I agree with what was said in previous posts about regulatory compliance challenges, but I also think these challenges will only increase at least for the next 10-20 years. Given the EU Medical Device...

The beginning of a project can be the calm before the storm or an insane rush to get things sorted and ready for the main project team work to start. As per PMBOK, the project is composed of five proc...

Using a similar but different example, birth control implants are also combination products. The implant is a tiny, thin rod about the size of a matchstick. A doctor inserts the implant under the skin...

A project manager requires many skills in order to succeed. There is no one sole skill that will allow the project manager to be successful. As emphasized in the PMBOK, effective project managers requ...

The experience I have comes from working within a device development group in a big pharma company organized in a project based environment. The organization structure is based on teams with specific ...

The beginning of a project is critical to the program as it is when objectives, scope, purpose, and deliverables to be produced are defined. Early in the program there can be a lot of unknowns especia...

The NDA is a great mechanism to protect the company during partner ventures, but not a substitute for a patent. For example, you find out that company ABC (to whom you never told your idea), has put o...

The gift restrictions are established by the Sunshine Act that came into effect in 2010 and it required companies such as pharmaceutical and medical device, including durable medical equipment supplie...

I really enjoyed this course. The course is well structured and provides pretty good insight of the device development process and design controls. As a professional with multiple years in the pharma-...

In addition to the examples mentioned in previous posts, Olympus Corp. of Americas (OCA), the United States's largest distributor of endoscopes and related medical equipment, will pay 623.2 million to...

I believe that teams should be empowered to make decisions and this is critical for product development to be effective and efficient. I agree with the previous post from srg36 that interdepartmental ...

I agree with all previous responses that pointed out best practices to form a good project team. From my experience, we do not get to choose who we will work with so we have to be professionals and le...

Companies structured based on functional, project, and matrix organization have their individual advantages and disadvantages, as discussed during this week’s lecture. I work in a hybrid organization ...

ISO 14971 is the standard well recognized by FDA and other regulatory agencies around the world for Risk Management. Some of the key aspects required to comply with ISO 14971 and therefore to be consi...

To add to previous posts on this forum, an approach I have seen is to breakdown risk analysis in three parts; design, manufacturing, and use of finished product. These analyses may involve experts fro...