I agree with the notion that an organizational structure leads to certain cultures within the work place that may make or break a potential project. In a functional organization, each department is divided and controlled by different functional managers. This…   Read more»

I feel as though each organizational structure has its own strengths and weaknesses; however, depending on the size or needs of the company one structure may be more advantageous than the others. For example, a functional organization may prove adequate…   Read more»

I have never worked as part as one of these teams; however, with that being said, I am torn between wanting to work with either a project-based organization or matrix organization. In project-based organization, there is no “silos of departmental…   Read more»

I feel as though all the mistakes you mentioned highlights the fault in companies when it comes to understanding how to handle risk management. I agree that risk management and design control are separate things and that risk management should…   Read more»

The major ISO regulation governing Risk Management for medical device companies is ISO14971. According to the link, the major requirements for a medical device company has to follow is to construct a Failure Mode and Effect Analysis (FMEA) and a…   Read more»

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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   Read more»