https://medicaldevicecourses.com/members/sic23njit-edu/activity/ Activity feed for Sami Choudhury. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 bb8eb9807d9aee4e69ac818c34b96ff4 https://medicaldevicecourses.com/activity/p/47471/ Wed, 22 Apr 2026 15:23:55 -0400 The points raised here about proactive versus reactive communication are well-taken, but I think there’s an underlying issue worth naming more explicitly: communication plans fail not because they’re absent, but because they’re treated as static documents rather than living frameworks….   Read more»

]]> 32a1eda8db087386946c05c717a27cbe https://medicaldevicecourses.com/activity/p/47469/ Wed, 22 Apr 2026 15:11:24 -0400 Partnering with a CRO doesn’t eliminate risk so much as it redistributes it. You’re trading execution risk for coordination risk; gaining the CRO’s expertise and infrastructure while simultaneously introducing new potential failure points: misaligned expectations, communication gaps, and reduced visibility…   Read more»

]]> 646ec75b7c29630606f70e04620415ea https://medicaldevicecourses.com/activity/p/47153/ Sun, 19 Apr 2026 17:51:32 -0400 The points raised about timing and legal versus ethical disclosure really stand out to me as I think Dev’s framing is spot on: meeting regulatory minimums is not the same as being ethical, and in medical devices especially, that gap…   Read more»

]]> 63bd69d425bd32b507eddb3f25d1448a https://medicaldevicecourses.com/activity/p/47150/ Sun, 19 Apr 2026 17:43:39 -0400 Both points about false alignment and the danger of locked-in assumptions really resonate with me. During my time at Boston Scientific, working on a delivery system for a next-generation heart valve, early-stage assumptions about component tolerances were often treated as…   Read more»

]]> 00de677d1df9d14dc8cb3f198f7e4c66 https://medicaldevicecourses.com/activity/p/47149/ Sun, 19 Apr 2026 17:34:02 -0400 Building on the point about revisiting cost estimates as the project progresses, it’s worth highlighting that in the medical device space specifically, PMs can leverage a risk-based contingency framework to navigate budget uncertainty more strategically rather than reactively. Since medical…   Read more»

]]> 4b0b9542d2c2ddc28a6124f5e03ef8bd https://medicaldevicecourses.com/activity/p/46428/ Sun, 12 Apr 2026 18:25:26 -0400 One dimension worth adding to this discussion is the role that supplier qualification and audit processes play in preventing this situation from arising in the first place. Ideally, before a contracted company even begins verification and validation, the hiring company…   Read more»

]]> 7d3eb63bcb86f0ef476f143e4811485d https://medicaldevicecourses.com/activity/p/46427/ Sun, 12 Apr 2026 18:10:58 -0400 A technical lead telling upper management that a timeline is unrealistic will land very differently if they frame it in terms of regulatory risk, potential FDA audit failures, or product liability exposure rather than purely technical constraints, because those are…   Read more»

]]> e444d4d2daec10c8c465eec5d8abc380 https://medicaldevicecourses.com/activity/p/46425/ Sun, 12 Apr 2026 17:54:43 -0400 One angle that hasn’t been fully explored is the idea of designating a lead PM who serves as the final decision-maker when conflicts arise, essentially functioning as a tiebreaker while still distributing workload across multiple PMs. Without a clear hierarchy,…   Read more»

]]> ca59ba95c40b636a262fe52e1aae1ed5 https://medicaldevicecourses.com/activity/p/45470/ Thu, 02 Apr 2026 16:19:33 -0400 There’s a difference between a company that rushes a product to market while deliberately concealing known safety concerns versus one that makes a calculated, transparent decision to accelerate timelines while openly acknowledging the remaining uncertainties to all stakeholders involved. As…   Read more»

]]> 44de58aefdfc3d44203520dea532760a https://medicaldevicecourses.com/activity/p/45467/ Thu, 02 Apr 2026 15:53:01 -0400 Instead of only adding buffer time at the end, it can be more effective to distribute smaller buffers around high-risk or high-variability tasks, especially those on the critical path. Building on the idea of real-time data, I also think iterative…   Read more»

]]> be79169ace1f826072fa028510b26bbb https://medicaldevicecourses.com/activity/p/43934/ Tue, 17 Mar 2026 00:38:02 -0400 One point that stands out to me from this discussion is how critical it is to treat the initiation phase as a stage for managing uncertainty rather than eliminating it. In fields like medical device development, it’s often impossible to…   Read more»

]]> 4b63574148ab980fa1bf52e9587564ea https://medicaldevicecourses.com/activity/p/43915/ Mon, 16 Mar 2026 21:07:59 -0400 One strategy that stands out to me is the role of organizational procedures, because they create the structure that allows the other tools, like meetings or tracking systems, to work effectively. While status review meetings and project management information systems…   Read more»

]]> 7804d28773b676d0b5570ffd17954236 https://medicaldevicecourses.com/activity/p/43914/ Mon, 16 Mar 2026 21:00:42 -0400 One aspect of EVM I find particularly valuable is its ability to improve communication between project teams and stakeholders. While several posts mentioned tracking performance and forecasting outcomes, the standardized metrics in EVM also make project status easier to explain…   Read more»

]]> e5ddd6590fb58861fd009bce6ac476d4 https://medicaldevicecourses.com/activity/p/43109/ Mon, 09 Mar 2026 01:20:54 -0400 I agree with many of the points mentioned, especially about creativity and negotiation leverage, but another possible reason could be strategic flexibility for upper management. Sometimes the total budget for a project is part of a larger portfolio of projects,…   Read more»

]]> 7a5736449b57a50dbfaeb5c8510890a4 https://medicaldevicecourses.com/activity/p/43108/ Mon, 09 Mar 2026 01:13:31 -0400 I agree with many of the points about checklists and pre-review meetings, but another helpful step is making sure the story of the design is clear before the meeting. Instead of just compiling documents, the team should prepare a short…   Read more»

]]> 5f38608646e36a2f6ad5b2c58b0c5381 https://medicaldevicecourses.com/activity/p/43107/ Mon, 09 Mar 2026 01:08:08 -0400 One idea that stood out to me in this discussion is that the decision to return to a previous phase is less about the amount of error and more about the type of issue being discovered. Sometimes early results appear…   Read more»

]]> 71a607d052ff4e051ebc8633d128237e https://medicaldevicecourses.com/activity/p/43106/ Mon, 09 Mar 2026 01:05:11 -0400 One angle I find interesting is how collaborations like BoneFix and FactoSet aren’t just about leveraging expertise or cutting costs, they also distribute regulatory and technical risks. In biomedical products, especially injectables, the FDA or other regulatory bodies scrutinize both…   Read more»

]]> fbc9c21c993d731fac3a40039272542a https://medicaldevicecourses.com/activity/p/42364/ Sun, 01 Mar 2026 21:25:33 -0500 I agree with Dev Doshi and Ehab B. that avoidance isn’t always the best strategy, especially for life-sustaining devices where eliminating risk could mean removing essential features. I’d add that avoidance works best in the design phase, while manufacturing and…   Read more»

]]> 823cf2125822da83966a4c5a3dc358a5 https://medicaldevicecourses.com/activity/p/42363/ Sun, 01 Mar 2026 21:23:44 -0500 I really appreciate all the insights shared here, especially the idea of running parallel validation to minimize production disruptions. Building on Dev Doshi’s point about regional divergence, one thing I’d add is considering how AI and digital twin simulations could…   Read more»

]]> e77f0d21b889cc99b8e3ffe1475e9674 https://medicaldevicecourses.com/activity/p/41598/ Mon, 23 Feb 2026 04:43:00 -0500 I really like the point that the DHF isn’t the true deliverable, but rather the evidence of sound decision-making. I don’t think the PM’s role shifts away from task management, but instead, task management becomes compliance-informed by default. In medical…   Read more»

]]> 63212eebc75ba4b5411be72994c1dfcf https://medicaldevicecourses.com/activity/p/41596/ Mon, 23 Feb 2026 04:33:38 -0500  One angle I’d add is that in medical device development, credibility with cross-functional teams can matter just as much as credentials on paper. A technical degree may help you earn trust from R&D and regulatory teams when discussing design controls…   Read more»

]]> 7e4d0f6d2574d497462a0fee0ead1ebd https://medicaldevicecourses.com/activity/p/41594/ Mon, 23 Feb 2026 04:26:59 -0500 I like the ideas about SharePoint and dashboards, but I wonder if the format matters less than when the lessons are captured. If teams wait until the final closeout, a lot of smaller but important insights get forgotten, so maybe…   Read more»

]]> 7c9b45d6b156752c5c0beddc8f6b029e https://medicaldevicecourses.com/activity/p/40655/ Sun, 15 Feb 2026 19:54:05 -0500 I think aligning business needs and customer satisfaction starts with redefining them as interdependent rather than competing priorities. In medical devices, especially, long-term revenue is directly tied to clinical outcomes, safety, and physician trust, so customer satisfaction is actually a…   Read more»

]]> aefd83807d151a78a5f9e47e138a62bd https://medicaldevicecourses.com/activity/p/40654/ Sun, 15 Feb 2026 19:50:06 -0500 I think the root issue here isn’t just version control software: it’s process discipline. If a design change request isn’t based on the latest revision, it should be formally rejected before review even begins, because otherwise you’re building on outdated…   Read more»

]]> 178c0b6ff0d4ff0788c4dbc038660fea https://medicaldevicecourses.com/activity/p/40653/ Sun, 15 Feb 2026 19:46:12 -0500 I think this situation is less about a design flaw and more about the original business assumption being challenged by real data. If the stent dissolves too quickly to provide long-term vessel support, then the product isn’t meeting its intended…   Read more»

]]> f2f137b727966a4c66e638451900c9ae https://medicaldevicecourses.com/activity/p/39769/ Sun, 08 Feb 2026 04:03:54 -0500 I think one aspect that often gets overlooked is how company culture affects the integration of design controls and project management. Even with shared documents and aligned meetings, the DHF can still end up incomplete or inconsistent. Embedding a mindset…   Read more»

]]> 81c5a36fc3bcd4ee29047a6175b948c0 https://medicaldevicecourses.com/activity/p/39768/ Sun, 08 Feb 2026 03:57:40 -0500 I think one commonly overlooked part of creating a strong DHF is treating it as an evolving document instead of something put together at the very end of the project. A PM can help by setting clear documentation standards early…   Read more»

]]> 948c691cc7a157afd2b96a6a0a245ece https://medicaldevicecourses.com/activity/p/39767/ Sun, 08 Feb 2026 03:53:30 -0500 One additional factor that strongly influences the medical device product life cycle is post-market surveillance and real-world performance data, which can extend or shorten a device’s lifespan after launch. Tools such as CAPA systems, complaint trending, and field performance metrics…   Read more»

]]> afa91fc8fbd63f9cb6de82a425b1b63f https://medicaldevicecourses.com/activity/p/38623/ Sun, 01 Feb 2026 06:23:54 -0500 Based on my research, I’d be interested in starting a medical device project focused on a collagen–chitosan hydrogel bandage for treating second-degree burns, since it has strong potential to support healing while offering intrinsic antimicrobial protection. The early steps would…   Read more»

]]> d66ac5d055e920b69f7e38f6312a7e4e https://medicaldevicecourses.com/activity/p/38620/ Sun, 01 Feb 2026 06:06:49 -0500 From my experience in the medtech industry, and building off what was said earlier, this distinction actually makes a lot more sense once you see it play out- I think of the product life cycle as a holistic timeline: concept,…   Read more»

]]> 0619a95e1eefd5c4b3c7529feb33e425 https://medicaldevicecourses.com/activity/p/38616/ Sun, 01 Feb 2026 05:51:55 -0500 I did a bit of research, and I agree that the PM’s role shouldn’t stop at market release. One added perspective is that post-market activities often function like a series of smaller, iterative projects, and PMs are well-positioned to structure…   Read more»

]]> 15fa9305e38854999f2e1b06aa5350d0 https://medicaldevicecourses.com/activity/p/36871/ Sun, 25 Jan 2026 19:22:15 -0500 I agree with how most of the responses highlight regulatory, quality, or systems engineering, but I think there’s another angle that’s just as important: communication and integration across disciplines. Instead of specializing purely in one technical field, a project manager…   Read more»

]]> 184e236d43dc95066a62ec181c14843f https://medicaldevicecourses.com/activity/p/36869/ Sun, 25 Jan 2026 19:17:05 -0500 I like how both responses point out that it’s less about “renewing a license” and more about continuous compliance. Another thing I’d add, from my own experience in industry, is that project management and regulatory teams often spend a lot…   Read more»

]]> 08763e5700add69cd47fc4be87d2cf84 https://medicaldevicecourses.com/activity/p/36866/ Sun, 25 Jan 2026 19:10:24 -0500 I’ve seen similar situations too, and I think the biggest shift comes from moving the conversation away from “who’s right” and toward “what’s best for the project.” One effective approach is setting clearer boundaries around roles and decision-making, so technical…   Read more»

]]> ea23dc2078e6d46441de19290aee822c https://medicaldevicecourses.com/activity/p/33645/ Thu, 13 Nov 2025 17:13:42 -0500 The reason these standards cost money is because organizations like ISO and ASTM are non-profit bodies that fund their operations through the sale of their standards. They invest a lot of time and expertise into developing and maintaining them, often…   Read more»

]]> 676cd91398cc5a082d38c65852d473e6 https://medicaldevicecourses.com/activity/p/33644/ Thu, 13 Nov 2025 17:06:45 -0500 I completely agree with your point about the importance of risk management assessments for medical devices. They really are essential for identifying and mitigating potential hazards before a product reaches users and patients. While the process can be time-consuming and…   Read more»

]]> 721d0ffc3fac98e911a5b0344eff6ce8 https://medicaldevicecourses.com/activity/p/33643/ Thu, 13 Nov 2025 17:00:26 -0500 A real life scenario of hazardous material causing significant harm would be in 2004 at the Centers for Disease Control and Prevention (CDC), where a serious lab safety breach took place. The hazard involved the bacterium Bacillus anthracis, which causes…   Read more»

]]> c1b2078b633e6bceea922457622bd77c https://medicaldevicecourses.com/activity/p/33572/ Sun, 09 Nov 2025 21:05:02 -0500 Controlled change really is what keeps product development from turning into chaos. Some common examples of device changes that need to be controlled include modifications to the materials used, updates to software or firmware, and adjustments to component dimensions or…   Read more»

]]> 2321fec2932827b435d07bc807f97604 https://medicaldevicecourses.com/activity/p/33570/ Sun, 09 Nov 2025 20:54:16 -0500 I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, validation, and verification give a solid technical framework, but they don’t always reflect…   Read more»

]]> 67f3f055f6765b50a624218596e9d1a9 https://medicaldevicecourses.com/activity/p/33569/ Sun, 09 Nov 2025 20:53:44 -0500 I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, validation, and verification give a solid technical framework, but they don’t always reflect…   Read more»

]]> 9f6c19dc3faabcf3b41a5a00562c7a09 https://medicaldevicecourses.com/activity/p/33568/ Sun, 09 Nov 2025 20:51:41 -0500 I think our current design control systems are much stronger, but not entirely error-proof. The Therac-25 tragedy definitely pushed the industry toward stricter verification, documentation, and risk management standards, which have made a huge difference. However, with AI and increasingly…   Read more»

]]> 9b9c9fbda41a9d42923970db4dccbd32 https://medicaldevicecourses.com/activity/p/33461/ Mon, 03 Nov 2025 03:23:15 -0500 Yes, I do feel safer knowing that validation and verification are applied to medical devices we use today and may rely on in the future. These processes make sure not only that a device is built correctly, but also that…   Read more»

]]> bb076253c80f90794f26b601654bde39 https://medicaldevicecourses.com/activity/p/33460/ Mon, 03 Nov 2025 03:20:24 -0500 The best way to translate a qualitative user need into a quantitative design input is to break the need down into measurable characteristics using engineering standards, research, and benchmarking. For example, if a user states the device must be easy…   Read more»

]]> b454818862bd339c2099a8335777930f https://medicaldevicecourses.com/activity/p/33458/ Mon, 03 Nov 2025 03:13:30 -0500 Validation and verification are both crucial parts of the medical device development process, but they serve different purposes. Verification ensures the product meets the specifications outlined in the design- essentially asking, “Did we build the device right?” This involves testing…   Read more»

]]> 9928fab92a3629b50fadeb1be9c6949e https://medicaldevicecourses.com/activity/p/33264/ Thu, 23 Oct 2025 16:45:57 -0400 When design control is used insufficiently, several serious issues can arise during the development of a medical device. One major problem is that design requirements may not be clearly defined, leading to products that fail to meet user needs or…   Read more»

]]> 3d3719f213755a1101aec1189bb67ffb https://medicaldevicecourses.com/activity/p/33263/ Thu, 23 Oct 2025 16:40:20 -0400 A company that comes to mind would be Theranos; the health technology company that claimed to have developed a revolutionary blood-testing device. The company allegedly manipulated and hid failed verification and validation results to make their technology appear more reliable…   Read more»

]]> a380e060f1451b75be6d0b8feb29607d https://medicaldevicecourses.com/activity/p/33262/ Thu, 23 Oct 2025 16:32:46 -0400 Yes, I definitely feel safer knowing that validation and verification are key and required steps in the development of medical devices. These processes ensure that devices not only meet design specifications but also function correctly in real-world medical settings and…   Read more»

]]> a4034b7d4f860ac773ea1e9c433dc55c https://medicaldevicecourses.com/activity/p/33190/ Sat, 18 Oct 2025 15:48:40 -0400 In my opinion, double-blind studies are definitely the most reliable way to test how well a treatment actually works. While single-blind studies help reduce some bias, there’s still a chance that researchers’ expectations can influence how results are recorded or…   Read more»

]]> 79c058931e80539fbede09cd0a4d6345 https://medicaldevicecourses.com/activity/p/33189/ Sat, 18 Oct 2025 15:36:20 -0400 Researchers use several strategies to minimize the placebo effect and ensure their results accurately reflect a treatment’s true impact on the person’s body. One common method is the double-blind study design, where neither the participants nor the researchers know who…   Read more»

]]> 7ee7b1d669c39de2e7b3adf7ad56268b https://medicaldevicecourses.com/activity/p/33188/ Sat, 18 Oct 2025 15:31:35 -0400 Clinical studies are essential for developing new treatments, such as testing cancer immunotherapies or innovative medical devices like heart stents, or hear valves to ensure they truly work before being approved for patients. They give researchers real-world data on how…   Read more»

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