https://medicaldevicecourses.com/members/cra24/activity/ Activity feed for cra24. Sat, 16 May 2026 11:58:01 -0400 https://buddypress.org/?v= en-US 30 hourly 2 bd481ec15cd68bebeb8babd02929c4a9 https://medicaldevicecourses.com/activity/p/48393/ Fri, 01 May 2026 13:54:24 -0400 Effective employee engagement strategies shift the workplace dynamic from transactional to relational by viewing employees as individuals rather than just human resources. In my experience, the most impactful approach is transparency combined with autonomy. As noted in the discussion, remote…   Read more»

]]> d43f8eb73832676279f744d6c02abdfe https://medicaldevicecourses.com/activity/p/48392/ Fri, 01 May 2026 13:39:33 -0400 To communicate a project’s sudden changes without appearing incompetent, a project manager should anchor the conversation in the original scope while orienting the narrative as strategies to move forward instead of problems at hand. By presenting the new reality as…   Read more»

]]> 3dbde76a67fdd0b6a9c41fbc806e54db https://medicaldevicecourses.com/activity/p/47671/ Fri, 24 Apr 2026 17:29:40 -0400 Effectively managing an underperforming sector of a team in clinical research requires a proactive, inquisitive approach, that seeks to address the underlying issues and reasons for underperformance, that balances necessary standards and thoughtful leadership. Root cause analysis is a method…   Read more»

]]> 47b7bc2e54ba48fcb60897c21555986b https://medicaldevicecourses.com/activity/p/47386/ Tue, 21 Apr 2026 17:40:10 -0400 I agree with the points you made, communication is often overshadowed in most STEM industries, but without the proper ability to explain the things you know, all the research is useless. In my position as a Research Assistant, my PM…   Read more»

]]> 424c14e9c665aabe0c04e4ba98b16fd0 https://medicaldevicecourses.com/activity/p/47384/ Tue, 21 Apr 2026 17:19:44 -0400 I have a personal experience related to this question. My first position as a Research Assistant had interesting work and taught me much about the industry and the process of conducting a longitudinal study. However, as time went on I…   Read more»

]]> 58a4fd0f460cf7e5afaa9e7694e95582 https://medicaldevicecourses.com/activity/p/46966/ Fri, 17 Apr 2026 20:05:08 -0400 The debate over mandatory disclosure mostly originates from the tension between public accountability and organizational survival. On one hand, transparency is key to maintaining societal expectations; for markets to be efficient and for consumers to remain safe, organizations must disclose…   Read more»

]]> adde6f5e459425b06ff5c762238e84d3 https://medicaldevicecourses.com/activity/p/46605/ Tue, 14 Apr 2026 03:12:00 -0400 In safety-critical projects, standard organizational planning must be augmented with specialized tools that prioritize redundancy and risk mitigation. As mentioned earlier, an essential technique is Failure Mode and Effects Analysis (FMEA), which enables teams to identify and address potential failure…   Read more»

]]> 25c4e402193ab5540dfed76709308d40 https://medicaldevicecourses.com/activity/p/46418/ Sun, 12 Apr 2026 16:08:34 -0400 In a professional engineering environment, a delay caused by external factors can require a transition from standard operations to crisis management. The first step is practicing proactive transparency; because the setback is outside the team’s control, you must immediately notify…   Read more»

]]> c8dd9ae19ab68a229343805095bd91c5 https://medicaldevicecourses.com/activity/p/44897/ Fri, 27 Mar 2026 14:27:41 -0400 You make a strong point about the value of EVM in tracking project performance. However, there is definitely a risk of relying too heavily on metrics like EV, PV, and AC. These numbers show what is happening, but not why…   Read more»

]]> b118406ab82301cfcf21d01533734946 https://medicaldevicecourses.com/activity/p/44718/ Wed, 25 Mar 2026 16:37:56 -0400 General management, regular review meetings, and organizational procedures are the three most prevalent qualities from those you had listed. Like those who replied above had said, all skills carry their own weight in the development of a product, but these…   Read more»

]]> 7f6ab044c298c4120431bf98f48e3725 https://medicaldevicecourses.com/activity/p/44716/ Wed, 25 Mar 2026 16:27:12 -0400 This week we covered the monitoring and controlling process and discuss its recursive nature throughout the duration of a projuct. As a PM, what are some tools or practices you can employ to ensure that you are thorougly checking the…   Read more»

]]> 595cbd64de96e97efbd573be2ce749ee https://medicaldevicecourses.com/activity/p/43484/ Thu, 12 Mar 2026 18:27:54 -0400 This week we go in depth in learning about verification and validation. What are the primary differences between verification and validation and in what phase of the project do they come into play? Additionally how does the validation of a…   Read more»

]]> 6b3c2bddf7aeca29f364abf8e62a4219 https://medicaldevicecourses.com/activity/p/43475/ Thu, 12 Mar 2026 16:34:25 -0400 As a PM it is fair to say one of your most daunting tasks is managing your team to ensure that all work gets done efficiently and effectively while adhering to the schedule you have set. However, each of your…   Read more»

]]> 61f907999da51955209985709ae04f4f https://medicaldevicecourses.com/activity/p/43074/ Sun, 08 Mar 2026 20:30:37 -0400 The responses above all indicate that monitoring is essential but needs to be within reason. Too little monitoring is negligence and too much is micromanagement, as a PM you need to be able to walk that line to ensure that…   Read more»

]]> b5dc2d10814b1a70df8420c784a26b94 https://medicaldevicecourses.com/activity/p/43072/ Sun, 08 Mar 2026 20:13:09 -0400 Balancing risk and reward in medical device development is less about eliminating all risk and more about managing risk to an acceptable level while still making progress. Standards like International Organization for Standardization’s ISO 14971 describe a structured process where…   Read more»

]]> 93cdc603fbc26798f0c1b7d1e534a91c https://medicaldevicecourses.com/activity/p/42466/ Mon, 02 Mar 2026 15:46:52 -0500 With week 7 we begin our second simulation and the project presented me with a question; how can you as a PM decide what factors to tweak during the test process? With the second simulation we are presented with a…   Read more»

]]> 5b7431fd653c4eb16b2ac801f79dec27 https://medicaldevicecourses.com/activity/p/42230/ Sat, 28 Feb 2026 17:18:43 -0500 My time in the medical device field has been fairly limited, but as opposed to resource management the pitfall my team faced was more oriented on time restrictions. We were working on a longitudinal study for an experimental device and…   Read more»

]]> c805686406b8b207f23e1a91b96933e0 https://medicaldevicecourses.com/activity/p/41792/ Tue, 24 Feb 2026 18:15:17 -0500 As many others above illustrate in FS the start of one event is tied to the finish of another as with es’s cutting wood example while with SF, the start of one event is tied to the progress of another,…   Read more»

]]> 5482ff68c85ba01f9a83dba75915f423 https://medicaldevicecourses.com/activity/p/41789/ Tue, 24 Feb 2026 17:57:36 -0500 This week we covered the concept of project planning and how to manage task start and finish times in relation to a goal. For any given project it may have subsets of designs or sections that need to be completed…   Read more»

]]> 6aa52104ffee95faee9132305359f837 https://medicaldevicecourses.com/activity/p/41405/ Sat, 21 Feb 2026 21:43:45 -0500 The idea of balancing between the PM’s responisbility to provide a product to marktet and properly managing the compliance of the DHF is something I have considered as well. My initial thought is, priority should stand on properly managing the…   Read more»

]]> 4267bccdb5d69e5e42fbd0808800aad1 https://medicaldevicecourses.com/activity/p/41144/ Thu, 19 Feb 2026 17:37:09 -0500 An interesting question Jacob, I believe a degree covers you in a broader sense while a certificate is for those who are looking for a specific craft. A degree can span a wide array of disciplines; for example if you…   Read more»

]]> f5247f29fc41d37a5c1f738872bbc0cc https://medicaldevicecourses.com/activity/p/41133/ Thu, 19 Feb 2026 16:17:15 -0500 In the week 5 lecture Dr. Simon discusses the concept of the PDCA cycle again; he elaborates on this cycle saying that projects often have different phases of completion and that once a phase has been “finished” it is incredibly…   Read more»

]]> 09d9c2ce043049137ffc9f22ffc39b24 https://medicaldevicecourses.com/activity/p/40681/ Sun, 15 Feb 2026 22:49:07 -0500 Project managers should align the needs of the business and customer satisfaction by ensuring that both have clear and measurable design inputs from the beginning of the project. This means firmly establishin the project scope to reflect revenue goals, strategic…   Read more»

]]> c4d1f6c7f9334a007edcdd30a0af1f82 https://medicaldevicecourses.com/activity/p/40674/ Sun, 15 Feb 2026 21:57:29 -0500 When animal trials provide results that differ from the projects intended goal or business strategy, it is a PM’s responsibility to reevaluate the project to fit the findings and not vice versa. Tampering with the results of a study is…   Read more»

]]> 16b3d970bc5a62beaac0b2a19419d764 https://medicaldevicecourses.com/activity/p/40669/ Sun, 15 Feb 2026 21:40:12 -0500 In addition to marketing analysis and SWOT, tools like risk management, technology roadmapping, reimbursement strategy planning, and post-market surveillance can significantly influence a medical device’s product life cycle. These tools help anticipate any potential hazards, regulatory challenges, component obsolescence, or…   Read more»

]]> f58ccddbc02df71b2a948ce25419cfb9 https://medicaldevicecourses.com/activity/p/39723/ Sat, 07 Feb 2026 19:38:59 -0500 When design controls and project management are treated as separate systems, verification, validation, and design reviews can face the difficulties of miscommunication and ineffective progress rather than be planned and effective. This separation can lead to gaps in traceability, late…   Read more»

]]> 08f0ec885171f3b8e5a73f68c0efdd83 https://medicaldevicecourses.com/activity/p/39720/ Sat, 07 Feb 2026 19:21:22 -0500 Throughout work on a given project, there are 9 points of design control that ultimately culminate into the Design History Form (DHF). The DHF is the end result of any project detailing the steps and processes and the ultimate decisions…   Read more»

]]> d72dc67d324eb266d5e8f2aa0978b644 https://medicaldevicecourses.com/activity/p/39517/ Thu, 05 Feb 2026 21:04:45 -0500 Design review and changes are going to be most prevalent in the check stage of the PDCA. The PDCA clearly outlines the steps and processes used to develop a system or device and gives a guideline for any who are…   Read more»

]]> dcab3ed825bb9862508c746f54a71195 https://medicaldevicecourses.com/activity/p/37515/ Tue, 27 Jan 2026 23:48:42 -0500 510(k)s and PMAs differ primarily in the level of risk they assume as a project, and the amount of evidence needed to fulfill that risk. A 510(k) is typically used for Class II (and some Class I) devices and requires…   Read more»

]]> 7efdea6de713a3792dcc47118e4d0087 https://medicaldevicecourses.com/activity/p/37453/ Tue, 27 Jan 2026 19:39:52 -0500 The relationship between the FDA and Project Managers is collaborative but stringent on regulations and constraints. PMs ensure that all aspects of a projects development phases align with the constraints established by the FDA. his means integrating regulatory strategy into…   Read more»

]]> fcd62fce943cb97d9b092cb1d260685e https://medicaldevicecourses.com/activity/p/37446/ Tue, 27 Jan 2026 18:42:36 -0500 An intersting extension to the proposed question gk376, the best way to mediate such an opposing conversation is to do just as you had said, stay neutral. Ultimately any dispute between an expert in the field and a project manager…   Read more»

]]> 887cafc8e08ceb4cd39276bfd9d4a217 https://medicaldevicecourses.com/activity/p/36664/ Sun, 25 Jan 2026 01:48:00 -0500 An interesting thought, when working in device development or research there are often questions that come up regularly throughout the process. Having the project manager on site to administer instructions and help to resolve any issues that may arrise during…   Read more»

]]> 7f48a026344c7321cf0a10efb86a0077 https://medicaldevicecourses.com/activity/p/36184/ Fri, 23 Jan 2026 05:14:30 -0500 An interesting thought Jacob; in my experience a project manager needs to be the most all around member of the team. That is to say, medical device projects often involve doctors, or biology specialists explaining or focusing on the importance…   Read more»

]]> accd2e66e8f17923ca8f94f79b640a78 https://medicaldevicecourses.com/activity/p/36183/ Fri, 23 Jan 2026 05:14:24 -0500