https://medicaldevicecourses.com/members/natalie-nashed/activity/ Activity feed for Natalie Nashed. Sat, 16 May 2026 09:37:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 8e88876b3258951f7f87273b4d0032a5 https://medicaldevicecourses.com/activity/p/33705/ Sun, 16 Nov 2025 19:54:41 -0500 One often overlooked part of global risk management is that even though the U.S., Canada, Australia, and Japan all endorse ISO 14971, they each interpret it a little differently The FDA focuses heavily on benefit-risk justification, while regions like the…   Read more»

]]> 4db5d0b383e7c562ba157f8e9eba2eb4 https://medicaldevicecourses.com/activity/p/33703/ Sun, 16 Nov 2025 19:47:57 -0500 It’s not idea when the project team also handles risk management in cases where the device introduces new technology or unfamiliar clinical use. When engineers are very close to the design, they tend to see the product through the same…   Read more»

]]> 0ec288b18b0163b851b6fe2ba5fa0df9 https://medicaldevicecourses.com/activity/p/33701/ Sun, 16 Nov 2025 19:44:08 -0500 I agree zero-risk devices aren’t realistic, but I think the bigger issue is that “acceptable risk” isn’t only an engineering decision, it’s also ethical and practical. Sometimes trying to drive risk to zero can actually create new risks, like adding…   Read more»

]]> 27fc3f75b979f91ca0bc249b8a2d05f3 https://medicaldevicecourses.com/activity/p/33515/ Wed, 05 Nov 2025 17:49:46 -0500 Design controls under 21 CFR Part 820.30 basically exist to make sure the device is intentionally designed, proven, and documented step-by-step instead of being developed randomly. Each part plays a different role. Design inputs define what the device needs to…   Read more»

]]> 051c11567aef788bc9b6b86670673c07 https://medicaldevicecourses.com/activity/p/33514/ Wed, 05 Nov 2025 17:40:17 -0500 Some examples of device changes that must be controlled include any change that can alter how the device performs, interacts with the user, or impacts safety. For example, changing a material inside a device (like switching to a different polymer,…   Read more»

]]> 7d91b89a3460bf2c1ebbd1b726731986 https://medicaldevicecourses.com/activity/p/33512/ Wed, 05 Nov 2025 17:20:33 -0500 I think the best way to balance user needs with business limits is to acknowledge that both sides are part of the design problem. In class, we have gone over how the design begins with user needs but that doesn’t…   Read more»

]]> d9c5c6b5c6a91c96f9978035664c0b8b https://medicaldevicecourses.com/activity/p/33368/ Thu, 30 Oct 2025 00:32:32 -0400 If I were a manager updating design controls, I’d start by improving communication and training before changing any documents or systems. Too often, people see design controls as roadblocks because they don’t fully understand how they fit into the bigger…   Read more»

]]> 5d458800ad815ffee6ad2814f7e3255d https://medicaldevicecourses.com/activity/p/33367/ Thu, 30 Oct 2025 00:27:41 -0400 I think verification and validation can sometimes happen at the same time, especially during prototype testing or early design iterations, but they shouldn’t completely merge. Doing both together can help teams spot issues early and make adjustments before things get…   Read more»

]]> 88ac199969dcf59fdb13876c44ee9082 https://medicaldevicecourses.com/activity/p/33366/ Thu, 30 Oct 2025 00:20:45 -0400 I agree that vague feedback can be hard to use, but I think teams can still learn a lot by watching how customers actually interact with a product instead of just relying on what they say. Observation and prototype testing…   Read more»

]]> d4bc8d561467d865321fc9f3697f72f3 https://medicaldevicecourses.com/activity/p/33268/ Thu, 23 Oct 2025 19:19:30 -0400 I think having a standardized process for handling adverse events is essential, but it should also include build-in flexibility. Each trial is different, and the severity or nature of an event might require a unique response. A clear chain of…   Read more»

]]> 40182990c29daf6017a17e2e2d7f1596 https://medicaldevicecourses.com/activity/p/33267/ Thu, 23 Oct 2025 19:10:52 -0400 I really agree with what a lot of people here have said about the gap between classroom learning and real-world clinical experience. I think spending time in a clinical setting would make a big difference for biomedical engineering students, not…   Read more»

]]> 7096a9437b656e329170a35b0ff7d34e https://medicaldevicecourses.com/activity/p/33266/ Thu, 23 Oct 2025 18:55:45 -0400 I think another interesting angle that hasn’t been mentioned yet is how the placebo effect can actually reveal the power of patient-clinician interaction rather than just being seen as an obstacle in data collection. In some cases, the way a…   Read more»

]]> 82378eefa78fbfc35d5d48111a4495b8 https://medicaldevicecourses.com/activity/p/33148/ Wed, 15 Oct 2025 03:11:27 -0400 To agree with many others, I think the product is overall the most essential part of the four P’s. You can have the best promotion, price, and placement, but at the end of the day it’s the product that goes…   Read more»

]]> ff957d06fb5960d143e058bd357bf04a https://medicaldevicecourses.com/activity/p/33147/ Wed, 15 Oct 2025 03:02:50 -0400 If I were to transition out of engineering, I’d probably lean toward marketing, especially since I’m pursuing a business minor. I think marketing would be a great way to blend the technical knowledge I’ve gained through engineering with the creative…   Read more»

]]> 12e2e84c57463081df326bc2bb03dca7 https://medicaldevicecourses.com/activity/p/33144/ Tue, 14 Oct 2025 20:24:40 -0400 I totally agree that the building trust is the biggest part of being a successful sales rep in the medical device industry. These relationships can last for years, and customers need to know they can rely on both the product…   Read more»

]]> 1734dedfdfb6cb783ead41041b3d6826 https://medicaldevicecourses.com/activity/p/32874/ Tue, 07 Oct 2025 19:07:02 -0400 Going private can be a good thing for a company like EA that you mentioned because it gives them more freedom to focus on their long-term goals rather than worrying about the quarterly profits they have to post. Without that…   Read more»

]]> 6859c2bca7dba662be5230eb0e6b6400 https://medicaldevicecourses.com/activity/p/32872/ Tue, 07 Oct 2025 18:58:20 -0400 I think most people choose an LLC over an LLP because of how much simpler and more flexible it is to manage. My brother actually started his own LLC creating websites for clients, and after talking to him and hearing…   Read more»

]]> 2420604fd03a4756af6efa73e60b5825 https://medicaldevicecourses.com/activity/p/32871/ Tue, 07 Oct 2025 18:50:09 -0400 I was also shocked when the Professor dropped this fact in the lecture video, 80% seemed really high to me for a medical device. I was talking to a classmate the other day and they were mentioning that at the…   Read more»

]]> 332bb459229356028e86c6ccb8212de4 https://medicaldevicecourses.com/activity/p/32576/ Tue, 30 Sep 2025 20:10:55 -0400 From what I’ve read, one of the most common issues during QMS audits is weak traceability, especially when companies can’t clearly connect design changes or complaints back to something they documented. Studies point out frequent findings in supplier management, such…   Read more»

]]> 19bb4da18ccabda7c31f0fe18dc7d7e8 https://medicaldevicecourses.com/activity/p/32573/ Tue, 30 Sep 2025 19:57:53 -0400 Quality assurance can also make sure Class III devices meet safety standards by focusing on strong documentation and traceability during design and development. Every change and decision should be recorded so that risks can be tracked and then addressed. I…   Read more»

]]> 7c623f59b703b18929f4e354a54c7612 https://medicaldevicecourses.com/activity/p/32572/ Tue, 30 Sep 2025 19:41:22 -0400 I think the biggest challenge right now is keeping quality control up to speed with how quickly medical device technology is advancing. Devices aren’t simply hardware anymore, they have AI, software updates, and connectivity, which makes risk management and validation…   Read more»

]]> ad925f5e6cdf0a815d543c44aadc4edd https://medicaldevicecourses.com/activity/p/32418/ Fri, 26 Sep 2025 19:24:32 -0400 I’ve also been interested in regulatory affairs since this class started, especially because Professor Simon keeps mentioning how it’s a growing field with a lot of job opportunities. What I keep wondering, though, is whether there is any creative aspect…   Read more»

]]> 791645e8436a7453e7268b762e43440c https://medicaldevicecourses.com/activity/p/32417/ Fri, 26 Sep 2025 19:16:45 -0400 I like how you framed this because it made me think of how it really is all about balance. I agree that engineers don’t need to be regulatory experts, but they need to know the “rules of the game”, the…   Read more»

]]> fe107e84c220685a337fd8ca8a4548fb https://medicaldevicecourses.com/activity/p/32416/ Fri, 26 Sep 2025 19:08:38 -0400 I think the FDA has a difficult position of wanting to encourage innovation while also making sure the devices are not going to cause harm and are productive. One challenge I think is about how long the approval process can…   Read more»

]]> ba46868cfdfa196ec4b5e345fafd4b96 https://medicaldevicecourses.com/activity/p/32075/ Thu, 18 Sep 2025 18:09:27 -0400 Biocompatibility throughout a device’s whole lifecycle is tough since the body will always react to foreign materials in some way. Even metals like titanium or ceramics can still cause issues over time. That’s why manufacturers look beyond just the base…   Read more»

]]> a51dc606e8cc2ea13f94a3395fb3d2cc https://medicaldevicecourses.com/activity/p/32074/ Thu, 18 Sep 2025 17:55:13 -0400 One thing I think is interesting when comparing academia and industry is the pace and priorities. In academia, it feels like the goal is more about discovery and publishing. You need to be patient and persistence and be able to…   Read more»

]]> 4d816e8463e38fae7d2ded1a9652d0b8 https://medicaldevicecourses.com/activity/p/32073/ Thu, 18 Sep 2025 17:47:54 -0400 I think everyone raised really good points about cost, time, variability in biological responses, and different supplier issues could all be hurdles in device development. Something I would like to add that was discussed in the lecture videos is that…   Read more»

]]> baca893e4be13e049694ae7dea2f08aa https://medicaldevicecourses.com/activity/p/31863/ Fri, 12 Sep 2025 19:32:11 -0400 Something I’ve noticed in my own group projects is how the environment has an impact on whether people actually share concerns or just keep them to themselves. Even if the manager isn’t the more technical person in the room, the…   Read more»

]]> 0d82ac25c000c6de60b29723ec505d2c https://medicaldevicecourses.com/activity/p/31861/ Fri, 12 Sep 2025 19:22:11 -0400 I like all the points that have been made so far, it does feel like academia follows a much more relaxed and less structed project management path than the industry does. This is definitely the case because the industry involved…   Read more»

]]> 46e4cf1fc6840b155d16ddcafb21e9c4 https://medicaldevicecourses.com/activity/p/31860/ Fri, 12 Sep 2025 19:11:01 -0400 I agree with what has already been said and discussed here so far, communication and active listening are vital parts of handling disagreements on a project team. Since we learned about the importance of project planning and how beneficial it…   Read more»

]]> 2f4aeaedeb4d927354771d48a2a867ab https://medicaldevicecourses.com/activity/p/31734/ Fri, 05 Sep 2025 17:36:04 -0400 I also wonder the same thing if internship and co-op experience gives you a step ahead when it comes to looking for a job. I feel like it’s very situationally based because I know of some people who had great…   Read more»

]]> b2e127eded520a7a67e6c506edff543d https://medicaldevicecourses.com/activity/p/31732/ Fri, 05 Sep 2025 15:45:06 -0400 As an undergrad student with no industry experience, my perspective is based off of what I have heard from others. I remember being in a seminar where the professor brought in a past student who is currently working in the…   Read more»

]]> ed60574fc6309f72f2cd71f0c6aa417a https://medicaldevicecourses.com/activity/p/31715/ Thu, 04 Sep 2025 18:35:28 -0400 @knm7 As an undergrad student pursing a master’s degree in biomedical engineering with the hope of working in the industry, I really appreciate this post. From a student perspective, I feel like taking courses stresses the deadline aspect of projects…   Read more»

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