In worked on a med-device for soft bone injuries that that I built with a group of 4 people. The design was based on a modification to a cam walker boot. The design was already similar in physical trails to…   Read more»

Intellectual property is one of the most important things to consider protecting when making an agreement. The contract should consider the benefit and risk of both parties and should be very clear in spelling this out. I think that all…   Read more»

I think the matrix organization is best simply because the advantages are centered around multiple control. There always a second opinion. Thought that can be difficulty to deal with sometime and may cause delays, it gives a higher degree to…   Read more»

I would not form a team based just on personal relationship. I would form a team based of the individual that best understand the objective of the project. Most people in industry can adjust themselves if the understand the project….   Read more»

When working on projects where other companies are involved. I think that the most efficient type of organization is the functional or matrix organizations. I think that is important simply because every individual is representing the entire company, and company…   Read more»

There are many ways risk are identified and dealt with in a company. In every department there are different risk factors that are considered for different perspective and that are sometimes only applicable to their department. In my experience risk…   Read more»

I think that avoidance is of the lowest severity simply because the problem is not his, however depending on the drawback to that product function it can be a difficult decision to make. I think that the highest severity would…   Read more»

I think that is anything in industry can easily lose its real purpose in the face of company agenda. Risk management should exist to insure that the used is completely safe and hot harmed at all by the device. However,…   Read more»

I believe that meeting minutes are extremely important, even so that there is a person at my job that would take notes during the meeting and then type it up afterwards and send it to everyone. I have seen in…   Read more»

In agree that the FDA may be more interested in insuring that the design controls for a specific device is within the FDA standards. For example, when a company send in a new IND to the FDA for a new…   Read more»

There are design controls in most countries that design and manufacture medical devices. There are all specific to their particular country and must follow the standards given by that particular country. However, that are many med-devices that can be found…   Read more»

One approach that I have seen companies marketing their product is through partnerships with larger more recognized companies. This allows for the product to be seen by people who may already follow the growth of that larger company. In development…   Read more»

In the industry there are indeed many products that can be discovered based on project needs. The Rees system is a product that is leaned about just by googling what is needed for monitoring equipment in validation programs, and the…   Read more»

There are a lot of interesting points made above which made it hard to make a decision. But from my research I would go with an LLC. As a mid sized company you can start as an LLC and change…   Read more»

Going through all the posts in this tread I agree with the majority of what everyone is saying- that I would not turn down a position based on the type of company. I would focus on the role and the…   Read more»

Public companies have shares that can be publicly traded in the stock market. Private companies do not have stock that can be publicly traded. One of the advantages of a private company is that Private companies are not required to…   Read more»

I think that inmost departments that are impacted by quality there is usually not enough focus on the big picture. In most departments the main focus are the goals of the particular department. While the quality department would focus on…   Read more»

I currently work in manufacturing and everything we do is review by Quality. Our department has a good relationship with QA who reviews our batch records. This may just be so due to the fact that manufacturing doesn’t really get…   Read more»

The article I looked at stated that the IOM report on the 510(k) process contains broad recommendations that may have significant consequences and impacts on the medical device industry. Specifically, IOM concluded that the 510(k) process “cannot be transformed into…   Read more»

I read an article about some rumors that Apple is trying to come up with a watch that continuously measures the blood glucose level. In the early 2000s, the FDA approved a device called the GlucoWatch. It used a low…   Read more»