https://medicaldevicecourses.com/members/es446/activity/ Activity feed for es446. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 c4b7fcf28f8e1f66d7f81730f88cece9 https://medicaldevicecourses.com/activity/p/20034/ Mon, 04 May 2020 03:23:45 -0400 As someone who has been working in the medical device industry for a few years now, I found the material in this course to be very relevant to my day-to-day life, much more so than any other course I took…   Read more»

]]> 59fcf07b835a5a2044dac14cf94333ff https://medicaldevicecourses.com/activity/p/20006/ Fri, 01 May 2020 02:15:38 -0400 I also agree that the motivation level of the project manager can definitely have a significant impact on the team’s motivation. However, this motivation has to show through the project manager’s actions rather than just their words. The project manager…   Read more»

]]> 6679596cee46c2457c1dd71173a2894c https://medicaldevicecourses.com/activity/p/20001/ Wed, 29 Apr 2020 20:33:01 -0400 I can see how there is a relationship between having exciting and challenging work, and being recognized for that work. It makes sense that someone who has had many opportunities to tackle new, challenging projects for the company receives more…   Read more»

]]> 05d816dd4aac00417dee34185a4cbf6b https://medicaldevicecourses.com/activity/p/19964/ Mon, 27 Apr 2020 02:02:19 -0400 One of the biggest motivators in my career has been the people I work with. I’m fortunate to be working on a team of very passionate, hardworking individuals who I get along with well, which motivates me to put in…   Read more»

]]> cd279b46c2ca96ffcf9aecade3bd4ac7 https://medicaldevicecourses.com/activity/p/19963/ Mon, 27 Apr 2020 01:13:12 -0400 A company can encourage employee retention by addressing the factors that motivate employees to stay at their jobs, as we discussed in this week’s lecture. The most influential of these factors are exciting and challenging work, opportunities for career advancement,…   Read more»

]]> 3b9996ac7f7b318f610907b38b1fa030 https://medicaldevicecourses.com/activity/p/19959/ Mon, 27 Apr 2020 00:03:45 -0400 I think that whether working overtime is associated with more or less motivation depends on why the individual is working longer hours. If they are genuinely passionate about their work and strive to go above and beyond, then it can…   Read more»

]]> 106b098b1b29006c6561cd385bed1a1b https://medicaldevicecourses.com/activity/p/19911/ Mon, 20 Apr 2020 03:02:13 -0400 It is important during a project that all members of the team are aware of what communication is expected of them, and how often, and this can definitely depend on the company’s organization. For instance, during a project I worked…   Read more»

]]> 8b66725de544f135ea10963b0a8124e2 https://medicaldevicecourses.com/activity/p/19907/ Mon, 20 Apr 2020 00:57:38 -0400 Quality Assurance involves performing activities necessary to ensure quality is being continuously maintained and improved on, and Quality Control involves actually identifying and measuring quality, but both are part of the overall Quality Management System within an organization. Within a…   Read more»

]]> 87c831e328d15192c5a75625e79e88ed https://medicaldevicecourses.com/activity/p/19901/ Mon, 20 Apr 2020 00:00:33 -0400 I am also in agreement that a new employee should not be hired in this case. Interviewing and selecting a good candidate, then having to train them on the job all to cover just a 3 month absence is counterproductive…   Read more»

]]> e3e184b1d860c640e7a6146d0935a980 https://medicaldevicecourses.com/activity/p/19853/ Mon, 13 Apr 2020 02:43:45 -0400 Many of the insulin therapy products used by individuals with diabetes can be considered combination products. The insulin itself is considered a drug, since it has the metabolic effect of lowering blood sugar, and the mechanism of administering the insulin…   Read more»

]]> f6a2bdba82bf25705ba349ef3af27efa https://medicaldevicecourses.com/activity/p/19847/ Sun, 12 Apr 2020 23:31:26 -0400 On several occasions during projects I’ve worked on, our project manager created a spreadsheet listing all the team members and when they were planning on taking PTO. This was located in the shared file drive, so every once in a…   Read more»

]]> 1bcc65295917a48d4af074d84d984590 https://medicaldevicecourses.com/activity/p/19838/ Sun, 12 Apr 2020 18:46:57 -0400 I worked on a project at my company involving a product that varied in design depending on the hospital’s preferred configuration, so there were hundreds of components in our catalog for this product. Several times during the course of the…   Read more»

]]> 09a9c5baeea149692e98de05b68591df https://medicaldevicecourses.com/activity/p/19795/ Mon, 30 Mar 2020 01:40:35 -0400 As a few of the posts above have stated, while the design team is working on the product development project, there should be a production team working in conjunction to ensure that production is ready to manufacture the product once…   Read more»

]]> 6769b55e411fae0078d54201f10ec66b https://medicaldevicecourses.com/activity/p/19793/ Mon, 30 Mar 2020 01:09:09 -0400 I think that since hazards are undesirable to come across in your project, then by definition a risk has a negative connotation, but the process of risk management is very beneficial and should be viewed in a positive light. Identifying…   Read more»

]]> bdfe2a4fc4113dae596597a69a8d4dec https://medicaldevicecourses.com/activity/p/19756/ Wed, 25 Mar 2020 01:04:52 -0400 Change Control is implemented as part of the Monitoring & Controlling process of a project, and occurs throughout the entirety of the project. It basically entails measuring the current state of the project against the baseline that was established during…   Read more»

]]> 2679ab877ef064e07e2e1b73705ed49f https://medicaldevicecourses.com/activity/p/19716/ Sun, 15 Mar 2020 17:41:32 -0400 As the posts above have stated, metrics are crucial in order to obtain the quantitative status of a project. Because of this, knowledge of software that can be used to track metrics is a useful skill for a project manager…   Read more»

]]> 2d349b125c5f7d8942b93f23e93b5f9b https://medicaldevicecourses.com/activity/p/19711/ Sat, 14 Mar 2020 18:10:35 -0400 From my experience, at my company the WBS is integrated into the project’s Gantt Chart. The highest level of the Gantt Chart will consist of the product development phases (Planning, Design and Development, etc.), which are each broken down into…   Read more»

]]> 9ce3381e6772697cd11c92215abf57b2 https://medicaldevicecourses.com/activity/p/19710/ Sat, 14 Mar 2020 16:03:05 -0400 As someone who is currently working in the medical device industry, I find the information discussed in this course to be very relevant to my day-to-day job. Even if you are an engineer, like myself, and not a project manager,…   Read more»

]]> a0c5371310e83aab693c129c2ee5118a https://medicaldevicecourses.com/activity/p/19676/ Mon, 09 Mar 2020 01:20:52 -0400 At my company, we manufacture heart lung machines and disposible tubing kits to be used with the machines. These tubing kits are customized depending on the components and configuration desired by the hospital, so the customer’s input is directly translated…   Read more»

]]> 64ad48dcc21e81e80884a5be872aebb7 https://medicaldevicecourses.com/activity/p/19663/ Sat, 07 Mar 2020 19:38:22 -0500 As many of the posts above stated I agree that a lack of communication within a project team can be detrimental to the team’s progress. That’s why I also agree that establishing the expectations for communication in the beginning of…   Read more»

]]> dd05a0201c0c2f8153696c528e0a39f3 https://medicaldevicecourses.com/activity/p/19648/ Wed, 04 Mar 2020 01:14:33 -0500 Design Validation is actually not always required in the product development process – a product may be sufficient with just Design Verification if it is a product that would not necessitate a clinical trial, i.e. a Class I device. For…   Read more»

]]> 3c60b506d9d30dfbb38862317462bbf8 https://medicaldevicecourses.com/activity/p/19612/ Sun, 01 Mar 2020 21:04:55 -0500 A challenge I’ve often faced when submitting a Change Notice at my company Getinge is that obtaining approval from all the required reviewers can take a while, since these reviewers are usually functional managers with many other responsibilities on their…   Read more»

]]> 729c54261f8d9f5049a55781f80d3ac4 https://medicaldevicecourses.com/activity/p/19611/ Sun, 01 Mar 2020 18:57:12 -0500 Logging work proved to be very useful in my job when I was helping develop a Design Verification test. My team and I were tasked with creating a test to measure the degree of spallation (tiny particulates breaking off of…   Read more»

]]> bb3c6a18c189b6ff537138ff853bb101 https://medicaldevicecourses.com/activity/p/19594/ Wed, 26 Feb 2020 23:36:54 -0500 Gantt Charts are very useful as a project management tool because they provide a visual depiction of the tasks that need completion. Similar to how a scatterplot can be used to see an overview of numerical data, a Gantt Chart…   Read more»

]]> b4d6aff2cf5b5676d10c2a43ceb56e3b https://medicaldevicecourses.com/activity/p/19563/ Sun, 23 Feb 2020 21:27:24 -0500 In my opinion both designing and executing a timeline can be difficult, and the difficulty of executing a timeline is dependent on its design. A well-designed timeline is the foundation of a project, and with clearly defined responsibilities and tasks…   Read more»

]]> 9e0593f913136724794180e9f5dfb207 https://medicaldevicecourses.com/activity/p/19540/ Sat, 22 Feb 2020 20:38:06 -0500 The first steps in the risk management process are Assess and Evaluate, meaning the risks of your project or product and the severity/occurrence of those risks must be identified before you can manage them. In this week’s lecture Dr. Simon…   Read more»

]]> 63756b8d4df30c66d7ecad30212031d1 https://medicaldevicecourses.com/activity/p/19538/ Sat, 22 Feb 2020 17:09:27 -0500 A useful method of handling scope creep which was mentioned in this week’s lecture is to create a Scope Management Plan during the Planning phase of the project. The Scope Management Plan can be part of the DDP and will…   Read more»

]]> 86e818587217c2dd7492a6cb1cb308e6 https://medicaldevicecourses.com/activity/p/19509/ Mon, 17 Feb 2020 01:47:06 -0500 The impact of Coronavirus on Chinese manufacturing is proving to have a huge impact also on global manufacturing, because many companies depend on Chinese-made parts for their own products. From a management perspective, this is unfortunately an issue that is…   Read more»

]]> d729c4646a10ed90dbef9635931685fc https://medicaldevicecourses.com/activity/p/19501/ Sun, 16 Feb 2020 23:03:21 -0500 At my current job I worked on a project where our project manager had two methods for tracking progress: One was a traditional timeline in the form of a Gantt Chart, and the other was a list of “off-timeline” tasks…   Read more»

]]> 839abd3c4af1e094ecc18fdc80d30166 https://medicaldevicecourses.com/activity/p/19500/ Sun, 16 Feb 2020 16:58:04 -0500 I also agree that in a real industry project there would be clearer communication within the team because they could meet face-to-face. However I think that since this particular simulation involves laboratory testing, there would be additional restrictions if it…   Read more»

]]> 208d986b6a2c4b33bde1c4ebf43b6b2c https://medicaldevicecourses.com/activity/p/19434/ Sun, 09 Feb 2020 19:21:53 -0500 I agree with ad487 in that as a project manager, it is important to understand that obstacles can and will occur during the course of the project. Oftentimes these obstacles are unexpected, and can cause major delays in the completion…   Read more»

]]> a84e89830cf393aab37306202862d009 https://medicaldevicecourses.com/activity/p/19417/ Sat, 08 Feb 2020 16:27:34 -0500 My company had a project based in Germany, with engineers from the United States and Turkey hired to support. The US side of the team was comprised of several engineers, including myself, and a project manager who would travel between…   Read more»

]]> 247d04560f1f815cbacd7c80fe583435 https://medicaldevicecourses.com/activity/p/19405/ Fri, 07 Feb 2020 00:08:49 -0500 I’ve had the opportunity to work on the output and verification phases of Design Control at the company I work for. The output phase mainly involved creating specifications for components that went into the device, which allowed me to use…   Read more»

]]> e8bc195fcd05ae83ff2617a8b72af280 https://medicaldevicecourses.com/activity/p/19347/ Fri, 31 Jan 2020 23:27:58 -0500 Like the individual a few posts above this post, I also am working at Getinge. I agree that it can be considered a functional organization in most cases. When it comes to routine operations, Getinge has specific departments that handle…   Read more»

]]> 4d50e4e622be8adb955e279e2793d689 https://medicaldevicecourses.com/activity/p/19346/ Fri, 31 Jan 2020 23:21:50 -0500 I believe it is quite problematic if an advertisement makes claims about the extreme activity a joint replacement can withstand if that level of activity was not intended by the manufacturer. Pushing the limits of medical devices past what has…   Read more»

]]> 1e234d86b7cdc9886d83abd403e7ddc0 https://medicaldevicecourses.com/activity/p/19345/ Fri, 31 Jan 2020 23:07:49 -0500 At the company I work for, the remediation project that I had originally been hired to work on was just cancelled a few days ago. Luckily I had already been assigned to another project, but regardless I understand how it…   Read more»

]]> 95dcc3a1a34443ca69ce566e3486e8ea https://medicaldevicecourses.com/activity/p/19308/ Sun, 26 Jan 2020 23:50:47 -0500 The implementation of the new EU MDR will pose a challenge for medical device manufacturers who sell in the European Union since, on top of any existing projects, they now must invest time, money and resources into ensuring their devices…   Read more»

]]> 1126e2b5be5d5b0c63580ba5f7d78f2d https://medicaldevicecourses.com/activity/p/19280/ Fri, 24 Jan 2020 01:04:54 -0500 One product that can potentially be classified as a wellness device (and that I am currently using as I type this post) is blue light blocking glasses. These types of glasses have surged in popularity in recent years as electronic…   Read more»

]]> 6df13737a5076c8b48f60177fe8f821b https://medicaldevicecourses.com/activity/p/19278/ Fri, 24 Jan 2020 00:00:59 -0500 It is very important to ensure that every member of a project team is aware of any challenges other members have overcome in order to avoid repeated mistakes. In many instances, each individual member of a project team will end…   Read more»

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