As stated here, there is a pretty big difference between an NDA/ CDA and a patent. There are also a few versions of NDA/CDAs, a one way to the company or from the company and a two way. Comapnies can provide information to and from each other in a two way NDA without much worry that their information will be shared to other people outside the…[Read more]

This is a tough question since you don’t always get a say in who is available to work with. But as a general rule, it is easier to work with people you have a good relationship with until you fundamentally disagree on something and cannot make a compromise. Also, you may not have friends in all departments and will eventually need to work with…[Read more]

I think my organization is a matrix type, but it also falls into a few othe categories from the website that another classmate posted (http://blog.hubspot.com/marketing/team-structure-diagrams#sm.00000pxiq60kn9dkivhcsc0fqkmx8).

We have a CEO, VPs of different functional groups but also of different franchises which represent markets. But because…[Read more]

I would agree with the matrix type organization as being very successful. It reduces redundancy and fosters working together to prevent re-inventing things that are required. Especially in medical devices where there is typically 1 core device with different variations for slightly different markets. Even in larger organizations, this type of work…[Read more]

This website explains this concept of AFAP and something else called “As Low As Reasonably Practicable” (ALARP). The idea is that the device has as many of its risks either removed or mitigated as much as possible with 2 categories of exception. One is not necessarily reducing risk with additional or redundant alarms or controls. The other is t…[Read more]

I work in Sustaining Engineering and though we don’t usually come up with new products and develop them, we do put a lot of work into getting and documenting VOC (voice of customer), and testing our solutions against the documented VOC. There are also a lot of failed projects that don’t work becasue the engineer failed to get proper VOC or didn’t…[Read more]

I agree as well. We have had many issues with timelines being unrealistic becasue they are set from above instead of by the people actually doing the work. In addition we miss holidays, forget to consider production (we are a 24/7 facility with little room for shifting), and one big one is forgetting to account for other countries holidays/…[Read more]

To your point, the ASTM and ISO standard test methods are very relevant to this question. They also can be modified for different applications after purchasing the test. The engineer does make up the test but they can use standards as guidelines and there are widely accepted statistical methods to analyse results. Ultimately the decision comes to…[Read more]