https://medicaldevicecourses.com/members/ehab-b/activity/ Activity feed for Ehab B.. Sat, 16 May 2026 10:34:20 -0400 https://buddypress.org/?v= en-US 30 hourly 2 998102103369d30cbf797b4b5c8b95bb https://medicaldevicecourses.com/activity/p/48664/ Mon, 04 May 2026 02:30:55 -0400 Both a project manager who is adamantly committed to a single solution path and a project manager who consistently says “yes” to new requirements are failing to regularly balance their current course with the project’s stated objectives. In my opinion,…   Read more»

]]> 416ebcbf11182e256c3b852a17e21916 https://medicaldevicecourses.com/activity/p/48662/ Mon, 04 May 2026 02:16:41 -0400 Maintaining vendor relations is one of the most important aspects of business that any company needs to attend to. Having had personal experience dealing with and interacting with dozens of vendors in my line of work at a hospital, it…   Read more»

]]> 14ab5554854cf87bd74ec60e62af2c8a https://medicaldevicecourses.com/activity/p/48657/ Mon, 04 May 2026 01:49:00 -0400 The sunk cost fallacy is one of the biggest cognitive traps that companies can fall for in situations like this. PMs can have tendencies to justify more additional rounds of testing to justify the money already spent, even when the…   Read more»

]]> 9e0a4b1e17d969472afe993e8695c377 https://medicaldevicecourses.com/activity/p/47905/ Sun, 26 Apr 2026 21:55:41 -0400 Trials should both be planned liberally upfront, and adjusted constantly throughout. Upfront planning should be liberal in the sense that buffers need to be deliberately built into enrollment windows, site activation timelines, and regulatory approval estimates. Experienced PMs in this space…   Read more»

]]> 965af1eada8e74ce5cfb89299ad74cd8 https://medicaldevicecourses.com/activity/p/47895/ Sun, 26 Apr 2026 20:47:37 -0400 I think the question of whether or not the model of accepted risk can become the new norm for medical devices is worth examining, even with the plethora of differences that exists between vaccine development medical device development. With vaccines,…   Read more»

]]> 94e85cd7fa74be9b4c6164a56831ae5e https://medicaldevicecourses.com/activity/p/47890/ Sun, 26 Apr 2026 20:07:53 -0400 One of the most important reasons why a company would outsource their clinical trials is cost efficiency. Building and maintaining an clinical operations within a company is expensive depending on the research being conducting. This way, a company can not…   Read more»

]]> 51a850d9e8a488cbe5cb42121d90d81e https://medicaldevicecourses.com/activity/p/47215/ Mon, 20 Apr 2026 01:01:46 -0400 The reason scope, time and cost feel so central is that they’re the most measurable. You can draw a Gantt chart, run a variance report or point to a budget number. But integration management is what determines whether individually driven…   Read more»

]]> 7fee051a1f75ced30f5809bc94ee079e https://medicaldevicecourses.com/activity/p/47212/ Mon, 20 Apr 2026 00:47:20 -0400 To Dev’s first question, I think it’s rarely a matter of intentional deception but rather displayed as a form of optimism bias that gets integrated into most layers of the project. The team pitching the project genuinely believes in it,…   Read more»

]]> fd2564b6eaadc69a5aad80e3d8d05b96 https://medicaldevicecourses.com/activity/p/47169/ Sun, 19 Apr 2026 19:49:46 -0400 Sami’s point on leveraging change control documentation for budget justification is a great point that I want to delve further into. PMs in the medical device development industry can take this a step further by integrating tools such as ‘Earned…   Read more»

]]> 725a7ea64383e587d59b8c02b2d77cb9 https://medicaldevicecourses.com/activity/p/46458/ Sun, 12 Apr 2026 22:29:21 -0400 @qbs2 The point about planning assumptions is one that I think gets overlooked a lot in practice. When a project plan is built, the sequence of activities developed based on several decisions regarding resource availability, technical dependencies, and readiness gates…   Read more»

]]> cf208a1b80997059bd2291c12bef8d76 https://medicaldevicecourses.com/activity/p/46456/ Sun, 12 Apr 2026 22:22:56 -0400 Actively listening to resistant stakeholders and working towards a collaborative solution is really the foundation of good stakeholder management. Resistance is not always irrational, as sometimes a stakeholder pushing back can be due some information or concerns that the project…   Read more»

]]> 514de55289cc831d90b388e14bb41d82 https://medicaldevicecourses.com/activity/p/46452/ Sun, 12 Apr 2026 22:04:28 -0400 The phase based approach to leadership is something that does not get discussed enough and the points you make are very insightful. Most conversations about PM leadership treat is as a fixed trait rather than something that should evolve alongside…   Read more»

]]> 12362d6589c5061460a556109e1ca66d https://medicaldevicecourses.com/activity/p/45121/ Sun, 29 Mar 2026 22:24:56 -0400 The board of directors should operate at a strategic level, rather than an operational one because it highlights an important structural dynamic within medical device companies. Their power lies not in executing the work, but in setting the boundaries within where…   Read more»

]]> 4d34e9c09185f5542dbf63cb81ebab3c https://medicaldevicecourses.com/activity/p/45116/ Sun, 29 Mar 2026 21:44:32 -0400 As other members of this discussion have mentioned, one of the most most effective ways of anticipating and combatting delays is to actually embed them into your project plan. It is almost impossible for a project to go entirely smooth,…   Read more»

]]> 8b09d3280e695e64d94521afd1e490c9 https://medicaldevicecourses.com/activity/p/45103/ Sun, 29 Mar 2026 20:01:06 -0400 Treating monitoring as a dynamic and on-going process is one of the best methods for a PM to catch any deviations early, when corrective actions are cheaper and less disruptive to the overall workflow of the project. Tools like earned…   Read more»

]]> a97327df4da3490b98d8bdd1c45909bc https://medicaldevicecourses.com/activity/p/43804/ Sun, 15 Mar 2026 21:25:29 -0400 Jacob, your argument about status review meetings as one of the most important tools for effective product execution brings up really strong points. While systems and procedures are necessary, they are only as effective if the team communicates properly during…   Read more»

]]> a9af938e3855d52e7a384be487257e85 https://medicaldevicecourses.com/activity/p/43799/ Sun, 15 Mar 2026 20:41:19 -0400 Dev, I think you made a really good point about connecting each team member’s task to a measurable output and to the next stage of development. When people understand how their work fits into the bigger picture, especially in something…   Read more»

]]> bf3ac09741fdb6ceb30ee5cd2b0dae5e https://medicaldevicecourses.com/activity/p/43781/ Sun, 15 Mar 2026 18:23:14 -0400 Although I do not have direct industry experience, I have found both from my senior capstone experience and the examples shared here are helpful for understanding how project plan execution would actually work in practice. Regular status meetings is one…   Read more»

]]> 0de051b7698c7b61d22a85069de1cb29 https://medicaldevicecourses.com/activity/p/43094/ Sun, 08 Mar 2026 22:49:10 -0400 The distinction you are drawing between surface-level deviations and foundational assumption failures is an extremely important judgement call a PM and project team have to make, and often does not get enough structured attention in most developmental processes. The challenge…   Read more»

]]> c4f4857c9a0ac4ac7ddadaaf37d9549f https://medicaldevicecourses.com/activity/p/43092/ Sun, 08 Mar 2026 22:29:10 -0400 The point about Design of Experiments is one of the more underutilized tools in this kind of situation. The advantage of a DOE approach over one variable at a time testing is exactly what was described by many of you,…   Read more»

]]> 4dd2508be3ebedf0fa16fc51501cc056 https://medicaldevicecourses.com/activity/p/43088/ Sun, 08 Mar 2026 22:01:17 -0400 The tendency in most PM frameworks is to define stakeholders in fairly transactional terms: the people who fund the project, the people who approve it, and the people who use it. Expanding that definition to include anyone who experiences the…   Read more»

]]> 4ae6441e5e7da30553fb5602ef0c3ba4 https://medicaldevicecourses.com/activity/p/42379/ Sun, 01 Mar 2026 22:40:03 -0500 The WBS is arguably the backbone of any project plan, but in medical device development it carries greater weight than a typical engineering project. In a regular engineering project, you are primarily dealing with technical deliverables and business milestones. With…   Read more»

]]> bc3d10d2b5dc27b8a165d456dbc353b2 https://medicaldevicecourses.com/activity/p/42365/ Sun, 01 Mar 2026 21:27:39 -0500 Slack should definitely account for uncertainty, but that doesn’t mean padding every individual task estimate. There’s a real difference between quietly inflating each task “just in case” and deliberately building contingency into the broader project plan. The problem with padding…   Read more»

]]> 35d495f39ea0f74e96e9f1f98f4ef2a1 https://medicaldevicecourses.com/activity/p/42357/ Sun, 01 Mar 2026 20:40:44 -0500 @dev-doshi You make great points in avoidance, as it is not always the dominant or most appropriate strategy to use in the development of medical devices. If we truly avoided all risk, we would never build implantable devices, never develop…   Read more»

]]> b88c92f20b5863e8a40b8c2f3e0c59eb https://medicaldevicecourses.com/activity/p/41569/ Mon, 23 Feb 2026 01:20:53 -0500 @aca your challenging of the idea that the DHF is the PM’s ultimate deliverable. If a PM’s mindset becomes to produce a perfect DHF, they risk placing too much focus on compliance instead of acting as a proper strategic leader….   Read more»

]]> 13fda056844530fd9b875e9054193561 https://medicaldevicecourses.com/activity/p/41565/ Mon, 23 Feb 2026 00:34:34 -0500 Krish and Shreya both bring up good points on something that goes deeper than surface level degree or certification. Krish, you make a good distinction that certifications signal good tool competency while degrees shape how someone thinks. Something like obtaining…   Read more»

]]> f3cb81e3a36b8efa6811e064d757a987 https://medicaldevicecourses.com/activity/p/41557/ Sun, 22 Feb 2026 23:51:06 -0500 Dev’s point about humility is a really substantiative topic that I think needs to be addressed more in actual practice. A PM who has the humility and confidence to say a phase needs to be reopened, without getting defensive or…   Read more»

]]> 69e31eb4de9e52eef9c7920db2beb3c1 https://medicaldevicecourses.com/activity/p/40704/ Mon, 16 Feb 2026 01:33:43 -0500 @aca You raise an interesting issue here, as this is not just a technical setback but a design control and traceability event. With a high risk device like the stent, dissolution rate is not a secondary parameter, due to its…   Read more»

]]> eb7320de9b7751dcafc374af997a94db https://medicaldevicecourses.com/activity/p/40699/ Mon, 16 Feb 2026 00:48:47 -0500 Changing the DSD is not just a technical adjustment, it is primarily a strategic decision that must be taken carefully (As it can be costly and time consuming, and often times is unnecessary depending on the situation to make changes)….   Read more»

]]> 265f3214b85cb2f190b2a4cf69f97e52 https://medicaldevicecourses.com/activity/p/40665/ Sun, 15 Feb 2026 21:19:27 -0500 For a Class III bioabsorbable stent, dissolution timing is the value proposition. It dissolving too quickly then it does not meet the customer needs or design input that was actually intended for the device. In this situation, the PM has…   Read more»

]]> 986ae9056d280e57521b6cceadbceab4 https://medicaldevicecourses.com/activity/p/39893/ Mon, 09 Feb 2026 02:15:06 -0500 The additional perspectives raised by Aby and Shreya highlight another important point within the product life cycle of medical devices that I overlooked, organizational alignment and operational execution by said organization. An emphasis on interdisciplinary collaboration needs to be strong…   Read more»

]]> abdda0185486b995c9a2812b665c6cb9 https://medicaldevicecourses.com/activity/p/39868/ Sun, 08 Feb 2026 23:18:30 -0500 Product life cycle in medical devices is shaped far more than just technological innovation, but more by the stringent regulations behind it. Regulatory factors, post market performance and strategic planning all play a large role in determining longevity than novelty…   Read more»

]]> b6f979b6cbb42917818698bbb1c8c2f0 https://medicaldevicecourses.com/activity/p/39856/ Sun, 08 Feb 2026 22:25:57 -0500 A DHF that is assembled only at the end of a project creates significant risk, as FDA auditors are focused on whether or not design controls were followed throughout the development of the project, and not just reconstructed after the…   Read more»

]]> 7e1a5d21479b52256024fd34d1889094 https://medicaldevicecourses.com/activity/p/38894/ Mon, 02 Feb 2026 02:43:22 -0500 The PM does indeed still have a role post-market, but it is important to be careful on where that role ends or blur on who actually owns the rights to the completed project. Once a device is created and approved…   Read more»

]]> bc7eb31c3a970b349366f87da52ed00b https://medicaldevicecourses.com/activity/p/38875/ Mon, 02 Feb 2026 01:43:39 -0500 Vansh does bring up a good point with what roll a PM should take with FDA regulatory compliance, however as Jacob and mmk brought up, the PM should still have a great deal of involvement with a main regulatory body…   Read more»

]]> 7f7d3f251e62747424c37245751b7825 https://medicaldevicecourses.com/activity/p/38857/ Mon, 02 Feb 2026 00:43:22 -0500 As a project manager, the responsibility is to keep long development timelines and large budgets under control by proactively managing regulatory uncertainty, particularly for Class II and Class III medical devices. A PM should never assume a best-case scenario timeline…   Read more»

]]> efb7c0e4c2f9c73f860904b0d0b5490b https://medicaldevicecourses.com/activity/p/37031/ Mon, 26 Jan 2026 05:12:06 -0500 @vanshamin I actually disagree on the premise that interpersonal skills far exceed the need of technical skills for a PM. I haven’t personally been on the side of project management, however I have been part of the team that executes…   Read more»

]]> e313f269be38112ae92dc9d1068662c4 https://medicaldevicecourses.com/activity/p/37029/ Mon, 26 Jan 2026 05:12:03 -0500 The emphasis placed on shifting the focus away from personalities and back onto the project itself is really good point that was made. To seg28’s point, clarifying expectations and roles early is huge, many conflicts aren’t personal but instead are…   Read more»

]]> 37906b20b32890bae2bebebbef156a01 https://medicaldevicecourses.com/activity/p/37028/ Mon, 26 Jan 2026 05:12:00 -0500 Many of the points raised about regulatory, quality, and systems engineering skills being the strong foundation for a PM are essential. Yet, the regulatory or QA aspects shouldn’t always be the primary specialization in all cases. I agree that those…   Read more»

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