What truly motivates me is helping people, or at least the idea of helping people. Although it can get muddled and diluted in these huge medical device companies, my main driving force to going to work every day and studying…   Read more»

@hk425 I completely agree with this post. Regular communication and coordination between teams working on different aspects of the same project is crucial to ensure that the project progresses smoothly and meets the desired outcome. It’s not enough to simply…   Read more»

Supplier diversity can bring benefits such as access to new ideas, perspectives, and business opportunities. Having backup supplies can be helpful in case of unexpected problems with the primary supplier. However, it’s important to balance diversity with cost savings to…   Read more»

Throughout this course I’ve learned a lot of about the “behind the scenes” activities that drive and effect projects. Mainly I think it was extremely helpful understanding the different pathways various types of medical device products need to undergo before…   Read more»

As a project manager it is important to keep team motivation high in order to drive project success. I think one of the important ways a PM can accomplish this is through leading by example through productivity, morality, and good…   Read more»

I took the decision of choosing one vendor backup instead of multiple. In the project provided, there were certain specifications that the coating needed for it to work on the catheter. Even though there were multiple vendors available that met…   Read more»

It is situation dependent, but if both teams are working on different aspects of the *same* project, then it is essential to take time weekly to make sure that everyone has a working idea of what everyone is doing. Deadlines…   Read more»

As many others, I’ve also experienced scope creep during my capstone project. For my capstone project, my team and I had to develop a software application in MATLAB to process fNIRS data. This required us to understand fNIRS data, the…   Read more»

Communication ensures that there is nothing left to assume and everyone has a handle of what the other team is doing. It wouldn’t be a waste of precious time to ensure that the teams understand what the others are completing…   Read more»

Hopefully an occurrence like this is not prevalent but in this case the best course of action may be to get another person to take up the role and its tasks. In some situations it may be very beneficial to…   Read more»

Quality control may be conducted in larger companies and projects because the outcome has more on the line rather than small companies. In most cases the large companies are planning to sell a larger amount to the general public while…   Read more»

Some mistakes of risk management are ignoring opportunities. Project managers are human. Like most other humans, they often associate risk with bad things. Even highly trained managers ignore the possibility that an opportunity can come from a risk event.  Successful…   Read more»

A risk-benefit analysis is a comparison between the risks of a solution and its benefits. It’s used to figure out whether a course of action is worth taking or if the risks are too high. People do this in their…   Read more»

There are 4 types of risk management. Risk management is not about the elimination of risk. Risk ca benefit businesses by creating productive opportunities, and risk management can increase efficiencies in administrative systems in a way that delivers improvements throughout…   Read more»

HAHA! Every day at my workplace. As I work at a small company, we are often at the whims of the CEO when it comes to new projects. Scopes can change depending on their desire or vision for the company’s…   Read more»

I see how it may be tempting for companies to implement cost saving policies in favor of creating a diverse vendor base. However important they may deem the bottom line, in the long run, more supplier diversity can save the…   Read more»

This is a complex ethics question that doesn’t have a simple answer. On one hand, transparency is important for building trust with stakeholders and ensuring accountability; on the other, there may be situations where disclosing certain information could harm the…   Read more»

It’s hard to tell how much information should disclose in the long term. But I believe the insert package, for example, has included everything the public should know. The part that is hard to define is the manufacturing process or…   Read more»

A well-designed Quality Assurance process is essential for project managers to guarantee that their products or services meet the expected quality standards and customer needs. By adhering to the prescribed steps of defining quality standards, establishing relevant quality metrics, creating…   Read more»

Process manager is also a significant role which will smoothen the over all process to complete the criteria for specific manufacturing process. When ANDA batches are approved by FDA the process needs to be validate while manufacturing on a commercial…   Read more»