When Verification tests fail, I think that the best approach is to first evaluate whether the model still fills the need of the customer. The testing parameters could’ve been set incorrectly because they excluded a large amount of customers. In…   Read more»

In my personal experience, I had to jump into a role working with a team in a functional organization, not yet knowing how organizations worked and the meaning of the tasks I was doing. Know that I know how projects…   Read more»

The Design verification and Validation test the design of your product. In an experiment, there are always statistical analysis to determine the significance of the results to prove or disprove the hypothesis. The Test Method Validation is to predict the…   Read more»

Determining the spec with tolerances is the most important part in the effectiveness of the design. It really depends on the application and market in my opinion. If it is an orthopedic implant, there should be a plan included to…   Read more»

I agree that those devices may need to be regulated by all three sub-agencies. If the design contains any drug or biologic components, the other agencies might come after us if we don’t get those components approved by them. I…   Read more»

A 510(k) is used for class II devices which rely on a predicate device for its design and purpose. If the device is the same category as a long existing device, this form can use the older device as a…   Read more»

In order to handle conflicts effectively, we should have open communication from the beginning of the project. Managers need to share what is expected of their employees before the start of the project.  One way to handle conflicts is to…   Read more»

If the cause of failure was with the device design, then verification will take longer, and the timeline should be anticipated to be pushed back. As a project manager, I would confer with the Engineering team to conduct a root…   Read more»

I think where the value goes depends case-by-case. Those decisions are often made before creating a project, and involves outlining the strategy and analyzing the market and economy. If the market and economy favor the needs of customers that aren’t…   Read more»

Incorporating newer technology will affect the project’s lifetime. Therefore, to determine the effect that newer technology will have, it should first be determined whether the new technology will help the team achieve their goal. Then, it should be determined whether…   Read more»

Upholding NDAs can build a contractor’s reputation as trustworthy, and help them build relationships with companies. A good contract should be made so that sensitive information should only be shared within the scope of the project. One way to balance…   Read more»

Before signing an NDA, one must read through the entirety of the document and understand every part of it. If there is any discrepancy, all questions must be answered and understood. You should know to what extent the information is…   Read more»

Written and Verbal contracts are both effective, however, for different purposes. A written contract is much more commonly used because its written agreement can be kept recorded for extended periods of time. An example is a non-disclosure agreement where someone…   Read more»

I think a solution to this problem could be creating surveys on staff satisfaction with the managers, as well as creating meetings to discuss and align team values and goals. When the manager hears out the opinions from the staff,…   Read more»

I think each member in a team should be a good fit with the role they take in a team. Relationships can be a challenge, so there should be a balance between have good relationships and knowledge. If someone has…   Read more»

During the Covid pandemic, communication between individuals and teams were very impacted. For functional organizations, a clear, hierarchical system must be maintained. Virtual work disrupted this because it prevented in-person supervision on staff members, and ultimately can cause delays in…   Read more»

The FMEA is most valuable when determining the risks on a device. It can detect additional failure modes that add to the list of possible risks. It determines the risk something can go wrong, and under what criteria a failure…   Read more»

I agree that risk avoidance is the best way to deal with any level of risk, especially in manufacturing. However, mitigation tools and acceptance criteria are also important to use in risk avoidance. Certain tools can be used such as…   Read more»

To determine the acceptable level of risk, it’s important to follow the Risk Management Process. First, do a Risk Analysis and Estimation to list the possible risks of the device for the analysis, and estimate their possibilities and severity for…   Read more»

Hi elm33, After this week’s lecture, I feel a lot safer knowing about Verification/Validation. These steps are there to catch flaws early on, and if the device will perform its intended function. Verification is there to test if the design…   Read more»