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…   Read more»

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 consultant helped to put together…   Read more»

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 product innovation and business plans are going to…   Read more»

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 and…   Read more»

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 with a widely different types of organizations. Some a…   Read more»

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 project manager had…   Read more»

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 plastic tube or more complicated as a…   Read more»

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 the medical device used in…   Read more»

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 to resolve a…   Read more»

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 project scheduler responsible for the initial development…   Read more»

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 with others, but we need to better understand what the real scope is. The project…   Read more»

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 Excellence is the beginning. The efforts…   Read more»

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 information, analysis and decision making. As the Professor indicated each organization may…   Read more»

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 dependencies. The ability to create a common view…   Read more»

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 need to fully understand reasons for change and…   Read more»

I agree with the different backgrounds addressing different roles such as statistican, regulatory submission expert or a biomedical engineer attached to the clinical study for provide technical support.  I would however state that all folks involved in clinical work be…   Read more»

The value of clinical studies in my opinion, looks at the larger picture of society. We would all probably agree that if a product, medical device or drug were developed and approved without a definitive plan and set of criteria,…   Read more»

So I agree with your comments regarding that medicine involves situations where values come into conflict. I also think that the regulators such as the FDA have put in place regulations to temper the potential expectations have with clinical studies….   Read more»

I think most folks would sense if they are being manipulated during a sales cycle or reading marketing literature. In the healthcare industry, working with professionals such as physicians we need to keep in mind that we should be presenting…   Read more»

Most companies in the healthcare industry have created mission and vision statements like Stryker, Novartis and Pfizer. They have cascaded that approach down to divisins and departments if the company is rather large also. Training sessions are setup to review…   Read more»