https://medicaldevicecourses.com/members/sts27/activity/ Activity feed for sts27. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ae97d4b2fbae8982d6f141af69b4f7df https://medicaldevicecourses.com/activity/p/22382/ Mon, 03 May 2021 01:53:48 -0400 I really learned about communication and problem solving through this class. (specifically through the simulations). While I have dealt with similar things before, the back and forth set-up required for these simulations encouraged me to try and be more straight…   Read more»

]]> bf2f570d559e9739b45646dc14e01974 https://medicaldevicecourses.com/activity/p/22381/ Mon, 03 May 2021 01:50:30 -0400 Honestly I think, at this exact moment in my life, I am happy being a researcher/engineer. I do not have the skillset to lead others yet. I’ve only just started graduate school and I am still in the, “learning” phase…   Read more»

]]> 77880a8c91ff9199085ff672a7fd399c https://medicaldevicecourses.com/activity/p/22379/ Mon, 03 May 2021 01:46:20 -0400 As someone who has really only done research in academic settings, I find this class helpful since it provides insights that I would not have been able to access from my other classes and experiences. Its unique in the fact…   Read more»

]]> c7b3160c73621f324cdbf32604e2369f https://medicaldevicecourses.com/activity/p/22281/ Sun, 25 Apr 2021 16:29:48 -0400 I have a huge tendency to fall into tunnel vision. I think its partially based on hyper focusing on a specific part of a project and also based on stubbornness. The issue is that it really only becomes clear that…   Read more»

]]> a55f30db5b5a926a145774a57c5da402 https://medicaldevicecourses.com/activity/p/22280/ Sun, 25 Apr 2021 16:21:37 -0400 It’s funny but I am very rarely motivated by competition, personally I find it stressful and somewhat demotivating. I have ADHD so motivation and executive functioning can be difficult for me. I think my main motivator is knowing that my…   Read more»

]]> 61d678d33f50ba46b0281831305c5ccf https://medicaldevicecourses.com/activity/p/22279/ Sun, 25 Apr 2021 16:10:29 -0400 As a graduate student who oversees a small hoard of undergrads, I have a bit of experience in motivation and how motivating others can modify their work. For the purpose of this prompt, I am going to reply via my…   Read more»

]]> 1b275afd8c36e270abedd7754a4297ac https://medicaldevicecourses.com/activity/p/22137/ Fri, 16 Apr 2021 18:48:27 -0400 My capstone project for undergrad focused on creating a continuous passive motion device (CPM) for the hand. We underestimated a lot of the completion dates for many parts of the project which resulted in a lot of scope creep for…   Read more»

]]> 55855c30f39ed126fbf78cec1bedf982 https://medicaldevicecourses.com/activity/p/22136/ Fri, 16 Apr 2021 18:37:59 -0400 Honestly, it depends on how this individual leaves the project. If the person is leaving the project abruptly then there will need to be major changes in work-flow and other individuals working on the project may be required to change…   Read more»

]]> 0b56e7a337988480cf855428f8c713d3 https://medicaldevicecourses.com/activity/p/22135/ Fri, 16 Apr 2021 18:24:41 -0400 I think your definition of HR pretty much answers your question. HR: reduces turnover, hires well suited-individuals for the job, and improves employee engagement. A medical device is really only as good as the team that works on it. HR…   Read more»

]]> 9d42fe039d84b67ad2e527f678ba0a52 https://medicaldevicecourses.com/activity/p/21894/ Sun, 28 Mar 2021 15:59:10 -0400 I am currently pursuing my Masters in a lab! When I was in undergrad I did a terrible job of logging my work: I often assumed that I would remember simple details and that many of my tasks just didn’t…   Read more»

]]> aaf5670e57d275823ae2e2a8bcd1aa76 https://medicaldevicecourses.com/activity/p/21893/ Sun, 28 Mar 2021 15:51:46 -0400 I think for the closing phase to be carried out effectively, it is essential that all parts required for the closing phase are clearly monitored and that it is ensured that they are completed correctly. The closing phase is not…   Read more»

]]> 2ac0ac5d413b6c74eefcd21398d7a80e https://medicaldevicecourses.com/activity/p/21892/ Sun, 28 Mar 2021 15:43:38 -0400 I agree with several of the commenters above. I think communication control may be one of the most effective and necessary parts of Monitoring and Controlling. While there are many techniques and tools that can be used during this process,…   Read more»

]]> 6dfed818c3fe2e7d82a3342f4b5d3a39 https://medicaldevicecourses.com/activity/p/21729/ Sun, 14 Mar 2021 18:29:41 -0400 My biggest emphasis would be on COMMUNICATION. Even with this week’s simulation, it was clear that communication can directly impact how a project plays out. Planning is one thing, executing a plan properly can only happen if all members are…   Read more»

]]> d4548ac3b4917e8100fe6954252d4053 https://medicaldevicecourses.com/activity/p/21728/ Sun, 14 Mar 2021 18:15:08 -0400 A specific or main cause of project failure is difficult to pinpoint. While I agree that communication seems to be a major factor in the success of a project, I think that sometimes project failure can just be due to…   Read more»

]]> 857f5934cd57c098f65c7507814d4930 https://medicaldevicecourses.com/activity/p/21727/ Sun, 14 Mar 2021 18:07:45 -0400 When I was working on my capstone project in undergrad we made a lot of assumptions about how easy it would be to program our device. The aim of the device was to open and close a hand, and we…   Read more»

]]> d39f57eb73f906bd6fc03b413522b006 https://medicaldevicecourses.com/activity/p/21534/ Sat, 06 Mar 2021 19:11:44 -0500 I think it depends on the project and the skill level of the group. If it is a team that is well acquainted with one another and is comfortable with the work, then the chances of delays may be reduced…   Read more»

]]> bb837880689e651b59c87b0051efaca3 https://medicaldevicecourses.com/activity/p/21533/ Sat, 06 Mar 2021 19:06:23 -0500 The planning phase is probably one of the most important parts of project development. In the scenario you discussed above there seems to be a huge lapse in planning and in communication. If the schedule had been planned and then…   Read more»

]]> 7c5bdcffd755eab50793edc454985d6a https://medicaldevicecourses.com/activity/p/21532/ Sat, 06 Mar 2021 19:00:38 -0500 The best way to overcome missing milestones is to plan in advance for potential issues and failures. The best plans always have backup plans, and in situations where a milestone is missed, it’s often essential to implement a pre-planned backup…   Read more»

]]> 01bc9ed3b0cfaf71de7440e03f0a6fdc https://medicaldevicecourses.com/activity/p/21454/ Sun, 28 Feb 2021 18:07:08 -0500 Gannt charts are used for scheduling and breaking down required tasks for a project. They’re useful in estimating and planning how a project should be completed and in what order the steps required for this project should be completed.  The…   Read more»

]]> 8d82aee7849418ef921474855479bbaa https://medicaldevicecourses.com/activity/p/21453/ Sun, 28 Feb 2021 17:59:27 -0500 I’ve found that I can avoid going back to the planning phase after the execution phase by planning backup plans prior to starting.  I work with tissues and cells: I can never just assume that things are going to work…   Read more»

]]> 4ed85f7c3ccadda58d0b8c60a3f9df2f https://medicaldevicecourses.com/activity/p/21452/ Sun, 28 Feb 2021 17:51:34 -0500 I also agree that this course is incredibly beneficial. Even if you are not going into industry, the things discussed in this course, such as project planning, the steps required for project planning, project execution, etc. are transferable and useful…   Read more»

]]> 76b564922729d5c875426c3b999dc453 https://medicaldevicecourses.com/activity/p/21388/ Sun, 21 Feb 2021 20:20:11 -0500 Personally, I think that the planning/initiation phase of a project is the most important. Without initiating or planning a project there is no project. Even if the project plan is changed dramatically over the course of the project, none of…   Read more»

]]> ff7c7b4d5365f0a5e8dcb122e25cae78 https://medicaldevicecourses.com/activity/p/21387/ Sun, 21 Feb 2021 20:14:42 -0500 As many of the other people have stated in this forum: communication is the key to handling issues that may arise due to workers not being, “robots”.  It’s often easy to forget that everyone in a workplace exists outside the…   Read more»

]]> 5f6f6365c199097551597904f6e5346f https://medicaldevicecourses.com/activity/p/21386/ Sun, 21 Feb 2021 20:05:08 -0500  Letting individuals set their own due dates can be tricky. As you said, those with inexperience tend to underestimate how long a task may actually take to complete and thus can set the project back. This can be avoided by…   Read more»

]]> dbb2d41bf58ffcf84343684504d22338 https://medicaldevicecourses.com/activity/p/21347/ Sun, 14 Feb 2021 19:58:15 -0500 I think it depends on the project manager and the people who they work with. A project manager who is extroverted may not need to have quiet time with their employees if their employees function fine under their method of…   Read more»

]]> 123d583ef1936b4f2abc83e9a6fcda9e https://medicaldevicecourses.com/activity/p/21346/ Sun, 14 Feb 2021 19:52:34 -0500  I feel as if I would be most suited for a project-based organization. I don’t personally have experience working in industry, but I do have a lot of experience working in academic labs. I thrive under conditions in which I…   Read more»

]]> 79699b925aa88f6288fe36e62e73a74b https://medicaldevicecourses.com/activity/p/21345/ Sun, 14 Feb 2021 19:42:12 -0500 I think that if this was a real industry project and we could have met face-to-face I would have been far more productive. My team mostly communicated through the canvas forum, of which I did not have notifications set up…   Read more»

]]> bf68769224c334710f37280650811a53 https://medicaldevicecourses.com/activity/p/21282/ Sat, 06 Feb 2021 20:43:18 -0500 Technically, I feel as if there should be back-up plans for emergency scenarios in order to prevent disruption. That being said, things like the ongoing pandemic and the impact of the ongoing pandemic are not always predictable. I think that…   Read more»

]]> 241f32b80c9d22387e9ea128ea698afe https://medicaldevicecourses.com/activity/p/21281/ Sat, 06 Feb 2021 20:33:49 -0500 If all of these organizational types ran perfectly, I think that a matrix organization would be the most efficient and effective in terms of project management, regardless of the project. The transfer of information and personnel in a matrix organization…   Read more»

]]> a6d31753cd4c63b0081c3a55d66613ca https://medicaldevicecourses.com/activity/p/21280/ Sat, 06 Feb 2021 20:23:15 -0500 In all honesty, it depends on the sub-field of biomedical engineering that I would be working in. If it were a field or project that I was not super acquainted with (ex. electronics) I would want a team that was…   Read more»

]]> 5887daeb0571f0d04fd20457dcbfbff7 https://medicaldevicecourses.com/activity/p/21214/ Sat, 30 Jan 2021 20:56:10 -0500 Ignoring skills that are specific to the industry, I think the most important skill a project manager needs to be able to do is communicate. Regardless of which industry, their job requires them to coordinate and oversee many different parts…   Read more»

]]> c282a5b2fcd9939016da5de3db2e025b https://medicaldevicecourses.com/activity/p/21213/ Sat, 30 Jan 2021 20:14:48 -0500 In some ways I would say that the skills required for project management are transferable. Overseeing other roles, organizing such, communicating, and just generally ensuring that the project proceeds are transferable. That being said, an understanding of the industry is…   Read more»

]]> 38a1c751f564cb3cec4cff93503eb517 https://medicaldevicecourses.com/activity/p/21212/ Sat, 30 Jan 2021 20:10:00 -0500 While I do think that, in theory, a global regulatory system would be great, I think in practice it would actually be less effective than having multiple regulatory systems. Look at the FDA, there are still occasionally products that, “slip…   Read more»

]]> 7def86e77a4f97ee09912da041be46af https://medicaldevicecourses.com/activity/p/21130/ Sat, 23 Jan 2021 18:21:43 -0500 I think that it is a reasonable investment solely because without technical knowledge you cannot be an engineer. That is the basis on which you go to school; i.e while there are many other scenarios in which you can learn…   Read more»

]]> 3a777b19fdbef808ccea3dcd63f39d78 https://medicaldevicecourses.com/activity/p/21129/ Sat, 23 Jan 2021 18:16:22 -0500 Although I am not a project manager, I do actively work in a lab and with a team. I’ve found that COVID did disrupt the flow of conversation and information early on, but by implementing required zoom meetings and other,…   Read more»

]]> fc84bb9caf34ebb9e35cc60705b9774d https://medicaldevicecourses.com/activity/p/21128/ Sat, 23 Jan 2021 18:13:45 -0500 I agree with many of the ideas above stating that a log should be created and so on, but I also think that the project manager should incorporate discussing mistakes, failures, and how those failures were dealt with into the…   Read more»

]]> ebbb9651278f6e806561f3f80175b9f5 https://medicaldevicecourses.com/activity/p/21056/ Mon, 30 Nov 2020 00:11:44 -0500 An NDA can prevent people from talking about the concept but it doesn’t give you a legal claim over the project or concept. A patent would allow you to not only claim rights to the product but to sue competitors…   Read more»

]]> d09cf2b9d44e94a18c2ef86ffd0c84d1 https://medicaldevicecourses.com/activity/p/21055/ Mon, 30 Nov 2020 00:09:28 -0500 So funny enough my father is a physician and I have actually seen him uncomfortably try and manage around companies or people who don’t entirely respect these restrictions. I think that these restrictions should not be lifted or changed; while…   Read more»

]]> c99df54fe0a0ed1daf9ef1a7f3c7ed6a https://medicaldevicecourses.com/activity/p/21054/ Mon, 30 Nov 2020 00:04:57 -0500 The main difference between the two is, as said in many of the responses above, documentation and defendability in court. An oral or verbal agreement is spoken, but unless there is further documentation to support that it did occur it…   Read more»

]]> fcfeae8dd94d46bb351974a1a3a9b326 https://medicaldevicecourses.com/activity/p/20913/ Sun, 15 Nov 2020 20:00:48 -0500 Another benefit of Post-market surveillance is that it protects patients. While it may save the company money and help the company make easy improvements to their devices as necessary, ultimately Post-market surveillance provides a mechanism by which a product is…   Read more»

]]> abef3343a913918050eb1316b0022039 https://medicaldevicecourses.com/activity/p/20912/ Sun, 15 Nov 2020 19:55:46 -0500 Another factor to consider is the Duration of harmful events. For example, cancer therapies and surgeries often cause adverse symptoms in patients that can last for the entirety of their treatment and even sometimes after.  If the cancer was going…   Read more»

]]> ab2d12e0905af224b96ac9d8bfde2117 https://medicaldevicecourses.com/activity/p/20911/ Sun, 15 Nov 2020 19:37:56 -0500 In medical devices specifically, I would think that the nature of how a device may fail and harm an individual and the extent of the harm would impact and contribute to the risk value. While the likelihood of failure/risk is…   Read more»

]]> 11af51e2066d70ebb1590ffa45e81213 https://medicaldevicecourses.com/activity/p/20909/ Sun, 15 Nov 2020 19:03:33 -0500 I think a balance of both individuals with whom you have a relationship and individuals who have the required skill-sets/knowledge base makes for a good project team. A team made entirely of your, “friends” might seem like a good idea,…   Read more»

]]> c827c5f207098dbc054e94c711b21459 https://medicaldevicecourses.com/activity/p/20908/ Sun, 15 Nov 2020 18:55:27 -0500 In all honesty, I think that the traits of upper and middle management are quite similar (depending on how you look at them). Both are required to be able to communicate effectively, articulate plans and goals, monitor the progress and…   Read more»

]]> 5c16974cdabc6ddb0ae32c64af0f93e3 https://medicaldevicecourses.com/activity/p/20907/ Sun, 15 Nov 2020 18:42:48 -0500 From my limited experience, I think I would actually prefer working in a project-based organization. While a matrix-organization does allow for potentially more personal growth since I would be working with a larger variety of people, a project-based organization would…   Read more»

]]> f96388a1173241fab09723665e2dc82e https://medicaldevicecourses.com/activity/p/20822/ Fri, 06 Nov 2020 17:14:28 -0500 Having these documents is one thing, making sure that these documents aren’t falsified is another. I think, along with ensuring that these documents are present and complete, the FDA most likely also looks into how accurate these documents really are. …   Read more»

]]> 1ede968ad0d8c6dc26c71636573dace6 https://medicaldevicecourses.com/activity/p/20816/ Thu, 05 Nov 2020 21:17:30 -0500 Personally, I think human factors validation should only be re-performed if the user interface has changed with whatever product update has been done. As said in your question, validation is often not required if it can be argued that the…   Read more»

]]> 7b66e441ea057fcd4e18083c468e344d https://medicaldevicecourses.com/activity/p/20815/ Thu, 05 Nov 2020 21:12:37 -0500 Unlike in the US, design controls are not required in Europe to release a product. I personally prefer the American method of requiring a DHF and DMF, specifically when the DHF is treated as an unchanging document while the DMF…   Read more»

]]> 099d9fc6d2b92eddcb8f01a63bce7549 https://medicaldevicecourses.com/activity/p/20793/ Mon, 02 Nov 2020 02:54:31 -0500 I write down almost everything discussed during meetings. Not all of the information is useful, but doing such both helps me remember the meeting better and provides a basis for writing my weekly plan. In all honesty, I would say…   Read more»

]]> 18f897d9fa775b0186a0193e615e797e https://medicaldevicecourses.com/activity/p/20792/ Mon, 02 Nov 2020 02:50:59 -0500 In all honesty, I think it depends on the nature of your research. If you are working with animals or humans then comparative documents would be IRB approval and approval from animal review boards.  If you view it from a…   Read more»

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