One of our largest issues for the project simulation involved having a clear line of communication. The presence of a discussion board in both the group canvas and main course assignment canvas was a confusing start. Thankfully, this problem was…   Read more»

I agree with the points above. Changing the DSD is a more difficult process compared to the test veriffication plan. However, my decision on whether or not it would be appropriate to change the DSD would depend on if it…   Read more»

EEFS should be considered multiple times during the project management lifecycle. As with risk management, holding regular meetings to assess EEFS is critical for the success of a project. Communication can play a key role in how EEFS are managed….   Read more»

My group performed similarly. We took a more collaborative approach. We first did a root cause analysis and identified the areas of error that could have contributed to the testing failure. From that, we listed ideas on which methods we…   Read more»

You bring up a really good point that I think is highly debated in this high stakes industry. Medical device developers will try to increase the scope and range the devices are usable to maximize usability and profitability. For example,…   Read more»

Something that stood out in the process of designing the bottle labels was how it failed criteria at the 37C bath test. Likely what occurred was the adhesive degraded in some form with response to heat, especially considering the labels…   Read more»

One main factor that can contribute to how a project management could set up a project organization can be based off of the overall status of the team communication and collaboration. Project-based organization allows for the most simple communication protocols…   Read more»

Maintaining stakeholder expectations together with managing the project scope is critical to the success of a medical device project. A look at the company structure will confirm that the key decision makers consistently track the scope. However, there still exists…   Read more»

One important nuance I have always noticed is that it has never been “Nature or Nurture” but rather “Nature vs Nurture.” It is not black or white, it is more comparable to grayscale. I think of it as a large…   Read more»

Verification testing is one of the most critical steps in the medical device development process. It is supposed to ensure that the product meets the design requirements, is compliant, and would work as expected. Unfortunately, many issues tend to arise…   Read more»

I personally believe that testing in extremes is important. For example, say the labels were only tested for what was deemed “practical application” and tests were never conducted on bottles wet for the time period. The labels pass without issue…   Read more»

Managing problem-solving in different teams means that collaboration, flexible thinking, and structure will be required in the decision making process. Teams with different specialties are able to provide a wider range of ideas which leads to better solutions for the…   Read more»

Fortunately, my group did not seem to run into any issues. However, we did run into a similar situation where everyone seemed to have a slightly different background. I believe it helped us as well. Our group was able to…   Read more»

DSDs include the key features of the device and outline in which conditions a device can not fail. Therefore, changing the DSD would almost certainly have implications of requiring changes within the verification testing as well. As mentioned in the…   Read more»

Project and program managers also have a big difference in decision-making and risk management. Project managers focus on mitigating risks within a single project. They are tasked with making sure deliverables stay on schedule and within budget while meeting stakeholder…   Read more»

Program managers oversee the progress made by project managers. For example, where project managers are concerned about finding time to use a lab, program managers are concerned with dividing lab use between different projects. In that regard, program managers are…   Read more»

In addition to the points listed, changing vendors might not be an option for some projects. This can be due to that product being the only one of its kind on the market, the only one that meets other criteria,…   Read more»

Diverse teams lead to the brainstorming of unique ideas because of those different backgrounds. These ideas can conflict with each other so it is necessary to identify which plans can be implemented together without creating more problems in the long…   Read more»

I definitely see medical device project management as being more about the financial and business side rather than just the technical aspects. It’s really about balancing budgets, keeping teams aligned, and making sure deadlines are met, all while ensuring the…   Read more»