https://medicaldevicecourses.com/members/ad487/activity/ Activity feed for ad487. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 bf5f4a681688fc6b018f1aeb66c1203a https://medicaldevicecourses.com/activity/p/20004/ Fri, 01 May 2020 01:48:42 -0400 @jjp93 I completely agree with the same interest in CRAs as I find value in performing and monitoring trials that related to medical research. It’s really interesting consolidating the data and analyzing it to manufacture better applications that can be…   Read more»

]]> 847299ec762c7cce87a5c9abf46dd275 https://medicaldevicecourses.com/activity/p/20003/ Fri, 01 May 2020 01:42:57 -0400 Posted by: @talha-chaudhry For the lecture this week, I was fascinated by the results of the study Dr. Simon referenced. The study asked employees why they stayed and worked at the company they are employed at. What motivates them kind…   Read more»

]]> 8d5b47c361a65b3929cdd5f6f31352b4 https://medicaldevicecourses.com/activity/p/20002/ Fri, 01 May 2020 01:22:02 -0400 Sponsors are an integral part of the project as they provide much for the resources required for the project to run. Thus, it is necessary to maintain strong ties and connections to sponsors or else essential funding/capital would not be…   Read more»

]]> 13a6b4b67a3993e4044ef6d185ba0c2b https://medicaldevicecourses.com/activity/p/20000/ Wed, 29 Apr 2020 15:23:06 -0400 Posted by: @ama59 People leave work because of “limited recognition and praise” but they stay for “exciting, challenging work.” If the work is interesting but there is no recognition, will people leave? If the work is uninteresting but they are…   Read more»

]]> d1f0f22fe05bd77ddd3240bf9df8cf3a https://medicaldevicecourses.com/activity/p/19999/ Wed, 29 Apr 2020 15:03:12 -0400 A large part of the reason why Americans put in substantially more work hours compared to other countries is due to the individual company cultures that the workers are situated in. This also varies from industry to industry,  but generally…   Read more»

]]> c00c0f42224eed46fd2b0ce75a3d1496 https://medicaldevicecourses.com/activity/p/19998/ Wed, 29 Apr 2020 14:36:10 -0400 I would be an engineer for a few years to gain the technical experience necessary to understand the ins and outs of the industry. However, my true goal is to work with people so I would want to move into…   Read more»

]]> ce92fb3e6df925902bf3b47cdf9beea0 https://medicaldevicecourses.com/activity/p/19927/ Tue, 21 Apr 2020 03:43:11 -0400 I think it is important to be positive and exude an encouraging and enthusiastic demeanor in order to motivate one’s team mates as a project manager. Nurturing a positive work culture and atmosphere can decrease workers’ stress and thus enable…   Read more»

]]> c8a87550f379271b314110c787ba88aa https://medicaldevicecourses.com/activity/p/19926/ Tue, 21 Apr 2020 03:27:30 -0400 Posted by: @ih37 A non-conforming material report (NCMR) is something that must get taken up with the current vendor to prevent the incorporation of defective equipment into a medical device project. An NCMR is generated by either the quality department…   Read more»

]]> 2762b78a323a0d2c7e13acd2f50885c4 https://medicaldevicecourses.com/activity/p/19925/ Tue, 21 Apr 2020 03:13:52 -0400 There are certainly benefits to employee retention mentioned above such as decreasing resources dedicated to employee training and recruitment costs. Other ways not mentioned is the benefit of preventing competitors from accessing the same knowledge base and talent that you…   Read more»

]]> eaab8e9b909bd660fd68a1b28a711952 https://medicaldevicecourses.com/activity/p/19889/ Sun, 19 Apr 2020 03:00:29 -0400 @gy66 I think that a thorough onboarding process when hiring a new member to fill a spot that is vacating is especially important. If this is not done well, then there can be clear gaps in knowledge that will affect…   Read more»

]]> c4802efd4970db05134a5d316cdbd6b3 https://medicaldevicecourses.com/activity/p/19888/ Sun, 19 Apr 2020 02:52:34 -0400 @ka234 Additionally, I find that in some companies, it falls on certain departments to take on the reactive, “firefighter” issues that are caused by other departments within the company. While working at Johnson and Johnson, I found that my manager…   Read more»

]]> 31d6a9de83182bcb6afcef80d2644553 https://medicaldevicecourses.com/activity/p/19887/ Sun, 19 Apr 2020 02:10:50 -0400 Like someone else said in this thread, if there are other members of the team that have skills that overlap with the one that is on maternity leave, they could take on some additional work load at the appropriate level…   Read more»

]]> e5e9c013b447e65dc322c9277fd6c764 https://medicaldevicecourses.com/activity/p/19846/ Sun, 12 Apr 2020 23:19:57 -0400 While problems in a project’s lifecycle are inevitable, it is vital to have lanes of communication between all members on the team so that they can deal with such problems. A PM can do his/her best to estimate the duration…   Read more»

]]> 483e302057855d26981269a7b516dbb8 https://medicaldevicecourses.com/activity/p/19843/ Sun, 12 Apr 2020 23:03:24 -0400 @shuhrah-chowdhury As you mentioned its imperative for the PM to take into account the level of involvement their team members are in other projects. In this way, they can control scope creep and the workload that should be distributed to…   Read more»

]]> 776a0f436cda0913d65b8d0f5e5576af https://medicaldevicecourses.com/activity/p/19842/ Sun, 12 Apr 2020 22:18:13 -0400 @shuhrah-chowdhury I agree with the statement saying that too much detail and being too specific can sometimes be a pitfall in the planning phase for a project. It is important for all members of a project to understand how tasks…   Read more»

]]> 3f16653571973bc6eb48f271ed1e0550 https://medicaldevicecourses.com/activity/p/19802/ Thu, 02 Apr 2020 00:44:12 -0400 Posted by: @ak977 Design Verification entails that the product you put out is what was actually requested and what the FDA has said is acceptable.Let’s say that the customer wants a product that addresses issues A, B, C, and D….   Read more»

]]> 1bf053d08ee079cf340699dc876858f8 https://medicaldevicecourses.com/activity/p/19801/ Thu, 02 Apr 2020 00:15:10 -0400 Customer input and managing the expectations of project deliverables are very similar in that it is important for the customer to understand the limitations and boundaries within a project. If they do not understand this on a fundamental level, then…   Read more»

]]> e270ec2de78a07da5e1767b614ad22b9 https://medicaldevicecourses.com/activity/p/19800/ Thu, 02 Apr 2020 00:08:27 -0400 I have seen the problem with scope growth in my limited experience working at Johnson & Johnson. While at Ethicon, some individuals on my team get pulled from their normal day-to-day tasks to take on other assignments that other project…   Read more»

]]> 051d77c1d98d4132c1bd18495d9dcef1 https://medicaldevicecourses.com/activity/p/19747/ Mon, 23 Mar 2020 00:26:11 -0400 At where I work, Johnson & Johnson, one of the many organizational process assets we have are task and approval matrices where we document the order/timeline of a task if it undergoes any important timeline changes or description changes. We…   Read more»

]]> e69a498a642594e4440e33b8805e9978 https://medicaldevicecourses.com/activity/p/19746/ Sun, 22 Mar 2020 23:53:04 -0400 According to the lectures from Dr. Simon, a risk is the probability of a hazard which (which is an undesired consequence) of occurring. They are important to discuss when managing a project as it can affect the timeline and the…   Read more»

]]> a2f134a8a83320c10fa1482b8f51c3ca https://medicaldevicecourses.com/activity/p/19745/ Sun, 22 Mar 2020 22:08:17 -0400 It can be quite difficult to estimate task duration if the wrong personnel are not responsible for allocating time for the tasks. For instance, during our mini-simulation, one of the team members who did not have expertise on the task…   Read more»

]]> a5967cb5c5e43db05584c03b04dd9def https://medicaldevicecourses.com/activity/p/19699/ Thu, 12 Mar 2020 04:42:26 -0400 Posted by: @mg482 Posted by: @devarshi-joshi After the development of team how do the execution process works or what does it do during the absence or vacation of an employee or with an personal problem? I believe if there is…   Read more»

]]> 747f7e4d9e8c41f2122e8c497a334ebc https://medicaldevicecourses.com/activity/p/19698/ Thu, 12 Mar 2020 04:35:35 -0400 This is my first time taking a course by Dr. Simon, but the knowledge is already so valuable to my brief experiences in industry. I work as a global supply chain data management co-op at Johnson & Johnson and a…   Read more»

]]> 0693ffdee0798c928ef85fb73f7b55ac https://medicaldevicecourses.com/activity/p/19697/ Thu, 12 Mar 2020 04:29:05 -0400 In agreement with hc255, metrics are important to showing progress on any project and revealing important trends in data within the project that would normally go unseen. Metrics inform management of how the project is doing as a whole and…   Read more»

]]> 0ae814cbf2a4f2cc31842fbd87617ac3 https://medicaldevicecourses.com/activity/p/19644/ Tue, 03 Mar 2020 05:39:06 -0500 Before a project even begins or a team undertakes a task, it is important for the entire team to be on the same page by setting expectations for how the team will communicate, share information and navigate setbacks. These are…   Read more»

]]> 02b86918337904ee869bdb7a186c40bf https://medicaldevicecourses.com/activity/p/19643/ Tue, 03 Mar 2020 05:28:44 -0500 It is extremely important to verify and crosscheck current knowledge and updates in procedure with the old planning procedure. This way, the process will always have the highest efficiency in completing tasks as the method of proceeding with the project…   Read more»

]]> de5d848a474cf87ac419287143bbc78b https://medicaldevicecourses.com/activity/p/19642/ Tue, 03 Mar 2020 04:44:58 -0500 If one employee is absent due to a personal problem or any other issue, it is the duty of management to reallocate the tasks for that individual to the rest of the team. As such, they should be ready to…   Read more»

]]> edcd75dcd34e1b63dd8c60e24994eff8 https://medicaldevicecourses.com/activity/p/19559/ Sun, 23 Feb 2020 19:57:45 -0500 Posted by: @ajm73 I believe one of the most important techniques/activities in monitoring and closing is conducting Design Change Requests. It is in this process that documents and processes are brought up to spec allowing to include several updates to…   Read more»

]]> 48a27487b0d78e476117ba779a43904d https://medicaldevicecourses.com/activity/p/19556/ Sun, 23 Feb 2020 19:07:06 -0500 @vcf3 I disagree as I think designing the timeline is the hardest step if there is no prior successful timeline with a related project to compare it to. The PM must be cognizant of his/her team member’s capabilities in completing…   Read more»

]]> 65e4d2cc73560f7b2c66a4d228feec63 https://medicaldevicecourses.com/activity/p/19551/ Sun, 23 Feb 2020 18:28:22 -0500 One thing that I have not seen discussed as much is everyone on the team having a complete understanding of who controls the project flow, timeline or schedule. It is usually the project manager, but sometimes – depending on if…   Read more»

]]> a0c48ac8cedacaf4fc1edea95b2921fd https://medicaldevicecourses.com/activity/p/19550/ Sun, 23 Feb 2020 18:02:41 -0500 Posted by: @devarshi-joshi According to me the most important 5 success factors are:1)Agreeing on the project goals2)Effective Communication3)Develop clearly defined plans with assigned responsibilities.4)Managing project scope effectively.5)Making sure of management support. So how are these factors individually important for a…   Read more»

]]> 29f258d8f18021dcaf02d2e6466dd859 https://medicaldevicecourses.com/activity/p/19549/ Sun, 23 Feb 2020 17:37:28 -0500 The method that eh76 described is a very sound way of identifying and assessing the risks for a medical device that has a similar medical device already on the market. Additionally, if the category and classification of a medical device…   Read more»

]]> 183faec80536e48800d237477dddac5b https://medicaldevicecourses.com/activity/p/19548/ Sun, 23 Feb 2020 03:55:23 -0500 An important aspect of any project management team is to properly forecast and project completion of future deliverables. Communication within the team is very vital so as cjm64 mentioned, good leadership is very important so that all members of the…   Read more»

]]> fb7e6e61d5db9278b7fe6fb9a40d7216 https://medicaldevicecourses.com/activity/p/19479/ Thu, 13 Feb 2020 05:13:25 -0500 In light of the recent Coronavirus outbreak, around the world – particularly in China – we are seeing various manufacturing sites get affected and come to a halt in production. This results in a heavy hit on the global supply…   Read more»

]]> bb7b051d3e8dbd38a983569631400384 https://medicaldevicecourses.com/activity/p/19478/ Thu, 13 Feb 2020 03:45:10 -0500 Feasibility studies are important and assess whether or not the project can realistically be done. In other words, it tests whether the protocol and the planned procedures work together properly to inform the stakeholders whether or not it is worth…   Read more»

]]> 7e45f6c6fb08c5cea184dff0f3616f18 https://medicaldevicecourses.com/activity/p/19475/ Thu, 13 Feb 2020 02:49:15 -0500 This is a really good question as it begs the question of what is the minimum amount of detail one should put into a project proposal in order to get it approved but not waste time on other projects in…   Read more»

]]> 83425aa7e8ebece8dd416e2a2d7f47ca https://medicaldevicecourses.com/activity/p/19465/ Tue, 11 Feb 2020 22:35:38 -0500 I agree with the aforementioned as setting up daily or weekly meetings to go over the completion in a task is important. In addition to going over milestones and ways to improve performance of a project, the team should also…   Read more»

]]> c09f04d3d269c5e8541bd3ab317e9166 https://medicaldevicecourses.com/activity/p/19464/ Tue, 11 Feb 2020 22:22:06 -0500 @266I agree with the sentiment stated here that low priority projects should be paused if it means the faster completion of a higher priority project. Company resources are finite and they can only expand on those resources (including workforce) if…   Read more»

]]> 4a869b043a7959e5bbda46507f628513 https://medicaldevicecourses.com/activity/p/19463/ Tue, 11 Feb 2020 22:01:56 -0500 Communicating with a global team is definitely extremely difficult as it is a huge logistical hurdle that can make or break the ability of a team to accomplish tasks on time and reach goals. My team is placed in North…   Read more»

]]> e5d7bf2b798a6d04690138053efabafd https://medicaldevicecourses.com/activity/p/19400/ Thu, 06 Feb 2020 05:56:17 -0500 This is an interesting question as the personality of a project manager can have a definitive impact on the success of the project as the team members essentially are directly influenced by the project manager. Thus, if the project manager…   Read more»

]]> 36bd3c7b32ce839c880d6fa5724bbba6 https://medicaldevicecourses.com/activity/p/19399/ Thu, 06 Feb 2020 05:38:44 -0500 Communication is definitely an important skill to have for completing tasks within a project, but it is important to specify that efficient use of communication and proper communication is also important. If things are “lost in translation” or miscommunicated, members…   Read more»

]]> 6fa7d98d18c0483163c615902e71000c https://medicaldevicecourses.com/activity/p/19398/ Thu, 06 Feb 2020 04:45:16 -0500 Although I do not have experience as a project manager, I can speak as a team member on a project some of the good qualities a project manager should have. I think a key tool to understand for being a…   Read more»

]]> 18bd78a473ee3113f3ffe56a3e8b4e0e https://medicaldevicecourses.com/activity/p/19320/ Mon, 27 Jan 2020 02:42:31 -0500 @ec52I agree that manufacturers should retest their devices and if they know their product is being misused it is their duty to fully educate the consumers the ramifications of mal intended usage. Too often nowadays we see medical devices being…   Read more»

]]> af18617e68923ff62a5fb218368b982d https://medicaldevicecourses.com/activity/p/19314/ Mon, 27 Jan 2020 01:15:43 -0500 @jordankayalOne thing I agree with that was mentioned is a thorough onboarding process that can let any new hires, co-ops or interns know of issues before they arise. In my limited industry experience, a good onboarding process helped me tackle…   Read more»

]]> 673c019019a92f6947a1d6c1cd0edcff https://medicaldevicecourses.com/activity/p/19313/ Mon, 27 Jan 2020 01:15:23 -0500 @jea42Expanding more on Josh’s point on various companies having issues with meeting the timelines and deadlines issued by the EU MDR, the rushed deadlines that multiple company executives are calling to delay can lead to many more issues. The regulation…   Read more»

]]> bbe05ec3cb480177906ff25e38fbc0e2 https://medicaldevicecourses.com/activity/p/19311/ Mon, 27 Jan 2020 00:25:51 -0500 @jea42Expanding more on Josh’s point on various companies having issues with meeting the timelines and deadlines issued by the EU MDR, the rushed deadlines that multiple company executives are calling to delay can lead to many more issues. The regulation…   Read more»

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