One of the most common ways that the fifth “P” of marketing is used in today’s environment is by using brand ambassadors on social media. While almost all companies have social media accounts of their own, many count on brand…   Read more»

Choosing a job based on corporate structure is an interesting point to bring up. While I have never formed an opinion of a company solely on whether it was an LLC or a Corporation, I think it is important to…   Read more»

As stated in many of the posts above, the avenue of setting up a business depends on the number of people involved and the type of business being set up. However, one thing that was not mentioned is that it…   Read more»

One example for filing for a DBA is for a business which has been bought by a new owner, but continues to operate as the same name. I once worked for a company which operated under a DBA. The situation…   Read more»

One important skill for a QC Engineer to have is investigative skills. The role of QC is not only identifying non-conforming products. Failures sometimes require a root cause analysis. A root cause analysis is a method of identifying the reasons…   Read more»

In my experience, inter-department relationships are best maintained by good communication. The quality signature on a Change Notice can often be the hardest to get, so a strategy that I use is to inform the quality representative of my intended…   Read more»

Using emerging technologies to assist in quality can be a very helpful tool for QA/QC departments. For examples, using AI to perform inspections along the production line can help ensure consistent inspection. This will also help with lean manufacturing because…   Read more»

One of the major recalls in the last few years has been the J&J/DePuy Hip Stem Recall in 2010. The hip replacement was a metal on metal implant which had a high failure rate and was leaving patients unable to…   Read more»

Working in the medical device industry, it may seem like the FDA rules and regulations are too strict and unnecessary. Compliance and design controls are major things that some companies spend years trying to figure out. However whenever you get…   Read more»

For the physician to realize his or her goal of creating a medical device, he or she would need to surround himself with others who are knowledgeable and experienced in product development, process development, quality control, and regulatory affairs. While…   Read more»

With several years of product development experience at a medical device company under my belt, I can say that one of the major factors in being able to complete projects is to be able to access more resources when they…   Read more»

Animal testing is a crucial part of biomedical research. Before any devices are implanted into humans, we must already have a very good idea of how it will react with the human body. The best way to do this at…   Read more»

From the perspective of the project manager, the biomaterial that is chosen for a device can impact the project plan in several ways. First is whether the material is being used for the first time. If the device is made…   Read more»

I am in agreement with the other posts above that projects need to meet all three objectives in order to be considered successful. A project can never be successful if it is not achievable, a project that is well understood…   Read more»

One thing that comes to mind when discussing combination devices is the regulatory pathway that it will take. The FDA has three seperate departments for reviewing products. Medical devices fall under the Center for Devices and Radiological Health (CDRH), drugs…   Read more»

The general phases of project management will be the same in different industries, since this is how the process has been developed and has proven to be effective. However, the nature of different projects will determine what tasks are involved…   Read more»

One difference that stands out to me between academia and industry is the source of funding. Researchers in academia often need to seek out funding in the form of grants for the particular research that they are trying to conduct….   Read more»

My advice to biomedical engineering student is to network and to go for internship/co-op experience which will expose you to design controls. It is important to develop contacts in the industry in order to hear about opportunities that may not…   Read more»

As someone working in industry, I think that a student who is fresh out of school and looking to go into industry needs to have at least one of these courses under their belt. The 70/30 ratio would do well…   Read more»

One difference that stands out to me between academia and industry is the source of funding. Researchers in academia often need to seek out funding in the form of grants for the particular research that they are trying to conduct….   Read more»