Medical Device Courses | pv223 | Activity

pv223 replied to the topic "Skills Learned in this Class" -

Sat, 30 Apr 2022 19:57:18 -0400

Something I will take away from this class and make sure to use in any scenario possible is to do my part in making sure that the project I am working on, whether it be as a manager or a… Read more»

pv223 replied to the topic "Understanding Project Management as a Non-Project Manager" -

Sat, 30 Apr 2022 19:47:28 -0400

While everyone may not become a project manager, most people will play a role in the project management process through their specific tasks assigned to them by the project manager. As a result, the knowledge gained from this class… Read more»

pv223 replied to the topic "Project Manager Decisions" -

Sat, 30 Apr 2022 19:19:59 -0400

Similar to the testing, the major factors that should be considered before bulk ordering a product from a vendor can be summed up to “Good” for the quality, “Cheap” for the price, and “Fast” for the amount of time… Read more»

pv223 replied to the topic "Why do people work?" -

Sun, 24 Apr 2022 21:25:40 -0400

These results are not that surprising to me, even as someone that is new to working in the biomedical field. This is because in a field like ours, there is always something new to discover and things to improve. The… Read more»

pv223 replied to the topic "Quick, Fast, Good? Pick Two" -

Sun, 24 Apr 2022 21:11:44 -0400

One of my choices will always be good as I am a firm believer that if you are conducting trials to portray the viability of a new product than the test that is being conducted in order to prove… Read more»

pv223 replied to the topic "How to manage and train low performers in common companies?" -

Sun, 24 Apr 2022 21:03:43 -0400

If I was put into a situation like the one you proposed, I would take the underperforming employee and meet with them to discuss their performance with them in an attempt to discover if there is a reason they… Read more»

pv223 replied to the topic "Vendor Decision" -

Sun, 17 Apr 2022 20:52:33 -0400

I chose to have just one extra vendor for the coating in the assigned mini-sim, not only because it would increase the time and cost for the project if we had multiple back up vendors, but because it would… Read more»

pv223 replied to the topic "Most Important Project Management Knowledge Areas" -

Sun, 17 Apr 2022 20:40:39 -0400

As @mmodi alluded to, I think Integration Management is one of the most important knowledge areas in project management. Not only does is play a part in every single phase of project management, it is the knowledge area that… Read more»

pv223 replied to the topic "Potential PM?" -

Sun, 17 Apr 2022 20:29:43 -0400

While I have held leadership positions in organizations I have been a part of, I cannot say for sure how well I would do in a PM position in the professional field until I have had the opportunity to… Read more»

pv223 replied to the topic "Medical Device Companies" -

Sun, 10 Apr 2022 22:56:49 -0400

I am a manufacturing technician at Siemens Healthineers and I work with production, management, engineering, and quality teams to build, configure, test, and ship out clinical chemistry machines to customers. What I really enjoy about my current position is… Read more»

pv223 replied to the topic "This Week's Simulation 3" -

Sun, 10 Apr 2022 22:38:01 -0400

Like Jada mentioned, most companies would have a non-disclosure agreement set up amongst all participating parties when working on a new product to ensure any news about the product, good and bad, does not get released prematurely until the… Read more»

pv223 replied to the topic "Different results from each test companies." -

Sun, 10 Apr 2022 22:24:47 -0400

In the industry, I believe they would solve it in the same manner that was involved in the most recent simulation. They would take a look at all the differences between the testing conducted at the contracted company and… Read more»

pv223 replied to the topic "Improving Team Performance" -

Sun, 27 Mar 2022 16:32:36 -0400

As the others have stated, communication is definitely a key aspect in making sure that a project succeeds so one of the first areas I would investigate is how the communications channels were being run before I was brought… Read more»

pv223 replied to the topic "Making connections between people and schools" -

Mon, 21 Mar 2022 23:41:08 -0400

Hello everyone! My name is Parth Vachhani and I’m a BME Masters student at NJIT and working at Siemens Healthineers as a manufacturing technician. I’ve included my LinkedIn page below: https://www.linkedin.com/in/parthvachhani/ I’ve also sent out connections to all of… Read more»

pv223 posted a new topic "Monitoring Time and Budget" -

Mon, 21 Mar 2022 23:36:47 -0400

In this week’s lecture we learned about different aspects of monitoring and controlling a project and how anything can really be subject to change throughout the life cycle. Assume you are a project manager and you are at about the… Read more»

pv223 replied to the topic "Verification Test" -

Wed, 09 Mar 2022 22:07:33 -0500

Based off of your wording, I am going to phrase my answer under the assumption that you curious as to how to create a test that is guaranteed to pass the first time around. Under that assumption, much like what… Read more»

pv223 replied to the topic "Verification Test" -

Wed, 09 Mar 2022 22:07:13 -0500

pv223 replied to the topic "What you need to get a job in project management" -

Wed, 09 Mar 2022 21:38:13 -0500

Like the others have said, having previous project management experience is a big advantage when it comes to landing a position as a project manager. It does not necessarily need to be big company project. For example, in my… Read more»

pv223 replied to the topic "Scope vs Design Controls verification" -

Wed, 09 Mar 2022 21:26:10 -0500

Put simply, design controls are a formalized approach that a company needs to follow the safety and efficacy of the device to the FDA. These are somewhat consistent between projects, depending on the class of the device. User needs,… Read more»

pv223 replied to the topic "Career Path to becoming a project manager" -

Sun, 06 Mar 2022 17:32:58 -0500

I completely agree with @ac825 in that it is definitely more important and beneficial to start off as an engineer and then move over to the project management side of things. Like with most parts of life, one cannot… Read more»

pv223 replied to the topic "Changing thee project" -

Sun, 06 Mar 2022 17:17:09 -0500

As you mentioned in your example, sometimes going back making a change in the project results with an even better situation than you started in. I agree with your statement that going back and changing a project can be… Read more»

pv223 replied to the topic "Work breakdown structure" -

Sun, 06 Mar 2022 17:04:08 -0500

While I agree with what everyone has posted so far, especially with the @mmodi stated regarding using a Gantt or Pert chart to create the most time efficient timeline, I believe that when ranking importance of tasks that you… Read more»

pv223 replied to the topic "Project Manager Changes" -

Thu, 24 Feb 2022 22:49:48 -0500

Regardless of whether it is a project manager that changes or a team member, it is difficult to have a smooth transition from one person to another, especially if it is someone higher up in the management chain. As… Read more»

pv223 replied to the topic "Project Planning" -

Thu, 24 Feb 2022 22:36:46 -0500

As a project manager, it is important to iron out as many details as early as possible to set a solid foundation for the course of the project. The lecture this week illustrated a few different methods of planning… Read more»

pv223 replied to the topic "Project Slack Time" -

Thu, 24 Feb 2022 22:11:37 -0500

I consider slack to be a pretty integral part of planning because it can help account for an unexpected delays that can occur throughout the duration of the project. Like the professor mentioned in his lecture, it is difficult to… Read more»

pv223 replied to the topic "Risk Management" -

Wed, 16 Feb 2022 23:32:46 -0500

I am of the belief that in our field of medical devices, and pharmaceuticals like you mentioned, that transference is not a risk management strategy that can be used and accepted from both the patients perspective and the manufacturers… Read more»

pv223 replied to the topic "Project Management Process" -

Wed, 16 Feb 2022 23:11:27 -0500

I agree, the planning phase is by far the most important phase during the project management process. This phase is the entire foundation that the project is built on and if it is not done properly, the chances of… Read more»

pv223 replied to the topic "Over budget project" -

Wed, 16 Feb 2022 22:52:20 -0500

I believe that the answer to this question varies depending on the situation. It could be possible that the manager had done some poor planning for the project, like @hodafattel mentioned, but it could also be a situation where… Read more»

pv223 replied to the topic "Examples of budget changes due to DSD testing" -

Sun, 13 Feb 2022 23:48:46 -0500

I would say having to request a budget change for additional experiments is quite probable. When making design verification tests in response to outputs from a DSD, it is highly unlikely that everything will pass the first time around… Read more»

pv223 replied to the topic "Dividing the Workload" -

Sun, 13 Feb 2022 23:36:18 -0500

I feel like a question like this depends on the project itself, it’s scope, and how interconnected each part is. For example, if it is a smaller project where the parts have little to no connection with each other,… Read more»

pv223 replied to the topic "Difficult People in Work Groups" -

Sun, 13 Feb 2022 23:20:27 -0500

When it comes to working with someone that is being difficult, I find that trying to approach the individual themselves first to see how we can reach compromise and find a way to work together in a way that… Read more»

pv223 replied to the topic "Organization type preference" -

Sun, 06 Feb 2022 19:24:45 -0500

The current company I work in seems to operate as a matrix organization. I have my manager that I report to but I often report to her manager as well. My job before this seemed to operate as a functional… Read more»

pv223 replied to the topic "Leaders: Nature or Nurture?" -

Sun, 06 Feb 2022 19:14:17 -0500

I am in agreeance with you on this topic. While there are people that are born with inherent leadership qualities, most of the qualities of a good project manager are developed over time and mentorship. Growing up there was a… Read more»

pv223 replied to the topic "Design Verification Testing" -

Sun, 06 Feb 2022 18:53:37 -0500

Not only should a test be detailed, like @ridmehta stated, but depending on the kind of device that is being developed you should also have different kinds of tests. If you had a blood chemistry testing machine for example, while… Read more»

pv223 replied to the topic "Power and Regulation" -

Sun, 30 Jan 2022 21:18:13 -0500

While I agree with the others that the FDA should not necessarily be given the authority to impose mandates, I do not believe that leaving that decision to just government bodies is the best solution either. Using today’s situation as… Read more»

pv223 replied to the topic "FDA ethics" -

Sun, 30 Jan 2022 20:52:13 -0500

I am on board with @Jbarbee and @cm539. While the FDA approving products that include antifreeze is not unethical, the lack of transparency on the inclusion is what I find to be unethical. While the amount of antifreeze in these… Read more»

pv223 replied to the topic "Class 2 device and 510(k)" -

Sun, 30 Jan 2022 20:35:36 -0500

If a new function is added to an existing class 2 device, than I believe a PMA would be necessary in order to ensure that: 1) The new functionality does not interfere with any of the existing functions of the… Read more»

pv223 replied to the topic "How do you deal with challenges?" -

Sun, 23 Jan 2022 16:00:15 -0500

Similar to @hodafattel, my challenging situation also stems from my Senior Design Project. The project that my group and I were working on was a proof of concept project, where the goals of our project were ones that have not… Read more»

pv223 replied to the topic "What kind of projects interest you the most?" -

Sun, 23 Jan 2022 15:41:42 -0500

Much like @mmd55 and @cassiem have said, projects that really pique my interests are ones that are complex but have a clear desired goal. By forcing you to think outside the box and look at the project from different angles… Read more»

pv223 replied to the topic "Team member skills" -

Sun, 23 Jan 2022 15:31:10 -0500

When it comes to working in a team for projects, I believe the best individuals to look for are the ones that are open and communicative but are also capable of independent work. By that I mean that once roles… Read more»

pv223 replied to the topic "NDA vs Patents" -

Wed, 15 May 2019 21:39:08 -0400

An NDA and a patent are two very different things. A patent is something that legally gives you full rights over an idea or a product and protects your idea as your own. This prevents others from claiming your idea… Read more»

pv223 replied to the topic "Restrictions for physician's gifts" -

Wed, 15 May 2019 21:39:08 -0400

As much as having a rule such as this sucks, it is a necessary rule that is enforced. Without a limit on the gifts we can give to our physicians, not only can they be influenced by the money/gifts that… Read more»

pv223 replied to the topic "Written Agreement v/s Verbal Agreement" -

Wed, 15 May 2019 21:39:07 -0400

A verbal agreement is an agreement that all parties agree on without it being written and signed. An example of this would be haggling to lower the price on a product or committing to do something while in a conversation…. Read more»

pv223 replied to the topic "Upper vs Middle Management." -

Wed, 15 May 2019 21:38:27 -0400

If I was asked this question years ago, I would have said neither. But based off the experiences I have had in the past four years, I would say I am more suited for upper management and am starting to… Read more»

pv223 replied to the topic "Medical Device Project" -

Wed, 15 May 2019 21:38:25 -0400

In my team, we started off by having the PM send out the DDP, a form to help him fill form a gantt chart, as well as all documents related to his project that he already had prepared. We then… Read more»

pv223 replied to the topic "Your Organizational prference; but why?" -

Wed, 15 May 2019 21:38:24 -0400

Based off my past experience on how group projects tend to go for classes here, I would say that I am used to the Matrix form that Dr. Simon used and would probably prefer it over the others. For one… Read more»

pv223 replied to the topic "Risk management and Labels" -

Wed, 15 May 2019 21:37:35 -0400

The reason labels are the least effective tool for risk management is that they are quite obviously not read. People often use common sense when opening up a product and more often than not figure out the way to use… Read more»

pv223 replied to the topic "Factors Contributing to Risk Values" -

Wed, 15 May 2019 21:37:33 -0400

How I remember it from the lecture, the three risk factors are Severity (S), occurrence (O), and noticeability (N) or S.O.N. The product of the numerical values for these three factors is how the Risk Priority Number (RPN) is assigned…. Read more»

pv223 replied to the topic "Manage Risk" -

Wed, 15 May 2019 21:37:31 -0400

For high level risks, I would do my best to mitigate the risk in an attempt to decrease the severity of the risk and then would try to employ transference to see if anyone else can do something to circumvent… Read more»

pv223 replied to the topic "Factors to Consider While making Gantt Chart" -

Wed, 15 May 2019 21:36:44 -0400

Throughout this year in my Capstone class, the use of a Gantt chart has helped my group and I tremendously in keeping track of our progress. It is easy for us to know which aspects of the project are dependent… Read more»