https://medicaldevicecourses.com/members/ajm73/activity/ Activity feed for ajm73. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 822752ba73b38536fb04a134074612b6 https://medicaldevicecourses.com/activity/p/18366/ Wed, 15 May 2019 21:47:41 -0400 One factor this can easily boil down to is the amount of resources that a company has. Should the company have the time, manpower, and money to invest in a trial, they should certainly undergo the trial themselves rather than…   Read more»

]]> cd4080eb9f86acb2fe049e357874569c https://medicaldevicecourses.com/activity/p/18363/ Wed, 15 May 2019 21:47:39 -0400 I can definitely understand why not getting enough praise or recognition might cause someone to leave their job. Human beings naturally want to feel appreciated for what they do. When you spend a lot of effort and time doing something,…   Read more»

]]> da45609bdf2713739701b00282458070 https://medicaldevicecourses.com/activity/p/18357/ Wed, 15 May 2019 21:47:36 -0400 For me, one of the biggest motivators to work for me is the sense of satisfaction in the excellence of the work I have done. It brings me great satisfaction to look back on a project, deliverable, or any other…   Read more»

]]> afb9130f40f17119584fc7f56b226fd4 https://medicaldevicecourses.com/activity/p/18235/ Wed, 15 May 2019 21:46:34 -0400 For myself, the three results that are listed that motivate me to work the most are having great people to work with, challenging work, and supportive boss/manager. I have had experience on the positive and negative sides of each of…   Read more»

]]> 55597c7409dd44e6be6547dbe4eb333c https://medicaldevicecourses.com/activity/p/18234/ Wed, 15 May 2019 21:46:33 -0400 I highly think this is due to the culture around work and the value system found in the workplace. Often times, the worth of an employee is measured by how much they can output/get done. So, in a competitive environment…   Read more»

]]> a75345d59a340a585f4f7fabb91fdb93 https://medicaldevicecourses.com/activity/p/18230/ Wed, 15 May 2019 21:46:31 -0400 A project can definitely have more than one priority. However, in these projects, it is best to determine the order of those priorities (which one is more important and such) so that proper allocation of resources can be done at…   Read more»

]]> 6aec97bfac5f959ba9b22b0cae7f595f https://medicaldevicecourses.com/activity/p/18215/ Wed, 15 May 2019 21:46:21 -0400 Ideally, all members of a project should be communicating with each other and the project manager. If that were not so, there would be no way for the PM to know what was getting done, or for different members to…   Read more»

]]> 92f95c222a0a3aa4c57bc287d3209b29 https://medicaldevicecourses.com/activity/p/18207/ Wed, 15 May 2019 21:46:17 -0400 Unless I’m missing something here, according to the MiniSim, the AquaWhoa coating IS from another supplier: HyrdoSurf from Conmodic, AquaWhoa from AND. I agree here with the point made that much of the purpose of getting another supplier is to…   Read more»

]]> 4c9371fff8716b1a1e56416ff128b50a https://medicaldevicecourses.com/activity/p/18205/ Wed, 15 May 2019 21:46:16 -0400 jr377, I would have to disagree drawing from experience. There have been people who are on a project with me doing a certain task who, for various different reasons, get transferred to another project. The reason for this often has…   Read more»

]]> 8ee609658e1035f7ca5f84c4bb421346 https://medicaldevicecourses.com/activity/p/18150/ Wed, 15 May 2019 21:45:48 -0400 Asking all stakeholders to identify potential risks is quite important. As said before, different stakeholders from different parts of the stream offer varying perspectives of the industry. While it’s important to include all potential stakeholders from the start, it is…   Read more»

]]> d11ceee84ce3bcccb9824745a8194416 https://medicaldevicecourses.com/activity/p/18148/ Wed, 15 May 2019 21:45:47 -0400 I’ve had experience with vendors where during a manufacturing process validation they become uncooperative. In our case, we were trying to find all of the steps of manufacturing that contain water in our product components. We can only document so…   Read more»

]]> c95d9898d0902095f4e8e17df4d871a7 https://medicaldevicecourses.com/activity/p/18146/ Wed, 15 May 2019 21:45:46 -0400 I believe the best way to avoid scope creep is to define a scope and then stick to it. Any deviations should become new changes or projects separate from the one that you are working on. For example, in a…   Read more»

]]> 935e30abebaf409d6b3adf954e39275c https://medicaldevicecourses.com/activity/p/18075/ Wed, 15 May 2019 21:45:11 -0400 In the company that I work in, engineers would open up something called a Change Order (CO) within a project to allow space to create changes to what ever documents need to be changed. The person would then redline the…   Read more»

]]> d8c94c8357dc0abcbe3cf9deeeb7208f https://medicaldevicecourses.com/activity/p/18072/ Wed, 15 May 2019 21:45:10 -0400 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 a project that…   Read more»

]]> dd08e5e712a1d0eba9b68f226345e7c3 https://medicaldevicecourses.com/activity/p/18071/ Wed, 15 May 2019 21:45:09 -0400 It is important to document the lessons learned during the course of a project. Documentations of decisions made or decisions/actions that would have been better if done are crucial to transferring the knowledge of the team members of others in…   Read more»

]]> 2145178c404910d3fcb8b6278b873a48 https://medicaldevicecourses.com/activity/p/17978/ Wed, 15 May 2019 21:44:20 -0400 When a calm and productive resolution can’t be reached in a situation like this, it is most important to try and stick to the facts and reconcile with what reality is. If something is impossible to be done in shorter…   Read more»

]]> 80ff069d19ada826fd9af6d0c41160c0 https://medicaldevicecourses.com/activity/p/17977/ Wed, 15 May 2019 21:44:19 -0400 From what I have seen these processes are followed pretty closely in terms of project management. What does not always stay consistent is the difficulty of the processes and how long they will take, particularly in the execution phase. Many…   Read more»

]]> 27d24e944127817577f97c03d0c07169 https://medicaldevicecourses.com/activity/p/17976/ Wed, 15 May 2019 21:44:19 -0400 In relation to the miniSim that was done this week, it would be best to find those who have closest knowledge of these tasks (have done them before typically or something of the like) and involve them in the conversation.Like…   Read more»

]]> 515da101bafdafeef42aaf0e887b5133 https://medicaldevicecourses.com/activity/p/17942/ Wed, 15 May 2019 21:44:02 -0400 I would say that the planning phase is one of the most important phases for a project. It is one of the most critical phases in terms of getting a project started. This is not just the case in terms…   Read more»

]]> 181018e84da710258b4378913fe55ddf https://medicaldevicecourses.com/activity/p/17939/ Wed, 15 May 2019 21:44:01 -0400 @alexandrabuga I don’t think that this is completely accurate. Depending on the company and how it is structured, sometimes employees wear many hats at once, being the critical members for many, many projects at the same time. This often is…   Read more»

]]> b0d541a018be9a13ccecf38ec210382b https://medicaldevicecourses.com/activity/p/17935/ Wed, 15 May 2019 21:43:59 -0400 In one of my previous positions, I and a team of other people had to create a tool that would basically verify Bill of Material data and compare it to new product code Bill of Material data, all done semi-automatically….   Read more»

]]> 4fa2bc597572c3b95d9c1a555794defb https://medicaldevicecourses.com/activity/p/17870/ Wed, 15 May 2019 21:43:26 -0400 Experience in the industry validates quite a bit of what was said here: communication definitely is key in leading a project and in working with team members. What I have seen is this: team members would often be proactive in…   Read more»

]]> b734fe3baa319c387a52a3f6ab56a01d https://medicaldevicecourses.com/activity/p/17869/ Wed, 15 May 2019 21:43:25 -0400 I quite agree with the point made about communication being a big challenge that PM’s have to face. If the team you are working with is one that is global, the language barrier becomes a huge obstacle to overcome. Sometimes…   Read more»

]]> fa67ac41bec18e9f4a7c8e8fca3f673b https://medicaldevicecourses.com/activity/p/17868/ Wed, 15 May 2019 21:43:25 -0400 Like some other people have mentioned here I think that the answer is really it depends. Of course, if a milestone that has been properly set (takes into account what is possible/resources to achieve) is missed then there is a…   Read more»

]]> b33554d6b2f095a790de17fdc83adfd5 https://medicaldevicecourses.com/activity/p/17795/ Wed, 15 May 2019 21:42:42 -0400 One of the most important things to take into account when dealing with a change in a project is what importance of the change is. Is it something that MUST happen (FDA regulation, critical business reason,etc.) or can it be…   Read more»

]]> 0684d4552b7966025c94316221144241 https://medicaldevicecourses.com/activity/p/17794/ Wed, 15 May 2019 21:42:41 -0400 Design validation is important in Project Management because it basically answers the question “Does this device do what it is supposed to do?”. If after testing is done the device is found to not perform at the requested level or…   Read more»

]]> e1fd7f67363f9cedbd95671472e8e954 https://medicaldevicecourses.com/activity/p/17793/ Wed, 15 May 2019 21:42:41 -0400 Scope creep can often be a problem faced in the medical device industry. How much noise it creates can differ however depending on who is being affected by the drift. In one of my experiences, part of my team was…   Read more»

]]> a3889754f6e4d2b8e3ee276a1800037e https://medicaldevicecourses.com/activity/p/17715/ Wed, 15 May 2019 21:42:02 -0400 Should there be a global standard created, and countries conform to it, there will be those countries that will decide not to conform to it and go with their own standards. I would be interested in hearing some thoughts on…   Read more»

]]> 4179a4715907d2431c152f1e39ff86fc https://medicaldevicecourses.com/activity/p/17712/ Wed, 15 May 2019 21:42:00 -0400 As another person said, it is important to step back and look at what has happened. Formulating theories on why something has not gone correctly is the first step to remediating the situation. When you can have at least a…   Read more»

]]> 7972b3c1552dc6cd7bd1ef16fe45548f https://medicaldevicecourses.com/activity/p/17711/ Wed, 15 May 2019 21:42:00 -0400 I agree with this point, I think that at some point, there will be a decline in a certain product: it is only a matter of time of when that is. When something replaces the product in having better use…   Read more»

]]> f916b31d1d9aa96d4d009576411b1c66 https://medicaldevicecourses.com/activity/p/17649/ Wed, 15 May 2019 21:41:26 -0400 While I haven’t been part of Design Control process yet as I am new in my current role, I do know that in a few weeks I will be part of a project that will be involved in creating a…   Read more»

]]> 5f2d8594da2cfd9095263152d484d457 https://medicaldevicecourses.com/activity/p/17648/ Wed, 15 May 2019 21:41:25 -0400 The best time to do to do validation and verification is most naturally towards the end of a project/process. At this point, the roles and responsibilities of these tasks have been determined, meaning who will do what in what place…   Read more»

]]> 064fa1e8cc30653809c83b1f1c52cc76 https://medicaldevicecourses.com/activity/p/17647/ Wed, 15 May 2019 21:41:25 -0400 In the part of the company that I’m in, my group is mainly responsible for heading DR’s and sending out the required documentations for the respective parties to review. In my and other co-worker’s experience, sometimes the best you can…   Read more»

]]> 57b1bc1ff1eb90f8be6f311e2e77d75f https://medicaldevicecourses.com/activity/p/17646/ Wed, 15 May 2019 21:41:24 -0400 I strongly agree with RyanRattazzi’s point about adding more tiers to the medical device classification system: it would be an unhelpful and unneccesesary addition to add something like a class IV device. From a risk indication perspective, Class III devices…   Read more»

]]> a80bd5fce3760c3fad619adca5581dea https://medicaldevicecourses.com/activity/p/17645/ Wed, 15 May 2019 21:41:24 -0400 One interesting point to mention however: will every country adopt this global standard (assuming you believe a global standard will occur)? I feel it is likely that even if there is a global standard created, some countries will decide not…   Read more»

]]> c01e22d01a4b946333e5932b465be27b https://medicaldevicecourses.com/activity/p/17644/ Wed, 15 May 2019 21:41:23 -0400 I think that regulation of medical devices is approaching a global standard. As mentioned in our class discussion, much of the world’s regulating bodies are catching up with each other in terms of how stringent regulations may be and the…   Read more»

]]> 6be81bbfc2906af3eec26cbcc603c351 https://medicaldevicecourses.com/activity/p/17551/ Wed, 15 May 2019 21:40:32 -0400 Interestingly enough I have had experience on both sides of the spectrum within engineering in terms of what skills were needed to succeed. In my time on the supply chain side, having interpersonal skills were crucial to doing well, as…   Read more»

]]> 3b811f27412ae2e177ee64aabab803ce https://medicaldevicecourses.com/activity/p/17549/ Wed, 15 May 2019 21:40:30 -0400 Through my experience at the company that I work at, I see that it has clearly adapted a project based structure. There are various project groups with their own hierarchies and reporting structures, each working towards a certain goal. One…   Read more»

]]> 4cc53a57746ad4022b134a8ca48206d8 https://medicaldevicecourses.com/activity/p/17547/ Wed, 15 May 2019 21:40:28 -0400 In the line of work that I am in, there are hundreds of potential projects that could be picked up. Oftentimes however, these projects are prioritized mainly according to how much it would cost/net the company and if they are…   Read more»

]]> 0104636e87cb5b42876e51ba1efc8a95 https://medicaldevicecourses.com/activity/p/17361/ Wed, 15 May 2019 21:38:50 -0400 Echoing points made earlier, it is absolutely crucial do understand what exactly you are agreeing to when signing an agreement. It is very easy to simply sign without reading through the agreement, since it may take some time and some…   Read more»

]]> cadaee6e2f8d3f597ce432a8f6b441f0 https://medicaldevicecourses.com/activity/p/17360/ Wed, 15 May 2019 21:38:50 -0400 While I haven’t had to sign a non-compete agreement, I do know it is something that is checked for if not self identified when applying for a company. Non-compete agreements can prevent one from working in another profession similar to…   Read more»

]]> 42fdb4167903159f082834bb5bb73aa9 https://medicaldevicecourses.com/activity/p/17359/ Wed, 15 May 2019 21:38:49 -0400 One article I found about this topic was related to the opioid crackdown that has been going on as of late. A former drug company sales manager admitted that he was part of a larger scheme to bribe doctors to…   Read more»

]]> 5b728583f31517ab061f9414a02bf8d0 https://medicaldevicecourses.com/activity/p/17312/ Wed, 15 May 2019 21:38:27 -0400 While I believe that I would have the skills to do either upper or middle management, I think I would prefer to be in middle management. It takes the right balance of ‘big picture’ view and ‘details’ view in order…   Read more»

]]> 54755649e6bc5fa3f0e014e03585a040 https://medicaldevicecourses.com/activity/p/17311/ Wed, 15 May 2019 21:38:27 -0400 I prefer a matrix style and also work in a matrix style organization where people are grouped together in their own groups with someone heading each group as a point person. When trying to route our deliverables, often times it…   Read more»

]]> a7dc4251bd30fb67d118eeccf7b30bc5 https://medicaldevicecourses.com/activity/p/17306/ Wed, 15 May 2019 21:38:24 -0400 Like mentioned, competition (healthy kind) is good within a company as it can often push employees to strive to do their very best. However it can get to the point where it may create negative stigma or environment. If the…   Read more»

]]> 954825d8c996c6aae22ede31a1b00107 https://medicaldevicecourses.com/activity/p/17202/ Wed, 15 May 2019 21:37:30 -0400 In terms of the how risk is prioritzied in my company, an assessment is made on the impact of the risk (monetary, time, liability, etc.) If the issue is one deemed high risk (will cost much money, and has high…   Read more»

]]> d9bfc9d7a11ab01da14ee4ba9ef2aea7 https://medicaldevicecourses.com/activity/p/17199/ Wed, 15 May 2019 21:37:28 -0400 search what is residual risk? Definition and meaning in google to find article by MBN

]]> 2245fe4f613ce2968ab19ed6de0d4c58 https://medicaldevicecourses.com/activity/p/17198/ Wed, 15 May 2019 21:37:28 -0400 At the end of the day, it seems that there will always be residual risk that a medical device company will have to deal with. The measures that companies take will not be guaranteed to completely eliminate risk. In fact,…   Read more»

]]> 40ab292cfd55edc77534ada1711e02f3 https://medicaldevicecourses.com/activity/p/17195/ Wed, 15 May 2019 21:37:26 -0400 To find the video search The $40 Internationally Standard Cup of Tea

]]> 5c49ea3bd23a37085516674244f7ad4a https://medicaldevicecourses.com/activity/p/17194/ Wed, 15 May 2019 21:37:26 -0400 This topic reminds me of a somewhat comical video that I had watched a while ago Similar to what is being talked about, this video gives an overview of standardization and how it is something that is used globally (particularly…   Read more»

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