuits and recalls simply because QA/QC was “too much of a burden”.…[Read more]

I personally feel the FDA is in the right for being as strict as they are. In fact, they may not be strict enough as the products that get released into the market often get recalled after further investigation. I’d say the FDA should be strict since their strictness can prevent harm to potential customers. I agree that although the FDA claims…[Read more]

Precision and accuracy play critical roles in medical device development as it is these factors that determine the validity of what a device claims to do. The FDA has guidelines that refer to calibration measures for instruments and such. In addition, in the case of instrumentation, the device in question has to produce consistent outputs with…[Read more]