https://medicaldevicecourses.com/members/mmodi/activity/ Activity feed for mmodi. Sat, 16 May 2026 08:28:56 -0400 https://buddypress.org/?v= en-US 30 hourly 2 6df89dc9858ee5aa89cdafd8d72c9a7d https://medicaldevicecourses.com/activity/p/25922/ Sun, 01 May 2022 05:59:19 -0400 The COVID-19 vaccinations received emergency use authorization which is the FDA’s way of expediting its availability during a public health emergency, when no alternatives exist, and when the benefits outweigh the potential risks based on interim or final phase 3…   Read more»

]]> 51002238ea6c993eabf35d346529eac1 https://medicaldevicecourses.com/activity/p/25921/ Sun, 01 May 2022 05:24:14 -0400 Whether your role is as a project manager, in research and development, marketing, or risk management – everyone on the team is working cohesively towards the same goal. Therefore, even for someone who does not plan to assume a managerial…   Read more»

]]> 617a83fef77f4e2d7b569090e9c0f4ca https://medicaldevicecourses.com/activity/p/25920/ Sun, 01 May 2022 04:44:09 -0400 This discussion reinforces the importance of doing your research and requesting smaller batches to confirm the service/product you are requesting meets expectations. This requires maintaining close contact and communication with vendors. As already mentioned, it is important that if a…   Read more»

]]> 0b8554ca34d67dab25eefa9cc1407740 https://medicaldevicecourses.com/activity/p/25871/ Mon, 25 Apr 2022 03:53:16 -0400 Out of all the responses, no one mentioned how our senior capstone was a perfect example of where a single project can have multiple aspects/requirements which are each a priority for the final product. For my senior capstone project, my…   Read more»

]]> c5b79769930059fa14a79cce0cd4266e https://medicaldevicecourses.com/activity/p/25868/ Mon, 25 Apr 2022 03:40:22 -0400 I am always motivated by the idea of a challenge. Even now, I always challenge myself to stay busy hence why I work full time, am a full time masters student, and am conducting research and development while also exploring…   Read more»

]]> 0b402e5f404800c95c178ea29b13dd4e https://medicaldevicecourses.com/activity/p/25858/ Mon, 25 Apr 2022 02:47:40 -0400 An underperforming employee leads to decreased productivity, diminished work quality, and a decline in collaboration/morale. If the reason an employee is underperforming is because they lack the specific skills required then it is important to provide adequate training or to…   Read more»

]]> e06a10c533d43358282de48ddb9e69e4 https://medicaldevicecourses.com/activity/p/25634/ Sat, 16 Apr 2022 22:07:24 -0400 According to the PMI Talent Triangle, an successful project manager requires technical project management, leadership, as well as strategic and business management skills. Based on my current experience leading the development of a medical device, I realized I do have…   Read more»

]]> 4df53305c5f83064d5a1976d6b1105e5 https://medicaldevicecourses.com/activity/p/25633/ Sat, 16 Apr 2022 21:20:55 -0400 It is interesting to read perspectives from a cohort of students from almost one year ago. I would have to say I do agree with everyone in that always having multiple contingency plans, in this case multiple vendors for procurement,…   Read more»

]]> 59aa53d5a4921d699288f8bea3ff4016 https://medicaldevicecourses.com/activity/p/25632/ Sat, 16 Apr 2022 20:55:31 -0400 Integration management has responsibilities during all phases (initiating, planning, executing, monitoring & controlling, and closing) of a projects lifespan. These include developing a proposal, creating a project management plan, managing/accomplishing the work, as well as monitoring and controlling the work…   Read more»

]]> ef463aa70cc6c3e36006cf3ed11fecc8 https://medicaldevicecourses.com/activity/p/25558/ Mon, 11 Apr 2022 03:49:39 -0400 As @MahdiaSChy mentioned, communication between involved cross functional teams is the best approach to problem solving. When I had to work to secure network configurations for several ultrasounds units, just being able to work through the problem with IT and…   Read more»

]]> ae315e70d9b0843fea908f108591839f https://medicaldevicecourses.com/activity/p/25555/ Mon, 11 Apr 2022 03:41:00 -0400 For students who are interested in translating their fundamental research to the marketplace and forming a startup there are several grants you can apply for such as the National Science Foundation Innovation-Corps (NSF I-Corps) grants or Small Business Innovation Research…   Read more»

]]> 9a2bd62caf42d61677156f921a496618 https://medicaldevicecourses.com/activity/p/25551/ Mon, 11 Apr 2022 03:29:05 -0400 Similar to @ac825 I also work as a service engineer under RWJBH. Right after undergrad with plans on continuing towards some level of higher education, this job provided the exposure I needed to medical devices in order to figure out…   Read more»

]]> 1b8704195417cdc07057cc369f1f85c9 https://medicaldevicecourses.com/activity/p/25214/ Sun, 27 Mar 2022 18:30:51 -0400 From my experience in both settings I would have to say that the medtech industry is similar to the healthcare industry in that for a project to succeed you need cross-functional teams interacting every step of the away. The aspects…   Read more»

]]> 25024d4b11501dd281210d8c3d970a7e https://medicaldevicecourses.com/activity/p/25209/ Sun, 27 Mar 2022 17:31:21 -0400 In project management, the most common aspects that need monitoring and controlling include: schedule, budget, resources, performance, and scope. From my experience during capstone, budget and resources were obtainable but they required networking or applying for additional grants which hindered…   Read more»

]]> 732b3836bf13f0bd83690d637f2a83fc https://medicaldevicecourses.com/activity/p/25208/ Sun, 27 Mar 2022 16:36:43 -0400 Hello! My name is Mehul and I am a graduate student at NJIT. Below is my LinkedIn. Looking forward to connecting!
https://www.linkedin.com/in/mehul-modi-50455314a
 

]]> 3a309ed0593c9460a4fb8a7b5709951b https://medicaldevicecourses.com/activity/p/25013/ Mon, 14 Mar 2022 03:07:03 -0400 In my current job, my employer does track productivity as a means of evaluating each of the employees. I feel like this is a common metric used across multiple industries as justification to push employees forward into higher level positions…   Read more»

]]> dc2253c18293353bde39259aaf7ddd06 https://medicaldevicecourses.com/activity/p/25008/ Mon, 14 Mar 2022 02:43:39 -0400 I have had experience where the initiation of a research project was poor and that resulted in major time setbacks and increased costs because we had to restart from the beginning. Consequently, I was working a lot more hours to…   Read more»

]]> e5dbc7cda88bd453e633132513743c41 https://medicaldevicecourses.com/activity/p/25005/ Mon, 14 Mar 2022 02:12:21 -0400 I agree with @Jbarbee in that there are multiple cross functional teams involved in seeing a project through. Any mistakes along the way that result in a time delay or an increase in cost will be impossible to cover up….   Read more»

]]> f6543c7d0072450a3701ebba3d05ff38 https://medicaldevicecourses.com/activity/p/24815/ Sun, 06 Mar 2022 17:30:12 -0500 Again I have to agree with @ac825 because as indicated by the PMI Talent Triangle, a manager requires technical project management, leadership, as well as strategic and business management skills. Without technical experience, working previously as an engineer, your only…   Read more»

]]> 6d4ac023dc08135276b3da0c33fe1708 https://medicaldevicecourses.com/activity/p/24812/ Sun, 06 Mar 2022 16:44:16 -0500 I agree with @tgt6 and @ac825. I believe it is very important to prioritize tasks that are needed for later tasks or are codependent, however, when tasks are independent of one another I think it is imperative that one considers…   Read more»

]]> 22dbcfbd68777310dd733a11f9071434 https://medicaldevicecourses.com/activity/p/24811/ Sun, 06 Mar 2022 16:24:28 -0500 In school, research, and at work, communication is the biggest common denominator that dictates success. Email, text, google hangouts, GroupMe, and Slack is what I typically use across all three to set up an open line of communication with a…   Read more»

]]> 4229702365d342a6501b1319e2ab40ee https://medicaldevicecourses.com/activity/p/24633/ Sun, 27 Feb 2022 18:39:37 -0500 I have never used a Pert chart but like @mmd55, I have created a Gantt chart before. Personally, I believe I would prefer a Gantt chart because for large projects where there are several tasks a Pert chart could get…   Read more»

]]> b2cf543bf2bd952439cf21d6aee904d0 https://medicaldevicecourses.com/activity/p/24631/ Sun, 27 Feb 2022 18:15:29 -0500 Investors usually have expectations in terms of how they want the resources they are providing to be used and it is the managers responsibility to make sure that they coordinate with the team in order to meet those expectations and…   Read more»

]]> 4b6bb5305c466f39d85897f8237593ea https://medicaldevicecourses.com/activity/p/24630/ Sun, 27 Feb 2022 17:33:55 -0500 I had some experience with this during my senior Capstone, where we had to create a Gantt chart to map the critical paths for completing our project. In task scheduling, early start is the soonest date you can begin any…   Read more»

]]> ead7a55c02e275e112edd9e6a024f434 https://medicaldevicecourses.com/activity/p/24524/ Sun, 20 Feb 2022 20:17:54 -0500 I agree with @mmd55, in that this discussion does boil down to what we prefer, either working for a startup/small and medium enterprise (SME) or a large company. I am currently working in both and would once again have to…   Read more»

]]> 5d431cc79ce91b8edf1795c8fcb9943a https://medicaldevicecourses.com/activity/p/24523/ Sun, 20 Feb 2022 19:36:28 -0500 The FDA had issued an Emergency Use Authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 Vaccine, the Moderna COVID-19 Vaccine, and the Janssen COVID-19 Vaccine given the pandemic level health crisis. Nevertheless, the FDA still performed their due diligence…   Read more»

]]> fd1d40706f72e1d2b6ca5b3dfdd35f0c https://medicaldevicecourses.com/activity/p/24522/ Sun, 20 Feb 2022 19:01:37 -0500 At my job I have been working on securing the PACs server for a set of new ultrasound units, however, the department who made the request is asking to have the studies sent to a server they have never used…   Read more»

]]> bb3a8f04343adc169d872951af4a8ea9 https://medicaldevicecourses.com/activity/p/24448/ Sun, 13 Feb 2022 03:13:54 -0500 I believe individuals should work on separate parts and that smaller groups should gradually form within the team before the product is finalized as an entire team. I agree with @anthonynjit in that every successful group understands the importance of…   Read more»

]]> d4fb133ce9719cfae0d94a1c5a57d03e https://medicaldevicecourses.com/activity/p/24446/ Sun, 13 Feb 2022 02:23:19 -0500 Design verification is where the manufacturers develop procedures to verify the device design – meaning confirming that the design outputs (reference criteria and evaluate device for proper functioning) meet the design inputs (complete, clear, and non-conflicting requirements relating to the…   Read more»

]]> 849422b1a967196446fdabcf2c3cc5d3 https://medicaldevicecourses.com/activity/p/24435/ Sat, 12 Feb 2022 21:48:18 -0500 I believe this perspective depends on multiple factors such as what field you are in, position/role, or the size of the company. If we focus specifically on life in industry where there are consumers and users; according to the PMI…   Read more»

]]> 39cc40a61437c8c7ae1f4a964afae27d https://medicaldevicecourses.com/activity/p/24363/ Sun, 06 Feb 2022 20:54:01 -0500 During projects in and out of the classroom, I have typically assumed both roles. I enjoy being hands on, using my technical knowledge, and working on aspects of a project but also like to plan and coordinate with others on…   Read more»

]]> 5c1f5bcc8ec771f576b1bf3e939c486e https://medicaldevicecourses.com/activity/p/24362/ Sun, 06 Feb 2022 20:09:47 -0500 Design verification is one of the nine design controls which is a phase where each manufacturer establish clear, complete, and unambiguous procedures during the actual development, as oppose to after as in the case of the validation control, to verify…   Read more»

]]> c7d300fb5d29c5dab539fd8003df6beb https://medicaldevicecourses.com/activity/p/24360/ Sun, 06 Feb 2022 19:37:23 -0500 As mentioned in the lecture there are nine design controls listed in 21 CFR 820.30 – these include: planning, input, output, review, verification, validation, transfer, design changes, and design history files. As stated by @mmd55, all nine parts are essential…   Read more»

]]> 9faf39742c0f6c5a8bc6ccf89719d4aa https://medicaldevicecourses.com/activity/p/24329/ Mon, 31 Jan 2022 03:51:30 -0500 I believe the most important FDA responsibility as mentioned by my peers is advancing public health by expediting innovation, hence the case, with companies such as Pfizer-BioNTech receiving emergency use authorization by the FDA for the COVID-19 vaccine. However, prior…   Read more»

]]> 52788a2747a3e02e96baebe0f558e693 https://medicaldevicecourses.com/activity/p/24325/ Mon, 31 Jan 2022 03:18:18 -0500 To clarify from my original post, I would think as per the conditions listed by the FDA for what devices qualify as a Class 2 device and what prohibits devices from filing a 510(k) as per the post from @anthonynjit,…   Read more»

]]> b721a8ead9857c906a9b83b6216b8bc0 https://medicaldevicecourses.com/activity/p/24324/ Mon, 31 Jan 2022 03:03:47 -0500 Thank you @wonbum-sohn for creating this post and for everyone who has responded. As mentioned in other threads, I am working on a point of care device for early cancer screening. Although the targeted biomarker of interest for the device…   Read more»

]]> 23df08699fad0027dc3d3e6ce5317528 https://medicaldevicecourses.com/activity/p/24320/ Mon, 31 Jan 2022 02:00:39 -0500 I have never worked in regulatory affairs, however, my understanding is that it is an essential segment of every industry, let alone the medical device industry. An individual working in regulatory affairs is responsible for overseeing product development, testing, manufacturing,…   Read more»

]]> 064097285f34e27e4ef9535791be813b https://medicaldevicecourses.com/activity/p/24229/ Sun, 23 Jan 2022 21:28:17 -0500 Hello everyone! I know for week 1 we were only asked to read through chapter 1 of the PMBOK Guide and information on organizational structures is in chapter 2, section 4.4 but I still wanted to respond to this post…   Read more»

]]> dcee772d498e8d8f8d742cf954e8faeb https://medicaldevicecourses.com/activity/p/24225/ Sun, 23 Jan 2022 21:28:15 -0500 To answer this question, let’s first define a program. A program is a group of related projects that are managed by a team as opposed to an individual. Therefore, as per chapter 1, section 2.3.2 in the PMBOK Guide, programs…   Read more»

]]> 04bb7763689ac309c35ec5f8d9abbe53 https://medicaldevicecourses.com/activity/p/24224/ Sun, 23 Jan 2022 21:28:14 -0500 It is interesting how everyone has reflected back on their days in senior capstone, which is a perfect example of a project – a temporary endeavor to create a unique product/service that drives change and enables business value creation. It…   Read more»

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