I work within a matrix organization, but as Dr. Simon mentioned in his lecture about his experience with a previous company, I would label it as a weak matrix organization. The reason I would call it a weak organization is because the communication between the project managers and functional managers is often lacking, causing the project team…[Read more]

I do not have any experience with clinical trials, but I think you raise a very important issue. Does over-regulation lead to a decrease in innovation? I believe that it definitely does, and there is a very delicate balance between sufficient regulation to ensure products released to the market are safe and too much regulation that prevents…[Read more]

In addition to the points mentioned above, from my experience a very critical step in the project initiation phase is to lock down the scope of the project. In my company I believe that one of our biggest struggles is scope creep. We just proceed with a project with a general idea of what is going to be in scope of the project, and often allow the…[Read more]

I would like to add to the discussion by talking about my experience with 510k submissions. It definitely is possible for companies to embellish characteristics of an implant or testing results to claim equivalency to a predicate device. We had a situation at work where we bought out a startup company that had a device that was currently being…[Read more]

I do not personally have experience with getting combination devices approved in the EU, but I did some research on this topic and I found an interesting article explaining that the EMA is considering developing a new guideline on quality requirements for combination products. In the EU, CE marked medical devices are provided separately but may be…[Read more]

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 file in the EU, it is subject to review by a Notified Body, and in the case of the 510k in the US, it is…[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, and what I found was surprising to me. In 2007 Directive 2005/50/EC was released about the reclassification of hip, shoulder and knee…[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. In one article I found, the author mentioned that between 2009-2014, 67 RFDs were submitted to FDA, and 69% of them were found to have…[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 marketing spinal implants with unique features which can only be achieved by 3D printing. My company has a…[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. I find that we really only use timelines, but we don’t use all the tools that could help us…[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. If a company is executing on projects that don’t fit in with its overall strategy then there are serious…[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 valued by us as a company. We often bring surgeons in for a “VIP experience,” where they get a…[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 tests are necessary which are not recommended or required by the FDA, or sometimes upon review of our…[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 policies regarding gift giving. Every year before the holiday season the president of our company sends out an email…[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 have a job in the medical industry, it was interesting to compare how my company’s strategy and procedures for medical device development…[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 the best. I think it is very important that there are distinct departments, but also I think it is great…[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 managers and department heads have different goals and it results in a tug of war for resources. Also, the project managers…[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 projects it feels like we spend more time arguing between departments than moving the project forward. One…[Read more]