I too agree with the comments above.  The probability of occurrence and the severity of the risk drive the risk values.  The occurrence can be frequent, infrequent or occasional, and the severity can be severe, significant or minor.  These factors…   Read more»

Changing design may be cost prohibitive , but sometimes it has to be done, even if it cause financial stress for a company.  The alternative is negligence, which can lead to criminal investigations or product liability. Product liability is the failure…   Read more»

My time tested risk management tool has been brainstorming with a SWOT analysis mind-set.  The ability to approach brainstorming honestly and to empathize with the perspective of a customer will allow non-obvious ideas and conflicts to surface and to be…   Read more»

My time tested risk management tool has been brainstorming with a SWOT analysis mind-set.  The ability to approach brainstorming honestly and to empathize with the perspective of a customer will allow non-obvious ideas and conflicts to surface and to be…   Read more»

Your question has a lot of depth.  As accepting clinical trials “as is” is easy because they have always been done a certain way.  It is easy to also conclude that it must be okay because patients provide consent.   The…   Read more»

@alexandrabuga Great topic, a nice contrast to typical posts.  I do believe that Henretta lics heirs were ultimately compensated – largely due the pubic cries of “foul”, which I believe appropriate.  You made some interesting points; I am ignorant to…   Read more»

@amd29, I think you’re suggesting the multi-billion dollar pharmaceutical industry has little value?  Which I would like to agree, but there is strong evidence to suggest otherwise.  Pharmaceuticals provide a host of benefits for disastrous conditions of human health -…   Read more»

Yes, I will consider having a partner.  Having a partner can be a great thing.  Therefore, you must consider what you’re will to trade off.  It is very important to have it all.  Having a partner also spreads the risk. …   Read more»

Medtronic and Boston Scientific are c-corps because they are publicly traded companies with thousands of shareholders.  S-corps are really tough to give an example because they are not created with the same goals of C-corps.  C-corps experience a double tax…   Read more»

The merit is very limited, and you actually make a really good point.  At a minimum, there should be a “time-out” period where comparison to products over a certain age are disallowed.  Medical innovation is happening so fast.  From the…   Read more»

I think the quality department can become to preoccupied with finding problems, which is not hard to do for any product.  Therefore, a collaborative environment must exist so that if problems are located, proper guidance is offered to product managers. …   Read more»

On occasion, I passively thought the two roles were the same.  Until I had opportunity to do QC.  There is a clear delineation between the two.  QA sets the policy and framework, while QC ensures its implementation and execution.  Both…   Read more»

If you select polymers then you will certainly need implantation, genotoxicity, system toxicity, irritation, sensitization, and cytotoxicity test.  Test like these are provided by many companies, and the delivery time can vary.  Therefore, as the project manager you have to…   Read more»

Both leave a legacy, but I tend to agree that I rather see the impact now.  Still, who’s to say that my research activity will not foster future research, as most science builds upon the work of previous others.  Consider…   Read more»

@merzkrashed great feedback.  Are you a product manager?  Some years ago I had the unfortunate experience of being apart of a product launch that was missing the product manager… I’m still not sure how that was supposed to work.  Needless…   Read more»

@merzkrashed great feedback.  Are you a product manager?  Some years ago I had the unfortunate experience of being apart of a product launch that was missing the product manager… I’m still not sure how that was supposed to work.  Needless…   Read more»

The planning phase has enormous value to the success of a project. It determine its trajectory.  However, often times the surprises don’t happen until you execute.  Therefore, execution is the more important phase.  It is when all the work happens. …   Read more»

I agree!  Specifically, the selection of vendors is critical.  This is especially true if the vendor is spread too thin, or they do not have capacity.   A recent article I read that assessed the success and failure of information technology…   Read more»

The change request log has definite importance, but the change request meeting is probably more significant.  Often it is very difficult to articulate a change request in text form – unless it is something simple – but anything requiring a…   Read more»

My favorite project is when I hired a software programmer to build a software app and he was on budget.  My worst was the programmer I hired before the successful programmer.  He was a habitual liar, and essentially, the lies…   Read more»