https://medicaldevicecourses.com/members/nick-carrillo/activity/ Activity feed for NCarrillo. Sat, 16 May 2026 13:08:55 -0400 https://buddypress.org/?v= en-US 30 hourly 2 d908cd493530147d394a2c1e8909e85d https://medicaldevicecourses.com/activity/p/33696/ Sun, 16 Nov 2025 19:06:45 -0500 FMEAs are indeed a useful tool for evaluating the types of failures a system could experience if one (or several) of its components fail. This is especially true for medical devices, which include various components/subsystems that, when under the right…   Read more»

]]> 33383a216e1869b2513d0e087acd9502 https://medicaldevicecourses.com/activity/p/33650/ Fri, 14 Nov 2025 18:44:23 -0500 I believe risk acceptance and its effect(s) are directly tied to the quality of the risk assessment itself, which also affects the form of a response to the hazard. When risk assessment is conducted, there is an order of precedence…   Read more»

]]> 254672a71aa31e9873dabd1f48f8395a https://medicaldevicecourses.com/activity/p/33647/ Thu, 13 Nov 2025 22:05:52 -0500 During my time as a co-op at GAF, I have witnessed a variety of hazards that had to be mitigated, mostly within the R&D labs. Each of the labs had a variety of equipment with varying levels of risk. One…   Read more»

]]> 7f29295ba236f4bc4850f15acd3a1a54 https://medicaldevicecourses.com/activity/p/33559/ Sun, 09 Nov 2025 17:04:10 -0500 @shreya This is a great set of ideas to build upon for the complexities of developing & reviewing a potential product, especially regarding living documents, progress traceability & structure. I want to add my thoughts on using these methods. When…   Read more»

]]> cf45ed3f42a58d8e43092c4b4fc47dbb https://medicaldevicecourses.com/activity/p/33543/ Sat, 08 Nov 2025 05:20:17 -0500 Both processes are necessary to ensure the product pleases two key stakeholders: the company itself and its customers. Maintaining this distinct difference between them enables specialized processes that cater to the target audience(s). Putting it together would unlikely be effective….   Read more»

]]> 1810911c298bd413764fb6b283cf0557 https://medicaldevicecourses.com/activity/p/33510/ Wed, 05 Nov 2025 16:39:34 -0500 Ideally, you’d imagine companies doing both. They need to fulfill regulatory requirements for the sake of remaining compliant, but they must strive to uphold product quality to maintain or improve their market share. This is especially true when considering all…   Read more»

]]> 2392008e9b46fdb27aae4ceaabc6b6a4 https://medicaldevicecourses.com/activity/p/33425/ Sun, 02 Nov 2025 04:33:43 -0500 Design teams, from my experience, tend to prioritize the most realistic aspects of a design. The end goal is to meet the customer’s requirements, yes, but at the same time, they cannot expect us to produce certain extraneous features that…   Read more»

]]> cf7b107289d31c364ef3c287a970b80c https://medicaldevicecourses.com/activity/p/33412/ Sat, 01 Nov 2025 22:01:35 -0400 691e2fe3c7135fc2e63a5f4c85138ae8 https://medicaldevicecourses.com/activity/p/33411/ Sat, 01 Nov 2025 22:00:57 -0400 bc5c98f37adfe2c94050a9e509e2be7f https://medicaldevicecourses.com/activity/p/33410/ Sat, 01 Nov 2025 22:00:49 -0400 cbbc0b5efd4319f9fdf8ace6926747f8 https://medicaldevicecourses.com/activity/p/33409/ Sat, 01 Nov 2025 22:00:28 -0400 d70cdb9798985add7624e88b4e611247 https://medicaldevicecourses.com/activity/p/33408/ Sat, 01 Nov 2025 21:53:48 -0400 Hi Jacob, you’ve provided a great definition of what makes an effective design input. There’s actually a mechanism that Dr. Simon discussed this week in the lecture. To turn a qualitative design goal into a quantitative result, you need to…   Read more»

]]> 04f6a777e2cf6a2b68b07d3edf5b7b8a https://medicaldevicecourses.com/activity/p/33384/ Fri, 31 Oct 2025 01:24:47 -0400 Meeting minutes are a useful tool for logging significant portions of a meeting, especially when discussing subjects such as design reviews/controls. This gives professionals the ability to keep tabs on a project’s progress through crucial milestones and data, especially during…   Read more»

]]> 160d230e1ae9ea1895cc5cfa0bb4d3ba https://medicaldevicecourses.com/activity/p/33288/ Sat, 25 Oct 2025 19:27:54 -0400 When discussing the placebo effect in a blind/double blind study and how it provides a neutral control for researchers to determine how well their drug performs, we focus on the assumptions that patients are making and how that psychological response…   Read more»

]]> 845c9e5c94993dd85d9e26ccff9cf709 https://medicaldevicecourses.com/activity/p/33287/ Sat, 25 Oct 2025 00:05:35 -0400 Unlike a good portion of the responses here, I believe the placebo effect is a reliable way to keep patients and researchers from having implicit expectations relating to the response to the given drug sample. It yields more accurate data…   Read more»

]]> 73967278d681da27f3d64f61bc4f6da0 https://medicaldevicecourses.com/activity/p/33286/ Fri, 24 Oct 2025 23:53:56 -0400 850fdd77e4e94229a151eaa8f28500d2 https://medicaldevicecourses.com/activity/p/33269/ Thu, 23 Oct 2025 21:11:30 -0400 Patients participating in a study should generally be compensated in some form, including financially. This is dependent on several factors, namely the phase of the study and the severity of the preexisting condition(s) they have been selected for.   For…   Read more»

]]> 697a48c3ef53c72d395dc718048f349b https://medicaldevicecourses.com/activity/p/33175/ Fri, 17 Oct 2025 05:52:35 -0400 As I’ve worked closely with designers, manufacturers, and everyone in between during my short time in the industry, I’ve gained much understanding of how a product should be developed based on market needs, statistical trends, and limitations. Thus, I’d likely…   Read more»

]]> 4ca957a4bb820f74036f177645c17e8e https://medicaldevicecourses.com/activity/p/33168/ Thu, 16 Oct 2025 21:03:52 -0400 The ethical value of AI can be twofold. On one hand, it’s a powerful resource that will help researchers & even designers compile a large chunk of pertinent information in a shorter period of time than it would take with…   Read more»

]]> 66c07170064b6699bbaa92b24686bbc5 https://medicaldevicecourses.com/activity/p/33164/ Thu, 16 Oct 2025 05:47:24 -0400 Patients should definitely have a say in the design of their products for companies. As they are the end users for the products intended to solve or at least mitigate their ailment(s), they can discuss what they enjoy most about…   Read more»

]]> ea2796ea25e7764d404be2a0801b8ec8 https://medicaldevicecourses.com/activity/p/32985/ Sat, 11 Oct 2025 20:00:46 -0400 When it comes to starting either a sole proprietorship or a partnership, it depends on the circumstances and type of business. It also depends on the amount of taxes, liability, and responsibility you are willing to take on.  Ideally, I’d…   Read more»

]]> f766d97fd821bac72bdec8aa33ea6f11 https://medicaldevicecourses.com/activity/p/32964/ Fri, 10 Oct 2025 18:46:20 -0400 For a small business, it would be most beneficial to start as simply as possible, aligning with your market aim. This includes aspects such as liability protection, taxation, flexibility in ownership, and capital management. For a medical device company, one…   Read more»

]]> 6e31ad36783676bec40f374d4686bbbb https://medicaldevicecourses.com/activity/p/32948/ Fri, 10 Oct 2025 02:55:45 -0400 The corporate veil is indeed a powerful tool utilized to protect individuals of interest within a larger organization. As you’ve correctly identified, this is not foolproof, as there are extreme circumstances that would allow prosecutors to point fingers at individuals,…   Read more»

]]> d536b8a5ec3baa661389e0ba8bf1b12a https://medicaldevicecourses.com/activity/p/32680/ Fri, 03 Oct 2025 17:27:12 -0400 Quality Assurance and Control are both crucial roles within the product development & manufacturing process. This is especially true for medical devices, where strict requirements need to be met and updated according to 21 CFR 820 or ISO13485, depending on…   Read more»

]]> f34cd01e95712fce545a81ef3d8ca2ee https://medicaldevicecourses.com/activity/p/32646/ Thu, 02 Oct 2025 22:01:01 -0400 In my bit of industrial experience, I have worked in various companies ranging from medium to large corporations. Their level of performance and quality was proportional to their size (or, better stated, their budget), which determined how much they could…   Read more»

]]> 8cacea1d5c4c04f9a1413ff8f10304a7 https://medicaldevicecourses.com/activity/p/32638/ Thu, 02 Oct 2025 21:14:55 -0400 This is a harrowing example that reveals not just a risk in the product itself, but also a potential breach of trust in those who are supposed to solve a patient’s problem. Those who neglect the need for an effective…   Read more»

]]> b3822f3b36ad8902f6063a758300075c https://medicaldevicecourses.com/activity/p/32440/ Sat, 27 Sep 2025 05:39:21 -0400 This is a great question that relates to a reply I gave in another thread.    As you’ve noted, engineers may have more or less responsibility depending on the size of the company they are working for. For instance, smaller…   Read more»

]]> 112c49cfe247b069f658e7613ccead8c https://medicaldevicecourses.com/activity/p/32412/ Fri, 26 Sep 2025 17:30:52 -0400 Balance and reality are key to success, indeed.  A combination of both would work. When developing a device, you have two things to worry about: the customer’s requirements and federal regulations. In this case, engineers must maintain a balance between…   Read more»

]]> 6fa02ed93bc3311fc9ee7a688ce43ccb https://medicaldevicecourses.com/activity/p/32391/ Thu, 25 Sep 2025 22:21:46 -0400 When it comes to newer technology that does not only involve physical devices (such as software), reform would be necessary as the FDA would need to define how it assigns these solutions. This can include categorized class designation for certain…   Read more»

]]> f5d4c03b189d24446882cbd91bc1b7a9 https://medicaldevicecourses.com/activity/p/32165/ Sat, 20 Sep 2025 23:35:26 -0400 Hey there, Atmeh, You bring up a point that I’ve learned at length about through courses and practical experience. I’ve learned that catching issues early in a process saves a lot of time and money. More importantly, it keeps risks…   Read more»

]]> 784758ed2ca1a4d0d637a354c44b2a2c https://medicaldevicecourses.com/activity/p/32079/ Thu, 18 Sep 2025 20:54:57 -0400 As a graduate student with some field experience, I am no stranger to receiving directives on what research needs to be completed to advance an employer’s agenda. The environment can be fast-paced and exciting, knowing this is a product close…   Read more»

]]> 3187a6d182191b0dacf0573e089904f9 https://medicaldevicecourses.com/activity/p/32040/ Wed, 17 Sep 2025 21:14:12 -0400 I unfortunately don’t have enough experience in academic research to provide a personal perspective, but I can share my experience in industry. During my time as a co-op at GAF, I saw a strong dedication to market research that helped…   Read more»

]]> b393ed896026b0632fb78dbd23720a21 https://medicaldevicecourses.com/activity/p/31905/ Sun, 14 Sep 2025 03:31:20 -0400 How important is the connection within a team to meet the project objectives in biotechnology?  This is one of the most fundamental aspects of a successful team, let alone a project. The connection between team members is critical in that…   Read more»

]]> 42941c4057f42c9db392c4e47113599c https://medicaldevicecourses.com/activity/p/31871/ Sat, 13 Sep 2025 05:12:18 -0400 I’ve spoken at length about this in another thread, but I was tasked with creating a working prototype for a novel concept in my undergraduate capstone class. Our team settled on creating a bottle that could hold half a gallon…   Read more»

]]> dae339715d606ba034ec94e050294429 https://medicaldevicecourses.com/activity/p/31856/ Fri, 12 Sep 2025 16:46:02 -0400 @jacobchabuel Hi, Jacob. You posed a great question. I myself am guilty of this pleasure (despite its detrimental effect). During my capstone project for my undergraduate degree, I was tasked with conceiving a novel idea to develop into a functional…   Read more»

]]> 54feabd0ca8e9ad41fbb0c8f346ae60c https://medicaldevicecourses.com/activity/p/31729/ Fri, 05 Sep 2025 13:19:08 -0400 Riddhi, you’ve provided a great introduction to this question.   I have asked myself the same questions many times recently. I have had experience in both areas to an extent, but mostly industry, I’ll admit. I am leaning towards industry…   Read more»

]]> 247b5976f17907490a73f818d30da5d6 https://medicaldevicecourses.com/activity/p/31725/ Fri, 05 Sep 2025 02:48:13 -0400 Is it reasonable to expect students to manage both a full academic course load and significant professional work experience? I have gotten to know people who are working full-time but taking some classes. Most (and I) agree that practical experience…   Read more»

]]> 9b6d8c6ebc3524aee3e6984adb69c958 https://medicaldevicecourses.com/activity/p/31710/ Wed, 03 Sep 2025 18:06:09 -0400 Riddhi, you’ve provided a great introduction to this question.   I have asked myself the same questions many times recently. I have had experience in both areas to an extent, but mostly industry, I’ll admit. I am leaning towards industry…   Read more»

]]> cf3a121a0436a3ef689d944cc22e9b8b https://medicaldevicecourses.com/activity/p/31707/ Wed, 03 Sep 2025 14:37:12 -0400 Between completing my undergraduate degree and master’s degree, I have gained some perspective on choosing between the “ivory tower of academia” and industry. Over the last three years of my career, I have explored both sides of the argument. In…   Read more»

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