Design Validation is actually not always required in the product development process – a product may be sufficient with just Design Verification if it is a product that would not necessitate a clinical trial, i.e. a Class I device. For…   Read more»

A challenge I’ve often faced when submitting a Change Notice at my company Getinge is that obtaining approval from all the required reviewers can take a while, since these reviewers are usually functional managers with many other responsibilities on their…   Read more»

Logging work proved to be very useful in my job when I was helping develop a Design Verification test. My team and I were tasked with creating a test to measure the degree of spallation (tiny particulates breaking off of…   Read more»

Gantt Charts are very useful as a project management tool because they provide a visual depiction of the tasks that need completion. Similar to how a scatterplot can be used to see an overview of numerical data, a Gantt Chart…   Read more»

In my opinion both designing and executing a timeline can be difficult, and the difficulty of executing a timeline is dependent on its design. A well-designed timeline is the foundation of a project, and with clearly defined responsibilities and tasks…   Read more»

A useful method of handling scope creep which was mentioned in this week’s lecture is to create a Scope Management Plan during the Planning phase of the project. The Scope Management Plan can be part of the DDP and will…   Read more»

The impact of Coronavirus on Chinese manufacturing is proving to have a huge impact also on global manufacturing, because many companies depend on Chinese-made parts for their own products. From a management perspective, this is unfortunately an issue that is…   Read more»

At my current job I worked on a project where our project manager had two methods for tracking progress: One was a traditional timeline in the form of a Gantt Chart, and the other was a list of “off-timeline” tasks…   Read more»

I also agree that in a real industry project there would be clearer communication within the team because they could meet face-to-face. However I think that since this particular simulation involves laboratory testing, there would be additional restrictions if it…   Read more»

I agree with ad487 in that as a project manager, it is important to understand that obstacles can and will occur during the course of the project. Oftentimes these obstacles are unexpected, and can cause major delays in the completion…   Read more»

My company had a project based in Germany, with engineers from the United States and Turkey hired to support. The US side of the team was comprised of several engineers, including myself, and a project manager who would travel between…   Read more»

I’ve had the opportunity to work on the output and verification phases of Design Control at the company I work for. The output phase mainly involved creating specifications for components that went into the device, which allowed me to use…   Read more»

Like the individual a few posts above this post, I also am working at Getinge. I agree that it can be considered a functional organization in most cases. When it comes to routine operations, Getinge has specific departments that handle…   Read more»

I believe it is quite problematic if an advertisement makes claims about the extreme activity a joint replacement can withstand if that level of activity was not intended by the manufacturer. Pushing the limits of medical devices past what has…   Read more»

At the company I work for, the remediation project that I had originally been hired to work on was just cancelled a few days ago. Luckily I had already been assigned to another project, but regardless I understand how it…   Read more»

The implementation of the new EU MDR will pose a challenge for medical device manufacturers who sell in the European Union since, on top of any existing projects, they now must invest time, money and resources into ensuring their devices…   Read more»

One product that can potentially be classified as a wellness device (and that I am currently using as I type this post) is blue light blocking glasses. These types of glasses have surged in popularity in recent years as electronic…   Read more»

It is very important to ensure that every member of a project team is aware of any challenges other members have overcome in order to avoid repeated mistakes. In many instances, each individual member of a project team will end…   Read more»