As you mentioned, handling projects in real-life situations can be quite stressful, and meeting deadlines often proves to be challenging, even with a detailed plan. In my role within the CNALab at NJIT, I have encountered situations where unforeseen interruptions…   Read more»

Whether Americans should be presented with facts to make their own informed decisions is an important aspect of the discussion. Considering the current state of information availability and the diverse perspectives on health and wellness, it will be worthwhile for…   Read more»

I agree with your assessment that relying solely on third-party companies may not be the most effective approach. Even with accurate form completion, the steps of evaluation and assessment remain. The challenge you’ve identified is transferring this information directly to…   Read more»

Design review meetings are meetings that happen at the end of each stage of the project process. This is when the team approves documents and allows for the project to move on further to next steps. In this meeting the…   Read more»

The approval process for design meetings are usually what causes a lot of delay within a project. There are so many things that managers need to track that causes them to put it off causing unnecessary delays and projects going…   Read more»

There are different leadership styles that a PM can implement but it all comes down to whether they want to be loved or feared as a leader. Every good leader will inspire and set clear expectations for their team but…   Read more»

A detailed plan is always going to include sub-plans that require planning with different areas within the project. There are many different components and plans that goes into a medical device so it requires sub-planning on specific teams required for…   Read more»

 I think that this is important, especially if you have a very important phase in the project that also requires a lot of attention. This can make sure it gets the attention it deserves and does not get lost in…   Read more»

I think that with different backgrounds, we have different perspectives. As a result, it is a lot harder to reach a mutual conclusion. That is normal and to be expected. I do not really see a problem with that though….   Read more»

The question of whether or not leaders are “made” or “born” revolves around how much emphasis is placed on innate traits vs acquired abilities. It is widely accepted that experiences and education have a larger role in shaping leadership qualities…   Read more»

1. Drug has chemical reaction and medical device do not have chemical reaction.  any other differences ?   Well, there are alot of differences between a drug and a medical device, both in application and definition. By definition, a medicinal…   Read more»

I personally like working under a manager who takes a less hands-on approach. This approach strengthens team members’ confidence to take responsibility for their job, fosters independence, and stimulates creativity. A hands-off leadership style enables people to more fully utilize…   Read more»

Personally, I think company culture is a major aspect of any company, but especially a medical device company, to fuel talent retention and attraction. It is important for any company to make their talent feel welcomed, productive, useful, and rewarded…   Read more»

If there is an idea that has the potential to be an extremely profitable or life-changing device, then money should never be a concern. One reason is that there are many routes, as a business, for you to be able…   Read more»

To guarantee that each team member contributes fairly, project management must take a proactive stance. Accountability is based on clearly defined roles and responsibilities that are in place from the beginning of the project. Regular channels of communication, like team…   Read more»

The preference for a hands-off or micro-managerial leadership style often depends on the team members and  project.  The hands off leadership style requires highly skilled and motivated team members. Also in this style sometimes there might be a lack of…   Read more»

In my opinion , it is not necessary that all team members contribute equally to projects. However, it is very important that each team member accomplish their goal. Some strategies that can help ensure that all team members are contributing…   Read more»

The Plan-Do-Check-Act (PDCA) cycle has four phases which are plan , do ,check and act. During these phases there are many specialities like biomedical engineers, clinicians, project managers, regulatory experts, and quality assurance specialists that work together to ensure the…   Read more»

This an interesting and a wide topic of discussion. In my opinion as an Engineer, in the medical device industry, a project manager with an academic background, including basic science or advanced degrees like a PhD, offers valuable skills. Their…   Read more»