The work that the team would have to do should be design with contingencies in the event of a member suddenly not being present. Some of the things I have seen in y experience is have very open dialog in team meeting about scheduling the work in advance. That way it can be adjusted if anyone have a vacation that they would like to plan. In the…[Read more]

I definitely agree that the planning phase would have to be revisited and redone. All the factors that are essential to the packaging line must be evaluated and it’s economic needs must be known. In my experience if the budget has very small room for change people will usually get spread a little more thin. I think that in cases like these c…[Read more]

I have experienced this quiet a few times as I work closely with PM’s. So anytime there is a change in a PM, due to any reason either the PM leaving or a senior PM taking over the project, there is always a kick off meeting to go over the project scope and the completed tasks as well as the uncompleted tasks. Anyone who plays a role in the p…[Read more]

I have worked on a project where we had to design a system where we had to have all our lab equipment backed up to a encrypted server. Some of our challenges were the risks that came with having different equipment being accessible in the server. Our risk management was around user access and actually getting the software to integrate with the…[Read more]

I am part of out weekly design control meeting for our company’s new product, we have a meeting where we discuss how we can improve the batch records and we assign task based on a tracker that we constantly update. Most of our improvement come from the operators that work directly with the manufacturing of the product. Our main objective and r…[Read more]

I have not even had to identify risk perspective from that large a range before, but I have seen different perspective about risk in my team. I worked on a project where the team leader main concern was the qualification behind the equipment. I work with the conversion of some of our labs to GMP labs and the risk management was surrounded around…[Read more]

I worked on a project where we had to collaborate with a different company or our validation projects. Because I was more familiar with the system and they were basically adding to our current system I basically came up with the risk management system and the focus of the meetings. I found the best place that the resources that we were getting…[Read more]

I also agree that the culture of the group is very important. It can get off to a rough start if the initial team is not very compatible . This is especially true when the project is ongoing or will be a permanent part of the company. I also think that picking a team that works well together is especially essential to making sure all the different…[Read more]

In the event that you are modifying a device to the point where you may need to have software modification, it will need validation. If it is a modification that do not need animal testing but may still require a higher level of safety when in use before the modification it may require just as much work and a class III device when going through…[Read more]

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 the boot, however we automated various function that brought together features that would usually be separate but needed in cases with soft…[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 the element that would protect you intellectual property should be your main agenda.

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 validation behind all the decision made. I think that the success of individual groups depends on all the…[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. I like my team to work as one unit with individual skills that way what someone would lack someone else can…[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 culture is very important to representing the company. For productivity of the project…[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 is defined in process development and in manufacturing is managed when deviations occur. Because I…[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 be acceptance because if you would assume the same risk as you did the as you did with avoidance then depending on the…[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, risk management it use to insure that the devices safe for the company to sell, keeping the company’s agenda as a first priority a…[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 many instances where having note can show how unproductive some meeting has been when there is no clear solution to a problem. This would…[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 drug. They are now just going to investigate to make sure that the design controls around the development and safety of the drug is within standards.…[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 in different country’s under the same company name. There are medical device regulation c…[Read more]