Something that many companies will do during the planning phase is to do experimental and characterization testing. They do not require any acceptance criteria or sample size requirements that verification testing needs and can be a good way to see…   Read more»

@sanam  This may actually mislead people who read this. Design verification is an end goal where it is good to keep in mind to think about the verification testing needed for a product in the early stages, but the actual…   Read more»

The risks I’ve personally seen deals with both sustaining of products as well as seeing a remediation for a product has failed in the field.  For sustaining projects, the project has been launched and there may be a few complaints…   Read more»

I think one highly important area of learning that this simulation was able to bring about was to take a step back and look at the design inputs and specifications. If you scrutinize the inputs and review the protocol, you…   Read more»

Adding to @nr473 who summed up the business area that a project manager must be very well, I also believe the project manager needs to be confident in their decisions and the decisions their team is willing to make on…   Read more»

I currently work in a matrix based organization and I think it works great once you have enough talent and personnel to work within the cross functional team. The past year has drawn up an issue with the loss of…   Read more»

Although I agree with everyone that all phases are important, I believe the phase (can be different names) right before verification and validation are the most crucial for project succession. Yes, good planning in the early phases in the planning…   Read more»

In my experience, that is dependent on the project that is being worked on. If its a minor change, a team can add a rationale, justification, or upload a new revision of each of the documents to explain if there…   Read more»

To further strengthen the argument for a matrix based organization, I have personal experience in the matrix based organization style. We even have a training based upon this to have everyone understand their role in the matrix and where culture…   Read more»

I wouldn’t say a project should be cutting corners, but rather use previously reliable data to prove that the new product is not a new worst case. This can be done in multiple ways to save money and time for…   Read more»

Posted by: @mark-abdelshahed So it really depends on the product. Most of the products functional testing are per ISO and ASTM standards, which are international standards that most of the international health authorities require. Sometimes there are extra standards to…   Read more»

If you received the design change request that was based on the current version, it would be best to have rejected the request and ask the person submitting the request to refer to the latest version or revision of the…   Read more»

Posted by: @ad487 From a management perspective, both from a small product management team within a global corporation or upper-level management, how would they be affected by situations like these?  For a small product management team within a global corporation,…   Read more»

This may entirely rely on the industry that the class II device is within and may vary on how well the industry is able to prove efficacy and safety of their device. Class II devices have a large subsection that…   Read more»

Posted by: @as934 My question is how far can you embellish how similar a new device is to a predicate device? What ethical responsibilities lie with the company when they take this risk? Given that fraudulent 510(k) notices are a…   Read more»

There is no avoiding initial mistakes in a project team. Its part of the growing pains that occur with newer teams and project managers. That being said, these failures should be incorporated into a growing list of things to watch…   Read more»

Posted by: @jordankayal Posted by: @ro56 Although great points were made, the most important things are numbers. How much money are you going to save?, how much profit we you going to make?. How long is it going to take?….   Read more»

Posted by: @orleron How do you think Project Management differs in different industries or different types of Project? If you are a great PM for doing Medical Device Projects, does that mean I can throw you into a software company…   Read more»

I work at Stryker currently where I mechanically evaluate the implants and instruments created by research and development as well as develop supporting documents based around testing itself. My company has a newly developed project management group that involves the…   Read more»