Medical Device Courses | eac25 | Activity https://medicaldevicecourses.com/members/eac25/activity/ Activity feed for eac25. Fri, 24 Apr 2026 18:41:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 4fe1559bc09468b0b494f026f55303fa eac25 replied to the topic "Disconnect in rewarding motivation" - https://medicaldevicecourses.com/activity/p/12613/ Wed, 15 May 2019 16:57:35 -0400 This disconnect doesn’t really surprise me. It’s very easy for someone who didn’t spend much time working on a specific project (usually upper management) to take a quick look at some metrics they might have available (hours worked, number of…   Read more»

]]> 8ffbca936e55aaab2808482e3f80c00e eac25 replied to the topic "Engineer vs. Manager" - https://medicaldevicecourses.com/activity/p/12612/ Wed, 15 May 2019 16:57:34 -0400 After becoming more familiar with managerial roles over this past semester, I can say that I don’t particularly want to become a manager anytime soon. I have a newfound understanding and appreciation for what managers do, but I think I’ll…   Read more»

]]> 5ee1ae50bfe0cdfe6a071a54077a5477 eac25 replied to the topic "What’s Your Motivator?" - https://medicaldevicecourses.com/activity/p/12507/ Wed, 15 May 2019 16:56:37 -0400 I think my biggest potential motivator is good coworkers. I’ve made some real lasting friendships through work that have carried on even after parting jobs. It’s interesting for me to learn more about people and it goes a long way…   Read more»

]]> 5cb364109caf5695b44f7c8c259d014f eac25 replied to the topic "Why do people work?" - https://medicaldevicecourses.com/activity/p/12502/ Wed, 15 May 2019 16:56:35 -0400 I think these reasons will definitely vary based on the kind of work people do. I think these numbers are pretty reasonable for a private sector engineering job, and generally within my expectations. When you get down to more part-time…   Read more»

]]> 1e9205591242c7ccf0df88ec982319b3 eac25 replied to the topic "Discussion Topic: Scope creep....when your project changes" - https://medicaldevicecourses.com/activity/p/12434/ Wed, 15 May 2019 16:55:57 -0400 The first capstone project I was assigned to suffered from scope creep, or rather a lack of scope definition. When the professor was describing the project at first, it was rather vague and only described the subject that the project…   Read more»

]]> 5e6b0d9eaadd2ee64d6d5bf3d3d73cb4 eac25 replied to the topic "Integration PM" - https://medicaldevicecourses.com/activity/p/12420/ Wed, 15 May 2019 16:55:50 -0400 I could consider my one summer internship an integration of sorts. I was in charge of designing a website with Google Maps API, and eventually we would have to integrate it with external data coming in through another website. The…   Read more»

]]> f898148df129ed2a1b32afe5877a13f7 eac25 replied to the topic "Procurement Management" - https://medicaldevicecourses.com/activity/p/12417/ Wed, 15 May 2019 16:55:49 -0400 Although I haven’t had any direct experience with procurement myself, I’ve caught glimpses of the processes in some previous jobs. When I worked in a restaurant, I often had to go back into storage to refill our supply of cups,…   Read more»

]]> cfd6c4b1059ccf399e1c581df47b75e8 eac25 replied to the topic "Ideal PM Processes vs. Real life" - https://medicaldevicecourses.com/activity/p/12340/ Wed, 15 May 2019 16:55:07 -0400 I think in general IPEC is always the framework for projects. What I’ve been told is that this cycle is typically disrupted when other people (usually higher-ups) hand you unexpected challenges and force you to do something.Speaking as something who’s…   Read more»

]]> 29ebf194c1fc38c1b592905a4167f3a8 eac25 replied to the topic "FDA Recall...Now What?" - https://medicaldevicecourses.com/activity/p/12325/ Wed, 15 May 2019 16:54:53 -0400 I think depending on the severity of the reason for recall, a number of scenarios could occur. For a situation where the risk to the consumer is small to moderate, as is with this EpiPen recall, the previous responses are…   Read more»

]]> 353683397bcae481789e3b5dc546edb8 eac25 replied to the topic "Design Review Meeting Culture" - https://medicaldevicecourses.com/activity/p/12321/ Wed, 15 May 2019 16:54:51 -0400 I’ve only been part of an “unofficial” design review meeting, but from what some of my classmates have told me it’s quite similar to what they experience. Everyone was emailed the document in review (in this case a DSD) a…   Read more»

]]> 9866fb44eccc9523b4858b7e2611137a eac25 replied to the topic "Monitoring & Controlling Techniques" - https://medicaldevicecourses.com/activity/p/12220/ Wed, 15 May 2019 16:53:56 -0400 I think the multitude of project document updates is one of the most important but often overlooked aspects of monitoring and controlling. All of these documents are going to be audited eventually so it is paramount to keep them organized…   Read more»

]]> 27570389d6df9bd41a3e60853bec4749 eac25 replied to the topic "Cost Analysis of Project" - https://medicaldevicecourses.com/activity/p/12215/ Wed, 15 May 2019 16:53:53 -0400 I was working on a project during my undergraduate where I had to develop a rehabilitation glove for stroke patients. We had acquired a budget of $3000 and had to decide what we needed for a prototype. I was made…   Read more»

]]> 7b01065e7e7338de9b1d96986e1b747e eac25 replied to the topic "PM: Quality Assurance Process" - https://medicaldevicecourses.com/activity/p/12147/ Wed, 15 May 2019 16:53:17 -0400 Adding on to this, here are some more quality assurance tools and techniques: Pareto chart: This is a bar graph where length represents frequency (e.g. of complaints) or cost, and where the bars are arranged left to right in order…   Read more»

]]> 6012f92303e4570e74270789e351965a eac25 replied to the topic "PM: Handling Team Issues" - https://medicaldevicecourses.com/activity/p/12136/ Wed, 15 May 2019 16:53:11 -0400 For vacations specifically, it helps a lot for a PM to talk with each team member they’re managing and perhaps get a heads up on when exactly they may take a vacation. This will help you avoid conflicts in the…   Read more»

]]> 51485787e795df74fa247926d597e9fa eac25 replied to the topic "Are Missed Milestones really Bad?" - https://medicaldevicecourses.com/activity/p/12076/ Wed, 15 May 2019 16:52:35 -0400 Thinking optimistically, I think the only way a missed milestone could be a positive would be when it reveals an issue. From what I gather, sometimes project managers don’t have total control over the deadlines of a project. Sometimes it’s…   Read more»

]]> 2d53b09b985b2456dee5360f371bfe5f eac25 replied to the topic "Benefits of this course" - https://medicaldevicecourses.com/activity/p/12071/ Wed, 15 May 2019 16:52:32 -0400 One of my friends had taken this course before and suggested it to me because it really helped with her knowledge of FDA regulations and when interviewers asked her about this. I had previously taken a few courses about FDA…   Read more»

]]> 73d3de573e66d46b2c6e7857db7f6725 eac25 replied to the topic "PM Internationally" - https://medicaldevicecourses.com/activity/p/12069/ Wed, 15 May 2019 16:52:31 -0400 There definitely will always be challenges communicating with international branches of the same company. As was previously stated, time differences, language differences, and cultural differences are all challenges to consider. However, I think the cultural differences will be the most…   Read more»

]]> d8bf9c27202802196083abd29f159313 eac25 replied to the topic "Work Breakdown Structure" - https://medicaldevicecourses.com/activity/p/11974/ Wed, 15 May 2019 16:51:35 -0400 Like many of the previous replies, a lack of communication and time has been one of the most prolific problems in the projects I’ve worked on. In one such project we had made an initial WBS that we would have…   Read more»

]]> 2ca78ea9daf4bbe5f40c652ad2fc55e7 eac25 replied to the topic "Underestimating Task Duration" - https://medicaldevicecourses.com/activity/p/11968/ Wed, 15 May 2019 16:51:32 -0400 I’ve experienced this during one of my internships. One half of the team was set to work doing programming for some output data from a technology no one had experience with (RFID chips), and the other half’s goal was to…   Read more»

]]> 056531426c3687cfe08321f0f9333b1b eac25 replied to the topic "Discussion Topic: What are the PM elements in your company?" - https://medicaldevicecourses.com/activity/p/11886/ Wed, 15 May 2019 16:50:43 -0400 I was once working on a small-scale project at Monmouth University where the project sponsor was the local fire department and my project managers in a sense were two professors. These made up the enterprise environmental factors since I don’t…   Read more»

]]> 82fb455627350dee17d839a4a4a5c9ca eac25 replied to the topic "Discussion Topic: Realities of Planned Value" - https://medicaldevicecourses.com/activity/p/11885/ Wed, 15 May 2019 16:50:43 -0400 One the biggest problems that can arise from an overestimated budget is of course layoffs. Not only will you lose employees who have been contributing to the project, the potential demoralizing effects on the rest of your employees will make…   Read more»

]]> 84bae42b3e8b29eb5a06bea357ee62fa eac25 replied to the topic "Discussion Topic: The critical path" - https://medicaldevicecourses.com/activity/p/11883/ Wed, 15 May 2019 16:50:42 -0400 When I was working with a 3D-printed foot orthosis project one of our side projects was testing out other possible materials to print it with. We had gotten all the way toward refining the final print design when we had…   Read more»

]]> 1072432795381b3dd9561a7e89db4ffb eac25 replied to the topic "General Wellness Product" - https://medicaldevicecourses.com/activity/p/11810/ Wed, 15 May 2019 16:49:56 -0400 This may be a strange angle to take, but I think those “energy wristbands” that were a mild craze a while ago can be considered a general wellness product. These were ordinary bracelets that were advertised to give you more…   Read more»

]]> 136ec0e266b2b6109a08baf33321e960 eac25 replied to the topic "LifeVest Wearable Cardioverter Defibrillator" - https://medicaldevicecourses.com/activity/p/11806/ Wed, 15 May 2019 16:49:54 -0400 For the mobile application, if the only function of the application was to show the heart rate I believe it still would be subject to FDA regulation. It certainly would have an easier time passing FDA hurdles than if there…   Read more»

]]> 3e78f1fb3453d778cc3988e0c170ba1b eac25 replied to the topic "Simulations" - https://medicaldevicecourses.com/activity/p/11804/ Wed, 15 May 2019 16:49:53 -0400 I believe having in-person meetings would definitely have made for a more efficient use of time. When you’re part of an online class where you may not necessarily be able to meet with your group members in person, it’s imperative…   Read more»

]]> 757cd1ca2cb499f751ece73ff5e961e7 eac25 replied to the topic "Validation vs. Verification" - https://medicaldevicecourses.com/activity/p/11711/ Wed, 15 May 2019 16:48:56 -0400 During one of my past internships I was part of a project where we had to program a website to monitor flooding. The verification of that project was essentially whether or not the website functioned. This consisted of learning the…   Read more»

]]> 86144508bada96038f4a4258edac8025 eac25 replied to the topic "Tests for validation and verification phase" - https://medicaldevicecourses.com/activity/p/11697/ Wed, 15 May 2019 16:48:49 -0400 For verification, it’s important to note that tests aren’t the only acceptable verification activities; a company can also utilize inspections and analyses for their requirements, which can sometimes be cheaper and/or less time-consuming than tests. Some examples of these alternate…   Read more»

]]> c3bda939ff67349bdd8b6cab280d4e17 eac25 replied to the topic "Thalidomide's Impact on Regulation and the FDA" - https://medicaldevicecourses.com/activity/p/11622/ Wed, 15 May 2019 16:48:11 -0400 My follow up question is, do strict policies stunt medical innovation and economic growth? This is a really good follow up question to think about. I believe strict policies do stunt medical innovation and economic growth, but it is necessary….   Read more»

]]> b3a86c536d9fdf90a786c955f67eb927 eac25 replied to the topic "Mobile Medical Applications" - https://medicaldevicecourses.com/activity/p/11620/ Wed, 15 May 2019 16:48:09 -0400 I find this point about the Fitbit app very interesting. I myself own a Fitbit and the associated app, and this app allows you to monitor various things such as sleep patterns, physical activity, and even heart rate (if your…   Read more»

]]> 3874eda7b46fe22250fb2cbedd2614fe eac25 replied to the topic "Meat without Murder" - https://medicaldevicecourses.com/activity/p/11574/ Wed, 15 May 2019 16:47:47 -0400 I agree with gingeranderson, if we’re hypothetically talking about getting technology to the point where artificially grown organs are nearly indistinguishable from human organs, then it would fall under the responsibility of CBER to regulate these organs. However, I believe…   Read more»

]]> b6264640352d6c64ba148d5dc3818360 eac25 replied to the topic "Discussion Topic: The 510k Process" - https://medicaldevicecourses.com/activity/p/11514/ Wed, 15 May 2019 16:45:35 -0400 It seems that a recent lawsuit about power morcellators in 2014 has brought up this issue again. Dr. Amy Reed underwent surgery to remove uterine fibroids using laparoscopic power morcellation, an otherwise routine hysterectomy. In this process, a tool is…   Read more»

]]> 1f54027a49eba5dc56f64a94554a196e eac25 posted a new topic "Potential FDA Changes under Trump" - https://medicaldevicecourses.com/activity/p/10446/ Wed, 15 May 2019 16:33:38 -0400 This concerns information we covered past in week 2 but I feel like this is a pretty relevant topic. Based on a recent executive order that Trump has made, it seems that Trump is trying to cut the amount of…   Read more»

]]> 76a7e014b5ef1144f5e56c0b07ba9666 eac25 replied to the topic Disconnect in rewarding motivation in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2558/ Mon, 01 May 2017 00:40:44 -0400 This disconnect doesn’t really surprise me. It’s very easy for someone who didn’t spend much time working on a specific project (usually upper management) to take a quick look at some metrics they might have available (hours worked, number of lines coded, etc.) and quickly but inaccurately award people that may not have deserved it if they asked…[Read more]

]]> 0 0e510415eda1b7d9dec0ed0d1652e819 eac25 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2557/ Mon, 01 May 2017 00:27:28 -0400 After becoming more familiar with managerial roles over this past semester, I can say that I don’t particularly want to become a manager anytime soon. I have a newfound understanding and appreciation for what managers do, but I think I’ll use that knowledge to be a better employee rather than become a manager. I think once I have more…[Read more]

]]> 0 5b19b4aee53894301ad7cce6e7808744 eac25 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2407/ Mon, 24 Apr 2017 00:01:31 -0400 I think my biggest potential motivator is good coworkers. I’ve made some real lasting friendships through work that have carried on even after parting jobs. It’s interesting for me to learn more about people and it goes a long way towards building a stronger team for the job at hand. I also feel like strong social interactions help out in…[Read more]

]]> 0 2bc1183c5d035cf2b486bebd51bdeafc eac25 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2402/ Sun, 23 Apr 2017 23:27:28 -0400 I think these reasons will definitely vary based on the kind of work people do. I think these numbers are pretty reasonable for a private sector engineering job, and generally within my expectations. When you get down to more part-time service or retail industry work however, that’s when I think money is the main motivator. That isn’t to say that…[Read more]

]]> 0 f61e17dc99f3ee0f318822a10feccbfe eac25 replied to the topic Discussion Topic: Scope creep....when your project changes in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2303/ Mon, 17 Apr 2017 03:05:02 -0400 The first capstone project I was assigned to suffered from scope creep, or rather a lack of scope definition. When the professor was describing the project at first, it was rather vague and only described the subject that the project would be about; in this case, it was based around the 3D imaging software MIMICS. After our group had decided to…[Read more]

]]> 0 04ea9d86bae5dcc882431c0cd59f9399 eac25 replied to the topic Integration PM in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2288/ Mon, 17 Apr 2017 01:03:54 -0400 I could consider my one summer internship an integration of sorts. I was in charge of designing a website with Google Maps API, and eventually we would have to integrate it with external data coming in through another website. The biggest issue at the time was finding a programming language that would allow for both the processing of the external…[Read more]

]]> 0 bba92f9eaa2a590564ce1354a19a0c17 eac25 replied to the topic Procurement Management in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2285/ Sun, 16 Apr 2017 23:10:35 -0400 Although I haven’t had any direct experience with procurement myself, I’ve caught glimpses of the processes in some previous jobs. When I worked in a restaurant, I often had to go back into storage to refill our supply of cups, takeout bags, etc. When I went back there, I noticed that there was typically a huge amount of whatever I needed to get,…[Read more]

]]> 0 42acbb531bbd1321a88479ca9209be3c eac25 replied to the topic Ideal PM Processes vs. Real life in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2191/ Mon, 10 Apr 2017 01:48:54 -0400 I think in general IPEC is always the framework for projects. What I’ve been told is that this cycle is typically disrupted when other people (usually higher-ups) hand you unexpected challenges and force you to do something.Speaking as something who’s worked under a rather lax project manager, I can say that a project with a very short planning…[Read more]

]]> 0 40e84ee1e9b2ed83621bb129d725e135 eac25 replied to the topic FDA Recall...Now What? in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2175/ Sun, 09 Apr 2017 22:38:29 -0400 I think depending on the severity of the reason for recall, a number of scenarios could occur. For a situation where the risk to the consumer is small to moderate, as is with this EpiPen recall, the previous responses are the way to go: pushing an ECO and following through on the process. However, is risk is high enough and/or if consumers make…[Read more]

]]> 0 7336fb2294dd3b2b0fc35504bb54a65b eac25 replied to the topic Design Review Meeting Culture in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2171/ Sun, 09 Apr 2017 21:48:36 -0400 I’ve only been part of an “unofficial” design review meeting, but from what some of my classmates have told me it’s quite similar to what they experience. Everyone was emailed the document in review (in this case a DSD) a week prior and was expected to have at least 3 notes to bring up about the document. One person was randomly chosen to be the…[Read more]

]]> 0 89838e7a541aedfb41d44f6bbf543bf2 eac25 replied to the topic Monitoring & Controlling Techniques in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2029/ Mon, 27 Mar 2017 01:23:05 -0400 I think the multitude of project document updates is one of the most important but often overlooked aspects of monitoring and controlling. All of these documents are going to be audited eventually so it is paramount to keep them organized and up to date to avoid future problems. If they’re not organized and kept out of date, I imagine you’ll start…[Read more]

]]> 0 6d0c65af695f62e0162072281dcfa6dc eac25 replied to the topic Cost Analysis of Project in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2024/ Mon, 27 Mar 2017 00:58:26 -0400 I was working on a project during my undergraduate where I had to develop a rehabilitation glove for stroke patients. We had acquired a budget of $3000 and had to decide what we needed for a prototype. I was made the chief financial officer of our group, but I was woefully inexperienced at anything financial so our spending was very much…[Read more]

]]> 0 4fd7efcd465820e2575dfb0ff266ceb2 eac25 replied to the topic PM: Quality Assurance Process in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/1932/ Mon, 13 Mar 2017 02:38:34 -0400 Adding on to this, here are some more quality assurance tools and techniques:

Pareto chart: This is a bar graph where length represents frequency (e.g. of complaints) or cost, and where the bars are arranged left to right in order of longest bar to shortest bar. Here the most significant matters to address are located on the left. These help when…[Read more]

]]> 0 1bee0b01e1eaf03308eae8aee3bd6fa6 eac25 replied to the topic PM: Handling Team Issues in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/1919/ Mon, 13 Mar 2017 01:35:44 -0400 For vacations specifically, it helps a lot for a PM to talk with each team member they’re managing and perhaps get a heads up on when exactly they may take a vacation. This will help you avoid conflicts in the foreseeable future. For example, if someone lets you know that they’re deciding to take a vacation during one of the most crucial parts of…[Read more]

]]> 0 677b5cfb50ea2dd32c34d527feff6716 eac25 replied to the topic Are Missed Milestones really Bad? in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/1845/ Mon, 06 Mar 2017 01:34:26 -0500 Thinking optimistically, I think the only way a missed milestone could be a positive would be when it reveals an issue. From what I gather, sometimes project managers don’t have total control over the deadlines of a project. Sometimes it’s dictated by a consumer, a sales manager, or a higher-up that may not have the insight into how long processes…[Read more]

]]> 0 b2da03dac7f65ec39ef1888eadf210f1 eac25 replied to the topic Benefits of this course in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/1840/ Mon, 06 Mar 2017 00:18:20 -0500 One of my friends had taken this course before and suggested it to me because it really helped with her knowledge of FDA regulations and when interviewers asked her about this. I had previously taken a few courses about FDA regulations but it never went into the same depth that this class goes into so I’m grateful for that. I also very much…[Read more]

]]> 0 13949f565b8eb68a99163f2f7a122d59 eac25 replied to the topic PM Internationally in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/1836/ Sun, 05 Mar 2017 23:57:22 -0500 There definitely will always be challenges communicating with international branches of the same company. As was previously stated, time differences, language differences, and cultural differences are all challenges to consider. However, I think the cultural differences will be the most important one to tackle. The cultural differences don’t have…[Read more]

]]> 0 0e7b7e2e662916161ddf27adb29d196b eac25 replied to the topic Work Breakdown Structure in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/1719/ Mon, 27 Feb 2017 01:52:56 -0500 Like many of the previous replies, a lack of communication and time has been one of the most prolific problems in the projects I’ve worked on. In one such project we had made an initial WBS that we would have updated as we gained knowledge of the processes we were working on, but as time went on we had forgotten and put it on the back-burner. This…[Read more]

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