Another form of risk control may be in restructuring manufacturing processes. Therefore the risk management is not necessarily redesigning the product, but how it is made, to reduce risk of failure. In this case, the manufacturing process may be adjusted…   Read more»

Typically, several inputs are determined based on the customer needs provided by marketing and the VOC evaluation done by R&D. These inputs are then consolidated to a list that is both extensive enough that it covers all needs but also…   Read more»

Another factor to consider in verification activities is testing conditions that the actual product will undergo. This is not to be confused with validation however, which actually evaluates how the product is physically used. For the verification, you are testing…   Read more»

My experience with design verification and validation is that both activities must have strategies developed in the planning phase of the project. For verification, the strategy varies depending on the type of design project. If it is a new product…   Read more»

@mmd55 As you mentioned, TMV are important for proving that the way we are testing the medical device is accurate and consistent, ensuring the decisions made about the product from the result of that test are valid. In the medical…   Read more»

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 these projects. 1.Planning – In…   Read more»

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) that requires a lot more resources, time,…   Read more»

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 such a monitoring tool. An advantage that…   Read more»

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. This is not a unique issue for the covid…   Read more»

@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 incentives to join a study and researchers need to…   Read more»

@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 that the internet is definitely still a game changer…   Read more»

@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, therefore if the new medical device requires a different surgical technique, though it…   Read more»

@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 following: – what medical device regulations govern the product they are selling and…   Read more»

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 considers themselves an employee. As mentioned above, C-corps…   Read more»

@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 larger company then…   Read more»

@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 be just as important. Does…   Read more»

@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, there are strict compendia regulations for how to test certain medical devices…   Read more»

@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 example, in my job the Quality department…   Read more»

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 employees at all…   Read more»

@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 effect on regulatory, I believe that it is a key aspect…   Read more»