https://medicaldevicecourses.com/members/rm829/activity/ Activity feed for rm829. Sat, 25 Apr 2026 02:14:09 -0400 https://buddypress.org/?v= en-US 30 hourly 2 369913c66a9bc995a6deb17858090da2 https://medicaldevicecourses.com/activity/p/28580/ Sat, 02 Dec 2023 22:25:58 -0500 I think this gave a solid overview of what to expect from multiple different areas of the biomedical world. As students at NJIT, we are told to choose a direct track (Mechanics, Materials, Instrumentation, Pre-Health) where our focus is very…   Read more»

]]> f3cc391b910a44be1854a1c8dcc5cb66 https://medicaldevicecourses.com/activity/p/28579/ Sat, 02 Dec 2023 22:17:40 -0500 Just because there are “verbal contracts”, doesn’t mean things should be less important that arguments in writing. Having a witness present (maybe someone somewhat familiar with whatever is being discussed) can allow for a (hopefully) unbiased recollection of events taken…   Read more»

]]> 5e6b2453b7a10f57111386f0f65daf7d https://medicaldevicecourses.com/activity/p/28578/ Sat, 02 Dec 2023 22:10:51 -0500 When considering a “sponsored event,” especially for something in a professional field, any location (as you mentioned) that someone would go to on vacation would be unreasonable. My first thought was some tropical location that may have ABSOLUTELY nothing to…   Read more»

]]> 02921f2ab0af03d2c211e7111876e155 https://medicaldevicecourses.com/activity/p/28543/ Mon, 27 Nov 2023 00:01:38 -0500 @ac825 I would like to add that an incredible amount of experience in the field may lead to a narrow-minded or tunnel-vision like approach to certain topics. I think someone can be counted on for projects that are directly in…   Read more»

]]> 782dbe990516f054cb4944b174775921 https://medicaldevicecourses.com/activity/p/28542/ Sun, 26 Nov 2023 23:42:19 -0500 This directly relates to the warning our professors give us at the beginning of our Capstone semesters “Don’t make group members with your friends, as your friend group may no longer stay together.” As ominous as this was, my friends…   Read more»

]]> 3c3c169cc14599bab1b2487ccbbe384e https://medicaldevicecourses.com/activity/p/28541/ Sun, 26 Nov 2023 23:36:37 -0500 I would say given the structure from the charts from the power point slides, I would agree that our teams are structured more around a Functional Organization. Each member of the team is responsible for their own separate subsection, which…   Read more»

]]> 51388dfc3ec06c7a6632b73e9efc62cb https://medicaldevicecourses.com/activity/p/28461/ Wed, 15 Nov 2023 15:22:00 -0500 Working for a company that manufactures medical devices (more specifically, I deal with nonconforming components), some of the main documentation I deal with (when determining the Severity and Occurrence of these errors) are these DFEMAs, PFMEAs, and FMEAs. A lot…   Read more»

]]> 42894d61f44bd775713638c47d1c8e5e https://medicaldevicecourses.com/activity/p/28460/ Wed, 15 Nov 2023 13:16:26 -0500 The Risk Management Process has a variety of different tasks that are encompassed within it. The Analysis portion that is involved includes a good amount of brainstorming where any risks that may involve a product should be listed, and their…   Read more»

]]> 0fede89bc114df610bdb0f65cabf0e74 https://medicaldevicecourses.com/activity/p/28459/ Wed, 15 Nov 2023 13:02:48 -0500 When releasing a biomedical device, there is of course a lot of reward from both a monetary standpoint, as well as a personal wellness perspective as the feeling of helping others may be a reward in itself. Both of these…   Read more»

]]> 22c90b125dae71404b3b47043c8cd78d https://medicaldevicecourses.com/activity/p/28458/ Wed, 15 Nov 2023 13:02:19 -0500 When releasing a biomedical device, there is of course a lot of reward from both a monetary standpoint, as well as a personal wellness perspective as the feeling of helping others may be a reward in itself. Both of these…   Read more»

]]> 9f40dbe375f1f9b5a5bf79a75622d354 https://medicaldevicecourses.com/activity/p/28434/ Sun, 12 Nov 2023 22:45:51 -0500 The device I’ll discuss is the LTV 950 ventilator: Functional – One functional requirement of the device is for it to output oxygen into a patient’s lungs when they are physically incapable of doing it themselves, or they have a…   Read more»

]]> 321e0ebe9ba6cb469f89f845deccf121 https://medicaldevicecourses.com/activity/p/28431/ Sun, 12 Nov 2023 21:46:35 -0500 @vthampi I would like to add to this by mentioning how even a small thing such as a misspelling, or even something as miniscule as missing an (s) at the end of a word will almost always be adjusted using…   Read more»

]]> 6583ae439aab65461b32c9d5fd62429f https://medicaldevicecourses.com/activity/p/28419/ Sun, 12 Nov 2023 15:52:59 -0500 Two benefits of Software Validation include: 1. Ease of Updating the Software: When using a software developed in a device, depending on how the software is constructed (especially considering how user-friendly and able-ing it is), updating this software to improve…   Read more»

]]> 7738d4fbd10bcad11662bdd3b955fbe1 https://medicaldevicecourses.com/activity/p/28371/ Sun, 05 Nov 2023 15:33:10 -0500 I would also agree with the others here that corporate responsibility is taken very seriously when it comes to medical device output. I think naturally companies are adamant about putting out a “good product,” but there are also so many…   Read more»

]]> 997bc20ea29e4765832ea03a8c4a9783 https://medicaldevicecourses.com/activity/p/28353/ Wed, 01 Nov 2023 12:27:44 -0400 I would guess that most of us have completed a Capstone or Senior Project in the past that was “in-theory” supposed to make it to market assuming a successful prototype was completed. What was included in this was market research,…   Read more»

]]> 6633ce5d5ba6900e5a376863175de0d0 https://medicaldevicecourses.com/activity/p/28352/ Wed, 01 Nov 2023 12:10:02 -0400 Coming from a company that outsources many of their different drawings, outsourcing is crucial to the manufacturing of medical devices. One of the best benefits is that on a large scale, you can train multiple different companies to be compliant…   Read more»

]]> 2ddafc0f4ae35091b74772e1190e87cc https://medicaldevicecourses.com/activity/p/28332/ Sun, 29 Oct 2023 23:40:57 -0400 What if I told you a company found the cure to the common cold, but it only works 50% of the time? What if a clinical trial (all stages) was performed and the drug outperformed the placebo? Now, what if…   Read more»

]]> ea0130f08d23241ab8d30d2ff5071247 https://medicaldevicecourses.com/activity/p/28331/ Sun, 29 Oct 2023 23:38:40 -0400 Clinical Research Study Manager was the job title that appeared when looking up Good Clinical Practices for me. The most common word I see in the job description is “lead” or “oversee and execute” showing the overall direction of being…   Read more»

]]> 87f3ffd8821364f9dd0950321e9cd8a8 https://medicaldevicecourses.com/activity/p/28328/ Sun, 29 Oct 2023 23:27:56 -0400 I completely disagree that placebos are “negative” effects or “sham drugs”. I think it’s an overall depiction of how much we still don’t know about the human body, and how much we rely on pharmaceuticals/procedures when the body can produce…   Read more»

]]> cf0f11666f12b22d7de4aa7978547fa8 https://medicaldevicecourses.com/activity/p/28293/ Fri, 27 Oct 2023 20:05:18 -0400 @archishak I agree that it is extremely important to have a competent team of cultured individuals to reach out to these specific populations. Not that it wouldn’t be reasonable, but I would argue that people are much more comfortable having…   Read more»

]]> 164bb5de1eea9799dfae67ed0047589f https://medicaldevicecourses.com/activity/p/28292/ Fri, 27 Oct 2023 19:56:19 -0400 I would like to add to atk27@njit.edu response stating that although not required for a management position, it definitely does not hurt to have an MBA or some business background to show that one isn’t narrowly focused on one specific…   Read more»

]]> 4c70140814067f5b567557242d7c6c5f https://medicaldevicecourses.com/activity/p/28291/ Fri, 27 Oct 2023 19:43:23 -0400 I would say it all boils down to what social media platform you are using to push your device. It can be argued that social media such as TikTok or Instagram are places that have ads targeted more for the…   Read more»

]]> 75e396ca9b34f8f4ec7d719ae82b3ef3 https://medicaldevicecourses.com/activity/p/28208/ Sun, 15 Oct 2023 16:38:07 -0400 Right off the bat, if you were to google what is a corporation, you would see “a legal entity that is separate and distinct from its owners” or “an organization  – usually a group of people”. This involves creating a…   Read more»

]]> 91dbc00d16367986b5188e6799377351 https://medicaldevicecourses.com/activity/p/28203/ Sun, 15 Oct 2023 04:12:13 -0400 As a supplier quality engineer co-op (and working full time over the summer) for a relatively large biomedical company, I can confirm that specificity is much more prevalent. I spoke to someone recently who currently works at Medtronic, but has…   Read more»

]]> 24d9ab5db919427e00fbdfb944290704 https://medicaldevicecourses.com/activity/p/28201/ Sun, 15 Oct 2023 03:50:40 -0400 If any FDA/Regulatory class is considered “business,” then I believe it should be added to the curriculum. Although the FDA medical device classification is more relevant to people who are preparing to design a product for human use, I think…   Read more»

]]> e16bc40f3da97e77e778c41e194f789c https://medicaldevicecourses.com/activity/p/28117/ Wed, 04 Oct 2023 21:42:38 -0400 I work as a Supplier Quality Engineer, where many different things come to my plate. I would say my main job is to work with nonconforming materials and disposition them according to what I think the best plan is. If…   Read more»

]]> ff16208c09061f51428265cec5a4bd76 https://medicaldevicecourses.com/activity/p/28116/ Wed, 04 Oct 2023 21:36:37 -0400 I understand where the annoyance is coming from. As someone who works in quality, there are definitely outlines in the SOP for certain documentation that seems almost too time consuming when the important information we know is there. I think…   Read more»

]]> 784a4cd825f50f9c51af1050b109a8ba https://medicaldevicecourses.com/activity/p/28115/ Wed, 04 Oct 2023 19:45:48 -0400 Working for a quality department that not only gets audited every couple of years, but also performs audits for their suppliers, many different factors come into play regarding errors that can be found during the audit process. Issues can be…   Read more»

]]> 7d8d30433d73daf42cd2a9a6b234a899 https://medicaldevicecourses.com/activity/p/28084/ Sat, 30 Sep 2023 19:44:13 -0400 I’d like to add that it all depends on the traceability of this error. Is this product CONSTANTLY having a label error where the sticker with information is peeling/half-legible? Is it only one batch/material out of many received from multiple…   Read more»

]]> fdc70fdcd2d1b7ae8c47877e1f5f3d3a https://medicaldevicecourses.com/activity/p/28082/ Sat, 30 Sep 2023 19:36:16 -0400 As someone who works for a medical device company with a class III medical device, our company is required to be audited every two years for compliance. Through the auditing process, there are many steps that need to be taken…   Read more»

]]> a9de93942cc54a40a53cedae7f93e464 https://medicaldevicecourses.com/activity/p/28080/ Sat, 30 Sep 2023 18:31:16 -0400 100% the FDA has biases towards certain companies and people. One of the main examples I can think of off the top of my head is Elon Musk’s Neuralink brain chip which already has FDA approval for in-human trials. This…   Read more»

]]> 23d85c53431d96f366d8cc7adcb5dc52 https://medicaldevicecourses.com/activity/p/28006/ Fri, 22 Sep 2023 20:57:15 -0400 [quote data-userid=”17580″ data-postid=”12546″] Preclinical research trials are know to be performed on a single lab creature such as rodent, pig, fruit fly, or monkey. Most recent research appears that having an animal model and conditional differences in the studies can…   Read more»

]]> 107d9fbb5901e494592e1d0a38de9639 https://medicaldevicecourses.com/activity/p/28005/ Fri, 22 Sep 2023 20:43:39 -0400 With so many different biocompatible or non-bioactive materials that we know exist, why are dental implants so expensive? Barring the procedures themselves, getting a dental implant proves to be incredibly expensive when we consider how small and somewhat non-invasive the…   Read more»

]]> c66d96130d0c9480ee846bc98edc33c3 https://medicaldevicecourses.com/activity/p/28002/ Fri, 22 Sep 2023 20:21:00 -0400 Interesting question… I think it’s safe to argue that there is a little bit of both. I would lean more towards the side that involves an interest in helping students and finding likeminded individuals to help assist in their research…   Read more»

]]> 44a965a3302db3c92ca92bff39f3b6d3 https://medicaldevicecourses.com/activity/p/27958/ Sat, 16 Sep 2023 20:08:04 -0400 Depending on the device that is produced, I would argue that the end user is most benefited from the success of a project. Especially in the medical device industry, where new innovations coming out have the ability to change lives…   Read more»

]]> e68aa8377a961076619a04ff4993011e https://medicaldevicecourses.com/activity/p/27957/ Sat, 16 Sep 2023 20:01:30 -0400 In the initial and planning phases of a project, there is a lot of work to be done regarding budgeted time, money allocation, task assignment, etc. However, even if we were to refer to past examples of the project/projects from…   Read more»

]]> 5911bd5237f9baa10be8acd790f31ec9 https://medicaldevicecourses.com/activity/p/27956/ Sat, 16 Sep 2023 19:55:35 -0400 I would like to piggy-back off of what both of y’all said by adding that the personal relationship one has with other people within the group is crucial to success. I remember one of the greatest warnings we got as…   Read more»

]]> 957ebe253b1f0753b304743de48e1956 https://medicaldevicecourses.com/activity/p/27910/ Mon, 11 Sep 2023 01:40:22 -0400 @cb447 Being a post-covid worker, I have had the privilege of working both in-person and online. As someone who HATES to commute even 30 minutes, I feel for your Pops that has to do the hour+ drive, in which working…   Read more»

]]> c74b28948dde2b6b34e66b341792cfd8 https://medicaldevicecourses.com/activity/p/27907/ Mon, 11 Sep 2023 01:29:42 -0400 I want to add, not as an exact issue of the application of Biomedical Engineering, but about the deal with job acquisition and what the major means. I originally joined Biomedical Engineering as a major to eventually work with prosthetics,…   Read more»

]]> bb2a00d82794199455ffb5d59c56473b https://medicaldevicecourses.com/activity/p/27906/ Mon, 11 Sep 2023 01:20:55 -0400 As a student currently pursuing an MS in biomedical engineering, I would like to think that the effort that I (and others) put into getting higher scores on exams, projects, and discussions have some sort of merit towards the work-place….   Read more»

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