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»

Verification tests whether design outputs match design inputs. Validation tests whether design outputs satisfies user needs. In my previous job as a Quality Engineer, I took part in the verification tests and validation activities. During the verification tests, we had…   Read more»

One way to improve design transfer is to implement the use of CAD drawings so manufacturing can better understand how to make the product. This can include a Bill of Materials, and what to include and not include in the…   Read more»

Companies will have Design Input and Design Specification documents in their DHF. They might not have a Design output because the Design specification might already outline the outputs. In some cases, the device output might not be available until after…   Read more»

Software Validation has many advantages. Software validation ensures that the device meets regulatory standards. This makes for quicker regulatory approval, and market access.  If the software is used in a hospital to store patient data, and track their medical history,…   Read more»

Validation is very important to ensure that the costumer needs are met. This may involve using Human Clinical Trials. This is a step further that Design Verification, which only checks if the Design specifications are met. In a case where…   Read more»

Placebo affects do not negatively impact a clinical trial. The Placebo group if compared with itself before comparing with the treatment group. Over many subjects, placebos results generally show insignificant data, with varying responses. Even in the case where some…   Read more»

I believe that in some cases it’s ok, where in other cases it’s not. In the case of a drug that required an IDE, it might be a good incentive just in case the patient may require additional treatments from…   Read more»

In a double-blind study, both the Investigator and Patient don’t know whether they’re being given the placebo or actual results. In a single-blind study, only the patient doesn’t know what’s being given to them. A double-blind study is better in…   Read more»

I agree that providing clear evidence based data on safety and effectiveness is important for doctor’s and patients. I think that patients want to feel that the product is safe and effective regardless on how the company claims that the…   Read more»