A company may want to protect intellectual property that is in the process of being patented and leaks could jeopardize the patent process as mentioned earlier. Also important are things that a compan...

The offer and acceptance part of contract law is one of the most important stages of the process to get right. This stage being completed successfully ensures both parties involved have a clear unders...

I think this may be related to patent law in term of the boundaries that the contractor can push. If they have access to confidential information and sign an NDA, but then go on to do something ever s...

I worked at a small company, but it had similar issues to the one you describe happening in a large company. Because all departments were so dependent on one another, the hierarchy was only clear if t...

To add to what has already been mentioned, it is also important to include the work breakdown structure (WBS) and WBS dictionary in the design development plan. Design controls are an important part o...

This is an interesting idea. To make something like this just an advantage, you have to remove the thing that caused the disadvantage. What is the disadvantage? The disadvantage is only present when t...

I had mentioned this is another thread, but as others have said, catching risks early is the best way to save money. It is also the most efficient at preventing harm. Creating an inherently safer desi...

Risk management is definitely most important during the premarket stage. By avoiding risks at this point, the company saves a huge amount of time and money. All forms of optimization are important to ...

This topic reminds me of the very depressing calculations some car manufacturers seem to have done in the past. Some companies are aware of problems in their device (in this case vehicles) so a hazard...

This is an interesting topic because many of the devices created in BME Capstone do require a certain level of design control documents. The trouble is the students are somewhat limited in experience ...

I can think of two major factors that would apply here. One is the size of your company. The other is the type of products your company makes. If you work in a very small company, you may be limited i...

@mb776 To piggyback on this line of thinking, it is really important to figure out the cause of failure. If it was a misunderstanding of the desire of the customer, that will have a very different res...

@knm7 Just to add onto what you said here, I agree that if the product is already released, marketing should be at the meeting, but I think they have a place in these meetings before the release at al...

@devdesai I am glad you brought this up because honestly this is one of the most interesting things I have learned in this class so far. I had no idea how important the marketing department was to the...

I have not worked in a biomedical device company in this way specifically, I only have non-medical materials experience in industry. What I have learned is basically that it depends on the company as ...