A great way to keep up with regulatory changes is via predicting what changes can occur. Some organizations undergo analysis of past regulatory changes in order to understand how regulation can develop in the future, thus allowing for earlier preparation…   Read more»

@sarahqudah1 I believe that with medical device projects, market adoption is one of the more overlooked issues. Cost and accessibility of the product are important to consider in the creation of it. High development costs create high costs of product,…   Read more»

Especially in terms of medical device development, early start and finish dates allow for flexibility in schedule that can be incredibly helpful based on issues occurring with the project. Issues with ordered resources, delayed meetings, and problems with deliverables can…   Read more»

While all these risks are incredibly significant, one that is constantly present from the beginning of a project is financial risk. Questions on the presence of the finances needed for resources, work, and further development, are details that permeate every…   Read more»

One thing to consider with the testing of worst-case scenarios is the resources that get used within this verification process. Worst-case scenarios can involve a multitude of possibilities without specification, and in turn need a large amount of equipment and…   Read more»

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»

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»

Outside of a project management role, project management skills can reflect well in leadership experiences and in management of personal goals.Project manager duties of creating goals, identifying what deliverables are needed, having a clear line of communication, and keeping note…   Read more»

A great way to see the difference in PMA and 510(k) pathways is to answer if the product is life sustaining, and if there is a predicate to the device. Life sustaining devices tend to go through the PMA pathway…   Read more»

I’m in favor of there being a leader acting as a main head with support. Having support allows for a leader to get quick feedback on goals and plans being implemented. Part of a leader’s duties in terms of project…   Read more»

For medical device classification ambiguity, it is important to understand the intended use of the device and present indications for said use. With the example of the artificial pancreas within the simulation, its intended use was to control insulin regulation…   Read more»

A huge factor that can play into preference can be the experience of the individual entering the team. For an individual who is new to the team and learning many skills, a more micromanaging technique can aid with the onboarding….   Read more»

For a project manager, handling team conflicts will involve a good amount of proactive action. As mentioned, many conflicts can arise from miscommunication, disagreement in methods, and from a difficulty addressing situations before they escalate. One way to address this…   Read more»

With communication breakdowns, it is important to identify potential areas of misunderstanding prior to conveying information. Many breakdowns come from the difficulty in including context, misrepresentations of tone, or assumptions of understanding information conveyed. It is important to understand that…   Read more»

It is incredibly important to predict what risks can come from including new technologies and adapting them within a project. New technologies are capable of coming with their own constraints, and with conflicts against existing work based on older technologies….   Read more»

I agree that typically values depend on a case-by-case basis, however in terms of medical devices I believe stakeholder values might take priority. For customer values there is typically a necessity involved that ensures a permanent presence of the customer’s…   Read more»