I work in R&D Lifecycle Management so our design change projects are an update or change to an existing product, not the development of a new product. However, we still use design controls to run ...

I am not personally aware of any companies that openly promote this, but there are definitely cases of negligence that, when caught in an audit, result in a CAPA (corrective action preventative action...

While I think that wearable device tracking may capture some adverse events that would have otherwise gone unnoticed, I think the issue of patient privacy would be a barrier to the implementation of s...

Its definitely an interesting observation that now, more than any other time in history, there is a large population of mixed race individuals that combine the biological profiles of multiple races. T...

@cb447 Selection bias is certainly a pitfall that clinical researchers may fall into if the only incentive for their study is monetary. However, as mentioned above, there are many other possible incen...

@mmd55 I agree that the medical device industry marketing still requires that human interaction element that it always has had, and that the physical storefront is not impacted. However, I believe tha...

@anthonynjit Medical devices involved in surgery have one primary customer: surgeons. Surgeons are skill based professionals that develop procedural techniques based on the device they are using, ther...

@anthonynjit Biomaterial/biomechanic/bioinstrumentation content of the training depends on the product, but in general I believe that a training course on a medical device product should include the f...

While C-corps require double taxation, they also offer the benefit of deducting employee benefits from taxes. And just like an S-corp, the owner can save on self-employment taxes if the owner also con...

@cem34 It is an interesting idea for a company to license off their medical technology to other companies that may find it lucrative to them, however it is likely that if it is not profitable for a la...

@cb447 I think you have covered many of the factors that go into starting a business, however I would suggest that while a good business idea is important, the expandability of that business idea may ...

@zbw2 Certain regulations are in place to standardize practices among all medical device companies, not necessarily because these regulations will impact the effectivity of the product. For example, t...

@jr377 In addition to personal networking and project exposure early on, a very effective form of communication I have seen between R&D and Quality is the collaboration to meet a shared goal. For ...

An often over-looked aspect of quality is training. As listed in the lecture and in the question above, training is one of the key aspects of quality control that must have a system in place to ensure...

@sara I think that its a very interesting question you pose about how diversity impacts different departments and working environments. While Karen mentioned how human differences shouldn't have an ef...