https://medicaldevicecourses.com/members/aca/activity/ Activity feed for aca. Sat, 16 May 2026 11:19:28 -0400 https://buddypress.org/?v= en-US 30 hourly 2 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»

]]> 511011c7f46dd74deeac3d324d6e10b2 https://medicaldevicecourses.com/activity/p/43077/ Sun, 08 Mar 2026 20:59:03 -0400 An interesting perspective that can be overlooked is how individuals who never interact with the project can still be a stakeholder since they are integral to being affected as a general byproduct of the project. For instance, when it comes…   Read more»

]]> d584cb627f8bd4290edb5d560ea43ad0 https://medicaldevicecourses.com/activity/p/42381/ Sun, 01 Mar 2026 22:54:30 -0500 As mentioned, estimation failures can be detrimental in the planning phase of a medical device since they can disrupt budgets and timelines but also the confidence of stakeholders. Compared to general engineering projects, medical devices have to meet strict verification,…   Read more»

]]> b6b91b93fb44b1aac8539f598dc849c5 https://medicaldevicecourses.com/activity/p/42378/ Sun, 01 Mar 2026 22:37:12 -0500 A PM has the responsibility to balance FDA expectations, shareholder pressures, and consumer needs. The way they may tackle these objectives is by prioritizing regulatory compliance and patient safety above all while managing cost, risk planning, timelines, and communication. The…   Read more»

]]> de5bcc982e962fd5db8475160496bd08 https://medicaldevicecourses.com/activity/p/42374/ Sun, 01 Mar 2026 22:22:03 -0500 An essential difference when it comes to constructing a WBS for medical devices is that it should be built around regulatory readiness as an ongoing process instead of a final step. In a general engineering project, compliance and testing usually…   Read more»

]]> d83a35a2e754419e354bdbea87bf99b7 https://medicaldevicecourses.com/activity/p/41543/ Sun, 22 Feb 2026 21:50:53 -0500 I agree, a certification can be complementary to a degree, especially for a PM. However, I would argue that it is also a representation of how much resilience a PM can have through the changes and fast developing technologies that…   Read more»

]]> 48867c4093548adaa1d7b06d30a79fba https://medicaldevicecourses.com/activity/p/41541/ Sun, 22 Feb 2026 21:37:25 -0500 I agree with Krish, a DHF is evidence that the developed device meets regulatory requirements. I would like to add a different perspective as well. It is also worthwhile to question if a DHF is actually the PM’s major deliverable…   Read more»

]]> a5681ecb3ed67edc3a8084cee434cf91 https://medicaldevicecourses.com/activity/p/41539/ Sun, 22 Feb 2026 21:16:53 -0500 As others have mentioned, a methodology for design review can be crucial when assessing changes from a completed project. A perspective that can also be considered is the importance of decision structures. This structure can relate to distinguishing between a…   Read more»

]]> 1f9c97a0c1f18d233f3abcdd2985a78a https://medicaldevicecourses.com/activity/p/40698/ Mon, 16 Feb 2026 00:42:32 -0500 Another impact to organizational structure that can be considered, it how accountability and making decisions can speed up a project, especially when there are technical risks and challenges that arise. In some instances, there can be weak functional decisions where…   Read more»

]]> d7aadd3313d996abcdffbc6554b01534 https://medicaldevicecourses.com/activity/p/40695/ Mon, 16 Feb 2026 00:19:45 -0500 A new concept that can be discussed is design controls and regulatory documentation and traceability when animal data affects the product’s timeline. In a Class III medical device like the bio-absorbable stent, since the dissolution rate can be directly caused…   Read more»

]]> 5fe43d523edcafd7be84ad10237a635c https://medicaldevicecourses.com/activity/p/40693/ Sun, 15 Feb 2026 23:50:24 -0500 In development lifecycle of a medical device, one aspect that hasn’t been discussed is how the development life cycle affects verification and validation. As mentioned, development lifecycles can be predictive however, there can be unpredictable setbacks that can lead to…   Read more»

]]> 05b488a53ff605b1e4f6da9de1ba73e9 https://medicaldevicecourses.com/activity/p/39894/ Mon, 09 Feb 2026 02:28:02 -0500 I agree with the standpoint on how a DHF should be an evolving document. It is also crucial to take into consideration that a DHF is not only an evolving document for regulatory record keeping, but it is also a…   Read more»

]]> 51a1285a65d625db395806be325ae6df https://medicaldevicecourses.com/activity/p/39890/ Mon, 09 Feb 2026 02:02:17 -0500 From the responses, I see that many focus on the significance of the Check and Act phases of the PDCA cycle, which is valid. However, I would like to emphasize that the plan phase is just as valuable since it…   Read more»

]]> eac582dd46103b4d067b49df18b3cfb2 https://medicaldevicecourses.com/activity/p/39871/ Mon, 09 Feb 2026 00:00:36 -0500 Regulatory and post market efforts are essential to a medical device’s product life cycle. I would like to add onto what Ehab mentioned; another point of view to consider is how collaboration of interdisciplinary roles impacts product life cycle. Devices…   Read more»

]]> 7113081e4a2fabc29c02292e3e69c53b https://medicaldevicecourses.com/activity/p/38901/ Mon, 02 Feb 2026 03:14:13 -0500 Building off of what Ehab mentioned as to how PM should have an understanding of FDA requirements and maintain involvement in project development. It is also essential to include another strategy such as implementing a system that is able to…   Read more»

]]> d0a1d1fc08df8b1e2e07299fe2fb24e6 https://medicaldevicecourses.com/activity/p/38889/ Mon, 02 Feb 2026 02:29:01 -0500 One perspective that can contribute to meeting deadlines is utilizing a decision based milestone plan tied to FDA risk thresholds with a range in timeline rather than having designated dates. In terms of Class II and Class III medical devices,…   Read more»

]]> a91a8cb0d2cf83f32920b12352c84dba https://medicaldevicecourses.com/activity/p/38873/ Mon, 02 Feb 2026 01:35:36 -0500 Once a product is in the post-market phase, a project manager’s role changes from developing to ensuring that the product maintains continuity, which involves coordination and an organized approach to learning, therefore preserving the development phase. Instead of focusing on…   Read more»

]]> 907b707018fe3ea0b04e0ff7199c8184 https://medicaldevicecourses.com/activity/p/36951/ Mon, 26 Jan 2026 00:59:34 -0500 Interpersonal skills are essential to PM than technical skills as a Vansh Amin points out and are required for facilitating collaboration. However, for these efforts to be established it is vital for a PM to have the trait of prioritizing…   Read more»

]]> f873600417f2ba5e2b5bdeffd73a9b7d https://medicaldevicecourses.com/activity/p/36946/ Mon, 26 Jan 2026 00:23:48 -0500 I’ve encountered situations where there was friction between problem-solving initiatives. An effective approach that can be considered is utilizing a more structured and stakeholder aware problem solving approach to address interpersonal conflict. Especially in medical devices when the individuals that…   Read more»

]]> 2ce07847902b17d4e1168d5c41d4024b https://medicaldevicecourses.com/activity/p/36939/ Sun, 25 Jan 2026 23:38:36 -0500 Although it can be agreed upon that most project managers are not required to have a deep level of understanding in technical projects and their expertise can be shown in regulatory disciplines, it is essential to acknowledge that medical device…   Read more»

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