I'd like to add that criteria for giving and receiving gifts often applies to both sides in a lot of company policies. Specifically, my company's policy is that I am not allowed to receive gifts of a...

When I enrolled as this class (which I did as an elective course), I was expecting to learn more about the technical details of the development of different types of devices themselves. I was pleasan...

As Juan mentioned, it was pretty easy to dig up an example of a kickback allegation that occured within the pharmaceutical/medical/device industries. Check out this example: In this example, Novartis...

I 100% agree that there should be a good balance of comfort & structure in an organization. I've worked in departments on both ends of that spectrum. In a structured department, team members are ...

I work in a matrix organization and I definitely think I prefer working in that environment. At my company, there are distinct departments within the product development portion of R&D. These in...

I agree with what many others have mentioned so far, that most likely managers do not directly pick their project teams. In that case, as you mentioned, having strategies to deal with conflicts is id...

As a few others have mentioned, technical transfer activities are not completed until a company has fully developed the medical device/drug/combination product and its manufacturing process. This oft...

As Murad and others have mentioned, meeting minutes are crucial for capturing meetings and holding meeting attendees responsible for decisions and actions. In my opinion, the concept of using meeting...

I think that even though Gantt charts are meant to document all of the related activities for a project, I think overall flexibility is key to delivering a project. Sort of related: A common thing t...

I think the DHF mindset of continuously documenting the "whole story" is more beneficial than the EU approach, where the design is evaluated at a single point in time. I think that documenting the en...

I agree with you, John. As others have mentioned, companies that have developed legacy products must have some level of documentation on the design and manufacturing processes at minimum. I think th...

Poor planning can definitely lead to a lack of proper design controls and therefore a medical device lacking in quality, as others have mentioned. As you mentioned in your example, when the people re...