https://medicaldevicecourses.com/members/mrlee5/activity/ Activity feed for mrlee5. Fri, 24 Apr 2026 20:02:28 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7d6e3e6590fc40dbb9a6d347ca169f1e https://medicaldevicecourses.com/activity/p/22783/ Sun, 27 Jun 2021 16:28:50 -0400 Posted by: @au45 Both matrix and project based organizations have their advantages and disadvantages as a project manager. As a project manager I feel a significant factor in finding success is being able to create a harmonious work environment where…   Read more»

]]> 97d4e4b1d0fc3cb7dd55a837b5acb65d https://medicaldevicecourses.com/activity/p/22782/ Sun, 27 Jun 2021 16:22:45 -0400 The company I work for would probably fit best in a matrix organization category. We specialize in ion channel drug discovery, so most of our work is focused on identifying promising compounds in the pre clinical stage that we can…   Read more»

]]> 80bb30e5ed8071e2414f9a9e53f2fa6b https://medicaldevicecourses.com/activity/p/22781/ Sun, 27 Jun 2021 16:20:32 -0400 Posted by: @jk299 So the company I would like to be in is a matrix organization because a matrix organization is one that” brings together employees and managers from different departments to work toward accomplishing a goal” it is a…   Read more»

]]> 2b34349f4cc695945839598504999860 https://medicaldevicecourses.com/activity/p/22714/ Mon, 21 Jun 2021 23:35:18 -0400 @jej7 I agree, lack of resources can lead to failures in risk assessment. I like the example that was given, with a poorly managed complaints department at a medical device company. This can be even further looked at from the…   Read more»

]]> fa77a8c676f33fc04ee01224ad99a227 https://medicaldevicecourses.com/activity/p/22713/ Mon, 21 Jun 2021 23:29:38 -0400 @zbw2 spoke on a good system to use when considering risks. They mention that during the brainstorming part of the process, priority should be put on risks associated with the most critical parts of the device that can’t be avoided,…   Read more»

]]> 8b6f91ebdb65129517d010916be4814f https://medicaldevicecourses.com/activity/p/22712/ Mon, 21 Jun 2021 23:24:55 -0400 @amandaally1029 well said. Risk assessment is a very important consideration. It puts into perspective the severity and harmful events that can be associated with the use of the device. Deciding whether the risks are low, severe, or moderate can help…   Read more»

]]> 9b003fd324f6c8c3ec276aebe2fbf9fd https://medicaldevicecourses.com/activity/p/22667/ Sun, 13 Jun 2021 18:20:13 -0400 @llefevre you did a good job highlighting regulations on medical devices in different areas across the globe. What stands out most to me is the information you provided from the World Health Organization on countries in African regions. With only…   Read more»

]]> 8687c66ced5e94a24e12f521e18b88ff https://medicaldevicecourses.com/activity/p/22666/ Sun, 13 Jun 2021 18:13:40 -0400 Posted by: @zbw2 China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA “revised [their]…   Read more»

]]> 53d4fd9c0459b99b2d7cdb3da3b63f4c https://medicaldevicecourses.com/activity/p/22665/ Sun, 13 Jun 2021 18:11:32 -0400 Design controls are used to ensure that medical devices meet user needs, intended uses, and specified requirements. These controls usually apply to the design of the product, as well as associated manufacturing processes. Though they aren’t required for all medical…   Read more»

]]> 7bc6628c0285eed7bd2bf93c8e7a5d2d https://medicaldevicecourses.com/activity/p/22609/ Mon, 07 Jun 2021 00:31:31 -0400 For the different roles in clinical research, I believe that having a clinical background would be a plus, but not necessarily a requirement. When considering positions like a statistician, you wouldn’t think that it would be too important to your…   Read more»

]]> 0e23656463aa3fb59246c52506f7cec7 https://medicaldevicecourses.com/activity/p/22608/ Mon, 07 Jun 2021 00:29:14 -0400 Posted by: @kc4310 @amd29, I think you’re suggesting the multi-billion dollar pharmaceutical industry has little value?  Which I would like to agree, but there is strong evidence to suggest otherwise.  Pharmaceuticals provide a host of benefits for disastrous conditions of…   Read more»

]]> 646363b7eebd2825dbaa9f030bf6d1dd https://medicaldevicecourses.com/activity/p/22606/ Mon, 07 Jun 2021 00:10:49 -0400 Clinical testing is an important part of the pharmaceutical drug development process. It helps researchers determine if a new treatment or medical device is safe and effective in people. Testing gives better insight into proper dosage, effects throughout the body,…   Read more»

]]> a83ccbfded11d42028a3be6214da0788 https://medicaldevicecourses.com/activity/p/22569/ Sun, 30 May 2021 21:33:40 -0400 Posted by: @dyc6 I think the best advertisements really know how to speak to their audience. I remember watching tv ads featuring McDonald’s Happy Meals as a kid, where they would show the different toys available in the meal, and…   Read more»

]]> c736a60e6ffbd78e0e11408cbfab029f https://medicaldevicecourses.com/activity/p/22568/ Sun, 30 May 2021 21:29:23 -0400 Unique, creative ideas that are entertaining usually works best when trying to get an audience’s attention. I personally can’t think of one of my favorite ads, but Nike has released a few commercials I like which draw a sense of…   Read more»

]]> d5d1ad6cae531bb6730c54c0421d0d49 https://medicaldevicecourses.com/activity/p/22567/ Sun, 30 May 2021 21:23:20 -0400 As many of you have noted, I don’t think that I have looked deep enough to understand the risk behind accepting a position based on company type. I think that the role and experience you’ll be obtaining from the role…   Read more»

]]> 85d40bd07cb705a5fd29d5ad7d7c9e54 https://medicaldevicecourses.com/activity/p/22511/ Sat, 22 May 2021 18:08:12 -0400 Posted by: @mem42 I haven’t witnessed anything exceptional, but in my other classes, we had a lecture about ethics and we discussed about different situations. As for my personal experience, I think that when you work in the industry you…   Read more»

]]> 66af91880016c89b401cd655bac0e595 https://medicaldevicecourses.com/activity/p/22510/ Sat, 22 May 2021 17:51:45 -0400 Quality management is a vital part of businesses, especially those that deliver products that could affect an individual’s health like those that come from the biotechnology industry. Medical devices and drug components all rely on the nature of QA and…   Read more»

]]> c099a6a221c39dc3d3dac26239e93128 https://medicaldevicecourses.com/activity/p/22509/ Sat, 22 May 2021 17:41:43 -0400 @ronakmandaliya made some points that I agree with. Quality specialists and engineers are some of the most important contributors to a business. Research and development/discovery can bring about most of the issues that would require quality engineering oversight, though other…   Read more»

]]> 4b1c94f5235d892d32cb3f38fde2c455 https://medicaldevicecourses.com/activity/p/22477/ Sun, 16 May 2021 21:35:45 -0400 There are scientists who are developing and using animal-free methods that are actually shown to be relevant to human health for studying diseases and testing products. There is a variety of cell-based tests and tissue models that can be used…   Read more»

]]> ab4f8fb2083840d38df3c14d5506dd5d https://medicaldevicecourses.com/activity/p/22476/ Sun, 16 May 2021 21:26:53 -0400 @puneet says it perfectly. Though animal testing can be a bit unethical depending on the perspective, it may be something that would be difficult to eliminate. Animals have been used for many years in research and with their use, there…   Read more»

]]> e3e64daa6a11ab04fff9f8df18ac07f9 https://medicaldevicecourses.com/activity/p/22475/ Sun, 16 May 2021 21:20:38 -0400 Posted by: @llefevre I’ve had a fortununate opportunity to work with both academia and industry in terms of research and I noticed many parallels but there are some subtle differences that I will outline. While working in an industry I…   Read more»

]]> ee27545abd3d2ecdb500447d013ca7ee https://medicaldevicecourses.com/activity/p/22435/ Sun, 09 May 2021 23:51:27 -0400 It is interesting seeing and hearing everyone’s perspective. Since BME would in a sense combine expertise in biology and engineering, I think that being part of this field of work would be very lucrative. Research continues to tranform the field,…   Read more»

]]> 4d1a38e2687a94da5f4cba1c9e0f8673 https://medicaldevicecourses.com/activity/p/22434/ Sun, 09 May 2021 23:45:00 -0400 @gsharma I agree with some of the points you made. Sometimes it seems that the more education you attain, the better off you are in the course of your career. Higher levels of education can help you move up the…   Read more»

]]> 4e1379f2b2ed3f18a455a3cf0a0e14e4 https://medicaldevicecourses.com/activity/p/22432/ Sun, 09 May 2021 23:35:31 -0400 Industry and academia can be a bit different, when considering the goals of each field. But, research holds an important role throughout any field. Sometimes both can go hand in hand if you can move forward the research and make…   Read more»

]]> 31989e4e6b0611038aab40e224022eb1 https://medicaldevicecourses.com/activity/p/22431/ Sun, 09 May 2021 23:29:04 -0400 @myton provides some good remarks. Industry and academia can be a bit different, when considering the goals of each field. But, research holds an important role throughout any field. From my experience, academic research prepared me for actual experiences and work…   Read more»

]]> cd9bc1e5211de1253abe36880c993a77 https://medicaldevicecourses.com/activity/p/22257/ Sat, 24 Apr 2021 19:39:17 -0400 I haven’t had too much experience with procurement management, but it seems to have significance directed towards costs and vendors. Normally it involves acquiring quality goods and services from preferred vendors within a specified budget. Something that I think is…   Read more»

]]> b525fe07d1e26a787977f0ef337c57e8 https://medicaldevicecourses.com/activity/p/22256/ Sat, 24 Apr 2021 19:29:45 -0400 Communication management is a very important knowledge area, especially considering how vital communication can be. It usually includes the processes necessary to ensure that the information needs of the project and its stakeholders are met. Project managers spend most of…   Read more»

]]> 12bdd74d8b60115b17deda95e0260486 https://medicaldevicecourses.com/activity/p/22255/ Sat, 24 Apr 2021 19:15:42 -0400 @ashleyfitzsimmons provided a great example. Clearly defined responsibilities will make handling discrepancies that may occur way easier. Aside from this, I think that another plus would be cost efficient and reliable suppliers. @jla33 gave a good list of things to…   Read more»

]]> a08d9031e8decc49f41b56b016281fd0 https://medicaldevicecourses.com/activity/p/22155/ Sun, 18 Apr 2021 17:02:07 -0400 Project cost management is an important area of knowledge in the planning process group, since costs are estimated, and the budget is defined. It includes the processes involved in planning, estimating, budgeting, financing, funding, managing, and controlling costs. It is…   Read more»

]]> 49630915a1fc0767d56f773b44f56c53 https://medicaldevicecourses.com/activity/p/22154/ Sun, 18 Apr 2021 16:55:29 -0400 @delany you made a good point, not all projects make it to this phase so that’s important to understand. Sometimes events occur that force the project to end in the middle of its cycle. I agree that it’s important to…   Read more»

]]> f661005116c7d2b1bc3ddd762b510f0a https://medicaldevicecourses.com/activity/p/22153/ Sun, 18 Apr 2021 16:50:53 -0400 Posted by: @ashleyfitzsimmons One important component of closing is creating a project closure report. This project closure report lists every activity that is required in order to close the project. This report enables the project manager and the team to…   Read more»

]]> 6c0d98a5b0cbcbb518e1a140ab0fa0dc https://medicaldevicecourses.com/activity/p/22081/ Mon, 12 Apr 2021 03:07:42 -0400 @nicoleb you make a good point. A big part of planning is understanding the possibility of absence, as well as timeline flexibility. There should be a fair way to incorporate vacation/absence in a manner that wouldn’t set back the project….   Read more»

]]> 50e89fe4daac49c011164803761c8e44 https://medicaldevicecourses.com/activity/p/22078/ Mon, 12 Apr 2021 02:59:03 -0400 @eowinomsm-edu agreed, being on the same page is the first step. Communicating effectively allows everyone to work on one accord, and keeps conflict and confusion from hindering the project. It also ensures key players are aligned on project goals and…   Read more»

]]> c9a280866a9709e6998fd6f9b4b8daf9 https://medicaldevicecourses.com/activity/p/22071/ Mon, 12 Apr 2021 02:51:19 -0400 Posted by: @ala26 Communication is extremely important for a successful outcome. Each member of a team should know that they must communicate if they have any issues where they cannot make the deadline. If you have a unresponsive member, the…   Read more»

]]> 7b1b0ba05adc7836e7c991cd82726d10 https://medicaldevicecourses.com/activity/p/21966/ Sun, 04 Apr 2021 20:06:32 -0400 Posted by: @niya-j A project cannot be implemented if there is no team to execute the plan. In the given scenario, I believe it is worth it to revisit the initial plan to have the project be successful and completed…   Read more»

]]> 839fc71392f5586075a8404297e71a61 https://medicaldevicecourses.com/activity/p/21965/ Sun, 04 Apr 2021 19:52:44 -0400 Posted by: @llefevre A milestone is a significant point or event in a project, also milestones have zero duration because they represent a specific point or event. It’s inevitable that not all milestones are going to be met on time…   Read more»

]]> e9935177a925c26145bc09efcebee553 https://medicaldevicecourses.com/activity/p/21962/ Sun, 04 Apr 2021 19:43:37 -0400 There may be a range of causes that lead to missed milestones, including technical issues, environmental issues, or even improper planning. Sometimes milestones can be missed for reasons that are completely out of the project team’s control. I think these…   Read more»

]]> 7ba0e661ac970846014ed430de099b43 https://medicaldevicecourses.com/activity/p/21927/ Mon, 29 Mar 2021 02:57:16 -0400 Posted by: @jmbellanich I think that the longer a project goes, the smaller changes the project team can make to the schedule, budget, and design without consequence. To give an example, it would be difficult to change to make large…   Read more»

]]> 1e5084e8c389633a59534ceeafcd40fb https://medicaldevicecourses.com/activity/p/21925/ Mon, 29 Mar 2021 02:48:12 -0400 @Puneet provides a great explanation. The planning phase is one of the most important in the project lifecycle. It would make sense to identify a good project manager in this phase being that planning is needed to identify desired goals,…   Read more»

]]> 35f4bb11a0ca5acf10287ddc27ad791d https://medicaldevicecourses.com/activity/p/21924/ Mon, 29 Mar 2021 02:41:12 -0400 @delany makes a great argument. Planning and preparations are notably the first part of the PDCA cycle. Being prepared is vital if you have hopes of success for your project. Lack of communication could also lead to failure. If you…   Read more»

]]> f5afc4158bc9a9e4739c790647b4c4ab https://medicaldevicecourses.com/activity/p/21833/ Mon, 22 Mar 2021 02:02:37 -0400 I believe that prioritizing is important in a matrix organization because there is a possibility that you’ll work on more than one project at once. This can lead to overload on team members, considering that the project workload is often…   Read more»

]]> 4427184def3e3fbb6906a40d6248db05 https://medicaldevicecourses.com/activity/p/21831/ Mon, 22 Mar 2021 01:47:24 -0400 @ps689 I also work for a company that utilizes a matrix organization structure. Things can pickup pace and be a bit confusing at times because of the multiple managers and projects. As you highlighted, scheduling conflicts can be a disadvantage…   Read more»

]]> 98aa070cb1add6bb893df7f637e22c1f https://medicaldevicecourses.com/activity/p/21830/ Mon, 22 Mar 2021 01:37:54 -0400 Posted by: @srg36 I work within a matrix organization, but as Dr. Simon mentioned in his lecture about his experience with a previous company, I would label it as a weak matrix organization. The reason I would call it a…   Read more»

]]> 636e7e9f02bcc5614625d5ec0571829b https://medicaldevicecourses.com/activity/p/21742/ Sun, 14 Mar 2021 20:54:31 -0400 Posted by: @gingeranderson As a project manager, I believe the ideal team would be comprised of someone who is a technical expert, an expert on the regulatory processes of the industry, and someone who is an expert on the jargon…   Read more»

]]> 5be61dc46236722f9985e600ad23ef19 https://medicaldevicecourses.com/activity/p/21741/ Sun, 14 Mar 2021 20:49:23 -0400 Excellent communication skills are vital in the workplace for project management because this helps with time management and efficiency. Being able to communicate well keeps the staff more focused on meeting deadlines. With doing so, staff will be able to…   Read more»

]]> 79dbe94353cfbf92e1b5550a00bfa552 https://medicaldevicecourses.com/activity/p/21740/ Sun, 14 Mar 2021 20:43:33 -0400 Posted by: @delany Organization. Without it, everything will crumble and nothing will be achieved. If a project manager is not organized, deadlines can be missed and work schedules can be thrown off balance. This can lead to a cascade of…   Read more»

]]> c0125d55de3beac66f55defb6e98ed51 https://medicaldevicecourses.com/activity/p/21676/ Sat, 13 Mar 2021 23:44:44 -0500 @akshay-sakariya you make a good point. Communication, and I would probably say organization, are important skills for success in project management. Ensuring that goals are achievable in a specific time frame requires some organization, as well as communication with the…   Read more»

]]> 477e29aef5bdc8ae09ea8795f17af437 https://medicaldevicecourses.com/activity/p/21675/ Sat, 13 Mar 2021 23:44:43 -0500 @smk45 summed it up well. Having a good understanding of projects priority will likely impact the success of the project and overall team response.  It is important for project managers to communicate urgent tasks and ensure that the entire team…   Read more»

]]> 30fc567e20ed7b5ac202d8eec0499404 https://medicaldevicecourses.com/activity/p/21674/ Sat, 13 Mar 2021 23:44:42 -0500 Posted by: @ssbufford Every good project manager has experience as a team member in some compacity. Some individuals luck up and are hired on with companies as project managers straight out of school but I believe most project managers have…   Read more»

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