Medical Device Courses | Ad282 | Activity

Ad282 replied to the topic "Avoiding Tunnel Vision" -

Tue, 28 Apr 2026 22:43:10 -0400

I can relate to this because I also tended to have tunnel vision during the simulations. What helped me the most was working with my team. They would bring up different ideas or challenge my thinking, which forced me to… Read more»

Ad282 replied to the topic "Why Do People Leave?" -

Tue, 28 Apr 2026 22:35:46 -0400

I agree that job satisfaction is important. At the end of the day, people leave for better opportunities. Most individuals are always looking for growth, whether that means higher pay or a promotion. Even if someone likes their job, it… Read more»

Ad282 replied to the topic "Overworked Americans vs. Motivation" -

Tue, 28 Apr 2026 22:29:49 -0400

I agree with your point that a lot of people work extra hours because of peer pressure and expectations, not just motivation. In my experience, it is pretty common to feel like you have to stay busy or be available… Read more»

Ad282 replied to the topic "Skills Learned in this Class" -

Tue, 21 Apr 2026 01:14:08 -0400

Like many others in this thread, one of the biggest things I’ve taken from this class is how important communication and team dynamics are, especially in project management. You can have a solid plan, but if the team isn’t aligned… Read more»

Ad282 replied to the topic "Motivation factors" -

Tue, 21 Apr 2026 00:53:21 -0400

In this situation, I think the passion for the work itself would be enough to keep me motivated. Even if there is no long term growth within that specific role, enjoying the field and the project would push me to… Read more»

Ad282 replied to the topic "Why do people work?" -

Tue, 21 Apr 2026 00:37:13 -0400

Like many others, I’m not really surprised by these results. I think most people value enjoying their work and the people around them more than we might initially expect. That said, I would’ve thought career growth and development would be… Read more»

Ad282 replied to the topic "Nine Knowledge Areas" -

Mon, 13 Apr 2026 20:20:04 -0400

I would go with time management, risk management, and quality management. Time is important because every project is working toward a deadline. If the schedule slips it can impact everything else. Risk is also a big one because there are… Read more»

Ad282 replied to the topic "Familiarity of eachothers work" -

Mon, 13 Apr 2026 20:06:44 -0400

I think from my previous experience at a job, having weekly standups worked really well for this. Everyone would go over what they were working on, so even if you weren’t directly involved, you still had a general idea of… Read more»

Ad282 replied to the topic "Changining staff" -

Mon, 13 Apr 2026 19:56:42 -0400

I agree that losing someone mid project can definitely slow things down, especially if they were handling a critical task. I think one of the best ways to manage it is to quickly identify if that task is on the… Read more»

Ad282 replied to the topic "Power of Stakeholders" -

Mon, 06 Apr 2026 21:34:08 -0400

@ms2678 I agree with your point that sponsors and stakeholders have a major influence on a project’s outcome. Your example of prioritizing speed over doing things properly is a good illustration of how their decisions can have long-term consequences. Saving… Read more»

Ad282 replied to the topic "Significance of Scheduling in the Planning Phase" -

Mon, 06 Apr 2026 21:00:23 -0400

I personally think it is better to build buffer time into the schedule whenever possible. A project manager’s role is to create a realistic timeline and ensure the project is completed on time, and part of that is anticipating that… Read more»

Ad282 replied to the topic "Project Delays and Returning to Schedule" -

Mon, 06 Apr 2026 20:29:58 -0400

During my last internship, I ran into a delay that impacted a key milestone. I was responsible for performing model compensation on additively manufactured parts, which required CT scanning to measure distortion. However, the CT scanner malfunctioned, and what was… Read more»

Ad282 replied to the topic "Overlapping activities" -

Mon, 23 Mar 2026 21:11:31 -0400

I agree with your point that going back to an earlier phase does not mean the project is moving backwards. In this situation, the planning phase gave a general idea of budget and timeline, but once more detailed information became… Read more»

Ad282 replied to the topic "Unexpected Time Delays - miniSim" -

Mon, 23 Mar 2026 21:05:03 -0400

In the minisim, shortening the animal experiment timeline increases risk because it can lead to incomplete or unreliable data. While it may seem like time is being saved upfront, it could actually create bigger delays later if the study needs… Read more»

Ad282 replied to the topic "Problem with the Vendors" -

Mon, 23 Mar 2026 20:58:04 -0400

The first step is to confirm the defects are actually coming form the vendor and not form testing or handling. Once it is verified that it is solely from the vendor, and this is the only qualified vendor, switching is… Read more»

Ad282 replied to the topic "Importance of Stakeholders" -

Mon, 09 Mar 2026 20:04:02 -0400

In terms of completing a project promptly, I believe the obvious answer is the manager. They are in charge of ensuring all tasks are being completed and that deadlines are being met. They are responsible for the overall success of… Read more»

Ad282 replied to the topic "Missing a Milestone Experience" -

Mon, 09 Mar 2026 19:56:54 -0400

During my last internship, I had missed a milestone. I needed to perform model compensation on a batch of parts. Basically, when something is being additively manufactured it will not print to the exact same dimensions as it is in… Read more»

Ad282 replied to the topic "Most Important Phase" -

Mon, 09 Mar 2026 19:31:17 -0400

I see a majority of individuals believe that the planning phase is the most crucial for project success. I have to say that I agree with these people because the planning phase is crucial for having the project be completed… Read more»

Ad282 replied to the topic "Managing Resources When Faced with Design Flaws" -

Mon, 02 Mar 2026 17:16:08 -0500

I think as a PM, when you do not have preliminary data to work off of, you have to go back to the basics. Even without past tests, you still have engineering principles, material properties, and risk analysis to guide… Read more»

Ad282 replied to the topic "Project Slack Time" -

Mon, 02 Mar 2026 17:05:54 -0500

Slack is important because it gives you flexibility. A project does not always go 100 percent according to plan, and issues will come up. Slack allows you to handle those issues while still finishing the project on time. Without it,… Read more»

Ad282 replied to the topic "Hiring team members" -

Mon, 02 Mar 2026 16:51:51 -0500

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»

Ad282 replied to the topic "Risk Responses" -

Wed, 25 Feb 2026 14:54:26 -0500

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»

Ad282 replied to the topic "Certifications vs Degrees for Project Management" -

Wed, 25 Feb 2026 00:28:10 -0500

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»

Ad282 replied to the topic "Team members personal issues with eachother" -

Wed, 25 Feb 2026 00:08:53 -0500

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»

Ad282 replied to the topic "Email Communication" -

Mon, 16 Feb 2026 18:18:43 -0500

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»

Ad282 replied to the topic "Are Missed Milestones really Bad?" -

Mon, 16 Feb 2026 17:59:28 -0500

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»

Ad282 replied to the topic "Making connections between people and schools" -

Mon, 16 Feb 2026 17:46:01 -0500

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/

Ad282 replied to the topic "How can a project manager excel in the Biomedical field?" -

Mon, 09 Feb 2026 22:24:02 -0500

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»

Ad282 replied to the topic "Determining project priority" -

Mon, 09 Feb 2026 22:06:18 -0500

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»

Ad282 replied to the topic "Different Project Manger Approaches" -

Mon, 09 Feb 2026 21:41:12 -0500

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»

Ad282 replied to the topic "What are challenges will we face if we missclassify a medical device ?" -

Mon, 02 Feb 2026 18:21:18 -0500

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»

Ad282 replied to the topic "Sizes of Project Teams" -

Mon, 02 Feb 2026 17:58:49 -0500

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»

Ad282 replied to the topic "Project Management for Non-PM Positions" -

Mon, 02 Feb 2026 17:45:31 -0500

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»

Ad282 replied to the topic "Pre-market Approval (PMA) vs. 510(k)" -

Thu, 29 Jan 2026 02:51:50 -0500

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»

Ad282 replied to the topic "Team Conflict with Project Manager" -

Thu, 29 Jan 2026 02:01:13 -0500

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»

Ad282 replied to the topic "How would you handle team conflict as a Project manager?" -

Thu, 29 Jan 2026 01:30:42 -0500

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»

Ad282 replied to the topic "FDA Responsibilities" -

Fri, 23 Jan 2026 05:14:22 -0500

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»

Ad282 replied to the topic "Leaders: Nature or Nurture?" -

Fri, 23 Jan 2026 05:14:20 -0500

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»

Ad282 replied to the topic "Remote or In-Person PM" -

Fri, 23 Jan 2026 05:14:15 -0500

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»