There is definitely a difference between verbal agreement and written agreement. Verbal agreements don’t seem very solid, and can be manipulated if there isn’t proof of the agreement. Written agreements seem a bit more trusting, since there is physical proof, and you know for a fact that this can’t be manipulated by the other party because its…[Read more]

I agree with the fact that if there is a business deal between two people, it shouldn’t involve other family members. Therefore, I don’t think that the restrictions are too much. Because its a dinner to discuss projects, it should be treated as a professional meeting, rather than a social meet. As for the gift giving, I also think that the…[Read more]

Dr. Simon, I learned a lot from this course, and I think I have a better outlook on what to expect in terms of going into the industry. I haven’t had any experience in the industry yet, and before taking this course, I didn’t know what to expect. However, now I don’t feel like I would be entering the industry with a blind eye. This course…[Read more]

I also agree with Adrian. If there is a set up for a collaboration, the organizational structure shouldn’t matter, but more so that the companies are working together and being efficient. However, companies individually can decide how they want to run their organizational structure to ensure proper efficiency. In this case, I believe that the…[Read more]

I think its best to work with people who are more knowledgeable in their area, than with people you are close to. I think its a bad idea to work with people you are close to just in case something goes wrong within the project, that will cause disagreements, and potentially ruin the relationship. However, as long as your team is willing to…[Read more]

I do not currently work in an organization, but if I had to pick the type it would be a matrix organization. I like that with this type of organization you can transfer knowledge about the project with other departments without it being an issue. I think to successfully run a project everyone must work together to ensure that production is…[Read more]

First, I’d want to make sure that everyone in the project understands what the device is, its purpose, its design, and how it will be processed. Once we understand the device and what is going to happen, we can then as a team decide together what we think the risks would be. Based on what we learned in lecture, we must consider the risks for the…[Read more]

one factor to consider is the assessment of the risks of the device. With this assessment you can determine the severity and number of harmful events associated with this device. Also, the probability of harmful events, duration, and the risk from false-positive or false-negative results for diagnostics. The reason why this factor is important…[Read more]

Risk Management is required by the ISO 14971, and must be completed by the company. The company will go through the cycle of assessing, evaluating, managing, and then measuring the risks. The company is responsible for taking all aspects of the product into consideration for risk analysis, such as the product itself, the design, and the…[Read more]

I think a successful validation process involves repetition and numerous trials of testing. I haven’t had experience in the industry with medical devices, but I have done research where we were required to do experiments and make sure that our results were real. We ended up repeating the experiment multiple times to make sure there is…[Read more]

Everyone raised some good points regarding verification and its importance. Verification is indeed an essential process in design control, and it can also aid in risk analysis. By verifying every aspect of a medical device (dimension, function, biocompatibility, life expectancy), you are able to learn more about the device, and what can be done…[Read more]

I also had to complete Requirement Documents and Test Plans for my capstone senior project. I agree that it does take a lot of time to complete because of the major details that are involved. However, these documents are definitely necessary when it comes to producing new products especially. For my capstone project, we had to design an…[Read more]

I’d also like to add on the importance of risk analysis for a Design Control System. Overall, everything boils down to the well-being of the people, and that is why the FDA needs to ensure that the product performs as promised, and is safe to use. However, anything can happen depending on the type of medical product you are using. For instance,…[Read more]

I also agree, the DHF documents should always be updated throughout the project. I have not had experience dealing with DHF files but based on what I have learned so far, I think that updating these documents frequently will be beneficial for the future of the project. This document also gives information on what worked and what didn’t through…[Read more]

I guess it depends on what role you decide to pursue. When it comes to clinical studies where it involves dealing with patients, then I think a clinical background may be necessary. Dealing with different types of people isn’t always easy, and the skill to remain calm and interact with them accordingly requires some experience. However, I don’t…[Read more]

One product that is very popular today are GoPro cameras. They do not use television to advertise their product but instead they have used youtube. However, they did not directly advertise their product but instead you see people using the GoPros and creating really clear videos. From this, it made people ask questions, and it ended up gaining…[Read more]