Posted by: @orleron Well, you did it! You made it to the end of Medical Device Development. The original intent of this course was to teach you what professionals in the medical device field do in the real world if…   Read more»

Posted by: @savery115 A small part of the lecture reviewed Upper Management vs Middle Management. Upper Management people are strategic and tend to set the groundwork and vision for what the company could be. Middle Management people are tactical and…   Read more»

I felt most drawn to the matrix organization. The reason I like that format is because it is more collaborative in nature than the functional and project-based methods. I am always inclined to believe that people are more apt to…   Read more»

Posted by: @dparekh Creating a list of risk is a good starting point, however, it is not enough on itself. You also need an action plan for each risk in order to be able to manage them effectively.We learned about…   Read more»

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?  Some risks must be accepted when considering what the device is, but I think…   Read more»

Posted by: @hg93 Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way to avoid project catastrophes. Continuously applying the…   Read more»

Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and…   Read more»

Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Before this, when I was…   Read more»

Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a “clinical background”. This means people who have been or are nurses, doctors, or other kinds of technical workers who interact…   Read more»

Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are…   Read more»

Posted by: @dh239 I feel that it is acceptable to take the risk of a clinical trial when the results of the trial are expected to either benefit or not affect those involved. This would be in the case of…   Read more»

Posted by: @llefevre It is estimated that globally, the market for Clinical Trials is in upwards of $44 Billion as of 2020 and is expected to grow by approx 6% over the next 7 years, mostly fueled by the need…   Read more»

Posted by: @amandaally1029 What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public company, and state the successes. I decided to…   Read more»

Posted by: @sahitya-sadineni After watching the videos from this week’s lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position based on the type of company it is? For me…   Read more»

Posted by: @christoph To a layman, a surperficial assessment of 510K process is that it is nonsensical.WHY are devices being compared to devices created 40 years ago.This makes no sense to me. Why arent the just assessed on their own…   Read more»

Posted by: @amd29 In the field we will be dealing with people of different backgrounds, accents, looks and drives. What do these human differences mean to you as it relates to your function in directing their operation in the creation…   Read more»

Posted by: @dipanpatel Ethics and Quality are very related; moral attitudes and conscious awareness of standards and guidelines have to be separate from intellectual/company’s agenda. As NJIT student studying ethics and/or professionals in the industry, have you come across ethical…   Read more»