Medical Device Courses | Ahmed Elmonier | Activity

Ahmed Elmonier replied to the topic "When Does a Surgeon Become a Brand Ambassador Ethically?" -

Sun, 18 Oct 2026 23:54:27 -0400

I think surgeons should definitely be compensated when they’re actually helping develop or improve a medical device. They’re providing their experience and knowledge, so I don’t really see anything wrong with that.But what I find interesting is how difficult it… Read more»

Ahmed Elmonier replied to the topic "Understanding Customer Needs in Medical Device Marketing" -

Sun, 18 Oct 2026 23:40:59 -0400

I think getting feedback from physicians and patients is really important, but I also wonder if just asking people what they want is always enough.Sometimes people get so used to doing something a certain way that they might not even… Read more»

Ahmed Elmonier replied to the topic "The Four Ps of Marketing for Medical Devices" -

Sun, 18 Oct 2026 22:59:20 -0400

I think all four are important, but I would probably lean more toward placement, especially when it comes to medical devices. I know most people mentioned product or price, which definitely makes sense, but I feel like having a great… Read more»

Ahmed Elmonier replied to the topic "Is the Best Medical Device Always the Best Selling Product ?" -

Sun, 18 Oct 2026 22:53:22 -0400

I think something else worth considering is what happens after the product is sold. I agree that a company with better marketing can probably sell more devices even if its product isn’t necessarily the best one out there. But I… Read more»

Ahmed Elmonier replied to the topic "In-House or Outsource: What’s Best for a Growing Business ?" -

Mon, 12 Oct 2026 00:37:34 -0400

I think outsourcing can definitely help a company save money, especially when it’s still growing and doesn’t have all the resources to do everything itself. But something I wonder about is whether companies always consider the extra work that comes… Read more»

Ahmed Elmonier posted a new topic "Is Every Good Investment a Profitable One?" -

Mon, 12 Oct 2026 00:21:08 -0400

One thing from this week’s lecture that got me thinking was how companies decide whether something is worth investing in. I never really thought much about the financial side of these decisions, especially when it comes to developing new medical… Read more»

Ahmed Elmonier replied to the topic "Should the corporate veil protect medical device executives?" -

Mon, 12 Oct 2026 00:13:04 -0400

I think one thing that makes this topic interesting is how much influence executives can have on decisions without actually being involved in the day-to-day work. Working in manufacturing, I’ve realized that decisions made at the management level can eventually… Read more»

Ahmed Elmonier replied to the topic "Switching Between Types of Business" -

Sun, 11 Oct 2026 23:59:51 -0400

I think it actually makes sense for a company to start with one business structure and change it later as it grows. Especially for a medical device startup, where the company might spend years developing something before it even starts… Read more»

Ahmed Elmonier replied to the topic "Who Should Be Responsible for Quality: Engineers or Dedicated QA/QC Teams?" -

Mon, 05 Oct 2026 00:39:42 -0400

I think quality should be everyone’s responsibility, but I don’t think that necessarily means everyone should have the same authority when it comes to quality decisions. Working in manufacturing has made me see the difference between the two.For example, as… Read more»

Ahmed Elmonier replied to the topic "Quality Assurance vs. Quality Control" -

Mon, 05 Oct 2026 00:32:20 -0400

I think another reason QC might get more attention is because QA can sometimes feel less visible to the people actually doing the process. Working in manufacturing, I can physically see when something is being checked or when a result… Read more»

Ahmed Elmonier replied to the topic "AI vs Human Judgment in QA : Who Makes the Final Decision ?" -

Mon, 05 Oct 2026 00:21:31 -0400

I agree that the QA professional should probably have the final say, but I also think the disagreement itself shouldn’t just be ignored after the decision is made. If the AI keeps identifying something that the QA person doesn’t see,… Read more»

Ahmed Elmonier replied to the topic "Regulatory Classification of Novel Devices" -

Sun, 27 Sep 2026 18:59:42 -0400

I think there should be an easier path for novel devices that are clearly lower risk. I understand being more cautious when there isn’t a predicate device to compare it to, but at the same time, being new doesn’t automatically… Read more»

Ahmed Elmonier replied to the topic "Predicate Devices and the 510(k) Process" -

Sun, 27 Sep 2026 18:45:08 -0400

I think your point about how strict “substantially equivalent” should be is interesting. Something else that made me think about this differently was the reading for this week. If a new device is cleared based on a predicate, and that… Read more»

Ahmed Elmonier posted a new topic "Can Product Claims Make Things More Complicated?" -

Sun, 27 Sep 2026 18:35:54 -0400

One thing that caught my attention from this week’s lecture was when Dr. Simon talked about how product claims can actually affect the regulatory pathway. I honestly never really thought about that before. I always assumed the pathway mostly depended… Read more»

Ahmed Elmonier replied to the topic "Role of Regulatory Affairs" -

Sun, 27 Sep 2026 18:29:36 -0400

I can see your point that Regulatory Affairs represents the company when communicating with the FDA, but I don’t know if I would separate protecting the company and protecting patients that much. I think in a regulated industry those two… Read more»

Ahmed Elmonier replied to the topic "From Pre-Clinical Research to Human Trials: When Is the Evidence Enough ?" -

Sun, 20 Sep 2026 20:55:06 -0400

This is an interesting question because I don’t think there is ever a point where researchers can say they have eliminated every possible risk before going into human trials. To me, the decision is more about whether enough evidence has… Read more»

Ahmed Elmonier replied to the topic "Deciding How to Perform Research in Industry" -

Sun, 20 Sep 2026 20:37:30 -0400

Having worked in manufacturing previously, I believe in addition to cost, equipment and timeline, I might consider how much control I want to have over the research process. Being in a highly regulated industry has helped me to understand that… Read more»

Ahmed Elmonier replied to the topic "Pre-Clinical Research: Academia(Passion) or Industry(Money)?" -

Sun, 20 Sep 2026 20:29:37 -0400

I believe both passion and funding are equally important; however, I do not believe that it is necessary for academia and industry to compete on who contributes more to each of them. To me, they represent different stages of the… Read more»

Ahmed Elmonier replied to the topic "Using Tech to Make Project Management Easier" -

Mon, 14 Sep 2026 02:46:06 -0400

I think technology can definitely make project management easier, but at the same time, I feel like it really depends on how people actually use it. From working in manufacturing, I’ve realized how important communication and documentation are when different… Read more»

Ahmed Elmonier posted a new topic "How Can Project Management Skills Benefit You Without Being a Project Manager?" -

Mon, 14 Sep 2026 02:17:21 -0400

Working in manufacturing, this week’s lecture made me think about project management from a different perspective. I always thought of project management as something mainly used by managers or people directly leading a project. However, after this lecture, I started… Read more»

Ahmed Elmonier replied to the topic "Pressure vs. Safety: A Project Manager’s Toughest Decision" -

Mon, 14 Sep 2026 01:47:49 -0400

Working in pharmaceutical manufacturing has made me look at this question a little differently. I agree that patient safety should come before meeting a deadline, but I also don’t think the decision should simply be between “keep going” or “stop… Read more»

Ahmed Elmonier replied to the topic "Can a Strong Initiating Phase Prevent Most Project Problems Later?" -

Mon, 14 Sep 2026 01:33:06 -0400

I agree that a strong initiating phase can prevent a lot of problems later, but I don’t think it can prevent everything. One point from the lecture that stood out to me was the importance of talking to the people… Read more»

Ahmed Elmonier replied to the topic "Academia VS Industry: What Draws You In?" -

Mon, 07 Sep 2026 03:05:09 -0400

I can say that I am more attracted to industry now because there are many possibilities of growing my career and discovering various roles. As for me, one of the main reasons why I want to go into industry is… Read more»

Ahmed Elmonier replied to the topic "Redesigning Medical Devices" -

Mon, 07 Sep 2026 02:55:57 -0400

Your concept of non-invasive continuous glucose monitoring seems to me an excellent example of an idea where improvement of the medical device does not necessarily include additional functionalities but rather the elimination of the factor that complicates the patients’ experience…. Read more»

Ahmed Elmonier replied to the topic "Making a Difference in Academia vs Industry" -

Mon, 07 Sep 2026 02:47:21 -0400

Absolutely, I agree with your perspective. While both industry and academia can have their impact on society, it will be absolutely different. Given that I work in CAR-T manufacturing right now, I would say that experience in industry definitely changed… Read more»

Ahmed Elmonier posted a new topic "Beyond the Classroom: Applying What We Learn" -

Mon, 07 Sep 2026 02:23:45 -0400

I currently work in Manufacturing for a CAR-T pharmaceutical product at BMS, so going into this course, I honestly thought it might not add much to what I currently do. However, after watching the first lecture, my perspective on the… Read more»