It is important to understand the other individuals point of view. There can be a multitude of reasons why the other individual is unresponsive or willing to have sit down meetings. Generally, if you are able to form a relationship…   Read more»

Within my company there was a project I worked on where we looked to have a new titanium bone screw system used with foot for bunionectomies, fractures and osteotomies released. The system was acquired through a product acquisition. There were…   Read more»

Gantt charts provide a nice holistic visual representation of all the tasks within a project and the timeline proposed to be followed. Within those tasks we can see the breakdown of the sub tasks as well as what needs to…   Read more»

Project planning as the majority of the posts above indicated is important and overall sets the foundation and path moving forward for the project. The planning phase I do agree that returning to activities at an earlier phase doesn’t mean…   Read more»

Within the company I work for, although I am not directly involved within the design review meetings, I have spoken to a couple R&D engineers who partake in these meetings. They describe the culture as stressful. The meetings generally are…   Read more»

Ethically speaking, I do not believe any project manager should feel the need to work those under his wing to exhaustion. The overall goal and objectives for the project are set forth in the beginning and if you are working…   Read more»

I agree with the majority of the above sentiments. Another important perspective to obtain would be that of the surgeon. Within my company, the R&D engineers work directly with the surgeons on designs and get their direct feedback on whether…   Read more»

In my experience with suppliers, they are always open to providing suggestions for process monitoring, potential avenues of future risk, and additional cleaning steps to ensure the safety of the product. This can come in handy with risk management because…   Read more»

Typically within the medical device company I work in, design changes are generally driven through an engineering change request. These ECRs generally have five phases where phase one is when the overall scope of the change in encompassed with the…   Read more»

I think it would be wise to get everyone familiarized before starting risk management meetings with the ISO 14971 standard. Before even running these risk management meetings it is important that everyone in the group that I am in charge…   Read more»

Currently, I work for a medical device company within the north jersey area. From my experience so far with the company, I would argue that is a functional organization. With such a large company it is difficult not to separate…   Read more»

I agree with the sentiments above in regards to picking project teams. Overall it is important to take a look not only at the team from a technical standpoint but from an interpersonal standpoint as well. If a team cannot…   Read more»

Risk management, from my understanding, is the act of ensuring your device is free from unacceptable harm. I believe the first step in any risk management plan is to determine your potential sources of harm that are directly related to…   Read more»

For the case of the syringe, it would depend on the interaction with the body. I think that would have rather large implications and would dictate the various routes that may have to be pursued. For the syringe, the plastic…   Read more»

I agree with the sentiments stated above as well. Overall you want to put a product out in the market that will in no way harm the patient and that can only be down through clinical or animal testing. There…   Read more»

In my current position, I work within a functional organization. From the lectures I can understand how the disadvantages come about however I have no run into an issue of having silos form between different groups. Every team has their…   Read more»

In response to ak977, I do believe that those are valid concerns to have over privacy. What I would propose as a potential solution is to have the transmitted data password protected, where the individual sending or receiving the information…   Read more»

I would argue that this product is a combination product. Abilify was first approved in 2002 and approved for use to treat Schizophrenia however the new novel aspect of this design is the sensor technology which tracks the ingestion of…   Read more»

I work on the Merger’s and Acquisitions team for my company and our main projects when it comes to purchasing an outside company is to integrate and remediate the company to our standards. Generally we use a gantt chart to…   Read more»

Replying to Amin’s post on the intended use of Medical devices. I believe the company developing the device should do their due diligence in determining potential adverse effects of how their device is interpreted and used. A company should be…   Read more»