Design change requests in medical device development are definitely a challenge I agree. An idea on how a company can handle these change requests is finding primary and back up options for the parts/...

I think the previous post has made some excellent posts and definitely highlights the potential problems with this exemption program from the FDA. However, even with all of these points stated, I feel...

I agree that companies can utilize techniques to create a DDP that is both structured but flexible such as a Gantt chart. Gantt charts are great at keeping your team informed about the development pro...

@bryan-xavier Your information about the Breakthrough Devices Program definitely changed my own view about this topic I created. When I found out about this certain predicament from Dr. Simons lecture...

In Dr. Simon's Week 2 Lecture, there are mentions of caution and avoidance of creating new devices that require a PMA. A PMA (Premarket Approval Application) does not allow a new device to use the sub...

I agree with the previous claims of underestimating regulatory requirements from the start. To add to that, picking the wrong classification of your medical creation will certainly create problems. Yo...

I agree for the most part that regulatory process may be a big risk in the medical device project management. However my opinion is more that the technical, financial, and regulatory risks are more eq...

I think the biggest challenge in managing medical device projects is regulatory hurdles. Regulatory hurdles can put a heavy impact on your medical device development cycle. For one, it costs a lot of ...

I think the biggest challenge out of the triple constraint is scope. Scope has to be almost perfectly planned out before the medical device development, especially before FDA approval. The scope needs...