https://medicaldevicecourses.com/members/krish/activity/ Activity feed for Krish. Fri, 24 Apr 2026 20:59:24 -0400 https://buddypress.org/?v= en-US 30 hourly 2 429484576a278a684d7ae01d5f38c993 https://medicaldevicecourses.com/activity/p/47168/ Sun, 19 Apr 2026 19:47:51 -0400 I do not think quality control is intentionally avoided in small projects, but rather it is scaled differently based on available resources and the level of risk involved. Small projects do not have the resources for dedicated quality teams or…   Read more»

]]> 3121ca04e47b444b0987fc8c31673d15 https://medicaldevicecourses.com/activity/p/47167/ Sun, 19 Apr 2026 19:46:56 -0400 Initially, Project Managers should evaluate both the critical path and whether the time reductions in the overall project schedule will be impacted by the reductions before determining if they will crash or fast track an activity. In general, when crashing…   Read more»

]]> da7be05ac88a09fa58058ee8aff15198 https://medicaldevicecourses.com/activity/p/47165/ Sun, 19 Apr 2026 19:46:30 -0400 My view is that creating effective teams can be accomplished without spending a fortune; there are many low-cost options available that can make an impact if done correctly and meaningfully. Project managers should focus on providing development opportunities for team…   Read more»

]]> 5421481db25500b803512e4bf97d6367 https://medicaldevicecourses.com/activity/p/46271/ Sat, 11 Apr 2026 03:54:33 -0400 Selection of whether to hire within or externally for a project manager may rely on each individual project’s uniqueness; however, there can be many advantages to hiring internally. These advantages include: familiarity with the company’s processes, culture, and expectations—leading to…   Read more»

]]> bebe45de97cceb895a71da37272dd035 https://medicaldevicecourses.com/activity/p/46270/ Sat, 11 Apr 2026 03:54:06 -0400 In my opinion, giving a product its license before verifying it is unethical because it will directly impact the safety of patients in biomedical manufacturing. Regardless of any marketing or stakeholder pressure, speeding or skipping over the verification testing puts…   Read more»

]]> c14319d680539b90c8959b1b982bd560 https://medicaldevicecourses.com/activity/p/46269/ Sat, 11 Apr 2026 03:53:34 -0400 I have found when project delays are due to events outside of a team’s control, reassessing the project plan is the most effective way to determine the actual critical path of the project. When there are major milestones being delayed…   Read more»

]]> 8dcf7b67d1d739cd151e6df2dc808b0f https://medicaldevicecourses.com/activity/p/44482/ Mon, 23 Mar 2026 04:21:24 -0400 General management and communication skills are vital for effective execution of plans because the methods used to complete the plan (such as work permission systems, status meetings and project management systems) are all reliant upon how well the project manager…   Read more»

]]> 458a5f1f5350dbc7c66f67ba2d095203 https://medicaldevicecourses.com/activity/p/44481/ Mon, 23 Mar 2026 04:20:40 -0400 It is essential for a project manager to manage expectations among the investors (shareholders), the FDA, and the customers (patients), and this requires that they prioritize compliance with regulatory requirements and the safety of patients. The requirements of the FDA…   Read more»

]]> a2103dbfdc496b2af27252dd98c7c686 https://medicaldevicecourses.com/activity/p/44480/ Mon, 23 Mar 2026 04:19:58 -0400 In the event that a defect spike occurs during the validation phase, I think that the first thing that should be done is to formally document the defect either through deviation or non-conformance instead of continuing normally. Continuing to validate…   Read more»

]]> 2b3125ec2bdabe3ed8c163b8db0c0364 https://medicaldevicecourses.com/activity/p/43835/ Mon, 16 Mar 2026 02:12:47 -0400 Although each phase is critical, the most important phase in the project process for longitudinal success is the planning phase, as it is when the project proposal, scope, and requirements are established. Such items are crucial as they set the…   Read more»

]]> e5a71c1a3970923c60cb82f3c9c3edab https://medicaldevicecourses.com/activity/p/43832/ Mon, 16 Mar 2026 02:03:27 -0400 The first step to effectively balancing expectations from all involved bodies (e.g., FDA, shareholders, and consumers) is for the PM to recognize that all these groups value different outcomes. Regulatory organizations are focused on safety/compliance, shareholders focus on ROIs, and…   Read more»

]]> b34b8d6379106f9e52276fba25eb5f69 https://medicaldevicecourses.com/activity/p/43829/ Mon, 16 Mar 2026 01:52:33 -0400 The phrase “everything is about risk” in risk management refers to the habit of organizations to contextualize decisions, meetings, and discussions around identifying/evaluating potential risk. Such a mindset is critical in the medical device industry, however, it can be excessive…   Read more»

]]> 41e47a2ae00921562df0c6e7ac9497e6 https://medicaldevicecourses.com/activity/p/43131/ Mon, 09 Mar 2026 03:26:03 -0400 @mmd55 You definitely bring up an interesting point about the relative importance of resources vs. management oversight in a project’s early stages. While having funding or other resources is definitely and obviously required to initiate many projects, effective management makes…   Read more»

]]> 48c99c416492b63d7327002dca3b5416 https://medicaldevicecourses.com/activity/p/43130/ Mon, 09 Mar 2026 03:15:56 -0400 A way companies can reduce the cost of returning to earlier development phases is through strengthening early-stage planning and risk identification. This can be facilitated by thorough design reviews, failure mode and effects analysis (FMEA), and early prototyping. As teams…   Read more»

]]> 398a7519c26ae39915e21c702a09a14f https://medicaldevicecourses.com/activity/p/43124/ Mon, 09 Mar 2026 03:07:09 -0400 A WBS definitely facilitates better project planning via facilitating the organization of a complex project into smaller and more clearly defined tasks that can be more easily managed and tracked. By deconstruing the total scope of work into a hierarchy…   Read more»

]]> fb736cb7d55c73755492088d8bc7951e https://medicaldevicecourses.com/activity/p/41772/ Tue, 24 Feb 2026 14:57:02 -0500 One aspect of EVM that has yet to be discussed is its value in forecasting, not just monitoring. EVM can certainly convey whether a project is ahead or behind, but it can do more than that. EVM enables PMs to…   Read more»

]]> 8ccc8a586e5003124f4fe909b4602ee0 https://medicaldevicecourses.com/activity/p/41724/ Tue, 24 Feb 2026 04:54:12 -0500 Another way to consider the distinction is to focus on what event is being protected. In FS dependencies, you are protecting the start of the successor task, since these tasks cannot begin until the predecessor task is complete. Thus, these…   Read more»

]]> 53eb776414e295a6295fb80ff208e7e6 https://medicaldevicecourses.com/activity/p/41704/ Tue, 24 Feb 2026 00:59:07 -0500 An additional way to mitigate financial pushback in front-end R&D could be to rework the product architecture before assuming the business case is fixed. Rather than presenting a high-COGS device as the only option, teams should explore modular design, platform…   Read more»

]]> 5301edba5322d0a653b984dbcb40435e https://medicaldevicecourses.com/activity/p/41368/ Sat, 21 Feb 2026 14:48:50 -0500 In medical device development, the PM’s responsibilities definitely expand beyond traditional management, but I would not say they shift completely away from it. Instead, I think compliance assurance is embedded in task management itself, as the DHF is not just…   Read more»

]]> e3b2ba5f5305e6eee5f4f2c4c8214b82 https://medicaldevicecourses.com/activity/p/41329/ Sat, 21 Feb 2026 06:51:50 -0500 For a project to return to a previously “completed” phase in the PDCA cycle, a PM needs strong skills in risk assessment, change management, and stakeholder communication. This is an extremely expensive and frustrating process, financially and politically. In such…   Read more»

]]> 6c5f42ff7d486352e0b6f2f2dd643a65 https://medicaldevicecourses.com/activity/p/41315/ Sat, 21 Feb 2026 04:30:37 -0500 As you had said, Jacob, I think the longitudinal ROI in Project Management for degrees and certifications serves different, yet complementary functions. I certainly agree that PMP/Six Sigma gives you the immediate credibility and a standardized framework that employers recognize….   Read more»

]]> 39577425cf857fb373ce823e6d05fd2c https://medicaldevicecourses.com/activity/p/40117/ Wed, 11 Feb 2026 00:42:46 -0500 Your example certainly highlights how verification failures often shed light on component selection and manufacturability issues rather than about the test itself. This certainly illustrates how the first time designs are truly tested against real-world constraints happens during verification. Thus,…   Read more»

]]> eef75f92946ea7206a7b4c35b7b8fe18 https://medicaldevicecourses.com/activity/p/40113/ Wed, 11 Feb 2026 00:08:49 -0500 An effective way to avoid such a situation would be to do integrate “version control checks” into the design change request process. For example, by mandating requesters to directly reference the document version/revision number prior to submitting a change request…   Read more»

]]> 128e6b9f4e5bdfe6266c7dbde10a5428 https://medicaldevicecourses.com/activity/p/40109/ Tue, 10 Feb 2026 23:43:28 -0500 Effective project managers can skillfully align business needs and customer satisfaction by rectifying organizational strategy and customer value. Typically, business needs and customer satisfaction are viewed separately. Business needs are focused on cost, efficiency, compliance, and fiscal growth, whereas customer…   Read more»

]]> 3177e75994e323e99884ea0818e552a1 https://medicaldevicecourses.com/activity/p/39828/ Sun, 08 Feb 2026 17:27:24 -0500 I think predictive development life cycles work most aptly in highly regulated industries, such as medical devices, when requirements and regulatory pathways are explicitly defined early. Their structure is one of their key strengths, including the incorporation of phase gates,…   Read more»

]]> fe4a59843d890765d469ac6ec2c0a509 https://medicaldevicecourses.com/activity/p/39406/ Wed, 04 Feb 2026 22:47:14 -0500 Design reviews and design change requests are most integral during the Check and Act phases. During the Check phase, verification activities are performed, enabling teams to assess whether outputs truly meet design inputs, user needs, and regulatory requirements, or only…   Read more»

]]> be0afb2bc190369f338c1643b41f269d https://medicaldevicecourses.com/activity/p/39320/ Wed, 04 Feb 2026 00:49:33 -0500 When design controls and project management are segmented, gaps may be created that could affect verification, validation, and design reviews. If schedules prioritize speed over requirements, verification activities could deviate from original design inputs. Validation can be affected if user…   Read more»

]]> b9d02fadfa85c603ef77c60da036118c https://medicaldevicecourses.com/activity/p/38492/ Sat, 31 Jan 2026 21:32:44 -0500 The relationship between the project and the product life cycle is that the project life cycle is embedded within the product life cycle. The product life cycle encompasses the entire process from conception through development to market introduction and, eventually,…   Read more»

]]> 63e290df152c511bb67cf64b07bc9602 https://medicaldevicecourses.com/activity/p/38390/ Sat, 31 Jan 2026 13:37:13 -0500 I have not formally worked in industry either, but I do have some knowledge of PERT and CPM in the medical devices industry, gained through conversations and internships. I certainly agree that PERT and CPM are rarely mentioned directly by…   Read more»

]]> 8313d5d858ba323c0373fc3ba6f71ed8 https://medicaldevicecourses.com/activity/p/38387/ Sat, 31 Jan 2026 13:21:27 -0500 First, I certainly agree that a PM’s role goes past market release to monitoring outcomes and project value. For post-market management, the PM’s main role would be to shift to oversight and, more specifically, to translate feedback on complaints/CAPAs/regulatory updates…   Read more»

]]> 17c78dfe3222b9a8b339673f88d89063 https://medicaldevicecourses.com/activity/p/36968/ Mon, 26 Jan 2026 02:31:07 -0500 The most effective medical device PM would be a cross between a specialist and a generalist. Due to the cross-functional nature of MDD projects, a PM’s true value may come more from understanding the regulatory backbone of biology, engineering, and…   Read more»

]]> 1978264d1fd8d91074b394f9bc34b506 https://medicaldevicecourses.com/activity/p/36967/ Mon, 26 Jan 2026 02:21:23 -0500 I certainly agree that most interpersonal conflict may arise from misalignment rather than dispositional differences. Misalignment may stem from expectations or from the styles of communication employed. Thus, PMs should first try to understand the root cause of the conflict rather…   Read more»

]]> df2f8e6effe411d69ce6ab9eb5de5403 https://medicaldevicecourses.com/activity/p/36962/ Mon, 26 Jan 2026 01:50:24 -0500 Project management is certainly a very demanding role, uniquely situated at the crossroads of biomedicine, regulation, and team coordination. Given its current state, I don’t think there’s really an either-or in the debate of “technical skills vs. interpersonal skills.” A…   Read more»

]]> de25b4688040a24469fb6db506e26eaa https://medicaldevicecourses.com/activity/p/33736/ Mon, 17 Nov 2025 13:15:54 -0500 I agree that medical device companies must prioritize patient outcomes and cost-effectiveness to run their corporations and practice efficient, value-based healthcare. The responses thus far have covered data analytics and partnerships with healthcare providers, which are needed to demonstrate measurable…   Read more»

]]> b8efdc3383cf0a272de7a53aa43f460d https://medicaldevicecourses.com/activity/p/33735/ Mon, 17 Nov 2025 13:14:47 -0500 I definitely agree that the choice of matrix structure should depend on the project, rather than being a one-size-fits-all situation. Reading the responses, I see that a strong matrix is preferred in highly regulated projects as it would enable faster…   Read more»

]]> 1f7be7316ffa11a7485397eaee4084f0 https://medicaldevicecourses.com/activity/p/33734/ Mon, 17 Nov 2025 13:14:14 -0500 I think the way you outlined that the balance of power between project managers and functional heads as the critical factor of whether matrix organizations works or does not is quite strong. Furthermore, I actually thought your examples highlight something…   Read more»

]]> c5f81df65e84e1a3203a7fd9a579afa2 https://medicaldevicecourses.com/activity/p/33642/ Thu, 13 Nov 2025 16:45:42 -0500 The key to determining whether a risk is truly worthwhile lies in evaluating how integral that risk is to the product’s intended use. However, it is crucial to strike a balance between ethical responsibility and technological progress. For example, in…   Read more»

]]> a1270f48740a8966ad83251bd0eb949f https://medicaldevicecourses.com/activity/p/33641/ Thu, 13 Nov 2025 16:34:21 -0500 I think everyone made really strong points about environmental conditions, user error, and maintenance being major risk factors for AEDs. I would like to introduce the additional risk of patient-specific failure in electro-pad adhesion. For example, excessive body hair, sweat,…   Read more»

]]> 04f6c0aefbbf4911712eb29ab6e378a9 https://medicaldevicecourses.com/activity/p/33636/ Thu, 13 Nov 2025 04:25:43 -0500 I really appreciate how many of you emphasized that the success of risk management ultimately depends not just on structure, but on how all participants are invited to engage. Personally, I believe that the combination of preparation, rotating facilitators, and…   Read more»

]]> 5dd9499ffa0847b79beea83c86144d8d https://medicaldevicecourses.com/activity/p/33541/ Sat, 08 Nov 2025 02:17:40 -0500 An important dimension to consider is how risk-based approaches guide companies in retrospectively building a DHF for legacy products. Legacy devices already have a level of technical documentation, however, the focus has been more on demonstrating current safety and effectiveness…   Read more»

]]> 9b47623ef56264111bcdcf39414ce092 https://medicaldevicecourses.com/activity/p/33540/ Sat, 08 Nov 2025 01:30:32 -0500 The Therac-25 disaster serves as a poignant reminder of the vital importance of design controls and verifications in medical device development. I realize that modern frameworks (e.g., IEC 62304 and ISO 13485) have greatly enhanced oversight and traceability, but I…   Read more»

]]> f52eedafb84c4fc08940dfdab8eebe01 https://medicaldevicecourses.com/activity/p/33539/ Sat, 08 Nov 2025 01:14:10 -0500 I wanted to add that the way design controls are perceived also goes a long way. A lot of tension is generated, I think, when design controls are viewed simply as a regulatory burden rather than a way to augment…   Read more»

]]> 376873f7db0176300108927fc3feca0a https://medicaldevicecourses.com/activity/p/33447/ Sun, 02 Nov 2025 18:47:18 -0500 When transferring design controls to a contract manufacturer, it is critical to maintain traceability and design intent throughout the production process. Even if contract manufacturers have strong QC & QA systems, there can still be gaps if communication/documentation is not…   Read more»

]]> 3c3ac0c830e09da0b3dc6858195bd873 https://medicaldevicecourses.com/activity/p/33444/ Sun, 02 Nov 2025 18:22:57 -0500 An interesting perspective is how emerging development models (e.g., human-factors-driven design) are reshaping the distinction between verification and validation. In traditional systems, V&V has been more linear to align with regulatory expectations. However, in new iterative development cycles, teams now…   Read more»

]]> e072bf10684ca43bd699178ff92220b4 https://medicaldevicecourses.com/activity/p/33442/ Sun, 02 Nov 2025 18:00:11 -0500 Another perspective to consider is how regulatory and ethical obligations can affect the balance between user needs and business constraints. In other industries, such as consumer technology, compromises between the two may result simply in less convenient user experience. However,…   Read more»

]]> d307a71003804edd3e4151feea5646a4 https://medicaldevicecourses.com/activity/p/33241/ Mon, 20 Oct 2025 13:19:15 -0400 Based on the responses thus far, transparency, bias, and privacy seem to be the three most critical and identified ethical challenges for using AI. I want to expand a bit on the accountability aspect, which becomes increasingly complex as AI…   Read more»

]]> d049a980b08fed51267f0308fdf7b25b https://medicaldevicecourses.com/activity/p/33240/ Mon, 20 Oct 2025 13:18:55 -0400 Virtual trials and telemedicine have certainly bolstered the inclusivity of recruitment, but another promising development is the use of real-world data (RWD) and artificial intelligence (AI) to select subjects more efficiently. There are CROs who are now increasingly partnering with…   Read more»

]]> 911ad5d821efad0ea80f8a8429652da9 https://medicaldevicecourses.com/activity/p/33239/ Mon, 20 Oct 2025 13:18:31 -0400 I agree that patient safety and data integrity are critical to ethical clinical research, and the principles of ICH-GCP certainly operationalize such goals. For example, ICH E6 (R2) emphasizes accurate documentation along with risk-based quality management systems, enabling sponsors and…   Read more»

]]> cfe35619f846397417d5047686a7da5a https://medicaldevicecourses.com/activity/p/33156/ Wed, 15 Oct 2025 17:35:53 -0400 Zoom is a company experiencing rapid growth due to its optimization of telehealth and virtual care. Despite Zoom being originally a video conference platform, Zoom now holds 36% of the US national telehealth market, with the industry projected to grow…   Read more»

]]> bf522fd854da50aeb1f2fda381a85258 https://medicaldevicecourses.com/activity/p/33154/ Wed, 15 Oct 2025 17:02:13 -0400 AI can certainly transform medical device marketing, particularly when it comes to understanding audience behavior and personalizing outreach. However, I think the real issue is striking a balance between the autonomy it should have in shaping medical communications and oversight. …   Read more»

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