I know a lot of folks in the medical field, and unfortunately the medical industry is riddle with kick backs. Just about all company’s are guilty of this in one form or another. As you will find, some companies are…   Read more»

It’s not so easy to come up with a name due what the class covers. With that said, I would say something along the lines of “Medical device development process” or “Product development for medical devices”, would provide a little…   Read more»

I thought this course did a good job of covering the key areas of the medical device industry, in additional to how people work within the industry. There are certainly areas within the fields that I now know is definitely…   Read more»

Based on my experience, I disagree with those that say corporate culture can change in the blink of an eye. This is usually the hardest to change, and what some mistake for culture change is simply a change in moral….   Read more»

I have worked on several projects like this before with some good and bad outcomes. From an engineering point of view, this can be a pain if the work culture and engineering processes are different in both companies. Also, if…   Read more»

Hi, In one my past job, I worked in a “Self directed cross functional team”, which I enjoyed and saw as having many advantages.This included creativity, such as each member offering an alternative perspective to the problem and potential solution…   Read more»

I agree that sample size is critical to any project. I don’t have any industry experience with sample size related to risk analysis, however, I was able to find an article that talks able sample size estimation which was a…   Read more»

Another method: Event Tree Analysis (ETA) It is an inductive failure analysis performed to determine the consequences of a single failure for the overall system risk or reliability. Event Tree Analysis uses similar logic and mathematics as Fault Tree Analysis,…   Read more»

I had the experience of sitting in on a couple of risk analysis meeting, and this is early in the process when the team are trying to determine if the project is a go or no go. This prevent the…   Read more»

There are always pros and cons with outsourcing, however, this is not really dependent on the size of a company, but more so to do with time, cost or if you have the expertize and setup to do the job…   Read more»

Meeting minutes are an extremely important part of any project, without this your project will easily failure. The bigger the project to the more important the meeting minutes are. Based on experience and as several you of you have already…   Read more»

I agree with most of that the FDA doesn’t demand specific test and to me this would be too much of an overhead and additional unwanted burden for them. I have some experience outside of BME with verification and validation,…   Read more»

Design inputs can and will come from various sources. Depending of the type of design, input can come from the customer, market research, feasibility study, medical standards, past projects, FDA, ISO, etc. Also, design input can change based on needs…   Read more»

I agree that all the parts are very important, however, I have to disagree with you on this point, that the communication management plan is the most important part of the DDP. Not that there is more important part, but…   Read more»

Fady, This is a very interesting and also important subject matter. To answer your question, even products that were designed and built pre 21 CFR, has to have some sort of design and technical documentation somewhere, and especially so if…   Read more»