Medical Device Courses | aysegultinas | Activity

aysegultinas replied to the topic "Are We Over-Relying on FMEAs?" -

Wed, 11 Nov 2026 02:47:27 -0500

I agree that the team matters more than the tool. One thing that makes it worse is the scoring itself. Since an RPN multiplies severity, occurrence, and detection, a failure that could kill someone but is rated as rare can… Read more»

aysegultinas replied to the topic "User Training in Risk Management" -

Wed, 11 Nov 2026 02:36:29 -0500

I like the CAP example because it shows training doesn’t have to be a one-time thing. I agree it’s the weakest control in general, but I think implants are a bit of a special case. With something like a hip… Read more»

aysegultinas replied to the topic "Risk Analysis of Unexpected Latch Release in Orthopedic Devices" -

Wed, 11 Nov 2026 02:31:18 -0500

Honestly the first thing I pictured was the attachment flying off while it’s still spinning. With a drill or saw, that could cut soft tissue, hit a nerve or blood vessel, or even leave a piece behind in the wound,… Read more»

aysegultinas replied to the topic "Verification vs. validation in medical device development" -

Wed, 11 Nov 2026 02:20:06 -0500

Do you think watching users during early testing is more useful than just asking them for feedback? I ask because what people say and what they actually do don’t always match. A surgeon might call a device easy to use… Read more»

aysegultinas replied to the topic "Making User Needs Specific Enough" -

Wed, 11 Nov 2026 02:14:21 -0500

I think the fact that two surgeons can have different experiences with the same device is actually something you can measure, not a reason to give up on measuring. In human factors testing (IEC 62366 is the standard most of… Read more»

aysegultinas replied to the topic "The importance of design changes and documentation" -

Tue, 03 Nov 2026 02:46:34 -0500

Design changes and documentation matter because even a small modification can affect a device’s safety, its performance or the way it’s manufactured. I also think manufacturing teams should be part of these discussions. They work with the product hands-on every… Read more»

aysegultinas replied to the topic "Why Packaging and Labeling Matter in Medical Devices" -

Tue, 03 Nov 2026 01:37:55 -0500

In my opinion packaging and labeling deserve as much attention as the device itself, because both have a direct effect on patient safety and on how the device gets used. A device can be designed perfectly and still cause serious… Read more»

aysegultinas replied to the topic "Why user needs should come before designing a medical device" -

Tue, 03 Nov 2026 01:31:47 -0500

I think it matters a lot to bring different users into the design process early, because they don’t all interact with a device the same way. A surgeon is usually focused on performance and precision. A nurse may care more… Read more»

aysegultinas replied to the topic "How Many Design Reviews Are Enough?" -

Fri, 30 Oct 2026 01:33:36 -0400

@bryan-xavier @james-olson I agree the user need comes first, but I’m not sure “consensus” works as a threshold. A room agreeing the device works is still an opinion. I think the threshold should be something you can check on paper,… Read more»

aysegultinas posted a new topic "Environment of use as a design input: the Philips CPAP recall" -

Fri, 30 Oct 2026 01:24:41 -0400

This week’s slides list environment of use as one of the main design input questions, next to function and performance. The Philips CPAP recall from June 2021 shows what happens when that input is too narrow.The problem was the polyester-based… Read more»

aysegultinas replied to the topic "When Design Controls Fail — The DePuy Hip Recall" -

Fri, 30 Oct 2026 01:14:39 -0400

I think a lot of the DePuy problem started at the design input stage, before any testing.ISO 13485 7.3.3 says design inputs should include information from similar designs. Metal-on-metal hips from the 1960s and 70s already had wear debris problems…. Read more»

aysegultinas replied to the topic "Foundations and Ethics of Clinical Research in Medical Device Development" -

Fri, 23 Oct 2026 00:03:46 -0400

Nobody has picked up the question about sham procedures yet, so I’ll take that one. I think shams should face stricter standards, but it depends on what the sham involves. The fake ultrasound device from our lecture slides is low… Read more»

aysegultinas replied to the topic "The Secret Ingredient in Every Clinical Trial: Trust" -

Thu, 22 Oct 2026 23:43:49 -0400

I think pz98’s question about blinded trials is the hardest part of this. One thing that helps is being upfront during informed consent that the study is blinded, and explaining that the patient won’t know which treatment they’re getting until… Read more»

aysegultinas replied to the topic "Can AI Replace Human Participants in Clinical Trials ?" -

Thu, 22 Oct 2026 23:36:10 -0400

I wouldn’t be comfortable using a device in a hospital if most of its evidence came from virtual patients. A simulation can only model what we already understand about the body, and the problems that end up hurting patients are… Read more»

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

Mon, 12 Oct 2026 21:07:02 -0400

I agree with the replies above that paying a surgeon for design input or testing is fair, while paying them per device sold is not. But I think the line is blurrier than it looks. A surgeon who spent two… Read more»

aysegultinas replied to the topic "Medical Device Marketing: Informative or Misleading?" -

Mon, 12 Oct 2026 19:59:31 -0400

I think most of the responsibility has to sit with the company, because they’re the ones holding the test data. A surgeon reading a brochure can’t see what was left out. The Kimberly-Clark and Halyard gown case mentioned earlier in… Read more»

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

Mon, 12 Oct 2026 19:43:24 -0400

I’d put price first, with one condition: we have to mean total cost of ownership, not the number on the quote. Hospitals run on thin margins, and a purchasing committee has to defend every acquisition. The purchase cost is part… Read more»

aysegultinas posted a new topic "Should the corporate veil protect medical device executives?" -

Sun, 27 Sep 2026 16:22:26 -0400

One of the main reasons people form a corporation is to protect themselves. The company is treated as its own “person” under the law, so if it gets sued or goes bankrupt, the owners only lose the money they invested…. Read more»

aysegultinas replied to the topic "Differences in team dynamics and leadership styles between corporations and research labs" -

Sun, 27 Sep 2026 15:47:44 -0400

I think structure and freedom affect creativity and productivity at different stages of a project, which is why neither setting wins outright. Freedom helps most at the start, when you’re coming up with ideas. In a lab, you can follow… Read more»

aysegultinas replied to the topic "S or C Corperation" -

Sun, 27 Sep 2026 15:36:42 -0400

Everyone here is focused on double taxation, which only matters once a company is making money. A device startup might go five or more years without revenue while it builds prototypes, runs bench testing, and works through the FDA. The… Read more»

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

Fri, 25 Sep 2026 01:12:40 -0400

I agree with dcapera that this isn’t really an either/or question‚ but I’d push a little further on why independence matters so much in this industry specifically․ Engineers‚ no matter how much they care‚ will always have a bias towards… Read more»

aysegultinas replied to the topic "Can Too Much Quality Control Slow Down Innovation?" -

Fri, 25 Sep 2026 01:03:59 -0400

I think this thread shows that the real issue may not be whether QC is necessary, but how and when testing is done. DarshP’s point about using similarity to approved devices connects to the FDA’s 510(k) pathway, where some devices… Read more»

aysegultinas replied to the topic "Quality Assurance vs. Quality Control" -

Fri, 25 Sep 2026 00:58:15 -0400

A lot of companies are resistant to QA‚ but QC has a pretty immediate payback: You inspect a batch and you can point to a defect rate going down․ But QA is much harder to “see” working․ If I spend… Read more»

aysegultinas replied to the topic "FDA Classes: Reform needed or fine as is?" -

Mon, 21 Sep 2026 20:31:36 -0400

The FDA classification system still works pretty well overall, but newer technologies make some of the categories harder to apply. Software, AI, and connected devices can create serious risks even if they are not directly interacting with the patient. Should… Read more»

aysegultinas replied to the topic "Who Should Be Responsible for Regulatory Basics?" -

Mon, 21 Sep 2026 20:17:36 -0400

I think it would be more effective for engineers to have a proactive way of keeping up with regulatory changes rather than only reacting once a change starts affecting a project. At the same time, I don’t think engineers should… Read more»

aysegultinas posted a new topic "Why Product Claims Matter in Medical Device Regulation" -

Sun, 20 Sep 2026 20:30:05 -0400

What I found interesting from this week’s slides was how much the claims made about a medical device can affect its regulatory path. Before this lecture, I mostly thought the FDA classified a device based on what the device was… Read more»

aysegultinas replied to the topic "Types of Research Models & Research Pitfalls" -

Thu, 17 Sep 2026 21:42:41 -0400

When Dr. Simon says “research model,” I took it to mean the model being used in the research design. Since he says to do a literature search first and be able to justify the model you choose, I think this… Read more»

aysegultinas posted a new topic "Pre-Clinical Research: Academia(Passion) or Industry(Money)?" -

Thu, 17 Sep 2026 20:54:22 -0400

Pre-clinical research can happen in both academia and industry, but I often wonder which one contributes more to real progress and what actually drives that contribution: funding or the personal motivation to discover something new?Personally, I lean more toward industry…. Read more»

aysegultinas replied to the topic "Should Companies Use Safer Materials or Take Risks With New Ones?" -

Thu, 17 Sep 2026 20:45:19 -0400

I agree that we need to innovate‚ but I do not therefore agree that we should shorten the testing process to get new materials to patients more quickly․ A better way forward is a more risk-based and efficient testing process․Pre-clinical… Read more»

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

Thu, 10 Sep 2026 23:37:42 -0400

The timetable is only one aspect of the project‚ and a project which is delivered on time may not be ideal․ And an open issue in the compliance or safety world can be a much more serious problem later on… Read more»

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

Thu, 10 Sep 2026 23:20:02 -0400

In my opinion starting with a simpler tool can be helpful when someone is still learning project management, because it gives them time to understand task tracking, deadlines, and team responsibilities without too many extra features. But I also wonder… Read more»

aysegultinas posted a new topic "Can a Strong Initiating Phase Prevent Most Project Problems Later?" -

Thu, 10 Sep 2026 22:59:49 -0400

One thing I find interesting about project management is how much the success of a project can depend on decisions made before the actual work begins. During the initiating phase, the team needs to understand the real business need, define… Read more»

aysegultinas replied to the topic "The Medical Device School - From Concept to Marketing" -

Thu, 10 Sep 2026 22:54:14 -0400

I think the point that you brought up there about intellectual property is a really good one because medical device development is so much more than just having a good idea․ It’s easy for biomedical engineers to think about whether… Read more»

aysegultinas replied to the topic "Beyond the Classroom: Applying What We Learn" -

Thu, 10 Sep 2026 22:41:17 -0400

Hi Ahmed, I liked your topic and wanted to said couple things.I had a similar reaction to the first lecture. What stood out to me was that the course seems focused less on memorizing information and more on understanding how… Read more»

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

Thu, 10 Sep 2026 22:38:38 -0400

I also find myself leaning more toward industry‚ I think it has to do with me liking the structure of an industry workplace‚ and the fact that I can see progress more clearly‚ milestones‚ and how what I do feeds… Read more»