For determining the duration of each task, it’s good to have an understanding of the team members performing the task, and what resources they have access to. Resources team members have access to determine time spent on the procedure. More…   Read more»

Within my experience, a key aspect of project plan execution is checking the feasibility of the project plan before making an effort to follow through on it. Some of my work is incredibly time-sensitive and requires costly resources. Keeping this…   Read more»

Project update meetings are a great way of getting an entire team onboard with the projects occurring, seeing who can help out for certain trouble spots, and making plans for future work based on everyone’s feedback. However, for long term…   Read more»

Within the medical device industry, the FDA device review  is the process in which FDA review teams review submitted data to determine whether to approve the device or not. In this process, there might be a meeting of an advisory…   Read more»

While external hiring can diversify staff, bring new skills to the team, and create a larger talent pool, internal hiring has a large amount of benefits that make it more beneficial to project managers. A reduction in hiring costs is…   Read more»

While I have not managed projects myself within academics or medical device development, in terms of improper estimation of costs I have also seen an extension within the project time-line. If the budget for certain projects is not enough, the…   Read more»

I do not have much industry experience either in addressing project planning, however in what projects I have seen and participated in there have been common factors. Before the initiation of any work such as data gathering, a key detail…   Read more»

This is an amazing definition of the concept of project initiation. Keeping in mind all the objectives of project initiation, I’m curious about what complications can arise within the medical device industry. A business case typically includes a summary of…   Read more»

Hello everyone! My name is Olena and I am a BME Undergraduate student at NJIT. Here is my LinkedIn, looking forward to connecting with you all!
https://www.linkedin.com/in/olena-sen/

This is a great definition of task scheduling! Another couple of details to include is that task scheduling can change throughout the project based on the schedule available, risks, technical specifications, etc. Observation and conversation with the individuals being scheduled…   Read more»

Emails are best for more formal communications and messages that are meant to be sent to a large number of individuals. In case multiple emails build up, it is a good idea to re-evaluate what older emails are important to…   Read more»

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»