Hey Roberto, I believe that those guidelines are a bit too restrictive, however they do serve a purpose. Basically, these guidelines are set in place so that a physician who is being pitched a product chooses that product only because…   Read more»

Maybe “Medical Device Production” or something along those lines, perhaps to make it clearer this is more about the business aspect of putting a medical device on the market versus the actual engineering of the device?

– Saad Ali

Dr. Simon, As some others have said, when I first enrolled in the course, I thought I was going to learn about the theory of developing medical devices and the technological knowledge that is required to do that. However, I…   Read more»

I agree with pretty much everything you said. I believe organizational structure can have an affect on the culture, but I think it’s mainly there to define the goals of the employee. Depending on the structure, the employee will be…   Read more»

I agree that choosing your team isn’t always an option and it’s better to find people who are good at what they do. For this reason, I don’t think it’s necessary to have someone you already have a good relationship…   Read more»

As others have said, the best organizational structure depends on the size of the company. Still, though, I think in most cases, the matrix organization would be best for most companies. This allows for resources to be managed properly and…   Read more»

I agree with what you’ve written above and I think the problem lies within the company’s philosophy itself. More often than not, these companies are not making devices to “help people” but rather to make money. With that, there are…   Read more»

Although I don’t have any direct experience with Risk Management, I would assume that people in risk management must be able to consider all possibilities and look very far ahead in terms of the outcomes of the product. That being…   Read more»

Hey Dhairya, Maybe I’m mistaken but I don’t think we can properly say which tactic we’d use for low severity or high severity without also noting the frequency of those risks. That being said, I think for low severity, I…   Read more»

The bullet points you listed as well as what others have said cover a lot of what is required of a Gantt chart. However, I’d like to emphasize what should be on a Gantt chart. Because it is a plan…   Read more»

I also agree that it is in a small company’s best interest to utilize outsourced manufacturing. This is mainly because, for a growing company that does not have the resources yet, they cannot afford to have slip-ups anywhere along the…   Read more»

As some have said, I think the biggest issue for design transfer would be communication between the design team and manufacturing teams. There should be a lot of oversight between the two to ensure that the integration is as seamless…   Read more»

I completely agree with you! All components of the DDP are very important, however if I had to choose one, it would most likely be the quality management plan. Quality management and control act as checkpoints as the device is…   Read more»

Hey Lamiaa, I guess the most obvious consequence of insufficient design controls is wasting time. Designing a medical device is no easy task and therefore requires many moving parts and complex processes. Small insufficiencies here and there can add up…   Read more»

Design Controls to me are basically risk management and safety checks for a company. These allow a company to run through a list of checkpoints before their product is put out on the market to ensure that they have done…   Read more»