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 responsibilities of their department. This can sometimes result in…[Read more]

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 device so any type of failure to a label can be considered serious. If it’s in respect to the labeling perhaps…[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 global regulatory body, it will essentially adopt all of the strictest rules possible from each country involved. The US would…[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 need 15% of technical expertise to succeed is a bit preposterous. This will also vary from department to department though and…[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 may be difficult for manufacturability or become extremely expensive when ordering from your vendors. When the tolerance is…[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 they were treated to some good food. Cars, vacations, and expensive watches may be a different story since those are more…[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 departments and how they interact with each other. I do wish you went into like manufacturing engineering (my current job) and…[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. In order to solve your problems, they need to be able to have access to a large array of documents and…[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 example, if you are working on a strictly mechanical device you may not need chemical or electrical engineers on the…[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 the technical level. Sometimes though it can be frustrating when the business minded upper management leaders expect…[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 responsibilities of their department. This can sometimes result in…[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 a risk has been addressed “As Far As Reasonably Practicable”. If it has been agreed to have reached that point then the…[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 (D) which is how likely you are to be able to detect the problem. These three factors are given numerical values and then…[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 document in that its gets updated repeatedly to include new failure modes or corrective/preventive actions which mitigate new or old risks.…[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 document where the marketing department goes out and does research to find a market gap or surveys medical…[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 be approved through design review meetings. These are very formal events which require an agenda, proposal, well prepared…[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 the right track towards becoming a successful product according to your customer needs. These customer needs are the…[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 order to make a quick buck, but perhaps did not realize the risk they put themselves in the process. For most,…[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 used in an implant elicited a reaction from the body and the immune system rejected the foreign…[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 usually have a team of clinical associates performing most of the procedures, I think the Investigator…[Read more]