One of the similarities between the technical file and a 510k submission is that both of these submissions must be reviewed and approved by the appropriate authorities before the company can market the device. In the case of the technical…   Read more»

I cannot post the link to the article where I found this information because I keep getting an error. However, the website was called Emergo Group.

Orthopedic devices such as hip and knee implants are classified in both the US and EU. In the US these devices are considered class II, but I did a little research about how these devices are classified in the EU,…   Read more»

I tried to post the link to the article but I kept getting an error. Below is the title of the article for your reference.

Title: COMBINATION PRODUCTS – 6 Guidelines to Follow When Developing Combination Products

I do not have experience working with combination devices, but several of the posts above mentioned the option of submitting an RFD, so I did some research on this topic to see if it is as easy as it sounds….   Read more»

I work in the orthopedics industry, specifically in the spine industry. Most of the devices that my company develops are used in spinal fusion surgeries. By far the biggest trend in spinal implants is 3D printed implants. Many companies are…   Read more»

My company uses Microsoft Project to manage project timelines, and we use Windchill to manage project documentation and our DHFs. I would say our project management awareness is medium. I feel like we definitely could use more project management tools….   Read more»

I believe these 4 categories are in the correct position. However, it sounds like you are speaking about a lack of harmonization between all the categories.I think it is very important that there is harmonization between all the 4 categories….   Read more»

Participation is a key element of my company’s marketing strategy. Our marketing department spends a lot of time interacting with our customers, trying to bring that personal connection that will make them feel that their opinions and their feedback is…   Read more»

In my company, typically for testing our implants we follow an FDA guidance document that details the recommended tests for that type of device, and we submit this test data with our 510k submissions. However, sometimes we feel that additional…   Read more»

I had to sign a non compete agreement when I started my job but I have not changed jobs yet so I can’t speak to this. However, one of my colleagues is going through this. He recently came over to…   Read more»

I just want to emphasize the fact that companies take these gift policies very seriously. For example, in my company every employee is required to complete yearly training on the AdvaMed Code of Ethics as well as our own corporate…   Read more»

I really enjoyed this course, and I think the best part of this course is that it really gives students a very good idea about what the real world is like working in the medical device industry. Since I already…   Read more»

I agree with many of the posts above regarding the benefits of matrix organizations. I think this is the structure that I would choose. To reinforce what was already mentioned, I believe that this is the structure that fosters collaboration…   Read more»

My company has a matrix organizational structure, and I would say that for the most part, it works really well and is an efficient way of running a project. One downside which Dr. Simon mentioned is that often the project…   Read more»

The organizational structure of the company that I work for is most similar to the matrix organizational structure that was discussed in the lecture this week. I have definitely seen the silo effect in my organization, where sometimes in our…   Read more»

My company uses many of the tools mentioned above to identify and manage risk. As the professor also mentioned, risk can be associated with the design as well as the manufacturing of the device. Risk can also just be associated…   Read more»

Another factor to consider when making benefit-risk determination suggested by FDA in this guidance document is whether the device is a novel technology addressing an unmet medical need. This means that the device has a breakthrough technology by providing a…   Read more»

I also work as an R&D engineer for a medical device company, and one thing I have noticed in my company is a lack of brainstorming to identify potential risks. I have found that many times our QA department just…   Read more»

Just to add to what was mentioned by several people, they mentioned doing design verification early and often. However, design verification cannot be performed until the design is frozen, which does not happen early in a project. However, you can…   Read more»