When working with people you may not know, that could be a good thing to allow for different ideas to come about. If you are not used to working with a certain person it may take some time to develop a working relationship, but it could lead to some great ideas that would have not been thought of otherwise. When working with friends, that could…[Read more]

The hardest part of a matrix based organization would seem to be getting people to be on their project team. If a person if involved in other projects it may be hard to coordinate with that person to get them involved in their project. It does seem like a way to fully utilize all of the resources available in the company without having to…[Read more]

I understand that having to pay may just be the cost of doing business, but I do agree having a database would be helpful to those smaller companies. Some smaller companies may have such innovative ideas and be able to really back that up with a product, but the cost of the purchasing these could really hinder that. If it were available in…[Read more]

FMEA does sound interesting Roberto. By being able to make sure you device fails and then fixing those failures could be a way to have a stronger more reliable product. On the flip side, if you are unable to fix those failures that could be a great indication that this project should be on the market. This seems like something could be useful in…[Read more]

A meeting to determine if a project is a go or no go seems to rely heavily on the risk management. It seems like a good idea to have multiple departments involved in this process to fully identify the risks associated with the project. Risk in pharma is certainly different than risk in a medical device company. Risk in pharma could be activating…[Read more]

When it comes to outsourcing, it seems that it can be a very hard process. The company wants to make sure their vendor is doing everything properly when they transfer it over. This would mean their is nothing left to chance anymore and the company has made sure their instructions are very clear to the vendor. In this case the vendor has to ensure…[Read more]

I unfortunately do not have industry experience in a design review, but I can imagine how these meetings impact the development of the project. During these meetings it must also be important to stay on top of the changes that need to be made to the documents or else it may become overwhelming. Also, with some many different opinions, it may be…[Read more]

Meeting minutes are important to recap what was said or done in a meeting. I have been tasked with taking minutes, but I know that no one really read them. It would be just sent to the manager and uploaded to SharePoint. Even though they were barely read they were a good tool to remember any action items that needed to be completed. It was good if…[Read more]

It seems that design controls can be ever changing with how the device is developed over time. Reading over the previous replies, it is true that companies can not change the design controls forever. If that were the case then they would never create an end product.There must be a point where they decide that the device is safe enough or the most…[Read more]

A very important part of the DDP is the scope management plan. If the scope of the project is not clearly defined and kept in focus nothing will get done to move the project forward. Once people working on the project know exactly what is needed to get done they can begin to work on it. Once the scope is clearly defined in a scope management plan,…[Read more]

When the process is not used properly, it results in a failed medical device as stated by those examples above. In the case of those recalled medical devices, it would be interesting to know what their design controls were and if they passed. It would also be interesting to know what made those companies feel that their products was able to be put…[Read more]

In my opinion it seems that the DHF could be a combination of the two. There could be some things that do not change throughout the design process, and then there could be things that are updated. Considering how much information the DHF holds, it seems unusual to limit its capabilities. Based on the lecture this week a DHF is supposed to contain…[Read more]