Like many others, I’ve never been a PM. However, if I were, the type of person I’d look to hire would honestly depend on the team I already have. If I’m running a team of highly specialized individuals who each…   Read more»

I think effective risk responses are the ones that are realistic and proportional to the actual risk, not just theoretical solutions pulled from a list. For example, if there is a risk of a supplier delay, instead of overreacting and…   Read more»

I think my personal experience adds some real insight here. I’ve met a lot of PMs in the medical device field, and most of them started with degrees in mechanical or biomedical engineering. They usually worked in product development or…   Read more»

One of the main goals of a project manager is to deliver a successful project on time. Since teams are made up of different personalities, conflict is almost unavoidable at some point. It’s the PM’s responsibility to step in before…   Read more»

Project managers can manage their inbox efficiently by organizing emails into folders based on projects or teams. These folders group related emails together so messages about a specific project or from certain team members are easy to find later instead…   Read more»

I understand the point that missing a milestone can sometimes lead to a better or more successful project, but I do not fully agree. Milestones are established to ensure a project meets key deliverables while staying aligned with company goals….   Read more»

Hello everyone, 
My name is Anthony D’Alessio, I attend NJIT where I am a master’s student in the mechanical engineering department. I look forward to connecting with you all. Please find my LinkedIn profile below. 
https://www.linkedin.com/in/anthony-d-alessio-aa54892b1/
 

Biomedical projects are especially challenging because project managers must balance strict timelines, FDA regulatory requirements, budgets, and coordination betweeen teams with very different technical backgrounds. Becuase of this, I think the most important skills for a PM in this field…   Read more»

I think the answer to this question is actually very simple. At the end of the day, a company is a business, and the goal of any business is to maximize profit while remaining competitive. If we take a step…   Read more»

I agree with many individuals in this forum where a hands off approached is better than a micro manager. A hands off leader allows the members to manage their own work which can lead to better working environments and more…   Read more»

As you have mentioned, there are three classes of medical devices, Class I, II, and III. Class I devices are those with the lowest risk and they are typically exempt from premarket review. Class II devices have moderate risks, they…   Read more»

I have had some experience working with teams for a project. In my personal opinion, I believe that smaller teams tend to work better to accomplish projects effectively. Obviously, there is a time and place for larger teams based on…   Read more»

Like many others in this forum, I believe that knowing the basics of project management is critical for one’s career even if they are not trying to become a PM specifically. As a mechanical engineer, it is basically a guarantee…   Read more»

The main difference between PMA and 510(k) pathways is the level of risk and market evidence required. For class II devices 510(k) is typically used and it allows manufacturers to demonstrate the equivalence to a preexisting medical device. Therefore less…   Read more»

When a team member has more expertise than a PM and a conflict arises, the project manager should utilize that expertise rather than compete with it. A lot of the times PM do not want to hurt their ego so…   Read more»

A project manager’s main goal is to lead their team and fulfill all the required deliverables for the project. Obviously in any team setting there will always be some sort of conflict to arise. The project manager must quickly pick…   Read more»

The most important responsibility of the FDA regarding medical devices is their role in protecting patient safety by ensuring devices are safe for their intended use. One of the reasons that this is so important is due to the fact…   Read more»

I think in any capacity of the world, people are taught to be leaders, and no one is truly a “born leader.” While many individuals may have better traits to become a leader than others, I do not think anyone…   Read more»

While there are pros and cons to both online and in person, I believe that in person PMs are a much more effective option. After dealing with numerous online interactions post pandemic, it is obvious that teams work much better…   Read more»