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 any kind, no matter…   Read more»

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 pleasantly surprised to learn that this…   Read more»

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: http://www.nytimes.com/2013/04/28/opinion/sunday/another-alleged-drug-kickback-scheme.html In this example, Novartis Pharmaceuticals enticed doctors to prescribe their…[Read more]

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 so uptight and overly professional that…   Read more»

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 include synthetic chemists, analytical chemists, chemical engineers and formulators,…   Read more»

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 ideal. I’d like to add that…   Read more»

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 often doesn’t occur until during or after Ph3 clinical trials (and often the…   Read more»

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 minutes is beneficial in every single industry, not just the…   Read more»

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 that happens at my job…   Read more»

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 entire development process and rationale for…   Read more»

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 that it may be worthwhile to compare their level…   Read more»

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 responsible for development & documentation of the…   Read more»