https://medicaldevicecourses.com/members/mmk68/activity/ Activity feed for mmk68. Sat, 16 May 2026 11:58:01 -0400 https://buddypress.org/?v= en-US 30 hourly 2 0d13605deca039b985afa910c852bb4e https://medicaldevicecourses.com/activity/p/48541/ Sun, 03 May 2026 00:44:21 -0400 As part of the fourth simulation, we are faced with the problem of ordering smelly (and therefore unusable) pouches from a cheaper vendor or switching to a more expensive vendor whose pouches don’t have that issue. While this isn’t close…   Read more»

]]> ae4e92c5f467b25b16648a1651eb875f https://medicaldevicecourses.com/activity/p/48540/ Sun, 03 May 2026 00:37:40 -0400 Enjoying one’s work is key to employee retention. While salary/benefits provides a very practical reason to leave or stay, from what I’ve seen in the workplace, factors such as interpersonal relationships, company culture, and engaging work carry a lot of…   Read more»

]]> b46360255d74a1c6450aa9a278ab37db https://medicaldevicecourses.com/activity/p/48538/ Sun, 03 May 2026 00:32:15 -0400 I think a big component to overworking is peer pressure and desperation for a job. Especially for recent grads entering into the workforce, you already likely had to struggle and fight for a job, especially in this job market. That…   Read more»

]]> 1d72beef94bf79dc34318ba52fa79481 https://medicaldevicecourses.com/activity/p/47910/ Sun, 26 Apr 2026 22:26:11 -0400 As discussed this week, clinical trials are important for class 2 and 3 devices. They also require significant planning, communication, and overview. The CITI training for clinical researchers warns about the dangers of selecting trial participants in regards to protected…   Read more»

]]> 5452e2ff34e78b94f1cc561b6b1145c8 https://medicaldevicecourses.com/activity/p/47909/ Sun, 26 Apr 2026 22:12:58 -0400 A project manager’s mindset greatly impacts the team. As others said above, a lack of motivation can spread like a virus. In my experience, good project managers I’ve had have come in early and are often the first ones on…   Read more»

]]> 379faa24a311bfc05bacc6e8813d6d94 https://medicaldevicecourses.com/activity/p/47902/ Sun, 26 Apr 2026 21:48:54 -0400 I have experience working for a CRO, so I feel I can provide some insight on that point. We have had many clients who are far from small pharmaceutical companies, and I suspect it might honestly look better for these…   Read more»

]]> 62eca9a7efdcabd3df0d1b5442398e81 https://medicaldevicecourses.com/activity/p/47901/ Sun, 26 Apr 2026 21:48:37 -0400 I have experience working for a CRO, so I feel I can provide some insight on that point. We have many clients who are far from small pharmaceutical companies, and I suspect it might honestly look better for these companies…   Read more»

]]> b17bfaf25d697ab57ead0f1da67e5359 https://medicaldevicecourses.com/activity/p/47160/ Sun, 19 Apr 2026 18:52:27 -0400 I chose to go with the two sources rather than the three because it is important to have the backup coating supplier, but I think having a third supplier introduces too much time and cost to the project without providing…   Read more»

]]> dc7d15b94598a055ee25a79ffd0388a3 https://medicaldevicecourses.com/activity/p/47159/ Sun, 19 Apr 2026 18:41:25 -0400 Unless people are working heavily across teams in a cross-functional discipline, I think each group needs a base understanding of what the others do. As seems to be the consensus on this thread, skipping steps, especially when it comes to…   Read more»

]]> 7c98483762c30fb18634c707b2414050 https://medicaldevicecourses.com/activity/p/47158/ Sun, 19 Apr 2026 18:33:14 -0400 I do see the point about the different coatings from the same supplier being risky, but for the earthquake part, that would depend on the company and which branch locations manufacture which components. I think a concern leading to the…   Read more»

]]> 54dd3b87e509ba19dc265e3a23872000 https://medicaldevicecourses.com/activity/p/46326/ Sat, 11 Apr 2026 18:51:57 -0400 I think a valuable tool, as a previous post mentioned, is categorizing changes based on level of severity or work needed. Minor changes don’t require an entire team meeting as an email would likely suffice. That way, the team can…   Read more»

]]> 921512a9f22e85e7595acc911310d4c0 https://medicaldevicecourses.com/activity/p/46323/ Sat, 11 Apr 2026 18:41:41 -0400 I think that, as in the minisim, facilitating a conversation between both parties is a key first step. In my experience, project managers have a very holistic view of the project and are more sensitive to pressures from upper management,…   Read more»

]]> 19761cfa0d28af38c6dbb9b7f0f0d7f4 https://medicaldevicecourses.com/activity/p/46321/ Sat, 11 Apr 2026 18:32:25 -0400 As many have said, rushing a medical device product means cutting corners, which can have severe ethical and health concerns down the line. There will be an understandable push to rush to be first to market, but from an engineering…   Read more»

]]> e6c377ba7a4b829f06ded9a200e5f10e https://medicaldevicecourses.com/activity/p/45008/ Sat, 28 Mar 2026 20:12:39 -0400 In any project, delays and setbacks are to be anticipated. However, your team is expected to meet certain hard deadlines, either for the customer or a regulatory agency, for example. In a scenario where everyone on the team is working…   Read more»

]]> ceb56b65107550c7e1c83a3f4d88bf31 https://medicaldevicecourses.com/activity/p/45007/ Sat, 28 Mar 2026 20:05:54 -0400 As many people have pointed out in this thread already, rushing the animal experimentation opens up the project to extra risk later down the road. Animal testing takes a significant amount of time. I’ve done a lot of work in…   Read more»

]]> dd52349171b06b5debb5323442a23050 https://medicaldevicecourses.com/activity/p/45005/ Sat, 28 Mar 2026 19:55:56 -0400 Gantt charts are useful tools to help you keep track of what tasks are on schedule, behind schedule, or ahead of schedule as well as providing an estimate of how long tasks should take. Medical devices are complicated projects with…   Read more»

]]> 6a0f66112cc7feae8cce59681b704b07 https://medicaldevicecourses.com/activity/p/43783/ Sun, 15 Mar 2026 18:39:20 -0400 This week we discussed various strategies to help with plan execution. These broadly include general management and product skills, work authorization systems, status review meetings, project management information system, and organizational procedures. While these are all important for a PM…   Read more»

]]> 921d9010c2ef21963ba815184a1874b8 https://medicaldevicecourses.com/activity/p/43782/ Sun, 15 Mar 2026 18:34:39 -0400 To prevent scope creep, eliminating vague statements when outlining the scope of the project, establishing an agreement with the customer about how changes can be implemented, and ensuring clear communication are all critical. For scope verification, the same strategy of…   Read more»

]]> 1548f6bd7d428e32c841518589326778 https://medicaldevicecourses.com/activity/p/43677/ Sat, 14 Mar 2026 19:43:18 -0400 I second what yg385 said. Team members should be aware of the time and energy requirements of a project and plan accordingly. In the case of major life events that would shift their ability to complete tasks or put in…   Read more»

]]> d1d7b9f9cf0ebcb4d7133ef98132e056 https://medicaldevicecourses.com/activity/p/43129/ Mon, 09 Mar 2026 03:15:04 -0400 Hello! Nice to meet you all. I’m a senior undergrad in the biomedical engineering BS/MS program (biomaterials concentration) at NJIT. https://www.linkedin.com/in/meghan-kinkade-4b6054252/

]]> 8b6ad2fd2d952e86ee3e5eb22f559617 https://medicaldevicecourses.com/activity/p/43125/ Mon, 09 Mar 2026 03:11:05 -0400 For my capstone project, many of the delays we ran into were communication-based. We needed to order chemicals, but since we had an external sponsor (and therefore external payment), we had to go through numerous additional steps to order the…   Read more»

]]> c941be6cfbdb5b90c326455e55be71e9 https://medicaldevicecourses.com/activity/p/43123/ Mon, 09 Mar 2026 03:06:53 -0400 I don’t know if there’s a good reason to keep the PM out of the loop financially. Everything in a company relates to finances. “Time is money,” and when it comes to the development of a medical device, it can…   Read more»

]]> 4e039d1c386930706221e7edf9749c84 https://medicaldevicecourses.com/activity/p/42375/ Sun, 01 Mar 2026 22:22:57 -0500 When creating a medical device, key expectations are to be met that are held by the FDA, shareholders, and customers. Especially for Class II or Class III devices, the FDA regulatory pathways can take significant time and money, and FDA…   Read more»

]]> 9111b92958fb8a95f1aaf2a4c086f143 https://medicaldevicecourses.com/activity/p/42371/ Sun, 01 Mar 2026 22:11:10 -0500 I think what is useful about the FDA regulatory aspects of medical devices is that once your device class and required documents/steps are determined, there is a relatively clear pathway that your team must follow for FDA approval. Of course,…   Read more»

]]> 58fb9aab0187a1808423d8ac18ce4667 https://medicaldevicecourses.com/activity/p/42249/ Sat, 28 Feb 2026 21:57:51 -0500 If members of your team are working on multiple projects, it may be useful to speak to the other PMs to get a sense of the project timeline to ensure that the project has people available to work on it…   Read more»

]]> 43068624d02c3edc4582221867f4dcc1 https://medicaldevicecourses.com/activity/p/41430/ Sun, 22 Feb 2026 02:02:34 -0500 As Dev said, there should be multiple design review meetings and controls such that there is no need to return to a completed phase. If a PM and their team are thorough, and the proper design documents have been maintained…   Read more»

]]> 557950bb852346c31fb626351b70752e https://medicaldevicecourses.com/activity/p/41429/ Sun, 22 Feb 2026 01:55:28 -0500 I think that certifications without the degree to back them up don’t really mean anything in an industry setting, whereas someone with a degree (say a Bachelor’s in Biomedical Engineering) would likely be encouraged to seek a certification such as…   Read more»

]]> 7bebc3512b4af1a9f9398bf315d16f13 https://medicaldevicecourses.com/activity/p/41428/ Sun, 22 Feb 2026 01:47:11 -0500 I agree with Krish that the PM’s role combines task management with the objective of completing the DHF and compliance assurance. While the PM shouldn’t be the only one focused on compliance, when trying to get a medical device to…   Read more»

]]> be09a4a4a840be93f8c83a7076f0f056 https://medicaldevicecourses.com/activity/p/40728/ Mon, 16 Feb 2026 03:36:25 -0500 I agree with Ehab that changing the DSD may not be necessary in this case due to the nature of its stipulations not including that the water bath had to be 37C. Additionally, if the DSD is changed any time…   Read more»

]]> 40c985b74dcef011d2929bfa59a01fd6 https://medicaldevicecourses.com/activity/p/40701/ Mon, 16 Feb 2026 01:12:06 -0500 In the first simulation that we were given this week, we met with an issue where a part of a product failed verification testing, and we had to propose ideas to rectify that. In a real-world situation, what would the…   Read more»

]]> 2d82e45b7406630dedfca56f2ef94550 https://medicaldevicecourses.com/activity/p/40571/ Sun, 15 Feb 2026 00:59:46 -0500 If the stents fail during in-vivo testing, the team as an entirety would need to re-assess the design. It would be critical to understand why the stents are failing and possible avenues to rectify that. It is also possible that…   Read more»

]]> 6a29689ecdcc1eb6c324d20b765b8e5a https://medicaldevicecourses.com/activity/p/39839/ Sun, 08 Feb 2026 19:27:03 -0500 Products like smartphones or less-strictly-regulated medical devices, such as Class I devices, can have a very fast product life cycle. I have seen that Class II and III products tend to have a longer life cycle due to the amount…   Read more»

]]> d45fd78c6dda4de4073aa3916233f409 https://medicaldevicecourses.com/activity/p/39837/ Sun, 08 Feb 2026 19:18:10 -0500 I agree with Sami that collaboration is a big component in ensuring a full completion of the DHF, especially when the design controls and project management processes are separated. If the two are completely separated and there is a lack…   Read more»

]]> 9c960648ec482dfb8ca33be3dac401f9 https://medicaldevicecourses.com/activity/p/39836/ Sun, 08 Feb 2026 19:07:52 -0500 In order to make sure important information isn’t overlooked in the DHF creation process, it is important to be constantly working on the document rather than waiting for the end. It also would likely be a team effort, of a…   Read more»

]]> 6198c92171c292159cd5e0d5adb4660e https://medicaldevicecourses.com/activity/p/38658/ Sun, 01 Feb 2026 08:59:54 -0500 Especially for Class II and III devices, the pathway to FDA approval can take many years and a sizeable budget. As a PM, what are ways that you can ensure the project is following the intended timeline and budget? From…   Read more»

]]> e1b9987bc8b9b390b57b590db1e15fa9 https://medicaldevicecourses.com/activity/p/38655/ Sun, 01 Feb 2026 08:50:02 -0500 I think that a crucial part of a PM’s job post-market release is ensuring that all the proper documentation has been collected and organized, and the PM should, as Sami mentioned, either prepare for post-market activities or help facilitate a…   Read more»

]]> 7a4aed075587326d8a19a0f50228e8f7 https://medicaldevicecourses.com/activity/p/38122/ Fri, 30 Jan 2026 15:12:43 -0500 I also agree with Vansh that it would be more under the purview of a regulatory control team member than the PM to ensure that FDA regulations are being upheld, but I believe that a close relationship between the PM…   Read more»

]]> c4e695f1c114de5a0c6486a33afdf18c https://medicaldevicecourses.com/activity/p/36717/ Sun, 25 Jan 2026 05:26:18 -0500 I think to be a successful project manager relies heavily on the interpersonal skills. If you have established respect and a rapport with your team, you would, in theory, be able to rely on them when your own technical skills…   Read more»

]]> e299ea9f93f66bc64ae760a4e9fe90bf https://medicaldevicecourses.com/activity/p/36716/ Sun, 25 Jan 2026 05:26:17 -0500 I think that the answer to this is very situational. If, as a PM, you anticipate being in charge of a very niche biomedical product, and future projects you manage will also remain in that niche, it would very much…   Read more»

]]> 6966e6bad55f9b406eb3a3ccc659ed79 https://medicaldevicecourses.com/activity/p/36715/ Sun, 25 Jan 2026 05:26:11 -0500