I think there are different situations with the labeling which could result in either immediate corrective action or even a recall. As we have have heard before, labeling is one of the three core components of what constitutes a medical…   Read more»

While this could make it easier to globalize healthcare and allow for easier import/export of drugs and devices, I think it will make it harder to bring new products to the market in the first place. Assuming there is one…   Read more»

I do think that interpersonal skills are a tremendous asset in the workplace, I do not think that people can just fake their way through without a good basis of technical understanding. Going so far to say they you only…   Read more»

To me, this is probably one of the hardest part of the design process. There are many problems associated with creating tolerances for various aspects of the product. On the one hand if you make the tolerance too tight, it…   Read more»

I do think these restrictions are a bit too harsh. Sure expensive steak and wine dinners are not the most useful allocation of resources but I also do not think someone is swayed into a huge business agreement just because…   Read more»

Dr. Simon, As someone who has been working at a medical device company for almost a year, I found this extremely relevant and helpful. It sort of reinforced some of the ideas I already had about the roles of certain…   Read more»

This is an interesting dilemma you brought up. I think you should divulge as much information as possible under the protection of the Non-Disclosure Agreement since it will be very difficult for the Consultant to help you if you don’t….   Read more»

I think as a project manager you would want a matrix structure. Project-based structure lacks efficiency in that there can be members of the team who are specialized in certain areas, but that area is not needed for that project.For…   Read more»

While these two are similar, I think education really separates these two levels of management. Being an engineer I am more inclined towards being involved in middle management as those are the people who go and get things done at…   Read more»

I currently work as a manufacturing engineering co-op for a medical device company which is most like a functional organization. Each department has their own managers (Manufacturing, Quality, Purchasing, R&D) and they usually conduct work independently on projects concerning the…   Read more»

If the risk has been deemed acceptable enough to reach the end user then I believe the best way to mitigate the risk is to have a scrupulously detailed Instructions For Use (IFU). Sometimes companies will have to determine if…   Read more»

You mentioned two of the big factors: Severity (S) of the failure and Occurrence (O) of the failure. These determine how serious the problem is, and how often it happens. A third factor which my company uses is the Detection…   Read more»

I would like to point out that no matter how creative and methodical you are, there will be risks that you will not be aware of until something goes wrong. The Failure Mode and Effects Analysis tool is a live…   Read more»

The Design Input Document (DID) and Design Specification Document (DSD) are very similar, but I think they belong to distinctly different steps in the product development life cycle. The DID is meant to be just the big picture type of…   Read more»

Working in industry, I am aware of design review meetings which happen almost weekly. One of the many engineers will have some sort of change which affects the inputs or outputs of the process or product, and this needs to…   Read more»

As mentioned above, verification is one of the most integral parts of the design control process and probably where engineers encounter the most problems. This is the first step where you really get to see if your prototype is on…   Read more»

I think this law is huge step forward on the clinical world. I can only imagine the difficulty that comes with finding willing participants for certain experiments. Dr. Simon mentioned some college buddies who would try these new drugs in…   Read more»

Personally, I do not agree with either statement made above. First, I am sure there are medical devices which have failed to improve human well-being or have even backfired and caused unintentional harm during clinical trials. Perhaps the metal being…   Read more»

I think it is very situational as to the qualifications for each position involved in the clinical. The investigator is someone who should probably have a clinical background, but may pass if they have certain other qualities. Since they will…   Read more»

This was a very creative form of satire which highlights sometimes the disconnect between management and engineering. Obviously there were some requirements which were laid out in this video and the leader of the company wanted to do everything in…   Read more»