I don’t really think there is a way to spin it that missing a milestone on a project is a positive thing. I understand what you are saying, in that missing a milestone means you are in turn spending more time on the specific task or step, therefore better perfecting it moving forward. However, had this task been done in the same fashion on time,…[Read more]

It is imperative for the specifications in the design input document during the planning phase to be accurate and clear. In order to accomplish this, there should be collaboration from many different people in order to cover all bases on this document. The customer needs need to be taken in mind in order for the engineers to plan out the details.…[Read more]

The planning phase is the foundation for all other phases of the project to come. A strong and detailed planning phase is essential to the success of the project. As mentioned, customer needs are a large and important role of the planning phase as they are the key to assessing what your product, in the end, needs to require. However, as was…[Read more]

Like yzs3 mentioned, sending the documents a week in advance could be very beneficial to allow for everyone attending the meeting to have time to read over and understand what will be discussed. In addition, the document itself must be very clear and very concise to allow for all in attendance at the design review meeting to have a clear…[Read more]

I don’t think that any essential projects should be cancelled or even put on hold due to them being “less of a priority.” This slows down the overall design process. Unless however, the project is unessential, then there is no reason to waste manpower or resources on it. But to answer the question, yes I think that more essential projects, such as…[Read more]

I think that the world is definitely moving towards one global system for regulations of medical devices. In addition, I believe that a global system of medical device regulation will have a plethora of positive benefits on the world. For example, it would allow countries to easily utilize products and devices from others without going through…[Read more]

In my opinion, the best time to carry out verification and validation steps would be consistently, as progress is made in the project. For example, on my capstone project, we are currently testing materials and designs as we develop in order to limit the amount of backtracking and re-developing we have to do when we find a failure. Verification…[Read more]

Specs of the product are essential in in the Design Specification Document to ensure that testing and development can be properly executed. The specs of the product must be properly documented to allow for product development in the future. In addition, any product will have a range of error in development accounting for slight variance in size…[Read more]

Properly selecting the members of a project team are just as important as any other step in the process, if not more important. A great product or device idea with perfect documentation and resources will never make it past production if the team working on the project is not a good fit. Not only does every member from management to employee need…[Read more]

This is a good question, that I wondered myself. It seems that there is a significant advantage in the timeline of developing a product if a product is labeled as class 2 rather than class 3. For products that have the risk factor of class 3, but are granted class 2 classification due to the fact that a similar product has been on the market seem…[Read more]

Completely re-making the classification system seems very unnecessary to me. Granted I have no experience of using this for anything outside of this class, but I think that there are fairly specific qualifications for each class, for example any device that sustains life, produces life or death information, or has a largely unknown risk profile…[Read more]

A project manager is required to be a sort of “jack of all trades” in the form that they must excel in so many areas in order to effectively get the job done. A successful project manager must be knowledgeable in the technical aspects of the project in order to analyze and execute decisions. A project manager must have excellent interpersonal…[Read more]

It makes sense that if there is a defect in the labeling of a product resulting in mass amounts of missing labels, that an easy solution could be to remedy the problem for future sales, and simply inform anyone who has received/purchased the medicine to check the dosage and usage directions online before using. But for the 99% of people who do…[Read more]

In response to the debate of whether or not there is a 70:30 ratio of importance of interpersonal skills over technical skills, jl959 makes a good point. Stating that this is not true in all cases due to different work environments is 100% true. Interpersonal skills are incredibly valuable in so many ways from presenting well in an interview,…[Read more]