In my opinion, it is always best to work with someone who is most knowledgeable about the task they will work on. While maintaining good relations with people in the workplace, you do not always need to “like” someone necessarily to be able to do your job. From my experience, work and friendships do not go hand in hand. That does not mean however,…[Read more]

I would have to disagree with most people on here. These regulations should not cost any money. There should be a standard set of rules that all companies should follow, similar to the way the FDA has guidelines for medical devices and holds certain standards for them before they are put in the market. These rules are important for safety, and…[Read more]

Hello,

This is an interesting article. While I do agree that yes, companies can make these common mistakes, it still does not hurt to follow a process. The article mentioned that risk management is looked at as a “checkbox” activity. The checkbox is there to guide the company on brainstorming the potential risks and figuring out how to prevent or…[Read more]

Other factors would also be the probability of the occurrence; degree of harm caused by the failure; number of individuals affected and how exactly the failure affects them. Also, I wanted to add that it really all comes down to objective judgement. Often, you can tell how severe a failure is just by looking at the nature of the harm it brings and…[Read more]

Human factors/usability engineering focuses on the interactions between people and devices. For medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and users can use the device safely and effectively.

In my…[Read more]

Meeting minutes are important because specific points can be made in a meeting that are important in moving the project forward. If we overlook those points or tasks, it could cost the team the quality and deadline on finishing the project. It can be really easy to forget what was stated and therefore, having meeting minutes is a very useful tool…[Read more]

Hey Roberto,

I agree with what everyone on this thread has said so far. However, I would also like to add that when “making up tests” it is often beneficial to read up on publications that have done similar clinical or preclinical testing. Although the product being tested might be novel, there is always a good chance you may be able to find…[Read more]

These products, although no longer under development, as you mentioned, are still being manufactured. If this is the case, then there exist documentation in order to create the product. I do not think it will be too difficult to use these documentation in order to create a DHF. At the end of the day, a DHF is a document that entails a list of…[Read more]

In my opinion, if you were to write a document on how to make a device, and give that document to someone else, they should be able to build an exact replica without coming back to you for questions. This is the basis of a design input or requirement. Each requirement would describe a component inside the device. It would list things such as the…[Read more]

Hey Lamiaa,

Good discussion question. I agree with all of the points on here. I just wanted to add also, that for a medical device, not following design controls can result in severe safety issues. It can cause numerous medical problems in patients as well as death in some cases. The reason that we have stringent design controls is to minimize…[Read more]