I agree with the general consensus in the above posts that the quality assurance process and quality control process is very important to ensure a device will be safe and reliable for the end user. However, I also agree with those who view the quality processes to be burdensome as well. Speaking from experience, the quality department seems to…[Read more]

I recently worked on a product that was recalled voluntarily by our company. I want to make the distinction between a voluntary recall and an FDA mandated recall. A voluntary recall is when a company’s post market surveillance of a product shows that there are recurring problems that they feel are a risk to the patient and therefore they…[Read more]

A de Novo is a classification process using a risk-based strategy for new, novel devices that have not been classified as of yet. The new ruling in 2014 streamlined the process by creating an alternative pathway that does not require submission of a 510k prior to a de novo request. Prior to this ruling, companies would have to submit a 510k, FDA…[Read more]

The question was raised whether the current 510(k) process is ensuring that the medical devices released to the market are safe and effective. The Institute of Medicine (IOM) investigated this question and found that the current 510(k) process is flawed based on its legislative foundation. One of their findings was that when the FDA assesses the…[Read more]

I work in Product Development, and what I would say is that in industry, timing can determine the success or failure of a product, therefore I believe that industrial research is approached in a different way. Taking the example of an animal study, in academic research, if there is a delay, the research group may just have to accept that delay…[Read more]

First of all, I think that the decision to outsource to this university just because a team member has connections there is a poor decision. In a best case scenario (which is probably what was assumed when making this decision), the team member will have more leverage with the lab to make sure they run the test exactly as planned and on time.…[Read more]

As the others have mentioned already, referencing the Toxicity Table from ISO 10993, there are different tests required for different applications. Therefore, if you know what application you are planning to use the biomaterial for, you just reference the corresponding row in the toxicity table to determine what testing will be required. Several…[Read more]

I worked on a project that was so volatile during the execution phase that it really did not follow any plan, and eventually it was cancelled. It really was a complete failure. One of the main contributing factors was that the planning phase was pretty much overlooked. It was an acquisition, not an NPD project, therefore it was not treated the…[Read more]

Many of the posts above mention the regulatory aspect of project management as a greater challenge in the medical device industry. I do agree with this, but I would like to expand on what ao242 mentioned about globalization. Many companies develop medical devices to sell globally, and in that case, not only do they have to conform to FDA…[Read more]

I have been working as a Product Development Engineer for 2 years in the medical device industry. My team is focused on designing implants and instruments for spine surgery. Overall, I really enjoy my work. Although certain projects that I have worked on have not been so enjoyable, looking at the big picture, I am satisfied with my career thus…[Read more]

I have only been working in industry, so I cannot speak to the differences between academia and industry. However, I can speak to what I have experienced in industry. My job is very structured, in that I am assigned to a project(s) and have specific parts of the project that I am responsible for. It is also structured in the sense that we work…[Read more]

I think that the answer to this question is highly dependent on the individual, depending on what they are looking to get out of their MS degree. For me personally, I think that a 50/50 ratio would be better, and that is because I am working in industry, and I am looking to gain knowledge that will help me perform better in my current job. I would…[Read more]