The amount of information included in an NDA can vary from project to project. It also largely depends on why the information needs to be shared. In academia, an NDA can allow researchers to present their findings before getting approvals…   Read more»

I think an NDA can facilitate the road to obtaining a patent. An NDA can help protect the idea from getting into the wrong hands, and legally allows you to discuss information without worrying about leaking it. You would have…   Read more»

This course was really informational above all. The lectures did a good job of explaining everything and the discussions made it easy to see how it applies to the real world. I learned a lot about medical device companies and…   Read more»

We have a Google drive folder set up that everyone has access to. Our PM uploaded each document and also created a rough draft of the DID which had a column on the side for comments. We had a week…   Read more»

I think I would prefer to work in middle management because I would want to be more involved in the project. I like to think critically and I am detail orientated. I feel that these two qualities would be very…   Read more»

I think I would prefer a matrix organization while working on a project. In a matrix organization you are a part of two groups, the functional group and project group. You also have two managers, one for the project and…   Read more»

An important factor of determining the value of the risk index is the tolerability of the risk. Often low risks such as mild discomfort associated with the use of the device can receive a low index number even if the…   Read more»

One risk-benefit factor to consider is how false-positive or false-negative results would affect the patient. In the case of a diagnostic device that produces a false-positive result, the patient would be incorrectly diagnosed with a disease. The patient would then…   Read more»

ISO 14971 requires a specific risk management process for medical device companies to follow. The major phases are risk analysis, risk evaluation, risk control, residual risk evaluation, risk/benefit analysis, and evaluation of overall residual risk acceptability. A risk management report…   Read more»

Often it is not the end user that is the source of design input. Especially for medical devices, more technical design inputs are inspired by suggestions from surgeons and other medical practitioners. These inputs can be improvements on fit of…   Read more»

Gantt charts are used to plan projects using long term and short term deadlines. In my experience it is important to incorporate both of these components to the timeline. Often, only hard deadlines such as those determined by external factors…   Read more»

Often times the case of insufficient design controls is actually the failure to establish good document management. The success of a medical device depends largely on its foundation. Good document management will consequently lead to clear and concise design controls….   Read more»

The purpose of the design input document is to define each user need as an objective and measurable design input. While developing the product each of these inputs must be addressed and included in the design specification document. This document…   Read more»

Design controls are to demonstrate that a product completes the user needs, meets inputs and requirements, is proven to meet the standards, and meets the performance criteria. The FDA clauses for Design Controls and ISO 13485:2016 clauses regarding Design &…   Read more»

If there is sufficient evidence already available for a similar device, V&V will only be necessary to make sure that the device meets the user needs (validation) and that the device functions as it should (verification). However, sometimes the results…   Read more»

The right to try law seems to be a viable option for those who have no other hope. Critics argue that such experimental trials can harm the patient, but these drugs have already been approved for clinical trials. That means…   Read more»

Since the laws were not in place at the time it is trivial to say that her family should have received compensation. The question is how can her family receive what they deserve today? Her two eldest grandsons wish to…   Read more»

I found this topic interesting as I have worked in a research lab at NJIT. During my time there I did receive a grant that would partially cover some of the materials required for my project. I didn’t think about…   Read more»

Colors do have the power to invoke emotion, whether it is positive or negative. However, when used in conjunction with other elements such as textures (specifically visual or perceived texture) and shapes also play a large role in appealing to…   Read more»

Cheerios has put out a great ad that really reinforced their brand image. The advertisement is called Good Goes Around and features many clips edited together. The overall message is just very positive and the song is catchy. There isn’t…   Read more»