https://medicaldevicecourses.com/members/aca/activity/ Activity feed for aca. Sun, 15 Nov 2026 11:42:43 -0500 https://buddypress.org/?v= en-US 30 hourly 2 f0d7691e60c753bd403191c926cdbaf8 https://medicaldevicecourses.com/activity/p/60192/ Sun, 08 Nov 2026 22:59:21 -0500 An important aspect of translating subjective user needs into measurable requirements is to actually understand the difference between quantitative data and attribute data. Quantitative data can provide more useful information since it allows engineers to measure how well a device…   Read more»

]]> 80b8ae39054fbc8924f1eb5832beb9be https://medicaldevicecourses.com/activity/p/60191/ Sun, 08 Nov 2026 22:47:30 -0500 There can be situations where a medical device could pass verification but fail validation, like an infusion pump that delivers medication at the correct flow rate but has a challenging user interface. Even though the pump does meet the technical…   Read more»

]]> 7e96296e36246a378d51b59e2eb61fd1 https://medicaldevicecourses.com/activity/p/60189/ Sun, 08 Nov 2026 22:27:45 -0500 Safety and reliability should always be a priority when it comes to adding new features to a medical device in general. Before moving forward with production, engineers would have to evaluate if the device would meet its design requirements, perform…   Read more»

]]> 52eefb97cb02d525c0530d130b42ebb9 https://medicaldevicecourses.com/activity/p/60092/ Mon, 02 Nov 2026 03:04:30 -0500 @ahmed-elmonier In cases where a medical device passes verification but fails validation, then the first step should be determining if the issue is the design itself, the process, or the original requirements. It is important to understand that human error…   Read more»

]]> 069615490e0bf6965213bff6ca8eb014 https://medicaldevicecourses.com/activity/p/60088/ Mon, 02 Nov 2026 02:43:26 -0500 Laboratory testing is useful in identifying technical failures to an extent, but a notable drawback is how much patient variability can affect the device’s performance. There can be differences in anatomy, age, or medical conditions that can directly impact how…   Read more»

]]> a4ab1c4334f0ba31d22b61c5073399f7 https://medicaldevicecourses.com/activity/p/60086/ Mon, 02 Nov 2026 02:30:51 -0500 Packaging should be treated with similar importance as the device itself when it comes to evaluating patient safety because even a well-designed medical device can be unsafe if the packaging fails. Adding to your perspective, in cases where a product…   Read more»

]]> cd9bbf25c40827e071ae424185f340fb https://medicaldevicecourses.com/activity/p/59693/ Mon, 26 Oct 2026 00:38:35 -0400 The way researchers respond to a patient’s personal experience when it does not match the data collected during a study is also an essential element to consider when it comes to bringing trust in clinical research. If a patient is…   Read more»

]]> 7a1f95cf3b0f5b6c2f315aeb212650ef https://medicaldevicecourses.com/activity/p/59687/ Mon, 26 Oct 2026 00:04:33 -0400 Adding to the significant elements in the systematic process of clinical research, I would add that the way researchers interpret results when it comes to patients drawing from a medical device trial is also essential. For instance, if a clinical…   Read more»

]]> 1caa9d16391f420b65c8845808b3f9e1 https://medicaldevicecourses.com/activity/p/59686/ Sun, 25 Oct 2026 23:38:48 -0400 When it comes to a medical device, it is imperative to discuss the performance of the product, which heavily depends on the physician or surgeon utilizing the equipment. Even if a medical device is overall excellent to an AI simulation,…   Read more»

]]> 08adca31ab9ca1ed112900db75f37dc2 https://medicaldevicecourses.com/activity/p/59132/ Mon, 19 Oct 2026 00:42:24 -0400 The decision is less about which company has the best product or best marketing and more about how difficult it would be for a hospital to switch to a new device. A hospital may already have staff trained on one…   Read more»

]]> 74bab4c68dabfbb3d1ed9af2b845103e https://medicaldevicecourses.com/activity/p/59128/ Mon, 19 Oct 2026 00:10:40 -0400 @ahmed-elmonier Disclosure of finances is important, but I don’t think it’s enough by itself. Even if the surgeon is completely honest about the financial relationship with a company, the relationship will always influence how they will view the medical device,…   Read more»

]]> 0704ff3b5bd40a94a84931f848bee521 https://medicaldevicecourses.com/activity/p/59126/ Sun, 18 Oct 2026 23:55:44 -0400 Medical device companies should be aware that targeting physicians or patient needs does not automatically mean that the product will succeed commercially. Many hospitals and healthcare systems have other priorities, such as costs, reimbursement, training requirements, compatibility with equipment, and…   Read more»

]]> baa183c75de761d774d57968528e8345 https://medicaldevicecourses.com/activity/p/58952/ Mon, 12 Oct 2026 01:16:38 -0400 This topic is one of the most interesting conflicts I’ve seen with medical device companies. There is a balance of financial sustainability and also to improve patient outcomes. I think the best course of action is to look beyond the…   Read more»

]]> e70408368a79104427d5f1510cd4fc96 https://medicaldevicecourses.com/activity/p/58950/ Mon, 12 Oct 2026 01:05:52 -0400 A medical device company can face events where it can entirely change its business structure when it begins transitioning from research & development to direct commercial manufacturing. In an early phase of a product, a company may just focus on…   Read more»

]]> 2b7e56af6e8d9dd8f9bdbb358621c34e https://medicaldevicecourses.com/activity/p/58949/ Mon, 12 Oct 2026 00:46:08 -0400 An important factor to consider when deciding to outsource is also how it can affect their ability to respond to problems or to improve long-term. In medical devices a design change can impact manufacturing processes, testing methods, or supplier specifications….   Read more»

]]> d1a09771600cc30c642d26463ef88d99 https://medicaldevicecourses.com/activity/p/58876/ Sun, 04 Oct 2026 22:47:49 -0400 One of the challenges with developing a unified quality system is not only deciding what the system will look like in its final stage but also deciding how the company will transition to the system. If there are two medical…   Read more»

]]> 9f547f1b4580e2d6a1a62ca71c237c78 https://medicaldevicecourses.com/activity/p/58874/ Sun, 04 Oct 2026 22:26:49 -0400 Many companies focus more on quality control because it can create a familiar reactive dynamic where problems are fixed after they appear. If a company relied on inspection for a long time and has been able to catch most defects…   Read more»

]]> e2b56be609a1e6d8fbd0f43cfb7229b8 https://medicaldevicecourses.com/activity/p/58871/ Sun, 04 Oct 2026 22:07:06 -0400 In this case, the final decision should heavily depend on the level of risk involved instead of just choosing an AI system. If the AI flags a quality issue and a QA professional disagrees, then the disagreement is actually a…   Read more»

]]> c3533b19be4151af039af2712c952e13 https://medicaldevicecourses.com/activity/p/58778/ Sun, 27 Sep 2026 23:12:43 -0400 Choosing the product claim is important when viewing it with the means to the future of a product and company. A company’s launch claims can influence more than just the FDA submission. The decision can affect how a device is…   Read more»

]]> 77cb05c9978fce3d97014de4b8fa387c https://medicaldevicecourses.com/activity/p/58776/ Sun, 27 Sep 2026 22:58:12 -0400 @ahmed-elmonier The FDA should definitely consider the specific kinds of risks a potential new device can pose when deciding a new pathway. Certain risks can be easily detected and controlled compared to other risks. For instance, if there is a…   Read more»

]]> 35ac419922df7028a556a386da2f8880 https://medicaldevicecourses.com/activity/p/58775/ Sun, 27 Sep 2026 22:34:18 -0400 It is important for the framework to evolve for AI integrated medical devices, and companies shouldn’t need a full reapproval for every update because it can become redundant. However, when it comes to changes that affect safety, performance, or clinical…   Read more»

]]> 85bf96b9fda50b65c301e3e7f03a5a25 https://medicaldevicecourses.com/activity/p/57984/ Mon, 21 Sep 2026 00:30:02 -0400 It is also important to consider how each environment from academia to industry is when it comes to helping individuals in smaller populations and how that can impact a project, especially when it comes to profit. Industry may provide more…   Read more»

]]> bcd552a4823bf88c0e755ff86adcbadb https://medicaldevicecourses.com/activity/p/57979/ Mon, 21 Sep 2026 00:09:20 -0400 Personally, it really depends on the project but an essential factor that should be taken into account for a project is the sensitivity or confidentiality of the brand new instruments or technology. In-house testing would be most preferred because the…   Read more»

]]> 4fd3d5033592e138b6820e752485edc4 https://medicaldevicecourses.com/activity/p/57974/ Sun, 20 Sep 2026 23:26:17 -0400 An important factor in determining clinical readiness is by looking at whether lab and animal studies showcase enough evidence of safety and efficacy. At the same time, one should identify the major risks that could affect human trials. The goal…   Read more»

]]> 3753bf7a34074992ea1dcb4f4ae25619 https://medicaldevicecourses.com/activity/p/57259/ Sun, 13 Sep 2026 23:35:13 -0400 Contributing to everyone’s perspective, an important part that comes from project planning may not be planning every individual task, but it can be identifying every major decision point. A team might not know what will happen during the development stage,…   Read more»

]]> 5e723b8cf09ab78f58d2286daabc5266 https://medicaldevicecourses.com/activity/p/57257/ Sun, 13 Sep 2026 23:05:03 -0400 From personal experience, another major conflict point that can be seen with teamwork is competing personalities. At times there can be certain members or subject matter experts that can be very straightforward or close-minded about how something can be done….   Read more»

]]> b5851fc890cc41da8562e43e79987b63 https://medicaldevicecourses.com/activity/p/57255/ Sun, 13 Sep 2026 22:52:21 -0400 Prioritization and judgement is an additional quality a project manager must showcase, especially when there are competing demands coming from stakeholders, engineers, or others. A project can have an organized timeline and a motivated team, but situations when there are…   Read more»

]]> de6e6f7f1593a054435e8bd06a67ffa4 https://medicaldevicecourses.com/activity/p/57142/ Mon, 07 Sep 2026 00:17:57 -0400 Another component that comes with dealing with teamwork that is challenging is the possibility of there being unclear ownership for certain tasks. Even when people want to contribute, the project can still face challenging issues if no one in the…   Read more»

]]> 47b272f14f975d7e0f7a973d9d616d96 https://medicaldevicecourses.com/activity/p/57139/ Sun, 06 Sep 2026 23:39:36 -0400 It is essential to be a well-rounded student as described in the conversation; many students take on more than they can chew, and it can ultimately affect their performance in certain aspects. I think it is important to see how…   Read more»

]]> 45735a80bd151b46ee6ced8a4d41ef77 https://medicaldevicecourses.com/activity/p/57137/ Sun, 06 Sep 2026 23:04:56 -0400 It is essential to have experience in industry, especially if you want to break into top companies; however, the experience matters less compared to how you explain your accomplishments. It’s important to keep in mind that one can be successful…   Read more»

]]> 32e663cdb40ffa078880948b3dbdf558 https://medicaldevicecourses.com/activity/p/48638/ Sun, 03 May 2026 21:52:02 -0400 For non-PMs, the understanding of project management concepts strengthens one’s risk ownership, even without formal authorization. In engineering roles, small decisions such as selecting certain materials or sizes, adjusting tolerances, or delaying tests can create downstream risks that aren’t immediately…   Read more»

]]> cb79e888fdf1f9d266af14258ebe9404 https://medicaldevicecourses.com/activity/p/48635/ Sun, 03 May 2026 21:39:29 -0400 System-level accountability is essential, and it covers aspects that involve a larger group of individuals who are underperforming along with individuals. At times, underperformance is less about the individual and more about how success is measured or supported in the…   Read more»

]]> 8bf11b398d302a09e8bb2c9ac902be34 https://medicaldevicecourses.com/activity/p/48633/ Sun, 03 May 2026 21:29:06 -0400 The decision is usually driven by the overall risk and the long-term cost instead of the unit price. Although it may seem reasonable to spend time investigating and finding a solution to a defect with a low-cost supplier, the effort…   Read more»

]]> ee29327e11d54eaac334bc188524bd8e https://medicaldevicecourses.com/activity/p/47892/ Sun, 26 Apr 2026 20:11:22 -0400 Agreed, blaming a specific person isn’t productive; instead, looking for a direct solution or remediation is most suitable. In many cases, elements such as site selection and early-stage predictions can keep problems from arising. In clinical trials, underperformance can be…   Read more»

]]> beb0c8b2b748c1babb20e3ee650f30e0 https://medicaldevicecourses.com/activity/p/47886/ Sun, 26 Apr 2026 19:17:38 -0400 Companies usually rely on the informal leverage systems when legal protection is not effective. Even though there aren’t any explicit quality clauses, vendors are usually part of a larger network where reputation, contracts, and long-term partnerships are a priority. Companies…   Read more»

]]> 5344fbf54a2caff2d681400e35507073 https://medicaldevicecourses.com/activity/p/47881/ Sun, 26 Apr 2026 18:51:13 -0400 COVID-19 is a special case where vaccines were able to achieve that “fast, good, cheap,” result compared to how it works traditionally. One difference is that instead of resolving all uncertainty before the approval, there was risk that was acknowledged,…   Read more»

]]> 48787c155fba9f66e9fd634826108498 https://medicaldevicecourses.com/activity/p/47213/ Mon, 20 Apr 2026 00:50:42 -0400 A way PMs can make an informed decision between utilizing crashing and fast-tracking is by questioning which decision is more reversible if something goes wrong. For example, since crashing means adding resources or supplemental support, then it can be scaled…   Read more»

]]> 39070671696bd10397df67436c8d2833 https://medicaldevicecourses.com/activity/p/47190/ Sun, 19 Apr 2026 22:34:47 -0400 Similar to Sami, in my time working as an intern at a medical device company, I was onboarded into a team at a later stage of a project, before FDA submission. One part that I believe is overlooked is when…   Read more»

]]> 23c271b970b03d00a94af9e8fd5d99a5 https://medicaldevicecourses.com/activity/p/47180/ Sun, 19 Apr 2026 21:23:39 -0400 One way a PM is able to navigate an unknown budget is by integrating changes that are centered on structured prioritization, phased decision-making and proactive escalation instead of waiting for a full budget before executing. If new regulatory requirements or…   Read more»

]]> c0223d8ac4fc63ac8e7115e870d31cff https://medicaldevicecourses.com/activity/p/46474/ Mon, 13 Apr 2026 00:49:52 -0400 One of the most difficult parts when it comes to working on a team project is maintaining team alignment as the project evolves. This also includes all stages of product development, from planning to production. As other commenters have stated,…   Read more»

]]> b4aeb91b3182c165c8f51be54794fb5e https://medicaldevicecourses.com/activity/p/46472/ Mon, 13 Apr 2026 00:34:24 -0400 From another perspective, project management tools are not only about having a planning aid, but they also work as a tool to support decision making through a system that shapes how a team can think about a project. As mentioned…   Read more»

]]> 30dfb2ef442f9e2443742b07ec103767 https://medicaldevicecourses.com/activity/p/46465/ Mon, 13 Apr 2026 00:03:00 -0400 Another perspective can be that the impact of changes to a project is not only about documenting and communicating the associated effects. The process also involves presenting the change as a choice with alternatives rather than a single solution to…   Read more»

]]> a7d3287d2f2635a4b6bf800d0503c4ef https://medicaldevicecourses.com/activity/p/45040/ Sun, 29 Mar 2026 03:34:26 -0400 It is also significant to take the perspective on how an overreliance on EVM metrics can also develop a false sense of control for everyone, especially in a highly complex project where progress can be nonlinear. EV, PV, and AC…   Read more»

]]> dfe288a16366818ce474bb8df32b12b4 https://medicaldevicecourses.com/activity/p/45035/ Sun, 29 Mar 2026 02:54:54 -0400 In one situation I encountered, my team was working towards a hard regulatory deadline for FDA submission. Initially, as in most engineering projects, there was a built-in buffer time that made the timeline feel manageable. However, right at four weeks…   Read more»

]]> 51ffffed37a14f01d2a364598441ac55 https://medicaldevicecourses.com/activity/p/45033/ Sun, 29 Mar 2026 02:28:42 -0400 The added advantage of a Gantt chart is that they are indispensable in the medical device industry since they not only map timelines but also make regulatory expectations visible compared to other project management tools. Medical devices are commonly developed…   Read more»

]]> 96dd35e240fc78c569274664d27ca271 https://medicaldevicecourses.com/activity/p/43796/ Sun, 15 Mar 2026 19:40:59 -0400 One technique that is truly effective is the work authorization system because it acts as a checkpoint or transition between the planning and action stages. A team may have reliable communication and meetings; however, if a task is executed without…   Read more»

]]> 29980076e44212916d3ca66d5adb9d2f https://medicaldevicecourses.com/activity/p/43788/ Sun, 15 Mar 2026 19:15:28 -0400 Project management information systems can be argued to be the most essential strategy since they are the central point where aspects such as planning, execution, communication, and accountability all fit together. A PM has to be diligent at leading, delegating,…   Read more»

]]> d4e9a8f62a7109046076bb91554e61b1 https://medicaldevicecourses.com/activity/p/43784/ Sun, 15 Mar 2026 18:54:49 -0400 Along with avoiding lack of communication and understanding the project requirements from the start, I would like to add that another challenge can occur in the development of a design phase. There can be an instance where engineers can add…   Read more»

]]> be0e75db303c2cbb13f91cb84d0e150e https://medicaldevicecourses.com/activity/p/43083/ Sun, 08 Mar 2026 21:40:20 -0400 In industry, a PM can rely on types of structured experimental strategies instead of trial and error. The simulation provided the opportunity to set out experimental designs to test our parameters. In my experience, it is crucial for teams usually…   Read more»

]]> ac53108bb06e997a655c1dc7ecb64af3 https://medicaldevicecourses.com/activity/p/43080/ Sun, 08 Mar 2026 21:19:51 -0400 It is also essential to consider a different perspective when it comes to coming back to the previous phase in a project. Overall, it is much less about the quantity of deviation of a project and more about if the…   Read more»

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