Consultants in my company or my previous company have been useful in bringing expertise where our group lacks or needs a third party view. For instance, my company had a large acquisition that needed some smoothing of culture and understanding…   Read more»

Honestly, this is one of the best courses offered at NJIT for younger professionals who aren’t sure of what career paths may have in store for them. This definitely provides the foundation of design controls and roles within a medical…   Read more»

It is important to understand the full implications of an NDA before signing. Some may sign them for their job multiple times on different patients and such. Others, like myself, will have an NDA that bares them from working on…   Read more»

In terms of enlightening the manager to the importance in QC and regulatory roles, there would need to be a reason why a project is being impacted significantly due to a loss in those pipelines. There are times that one…   Read more»

Organizational structures, in addition to more effective communication and autonomy in a project, provide the handoff of the project from development to post launch as well as lead the culture of the company. Projects that have a matrix based team…   Read more»

In the world of medical devices, there is no such thing as a waste of money for risk assessment. When a device deals with aiding in human function with direct contact to user, then there is a need for risk…   Read more»

Another internal risk can be seen where the transfer from prototype to process equivalent part may not be as easy due to a poor CQA list or difficulty of manufacturing of the parts. This can set a project back months…   Read more»

Another form of risk control during design is knowing the intended misuse scenarios and how they can be mitigated during design. Lets say they know a scalpel can cut easily and is sharp on all sides. The design can force…   Read more»

The company I currently work for does not let any sort of failures go through. Since I work at a medical device company, the product affects patient care and health which in turn, if product fails, can be a big…   Read more»

Statistical sampling can be pretty dependent on what you are working towards. There are guidelines to follow an ANOVA for a process to validate their systems which can be very different from medical device validation. Medical device validation can often…   Read more»

As said by mcf29, there are many different qualifications that the manufacturer goes through to validate their processes. They usually need to also go through different steps on how they validate their systems whether that is an MSA (variable or…   Read more»

Just going back to TMV, its less specific for low variation, but rather determining whether that variation is consistent for different users. There is always going to be tests that have a large bias and TMV covers the aspect that…   Read more»

Not all design inputs are necessarily related to some performance output. For some requirements such as color or force, there is an output that can be related to manufacturing or test related value. For some inputs such as ones based…   Read more»

I actually have a large amount of experience with test method validation as I recently completed my labs validation for our non-compendial testing. Test method validation is not needed for standardized testing, but is needed for all testing that is…   Read more»

One of my previous coworkers went from working in an engineering research lab to a clinical research associate position. He was only a year or two into his career so the transition to the next job was a big step…   Read more»

I agree with the prior authors of the statements saying that there currently is no way to prove on why a vaccine may be more effective. You could compare it to different generations of people living in a specific area,…   Read more»

Usually a phase 2 trial will have a more statistical sample size with the medication with the most favorable outcome from phase 1. This extended time is used to start to derive the efficacy of the drug as well as…   Read more»

There are probably more specifics that would need to be involved as the previous commenters suggest. If the items are single use or limited use items, this would go to retail or the physicians. These items aren’t made to last…   Read more»