https://medicaldevicecourses.com/members/traceymraw/activity/ Activity feed for TraceyMraw. Fri, 24 Apr 2026 17:56:18 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b051ac5e7861f353bd3e74437013a4ed https://medicaldevicecourses.com/activity/p/22378/ Mon, 03 May 2021 01:13:02 -0400 I would want to begin my career in engineer positions. After gaining a several years of technical experience, I would then want to move into a management or leadership role. I am interested in eventually pursuing management positions, but I…   Read more»

]]> cd73e859c37aeaf1b1a43da35b3968a4 https://medicaldevicecourses.com/activity/p/22377/ Mon, 03 May 2021 01:03:42 -0400 Being previously familiar with design controls, this class is helpful in tying in the project management aspect of a project. I hope to eventually lead projects in a PM role, and this class has taught me a lot about what…   Read more»

]]> 44031877a17389b3e314557c2bfd8119 https://medicaldevicecourses.com/activity/p/22376/ Mon, 03 May 2021 00:58:33 -0400 One of the most important things I’ve learned in this class is the importance of communication in all parts of project management. Communication plays a role throughout every part of project management and is essential in leading an effective project…   Read more»

]]> c2d0c39be87403df91e368c92464410c https://medicaldevicecourses.com/activity/p/22241/ Thu, 22 Apr 2021 19:19:09 -0400 My biggest motivator is working with good coworkers and managers. A good project team would create a strong work environment and allow for productivity and efficiency within projects. To me, a good environment to work in would be a great…   Read more»

]]> 01dd3277c98475a4a29eab9a81312542 https://medicaldevicecourses.com/activity/p/22240/ Thu, 22 Apr 2021 19:05:47 -0400 I believe the most important factors would be if the company running the trial has adequate facilities and resources already present within the company. If a company does not already have these, it would take significant time and possibly delay…   Read more»

]]> 2abbc213c5fa29a7931be9def9c3af05 https://medicaldevicecourses.com/activity/p/22239/ Thu, 22 Apr 2021 18:57:38 -0400 In a clinical project team, I would be interested in working in a regulatory role. I am interested in how the process followed to review and approve devices by the FDA. Additionally, I believe regulatory plays an important role in…   Read more»

]]> 3e4abcddf4d5f282958ef44e982f1565 https://medicaldevicecourses.com/activity/p/22140/ Fri, 16 Apr 2021 19:14:42 -0400 I experienced scope creep throughout my capstone project. The scope creep was encountered in the project description portion of the scope determination. Due to the relatively short time period of the capstone project, the product description was determined before material…   Read more»

]]> 76e0701fec048f7bc5e85c9ba33adc90 https://medicaldevicecourses.com/activity/p/22139/ Fri, 16 Apr 2021 18:59:15 -0400 One way to minimize transition time between new personnel is to keep detailed records of the work involved in each position throughout the entire course of a project, rather than waiting until the end. If each position keeps notes and…   Read more»

]]> 5d748d14691e2f2fb02d7c458dc632ea https://medicaldevicecourses.com/activity/p/22138/ Fri, 16 Apr 2021 18:52:29 -0400 I believe HR is essential for creating a good work environment. While it is very important to acquire employees with the qualifications and experience needed, it is also very important in selecting employees that will work well with the team….   Read more»

]]> 849d8c380dd4356bd588817daa4d0f13 https://medicaldevicecourses.com/activity/p/22044/ Sun, 11 Apr 2021 17:29:02 -0400 During my Capstone project, we had unexpected delays in acquiring materials. Our main component was an impact absorbing material we were receiving from a vendor. This was expected to be a fairly simple task, due to previous work with the…   Read more»

]]> f012af4c96da9b644afd446776d3f0f1 https://medicaldevicecourses.com/activity/p/22043/ Sun, 11 Apr 2021 17:08:36 -0400 I believe the proper time for project initiation is when you can prove a need for a project, a market, and that the project is feasible. I think the project being feasible is the most important part to initiate a…   Read more»

]]> 69f93ba05cc90bb4dc399730af69e99c https://medicaldevicecourses.com/activity/p/22041/ Sun, 11 Apr 2021 16:36:17 -0400 During my Capstone project, my group initially created detailed plans of the design and materials we would need to complete the project. We then estimated our budget based on the cost required to purchase the necessary materials. We were creating…   Read more»

]]> 8041a3c5f2835041c765d21e66223003 https://medicaldevicecourses.com/activity/p/21868/ Fri, 26 Mar 2021 18:57:42 -0400 I believe some missed milestones may be out of the projects team’s control and that it may not be possible to make up for the lost time. However, I think these delays make it more essential to adequately plan the…   Read more»

]]> 7598f7f918f0292bc89dfd5f4e59e0fa https://medicaldevicecourses.com/activity/p/21867/ Fri, 26 Mar 2021 18:57:35 -0400 I believe some missed milestones may be out of the projects teams control and that it may not be possible to make up for the lost time. However, I think these delays make it more essential to adequately plan the…   Read more»

]]> 185ee50c094a4f668ebe685e278cf8a6 https://medicaldevicecourses.com/activity/p/21865/ Fri, 26 Mar 2021 17:58:10 -0400 In a situation like this, I believe any previous data collected should be used to help determine the most efficient way to verify the new device. However, I think the altered instrument should be fully verified before moving forward. Although…   Read more»

]]> 7fade030a6ff9d6a3f79e403a64ead4f https://medicaldevicecourses.com/activity/p/21864/ Fri, 26 Mar 2021 17:52:42 -0400 During the second simulation, I found it helpful to first brainstorm all the things we thought could be the problem. From there, we were able to evaluate which were more probable as well as which would be the easiest and…   Read more»

]]> 6e154858eb4df4e625e8e03710e9023e https://medicaldevicecourses.com/activity/p/21635/ Thu, 11 Mar 2021 00:36:20 -0500 In the executing process, I think the most important consideration for a project manager is to have strong communication both within their project team as well as to any other individuals that may play a part throughout the project execution….   Read more»

]]> 6847867c74a66765e311dc4b56d147e7 https://medicaldevicecourses.com/activity/p/21634/ Thu, 11 Mar 2021 00:18:34 -0500 I would think that the planning process is just as important as the mentioned parts of the executing process. Without adequate planning, there would be many challenges including unclear tasks, unfeasible durations and deadlines, and an inefficient project team. However,…   Read more»

]]> 4ce30f187059b3a55b01f2b92ada459d https://medicaldevicecourses.com/activity/p/21633/ Wed, 10 Mar 2021 23:55:51 -0500 I think poor communication would be a major reason for a project to fail. Communication is necessary during all aspects of the project, and without it there would be much difficulty in completing the project successfully. In the Initiation stage,…   Read more»

]]> 91f16905fe25800a6396b552d997e76e https://medicaldevicecourses.com/activity/p/21526/ Fri, 05 Mar 2021 19:37:14 -0500 In dealing with failures, I think the first step is to list out every aspect that may be causing the failure. From there, the aspects can be prioritized based on which seem more probable to cause the failure as well…   Read more»

]]> da45ebc0967dca41e10c11cc4a949799 https://medicaldevicecourses.com/activity/p/21525/ Fri, 05 Mar 2021 19:12:28 -0500 I think the engineers and manufacturing individuals should be included in developing the design inputs. These individuals would be able to best ensure that the design inputs created are within the abilities of both those designing and manufacturing the device….   Read more»

]]> 202f737c519c1ceaedf4c439ef4ac880 https://medicaldevicecourses.com/activity/p/21524/ Fri, 05 Mar 2021 18:42:07 -0500 On a previous project to create a protective device for children, the customer wanted the device to look aesthetic or socially acceptable so that children would want to wear it. The challenge of this was that making a device look…   Read more»

]]> 3fdb05b312ab7c09e42eef70c0fe6281 https://medicaldevicecourses.com/activity/p/21441/ Fri, 26 Feb 2021 18:51:10 -0500 I believe having parallel and overlapping tasks can lead to an earlier completion of a project. The Gantt chart allows a project team to determine which tasks depend on others and decide which independent tasks can be completed at the…   Read more»

]]> 6665ce2819dc3694051868ad4d26b648 https://medicaldevicecourses.com/activity/p/21440/ Fri, 26 Feb 2021 18:38:31 -0500 I believe it is a rigid rule that verification takes place during the execution phase of a project. Since verification is done to ensure design outputs meet design inputs, beginning verification earlier during the planning phase would not be ideal…   Read more»

]]> 01033d03cd181ef09cd20199e10174c2 https://medicaldevicecourses.com/activity/p/21439/ Fri, 26 Feb 2021 18:16:01 -0500 I do not have industry experience, however, during my senior capstone design project, we created a work breakdown schedule for our project. During the duration of the project, the pandemic caused many unexpected delays, however the work breakdown schedule allowed…   Read more»

]]> d6e92a25041c1638ce7315bfd047a930 https://medicaldevicecourses.com/activity/p/21373/ Fri, 19 Feb 2021 21:32:01 -0500 During my capstone senior design project, my advisor explained the difference between verification and validation as verification is performance testing to ensure design outputs meet the design inputs while validation is simulated use testing to ensure that the device created…   Read more»

]]> 83b8511260b6b21d30a390eaf00b0815 https://medicaldevicecourses.com/activity/p/21372/ Fri, 19 Feb 2021 20:29:31 -0500 I previously interned at a small, additive manufacturing start up company. Due to the size, the project team generally included everyone in the company. This created a highly interpersonal culture in the organizational where everyone worked together and collaborated frequently and…   Read more»

]]> c86d55ebe2d596f35c021d8fa82c378c https://medicaldevicecourses.com/activity/p/21371/ Fri, 19 Feb 2021 20:03:09 -0500 I believe the planning phase of the project cycle. Although the initiating phase first introduces the project, the planning phase lays out the specifics of the project that the initiating phase does not get into, such as a detailed scope…   Read more»

]]> 1c4e9abeacdba05d13446675208cd265 https://medicaldevicecourses.com/activity/p/21335/ Fri, 12 Feb 2021 21:34:45 -0500 If this was a project in industry, I believe the initial meeting and planning of how to address the challenges presented would have been very similar. My simulation group had all done research and reviewed the necessary information prior to…   Read more»

]]> 97513c6ba46f1f1360b360c3edea39e8 https://medicaldevicecourses.com/activity/p/21334/ Fri, 12 Feb 2021 21:14:23 -0500 I previously had an internship with an additive manufacturing company with a project-based organization. For this company, I believe it was the best option due to the size of the company. It was a very small company so a functional…   Read more»

]]> b28e90e8b1f316cbb9ae96d36ffd79e7 https://medicaldevicecourses.com/activity/p/21333/ Fri, 12 Feb 2021 21:01:29 -0500 I do not work in industry yet, but I believe I would be most suited for either a matrix or project-based organization. I enjoy working in groups with individuals who have different focuses or experience. I feel that I work…   Read more»

]]> ea0af9da16c04049b4f4b5dd5098e1c6 https://medicaldevicecourses.com/activity/p/21271/ Thu, 04 Feb 2021 18:19:48 -0500 I believe a unified theory for PM can only potentially exist in a very general form. For example, the text for the course, the PMBOK Guide, discusses PM techniques in a general form but within any specific company these would…   Read more»

]]> ed852076f26ab15d1dcda14115ac5835 https://medicaldevicecourses.com/activity/p/21270/ Thu, 04 Feb 2021 18:05:10 -0500 I believe the biggest problem from situations like a pandemic would be unavoidable delays in the schedule. As previous comments pointed out, this will create delays in shipping/receiving deliveries due to more individuals working from home than normal conditions.  In…   Read more»

]]> 9afe73fb014b42229cd681b398c5afa6 https://medicaldevicecourses.com/activity/p/21269/ Thu, 04 Feb 2021 17:55:02 -0500 I believe a matrix organization would be the most efficient in regards to project outcome and team coordination due to the management of resources limiting the duplication of those resources and knowledge transfer between projects as well as departments. Although…   Read more»

]]> 58d4a43f5f1ff9623fa780356bcc4f8a https://medicaldevicecourses.com/activity/p/21211/ Sat, 30 Jan 2021 19:02:32 -0500 For a new project manager, I believe communication is the most important. Although there are many other emotional skills that are possibly more important for a leader, for a new PM I think the best way to learn the skills…   Read more»

]]> d5138dd623b7bbf79f40d74782251dc4 https://medicaldevicecourses.com/activity/p/21210/ Sat, 30 Jan 2021 18:44:48 -0500 I do not think the world is moving towards a global regulation system. Although a global system could potentially benefit highly developed countries with more advanced medical systems (for example, some comments discussed improving import/export of medical devices), I think…   Read more»

]]> be477585ba29203649393c84670c4540 https://medicaldevicecourses.com/activity/p/21209/ Sat, 30 Jan 2021 18:33:13 -0500 I agree with many of the comments that communication and organization skills are important. I believe the most important skill to be a successful PM is to be a team player. As a leader, communication and organization are very important…   Read more»

]]> 0bd79b332a0516186699cb7014044110 https://medicaldevicecourses.com/activity/p/21125/ Fri, 22 Jan 2021 18:21:01 -0500 During the early period of the Covid-19 pandemic, I was working as a prototype designer. I was primarily communicating with clients through email with occasional phone calls. I found it challenging to provide and receive feedback on designs as there…   Read more»

]]> 8fd1ea3d09e31d6d4e7f22df39daba5c https://medicaldevicecourses.com/activity/p/21123/ Fri, 22 Jan 2021 18:08:21 -0500 During my Capstone senior design project, my team rotated the role of PM so that each of us had an opportunity to act as PM and learn the role. This differs from many of the experiences discussed in the sense…   Read more»

]]> 54596653a6ad7177c30c8a6647dfcbfd https://medicaldevicecourses.com/activity/p/21121/ Fri, 22 Jan 2021 17:55:52 -0500 During an internship with an additive manufacturing company I held a project management role in a new small project. I worked with a modified version of the Agile PM technique in which we initially planned the expected chronology of the…   Read more»

]]> 3a9ffb9a52a8a8c9a980f4ba7514ae83 https://medicaldevicecourses.com/activity/p/19227/ Mon, 02 Dec 2019 00:54:22 -0500 I agree with most of the comments regarding buying a meal for a physician, I think it is only acceptable to pay for the meal for those involved in the discussion of any project or work issues. Anyone additional who…   Read more»

]]> 96e02516e9b6d67ab12d5d5583d420cd https://medicaldevicecourses.com/activity/p/19226/ Mon, 02 Dec 2019 00:39:07 -0500 I enjoyed this course a lot, I found all of the information very useful and it gave me a good idea of what types of positions I might be interested in working in within companies. I also liked the order…   Read more»

]]> 647998529aaafbbaaba805d2f6c7b15d https://medicaldevicecourses.com/activity/p/19225/ Mon, 02 Dec 2019 00:29:16 -0500 I have not worked in a company that has hired consultants, however I think consultants would be most on short term projects. If a project requires extra people working on it or someone with a specialized skill set, but the…   Read more»

]]> 83dd69b3db73f22d5afa960e9ed0eee9 https://medicaldevicecourses.com/activity/p/19159/ Sun, 24 Nov 2019 03:23:31 -0500 I have not had this experience in industry, but I have been working on my senior design project with two direct advisors. The biggest conflict I have had are that different tasks are prioritized by each advisor. The deliverables required…   Read more»

]]> cc0c90fd4fc2952ee62f3847e076b01f https://medicaldevicecourses.com/activity/p/19158/ Sun, 24 Nov 2019 02:47:21 -0500 I would prefer to work in a matrix organization for the transfer of information benefits. It would be important to ensure that the schedule are managed well between departments and projects to avoid conflicts between them. But I think the…   Read more»

]]> 5fc57f2957d732a5982080115c018607 https://medicaldevicecourses.com/activity/p/19157/ Sun, 24 Nov 2019 02:05:57 -0500 I would like to work in a matrix organization because of the ease of transferring information between projects and departments. Though there may be scheduling conflicts and issues with any individual having multiple bosses to answer to, I think the…   Read more»

]]> 797ea4c1f8c8fb4eff9ffa66134d9f1b https://medicaldevicecourses.com/activity/p/19080/ Fri, 15 Nov 2019 23:13:32 -0500 Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the past? Which do you find the most beneficial or prefer to use…   Read more»

]]> 4efc3a32d62c0626631e21a17ec49c92 https://medicaldevicecourses.com/activity/p/19079/ Fri, 15 Nov 2019 23:01:33 -0500 As the previous comments have pointed out, ISO 14971 governs risk management in medical device companies. The major requirements ISO 14971 sets for medical device companies are a safe design of the medical device to remove risk, protective measures for both…   Read more»

]]> 3fcd88569e681709633343dc6b45c177 https://medicaldevicecourses.com/activity/p/19078/ Fri, 15 Nov 2019 22:22:23 -0500 Similar to the scalpel example in the lecture, I think there are many surgical tools where the risk must be accepted. For tools such as bone drills and saws,  taking away the dangerous aspect of the tool would also remove…   Read more»

]]> 72ffc55acb6504424ed947ba8d2343ec https://medicaldevicecourses.com/activity/p/19020/ Fri, 08 Nov 2019 18:39:37 -0500 A simple example I can think of is a surgical wrench. This device would definitely require a torque test to ensure that it can apply the torque necessary for the procedures it’ll be used in. In addition to that, there…   Read more»

]]>