Echoing points made earlier, it is absolutely crucial do understand what exactly you are agreeing to when signing an agreement. It is very easy to simply sign without reading through the agreement, since it may take some time and some mental work to understand the exact terms. However, if the case presents yourself where you are in a situation you…[Read more]

While I haven’t had to sign a non-compete agreement, I do know it is something that is checked for if not self identified when applying for a company. Non-compete agreements can prevent one from working in another profession similar to the one they were just working in for a certain period of time, so naturally that is something a company must ask…[Read more]

One article I found about this topic was related to the opioid crackdown that has been going on as of late. A former drug company sales manager admitted that he was part of a larger scheme to bribe doctors to have them prescirbe a fentanyl spray called “Subsys” to patients that were not meant to have prescribed to them. Originally, the drug was…[Read more]

While I believe that I would have the skills to do either upper or middle management, I think I would prefer to be in middle management. It takes the right balance of ‘big picture’ view and ‘details’ view in order to effectively communicate the importance of the execuation of tasks while also actually identifying the resources needed in order to…[Read more]

I prefer a matrix style and also work in a matrix style organization where people are grouped together in their own groups with someone heading each group as a point person. When trying to route our deliverables, often times it requires collaboration between different groups, with some groups having to wait for inputs from other groups in order to…[Read more]

Like mentioned, competition (healthy kind) is good within a company as it can often push employees to strive to do their very best. However it can get to the point where it may create negative stigma or environment. If the competition is too highly enforced, then there can be destruction of team dynamics where people are seeking to blame others…[Read more]

In terms of the how risk is prioritzied in my company, an assessment is made on the impact of the risk (monetary, time, liability, etc.) If the issue is one deemed high risk (will cost much money, and has high liability) these are deemed higher priority and are dealt with as soon as possible (think resulting in NC’s and CAPA’s or dealing with…[Read more]

search what is residual risk? Definition and meaning in google to find article by MBN

At the end of the day, it seems that there will always be residual risk that a medical device company will have to deal with. The measures that companies take will not be guaranteed to completely eliminate risk. In fact, even if companies provide warning labels, seminars, trainings, what have you, there will always be the possibility that a user…[Read more]

To find the video search The $40 Internationally Standard Cup of Tea

This topic reminds me of a somewhat comical video that I had watched a while ago

Similar to what is being talked about, this video gives an overview of standardization and how it is something that is used globally (particularly this video talks about ISO. One of the main points that are made is the importance of standardization in terms of…[Read more]

Not having good design controls can definitely cause product failures as mentioned above. If design controls are not used properly, users of products may use it and cause great harm to themselves or to their assets. However, another degree of this that is not always talked about is not sufficiently meeting the performance standards of customers.…[Read more]

More information contained here (referencing my earlier post)

In a DHF, all the documentation that went into preparing a product and designing it is contained. It contains all the neccessary documentation and proof that a product was made within spec of what was set out as well as within spec of regulating bodies. In essence, it is a history of how the product came to be what it currently is. In a DHR, all…[Read more]

While I have not been able to attend design review meetings as my job function doesn’t include doing so, I have had interactions from the results of a design review meeting. Once a design review meeting has occurred and sufficient revisions are made to the product based on feedback, the product can start the process to go into production.…[Read more]

As many have said above, having meeting minutes that clearly document what was talked about and the action items that arose as a result is crucial. These minutes are essentially a snapshot of the meeting, allowing those who attended to quickly remember what was talked about and those not in the loop to understand the reasons for some decisions. I…[Read more]

Within my own experience with Gantt Charts in industry, as others have said, it is a tool to help keep a project on track. It outlines the necessary steps that need to be taken, and the sequences they need to be done in so that a project can be completed in entirety and on time. One person made a point however that it documents what should be…[Read more]

The DID and DSD are both necessary in their own right as they can be meant for different audiences and purposes. DID’s basically outline the high level overview of what the product is going to be like: red, can make sounds, light enough to hold, etc. For those levels of people involved with products who only have time/bandwidth to care about the…[Read more]

I found the same thing when I was working with my Capstone Project here at NJIT. Our team was looking into the possibility of patenting our device, so we looked into the different rules surrounding that. We found much of what you found, in that NJIT basically owns the rights to whatever was formed during the time at NJIT. If it was done with “NJIT…[Read more]

Overall, double-blind studies are not meant to increase some sort of significance to the investigator, but is more about collecting good data that is not tainted. In single blind studies, there is chance of bias occluding results, therefore causing data to not be reflective of reality. In a double blind study however, the element of bias is…[Read more]