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. Your potential product will fall under a single or a combination…   Read more»

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 to be definitive. If it turns out the…   Read more»

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 money to submit these regulatory applications. Depending…   Read more»

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 equally present and intertwined with each…   Read more»