Medical Device Courses | ama224 | Activity

ama224 replied to the topic "How to manage and train low performers in common companies?" -

Fri, 29 Apr 2022 07:35:07 -0400

In my opinion, low performance is because of one of a few things including lack of motivation, a toxic work environment, or just the person likes being a pencil pusher and doing whatever for the money. In any case, as… Read more»

ama224 replied to the topic "What’s Your Motivator?" -

Fri, 29 Apr 2022 07:03:05 -0400

My biggest motivator is ambition. When it comes to work I don’t care about the money (yet) but rather that feeling of fulfillment. I want to make sure what I’m doing I’ll enjoy, be happy with, and most importantly makes… Read more»

ama224 replied to the topic "Skills Learned in this Class" -

Fri, 29 Apr 2022 04:30:05 -0400

Something that was very different about this class compared to Dr. Simon’s other class was the simulations. In school, we learn all these concepts and skills that sometimes we never even get to use once we go into the industry…. Read more»

ama224 replied to the topic "Why do people work?" -

Wed, 20 Apr 2022 06:43:04 -0400

These results actually make so much sense. I’m someone who rejected a six fig job because I didn’t like that type of work and was willing to take the pay cut to be happier with what I do in my… Read more»

ama224 replied to the topic "Overworked Americans vs. Motivation" -

Wed, 20 Apr 2022 06:30:32 -0400

The American work-life balance is very poor however I don’t think Americans are overworked because they are trying to one-up their peers. From my personal experience, I’ve noticed that there’s a lot of acting and dragging when it comes to… Read more»

ama224 replied to the topic "Quick, Fast, Good? Pick Two" -

Wed, 20 Apr 2022 06:07:53 -0400

As mentioned the financial state and decisiveness are key components when making this decision. Quality in my opinion should never be the one to be sacrificed especially in this industry so I’d have to say good and fast. If you… Read more»

ama224 replied to the topic "QA vs QC" -

Sun, 17 Apr 2022 05:28:15 -0400

quality assurance deals with process checklists, standards, documentation, and auditing whereas quality control is more so inspection, software testing process, peer reviews, etc.

ama224 replied to the topic "Human resource management" -

Sun, 17 Apr 2022 05:18:14 -0400

In my opinion, delivering a successful project should never rely on an individual, especially if there’s a whole team involved with the project. In this specific case, if the planning phase was executed properly I’d say for those short 3… Read more»

ama224 replied to the topic "Vendor Decision" -

Sun, 17 Apr 2022 04:55:48 -0400

I think it’s best to have as many backup options for when worse comes to worst similar to the sim from last week where an unplanned cytotoxicity problem got in the way of business. We had to find an alternative… Read more»

ama224 replied to the topic "This Week's Simulation 3" -

Mon, 11 Apr 2022 05:14:43 -0400

Aside from actually finding the root of the cause of cytotoxicity, I think what Dr. Simon wanted us to take away was that it is imperative to get through all verification steps in the process before anything else happens. Now,… Read more»

ama224 replied to the topic "How poor planning affects a project" -

Mon, 11 Apr 2022 04:36:21 -0400

I’ve definitely faced projects in the past where I’ve felt the initiation could’ve been better. Like anything, if a strong foundation isn’t set to build upon, then the more you stack up the more likely it’ll topple off at one… Read more»

ama224 replied to the topic "Testing" -

Sun, 10 Apr 2022 23:35:50 -0400

I agree Naglaa, the hardest part of these simulations thus far has been setting up the test procedure. I’d say this comes with both our lack of experience setting up these kinds of tests and our ignorance with the root… Read more»

ama224 replied to the topic "Healthcare Project Management" -

Sat, 26 Mar 2022 02:23:23 -0400

As a general response, I would say that project management is relatively the same across the healthcare spectrum. I agree with csimmonds that project management definitely places an emphasis on safety and clinical trials, however, when it comes to healthcare… Read more»

ama224 replied to the topic "What you need to get a job in project management" -

Sat, 26 Mar 2022 01:39:26 -0400

In terms of prerequisites in certification/education, I don’t believe there’s a bachelor’s degree specific to project management, and even if there were a master’s degree that was that specialized I don’t think it serves as much leverage as experience would…. Read more»

ama224 replied to the topic "Making connections between people and schools" -

Wed, 23 Mar 2022 21:03:13 -0400

Hello!
I’m Adam doing my masters in BME at NJIT while working at GE Healthcare. Below is my LinkedIn link, I look forward to connecting!
https://www.linkedin.com/in/adam-abdelrazek/

ama224 replied to the topic "In planning, the method to calculate each task duration." -

Sun, 13 Mar 2022 03:51:17 -0400

As shown from the Mini-sim, scheduling is anything but easy and one mishap can lead to the other. Calculating of course is tailored depending on the situation in hand, but it all comes down to experience. As you saw in… Read more»

ama224 replied to the topic "Communication during a project management" -

Wed, 09 Mar 2022 22:41:36 -0500

As you mentioned communication is key to getting the ball rolling with any type of group work. Internally in a company setting, we used jabber to communicate and teams to work interactively. however with school group projects and with my… Read more»

ama224 replied to the topic "Executing Process Progress" -

Wed, 09 Mar 2022 22:08:00 -0500

Contrary to some of my peers I wouldn’t start reaching out to other suppliers immediately but I would already have other vendors lined up and backup/substitute plans for emergency situations such as this. With any type of business, you have… Read more»

ama224 replied to the topic "Difference in communication when working from home" -

Wed, 09 Mar 2022 04:40:29 -0500

I’ve experienced working from home with minimal commuting, working in an office with a normal commute routine, and then fieldwork where most of my day is commuting and the accompanying paperwork or rather “office work” is done at home. With… Read more»

ama224 replied to the topic "Career Path to becoming a project manager" -

Mon, 07 Mar 2022 04:02:42 -0500

Contrary to most of my peers I believe that it can go either way, in that whether you start off as a team member or go straight into management comes down to you and your personality skills more so than… Read more»

ama224 replied to the topic "Penalization for Going Over Budget and Time?" -

Wed, 02 Mar 2022 04:58:14 -0500

Being penalized for going over time and more particularly the budget should be punishable only under certain circumstances. What I mean by this is sometimes a project manager, employee, group leader has a vision and is confident enough to see… Read more»

ama224 replied to the topic "Organizing tasks" -

Wed, 02 Mar 2022 04:06:57 -0500

I agree there should be one place virtually for ideas and notes to be accessed too. Technological advancements through apps such as google drive, Microsoft teams, etc. There are also Gantt charts as Dr. Simon mentioned before and other collaborative… Read more»

ama224 replied to the topic "Time vs. Money" -

Tue, 01 Mar 2022 03:13:36 -0500

This is an interesting question since an argument could be made for either choice, and I agree with my peers that a balance between both is key and specifically the comment made that “Time is Money.” However, if there’s no… Read more»

ama224 replied to the topic "Unique Project Challenges for Medical Device Companies" -

Tue, 01 Mar 2022 03:13:34 -0500

So I currently work with GE Healthcare and their Medical devices and one of the biggest concerns hospitals always have when setting up these devices is patient records/data. Some hospitals prefer to use our data management program called MUSE which… Read more»

ama224 replied to the topic "Project Slack Time" -

Tue, 01 Mar 2022 03:13:33 -0500

There is no question that slack is necessary because stuff happens, and unexpected hiccups in any project… should be expected. As the professor mentioned accounting for slack in a project’s timeline is important to the success of the project. As… Read more»

ama224 replied to the topic "Design Controls" -

Sat, 26 Feb 2022 02:53:36 -0500

All design controls tie into each other in some way so it’s difficult to single out an “essential” design control. However, since the first 9 design controls serve as a basis whereas the actual content differs from company to company,… Read more»

ama224 replied to the topic "Leaders: Nature or Nurture?" -

Sat, 26 Feb 2022 02:53:35 -0500

I don’t think that Leadership of Nature vs. Nurture but instead a case of Nature AND Nurture. Being “born a leader” obviously isn’t literal but I believe it comes from the nature a leader was bred in. At the same… Read more»

ama224 replied to the topic "Different Project Manger Approaches" -

Sat, 26 Feb 2022 02:53:35 -0500

Whether I am the leader or working with a leader I prefer to work hands-off. One of the biggest things that make most jobs so annoying is the feeling that corporate feeling of “work.” There are enough regulations, design controls,… Read more»

ama224 replied to the topic "Should Interpersonal skills be more valuable than technical skills?" -

Sat, 26 Feb 2022 02:52:56 -0500

I agree with some of my peers that depending on the type or environment of work this ratio should be justified. However, I partially disagree with ih37, in that interpersonal skills don’t necessarily mean “talking your way to the top… Read more»

ama224 replied to the topic "Verification and Validation" -

Sat, 26 Feb 2022 02:52:53 -0500

That’s a very good question I actually had before too and upon taking Dr. Simon’s class from last semester I got the proper response. So essentially Verification is making sure that all the specs were met from the DID which… Read more»

ama224 replied to the topic "Power and Regulation" -

Sat, 26 Feb 2022 02:52:53 -0500

As many of my peers have mentioned the FDA’s role is to put things in check by ensuring safety. You should definitely have the choice to make a decision when it’s regarding your own life however when others’ safety is… Read more»

ama224 replied to the topic "Best Processes/ Phase" -

Sat, 26 Feb 2022 02:52:18 -0500

Since every project is different and ranges in sophistication and complications so there will definitely be one phase or process that will outweigh the other when comparing projects. However, it makes sense for the planning and development phase to be… Read more»

ama224 replied to the topic "Probability of failure" -

Sat, 26 Feb 2022 02:52:16 -0500

As Dr. Simon mentioned before one of the steps of marketing a new device is analyzing similar devices and being aware of what’s out there in the market. As new as an item may seem there’s always some other product… Read more»

ama224 replied to the topic "Pros and cons related to risk management and project management" -

Sat, 26 Feb 2022 02:52:16 -0500

Well one of the biggest pros of diving the risk management and product management team, as some of our other colleagues have alluded to, is that there wouldn’t be that biased from those who were involved in making the product… Read more»

ama224 replied to the topic "Design "Overvalidation"?" -

Mon, 06 Dec 2021 15:38:37 -0500

For predictive measures, I don’t think a team would decide to log more inputs than necessary. The intentions of the project might be to go above and beyond however at the end of the day it’s a business and you’d… Read more»

ama224 replied to the topic "Validation vs Verification" -

Mon, 06 Dec 2021 15:38:34 -0500

In my experiences with validation and verification in the field, validation is the back and forth we have with customers to try and meet their needs. For example, at the defense company I used to work at, after being presenting… Read more»

ama224 replied to the topic "Why VERIFICATION is important? and Your ideas to improve Verification process ?" -

Mon, 06 Dec 2021 15:38:34 -0500

Verification is what ensures the quality of a product and serves as the structure of design controls. Without verification, I don’t think a project can “check out.” It also serves as security to avoid any future problems. With verification, you… Read more»

ama224 replied to the topic "To risk manage or not to risk manage?" -

Mon, 06 Dec 2021 15:38:33 -0500

Risk management is an integral part if not one of the most pivotal sequences of the planning phase. Not just in medical devices, but in any engineered product that will be used in society. An example Dr. Simon had mentioned… Read more»

ama224 replied to the topic "how far is "As Far As Possible"" -

Mon, 06 Dec 2021 15:38:33 -0500

Well, I think the regulation being labeled “As Far as Possible” was meant to be kept as a discrepancy because the limit would vary based on the device and its severity threshold. For example in the company I work at… Read more»

ama224 replied to the topic "Risk management and Labels" -

Mon, 06 Dec 2021 15:37:04 -0500

One of the aspects of my current job is Installing medical equipment for hospitals and typically we keep labels and instructions for certain devices once it is ready for use by the healthcare provider. However, I have never seen anyone… Read more»

ama224 replied to the topic "Organization types of medical devices?" -

Mon, 06 Dec 2021 15:36:40 -0500

I think my company would be best suited as a functional organization. I like the idea that projects are done within a department and how advancements and positions are clear-cut. Also having one shot caller can be, yes, a bit… Read more»

ama224 replied to the topic "Double Blind Vs Single blind Study" -

Sun, 31 Oct 2021 14:05:59 -0400

I believe that the biggest difference between single or double-blind studies is the psychology behind it. Depending on the situation it may be useful to conduct one as opposed to the other. In the specific example given I don’t think… Read more»

ama224 replied to the topic "WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?" -

Sun, 31 Oct 2021 14:05:59 -0400

Well first and foremost, the purpose of any clinical study is to ensure the wellbeing of the public. That is the point of the study, you’re running trials to make sure it’s not detrimental to a person’s wellbeing. Now, as… Read more»

ama224 replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" -

Sun, 31 Oct 2021 14:05:58 -0400

In terms of the ethicality of placebos, I believe they are very ethical because you aren’t actually doing anything to the patient. In terms of necessity, I believe they are very necessary. I’m a firm believer in medicine when treating… Read more»

ama224 replied to the topic "Family Businesses" -

Mon, 18 Oct 2021 13:45:49 -0400

I will answer this based on my situation since my father owns a business that will in fact be passed down to me and my brother. As we learned from the lecture a sole proprietorship is reliant on just the… Read more»

ama224 replied to the topic "Accepting job based on company." -

Mon, 18 Oct 2021 13:45:49 -0400

I think it all comes down to what you’re looking for and at what point in your career/life you’re in. For example for me right now I don’t have a family I need to support nor am I looking to… Read more»

ama224 replied to the topic "Factors going into Buisness" -

Mon, 18 Oct 2021 13:45:38 -0400

So first and foremost I would distinguish the type of business I want to start. In my case I know I’s want to begin an LLC. Now I’ve already experienced the 9-5 lifestyle and I absolutely hate it. I also… Read more»

ama224 replied to the topic "Discussion Topic: The Fifth "P" of Marketing" -

Mon, 18 Oct 2021 13:45:34 -0400

As several of my peers mentioned Social Media is the biggest form of participation in marketing in current times and what’s kind of funny is that even the other forms of participation marketing lead back to Social Media. For example,… Read more»

ama224 replied to the topic "Advertising" -

Mon, 18 Oct 2021 13:45:33 -0400

I think it’s very interesting how advertising works depending on the targeted audience. For example, an iconic one for me as a child was the chef Boyardee rolling can one. I remember going to the grocery store with my mom… Read more»

ama224 replied to the topic "Transition from Engineering to sales or marketing?" -

Mon, 18 Oct 2021 13:45:33 -0400

I could definitely see myself being a sales rep and dealing with the customer directly since that’s what I’m used to and enjoy from working in the restaurant business my whole life. However, I wouldn’t want to steer away from… Read more»