I agree with most of the comments regarding buying a meal for a physician, I think it is only acceptable to pay for the meal for those involved in the discussion of any project or work issues. Anyone additional who…   Read more»

I enjoyed this course a lot, I found all of the information very useful and it gave me a good idea of what types of positions I might be interested in working in within companies. I also liked the order…   Read more»

I have not worked in a company that has hired consultants, however I think consultants would be most on short term projects. If a project requires extra people working on it or someone with a specialized skill set, but the…   Read more»

I have not had this experience in industry, but I have been working on my senior design project with two direct advisors. The biggest conflict I have had are that different tasks are prioritized by each advisor. The deliverables required…   Read more»

I would prefer to work in a matrix organization for the transfer of information benefits. It would be important to ensure that the schedule are managed well between departments and projects to avoid conflicts between them. But I think the…   Read more»

I would like to work in a matrix organization because of the ease of transferring information between projects and departments. Though there may be scheduling conflicts and issues with any individual having multiple bosses to answer to, I think the…   Read more»

As the previous comments have pointed out, ISO 14971 governs risk management in medical device companies. The major requirements ISO 14971 sets for medical device companies are a safe design of the medical device to remove risk, protective measures for both…   Read more»

Similar to the scalpel example in the lecture, I think there are many surgical tools where the risk must be accepted. For tools such as bone drills and saws,  taking away the dangerous aspect of the tool would also remove…   Read more»

A simple example I can think of is a surgical wrench. This device would definitely require a torque test to ensure that it can apply the torque necessary for the procedures it’ll be used in. In addition to that, there…   Read more»

Most of the responses mention documentation in academia being things like lab manuals and lab notes. But if the research being done in academia is being used to develop some type of new medical device, would it be required to…   Read more»

I believe all changes must be controlled. Whether its a change in some type of documentation or a change in a design input leading to a change in the design of the device. In order to keep an accurate record…   Read more»

From my experience, meeting minutes are extremely beneficial for resolving conflicts over matters that were discussed in the meeting. Any time an issue that was previously discussed is brought up following a meeting, it is often the easiest to resolve…   Read more»

Most of the posts above explain the difference between verification and validation well. If there is still confusion on it, an example that I’ve found helpful is say you’re designing a new tool for surgery. Based on discussion with a…   Read more»

I’m currently working on a project for my undergraduate senior design project in which we are creating the prototype for a new medical device. For this project, my team is working our way through the 9 parts of the Design…   Read more»

Out of the clinical research roles, I would be most interested in working as an investigator. My first reason for this interest is I would want to participate in the treatments for the subjects. I also like the ability to…   Read more»

I’ve recently heard from multiple professionals in industry about the benefits of some type of clinical experience. Even if the experience it is less official than a position as a nurse or a doctor, experience in ways such as observing…   Read more»

While I was completing undergraduate research at NJIT, I assisted with starting a new study using Functional near-infrared spectroscopy (fNIRS) as an imaging technique. The investigators completed the IRB application and received IRB approval, though I was not involved in…   Read more»

This past summer, the company I worked at utilized local artists to endorse a new product. The target population was young adults and the plan was to start selling the product locally, and as it becomes more popular expand the…   Read more»

One product I’ve seen advertised significantly, but not at all through television, is the popular app TikTok. This app is a social media platform that allows the user to post videos they create. It is becoming popular for short music…   Read more»