https://medicaldevicecourses.com/members/naomialves/activity/ Activity feed for NaomiAlves. Sat, 25 Apr 2026 03:48:56 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7d3dcf0878dea0e9079b06dfc62ea42a https://medicaldevicecourses.com/activity/p/33713/ Mon, 17 Nov 2025 00:02:31 -0500 In my experience, the most effective usability risk strategy is the one that ties real user behavior directly to risk controls. For example, during my capstone experience my team and I went over numerous “user simulations” with our customer to…   Read more»

]]> b4dc65efb9c4ef9deedaf9a01a266926 https://medicaldevicecourses.com/activity/p/33712/ Sun, 16 Nov 2025 23:13:44 -0500 I think this is a great question because it is definitely something that isn’t talked about often. When working on my capstone project, my team and I definitely had instances were adding improvements for optimization for our device only introduced…   Read more»

]]> f88273089d89560ec77f1a5327c5d9b2 https://medicaldevicecourses.com/activity/p/33711/ Sun, 16 Nov 2025 22:44:25 -0500 First and foremost, it is important to understand that the critical characteristics of the risk profile for a medical device include the key attributes that define how risky the device is, how those risks manifest, and how they can be…   Read more»

]]> 2a42be3359068cf407bd25f27ab01740 https://medicaldevicecourses.com/activity/p/33236/ Mon, 20 Oct 2025 02:37:02 -0400 As the use of AI becomes more prominent in our society, I think you’re right to frame AI as both an opportunity and a challenge in medical device marketing. In one sense, it has the potential to streamline marketing projects…   Read more»

]]> e14ec931a510df9c11febe8b39030f8b https://medicaldevicecourses.com/activity/p/33235/ Mon, 20 Oct 2025 02:16:22 -0400 In addition to sales meetings and commercial marketing strategies, surgeons can also play a big role in promoting new devices, especially during early market adoption. However, this can sometimes cause confusion between what is considered scientific endorsement and commercial promotion….   Read more»

]]> 9b6cd8975465a0cabf564d75b069c008 https://medicaldevicecourses.com/activity/p/33234/ Mon, 20 Oct 2025 02:11:30 -0400 When it comes to labeling and regulatory submission most companies localize their formatting to the regulations of specific regions, but what about marketing strategy? For example, a patient-monitoring device might be sold on innovation in the U.S., but on affordability…   Read more»

]]> cd9cac39fdf86588317db80311e6e378 https://medicaldevicecourses.com/activity/p/32925/ Wed, 08 Oct 2025 21:26:41 -0400 This is a great question to ask, especially in today’s technologically advanced society where physicians are now able to provide telehealth services. In my opinion, if a physician were to start their own business, I would recommend that they take…   Read more»

]]> 2c852134461e01823bdea282a683d640 https://medicaldevicecourses.com/activity/p/32889/ Wed, 08 Oct 2025 02:00:35 -0400 I can definitely understand why an LLC would be an appealing choice when considering how to start a business, however, I lean more towards the sole proprietorship approach. The reason for this is because of the simplicity and independence it…   Read more»

]]> e42d576d61e719b5cccd0d92fab93d76 https://medicaldevicecourses.com/activity/p/32887/ Wed, 08 Oct 2025 01:23:00 -0400 When it comes to experiencing leadership styles in both a corporate and academic setting, I can say that I have been very fortunate to have mentors and supervisors who were not only passionate about their work, but were also passionate…   Read more»

]]> 241c2c16f986423edd2ef17ca82165b4 https://medicaldevicecourses.com/activity/p/32794/ Mon, 06 Oct 2025 03:41:46 -0400 I can understand where you’re coming from when you mention that the merging of companies can create fragmented quality systems, which in turn slows company progress. However, I think your statement of having a globally standardized system already exists, but…   Read more»

]]> f03d810cb9adeb9628911a90dfe7d235 https://medicaldevicecourses.com/activity/p/32792/ Mon, 06 Oct 2025 03:21:16 -0400 As is the case for any team, communication between members is key to success. When scaled to a larger size, communication between departments is how a company knows its staying on track and that their product ultimately reflects their mission…   Read more»

]]> 06dc3266c6c331f7b363b002579d078f https://medicaldevicecourses.com/activity/p/32787/ Mon, 06 Oct 2025 03:09:34 -0400 I don’t have any experience with audits, but I like the idea of viewing audits as learning tools rather than check-ins that create more work. However, to shift this culture, leadership needs to promote transparency, not just compliance. This is…   Read more»

]]> 7ad580924659a3e29eb34ee2f732659a https://medicaldevicecourses.com/activity/p/32339/ Wed, 24 Sep 2025 17:38:34 -0400 From what I gathered from our week 4 lecture video, it appears that a lot of people in regulatory affairs actually come from a research or lab background, which allows them to understand the science/technicalities behind their work. In my…   Read more»

]]> ed6b3909dc0c83ae5b015fe954550644 https://medicaldevicecourses.com/activity/p/32338/ Wed, 24 Sep 2025 17:34:01 -0400 One example that comes to mind is not exactly a natural outbreak, but the Tuskegee Syphilis Study in the United States. This was a 40 year long study, which targeted black males of a certain criteria, not for the purpose…   Read more»

]]> d1049950fe0668344899f8243b6d6b1b https://medicaldevicecourses.com/activity/p/32336/ Wed, 24 Sep 2025 17:22:40 -0400 Compared to pharmaceuticals, where refinement of a drug is through a fixed and repetitive pipeline, clinical trials for medical devices serve two major purposes. The first being to prove safety and effectiveness for regulatory approval, and the second being as…   Read more»

]]> 64c9a536fe0fd9231de6d57f642eda81 https://medicaldevicecourses.com/activity/p/32251/ Mon, 22 Sep 2025 03:57:40 -0400 When it comes to biomedical engineering projects (or any type of project really) material choice can make or break your schedule. If I were a project manager, here’s how I would think about choosing material for a project. One of…   Read more»

]]> f8c58724a67a59853924b8f08015effe https://medicaldevicecourses.com/activity/p/32249/ Mon, 22 Sep 2025 03:51:21 -0400 Hydrogels really stand out because of their water content and biocompatibility. For example, hydrogels are being used in wound healing dressings because they keep the environment moist, they can be used to create scaffolds for tissue regeneration, and can even…   Read more»

]]> d538649fc3a71ed169748b30f34265cb https://medicaldevicecourses.com/activity/p/32245/ Mon, 22 Sep 2025 03:35:15 -0400 I agree with you, scientific research does seem to apply stricter oversight than a lot of other industries that impact animals (beauty and food), which is an important distinction. For instance, before the 90s many beauty brands conducted a lot…   Read more»

]]> 8ec8fdfa41865b9f0e94a44ae7864fd1 https://medicaldevicecourses.com/activity/p/31830/ Wed, 10 Sep 2025 20:03:35 -0400 I think when a team disagrees with a project manager’s decision, the most important thing is communication. The manager should explain the reasoning behind the decision clearly, because sometimes conflict happens just because people don’t fully understand the “why.” At…   Read more»

]]> 74062b5d36dfe04eea4079a753b782a2 https://medicaldevicecourses.com/activity/p/31829/ Wed, 10 Sep 2025 19:51:40 -0400 When working on my senior capstone project, I had a similar experience where things didn’t go according to plan, and honestly, I think that’s where Gantt charts really show their value. They don’t just map out the “ideal” timeline, they…   Read more»

]]> 35e3b465584972cc365f8e19ae17a833 https://medicaldevicecourses.com/activity/p/31828/ Wed, 10 Sep 2025 19:19:55 -0400 I agree with a lot of what’s previously been said here, in regard to AI having potential in project management, but it in a way that limits it to working as more of a supporting tool rather than the main…   Read more»

]]> d84733465d9e05444e293bb0d7cb9cc1 https://medicaldevicecourses.com/activity/p/31755/ Mon, 08 Sep 2025 00:39:48 -0400 I think it is reasonable for students to want both strong academics and professional experience, and that colleges should have some type of system in place to make it more manageable, especially with all the money we pay in tuition….   Read more»

]]> 33128a72074117babad6eac04186844a https://medicaldevicecourses.com/activity/p/31741/ Sat, 06 Sep 2025 15:08:53 -0400 With a job market that is as competitive as our own, I think having a co-op, internship, or even solid lab work on your resume can really make a big difference and it shows employers that you can apply what…   Read more»

]]> f999998a7c895087b6af1dc1a800e7ec https://medicaldevicecourses.com/activity/p/31740/ Sat, 06 Sep 2025 14:36:47 -0400 While the medical device development process is important and highly structured, I would argue that it’s not always useful for individuals to pursue this certificate if medical devices are not their main focus. The reason comes down to relevance towards…   Read more»

]]> ec66f5b32abb742fee0c142318d25e7f https://medicaldevicecourses.com/activity/p/31737/ Sat, 06 Sep 2025 01:56:30 -0400 0