So I have seen NDAs and CDAs for a long time. My perspective is that folks sign them very quickly to move their business forward but rarely "read" the fine print and leave it to their laywers. This is...

A couple of years ago, I hired a physician to consult on a medical device for a surgical medical device. The device was part of a combination product used in surgeries to control bleeding. The consult...

The non compete seems to have more impact to folks in R&D, senior management and the sales and marketing organization. Clearly individuals that have had access to critical information such as new ...

I am the PM on my class project and I would reference the Tuckman team forming model. In our first week we went through the forming and storming phases. The group was trying to get to know each other ...

I think in order to answer the question, it might be more important to characterize the size, maturity and existing organizational structure of the medical device company. Medical devices are made wit...

in a previous role, i had a group of supply chain project managers responsible for product launches, so you could say we were a PMO group. We developed a set of processes to manage the projects. Each ...

Your comment about product availability reminds me of a potential risk that I have experienced. Many medical devices have components that are outsourced from a supplier. They could be a "simple" as a ...

My perspective is that Post Market Surveillance is where the rubber its the road. With all the efforts of design engineering and the design controls, in some situations, it is only when we really have...

I have used many of the tools mentioned including brainstorming, fish bone diagrams and FMEA. i think it is important to know when to use them in the right situation. For example if you are doing it t...

I know how you feel about incomplete Gantt charts. Having run projects for years, I think that the effort to develop gantt charts seem a little overwhelming. Having a project manager or designated pro...

Scope management is definitely an important part of project management of medical devices. Gathering elements from different individuals certainly can bring additional elements potentially incongruent...

I agree with the comment that the DID and DSD documents will not guarantee a quality medical device product. The overall process beginning with the voice of the customer (VOC) a term from Operational ...

My perspective is that the various artifacts such as Design input Document, Design Specification Document and/or Design Output Document are important to document the robust process of gathering inform...

Having been a project manager, I can say the Gantt Chart is extremely valuable in the initial stages to better communicate relationships between tasks especially when team members think there are nol ...

My view of design controls is to provide a complete product lifecycle to medical devices. In the early stages of project definition to the ultimate regulatory approval and post market surveillance, we...