https://medicaldevicecourses.com/members/smc24njit-edu/activity/ Activity feed for smc24@njit.edu. Fri, 24 Apr 2026 22:39:12 -0400 https://buddypress.org/?v= en-US 30 hourly 2 f4acc9d1e9d769fecdb95cf7037e4523 https://medicaldevicecourses.com/activity/p/31540/ Sun, 04 May 2025 21:19:33 -0400 Like many others, one of the things that motivates me is the desire to create something meaningful. I want to be a part of something that has a true positive impact on the lives and well-beings of people every day….   Read more»

]]> dde66511cbda798a9221b0ebd3b64f2f https://medicaldevicecourses.com/activity/p/31539/ Sun, 04 May 2025 20:43:33 -0400 There are absolutely more factors to consider when selecting a vendor. For example, delivery timelines and reliability is essential to avoid delays, especially when working on time-sensitive projects. Another one is regulatory compliance and any associated certifications. When working on…   Read more»

]]> 3135f05634f43f7c477bc2e2b6bfc8ef https://medicaldevicecourses.com/activity/p/31538/ Sun, 04 May 2025 20:29:37 -0400 One important thing I know I have learned in this class is the project management is much more than just planning. Beforehand, I did not really know what project management was. I had assumed that the majority of the work…   Read more»

]]> 6218b9402645464502872e9b4d6a5ea0 https://medicaldevicecourses.com/activity/p/31427/ Mon, 28 Apr 2025 00:06:58 -0400 There are dozens of factors to consider when selecting a vendor. In addition to cost and quality, one of them is the reliability of a vendor. You clearly would not want to select a vendor who is not able to…   Read more»

]]> 0666a296f8bea97a380dcb66e32ab331 https://medicaldevicecourses.com/activity/p/31426/ Sun, 27 Apr 2025 23:53:37 -0400 Stakeholder engagement is crucial to the success of a project, especially through clinical trials since this can be such an important stage for a project. Stakeholder engagement heavily relies on active listening, transparency, and mutual respect. Active listening can ensure…   Read more»

]]> 29b668ef2ea5401b61d520d499d74986 https://medicaldevicecourses.com/activity/p/31425/ Sun, 27 Apr 2025 23:22:46 -0400 Is job satisfaction the most important factor in employee retention and productivity, or are other factors such as compensation, authority, and interpersonal relationships equally important. There are a ton of factors when it comes to employee retention. Job satisfaction is…   Read more»

]]> fccdf731eaeb53873c7d1559b6e932ad https://medicaldevicecourses.com/activity/p/31335/ Mon, 21 Apr 2025 02:26:35 -0400 The first step would definitely be to conduct a thorough risk analysis, considering things like the scope, resources, deadlines, and potential impacts on quality. Cost benefit analysis specifically can really help determine what may offer the best balance between saving…   Read more»

]]> 7d4bd04f95b9a9cf58a398073dc8d9b1 https://medicaldevicecourses.com/activity/p/31333/ Mon, 21 Apr 2025 02:15:33 -0400 I feel the biggest factor in deciding a number of vendors is a projects risk tolerance. In the case of medical devices, such as in the minisim, the tolerance is very low. There is very little room for errors and…   Read more»

]]> 84d1dc6ac5f7b9c134d7919faec5a3c0 https://medicaldevicecourses.com/activity/p/31332/ Mon, 21 Apr 2025 02:03:26 -0400 I definitely believe that an overemphasis on regulatory considerations can limit quality management. An overemphasis can often encourage a “just enough” mindset where the regulations are met, but not exceeded. It is important to remember that regulations are not a…   Read more»

]]> 4140dfc756226d9cf0cfc59d8e6a6604 https://medicaldevicecourses.com/activity/p/31258/ Mon, 14 Apr 2025 02:25:01 -0400 I can definitely relate to having my definition of a stakeholder changed. What changed for me the most was that a stakeholder technically does not even have to be a person. I always thought of a stakeholder as a single…   Read more»

]]> 4cf82141138bb65ad3de73d6c83d9d65 https://medicaldevicecourses.com/activity/p/31253/ Sun, 13 Apr 2025 23:55:03 -0400 I personally believe that the planning phase is the most important phase of project management. I believe so because poor planning can doom a project from the start. Without thorough planning, a project will run into too many walls and…   Read more»

]]> 724255a5f13205f44daebbcc8d81302a https://medicaldevicecourses.com/activity/p/31252/ Sun, 13 Apr 2025 23:43:14 -0400 In my experience, the best ways to document and share “lessons learned” or other important announcements is through a tool like Microsoft Sharepoint. Sharepoint is a very useful tool that many organizations use to store useful documentation and have it…   Read more»

]]> 6b78895c2c5947994d0cfff1ee709ceb https://medicaldevicecourses.com/activity/p/31183/ Mon, 31 Mar 2025 03:05:15 -0400 One way I think it is best to organize a meeting is to get straight to the point. I have been a part of meetings with introductions to people or topics, Q&As, or unrelated company updates at the beginnings of…   Read more»

]]> 50d615d0dc4d0d53b51b9450ee5f2a4b https://medicaldevicecourses.com/activity/p/31177/ Mon, 31 Mar 2025 02:49:21 -0400 When working with medical devices, larger companies not only deal with rules, regulations, and guidelines from the FDA, but for regulatory bodies outside of the US as well. Say you worked for a large company, and the European Medicines Agency…   Read more»

]]> 98a847944a60ee91858dd19e3641cc97 https://medicaldevicecourses.com/activity/p/31175/ Mon, 31 Mar 2025 02:04:59 -0400 Managing change fatigue can absolutely be tricky, especially in the medical device field with so many regulatory bodies and guidelines that can force very suddenly. Too many of these changes can lead to change fatigue, but with such strict laws…   Read more»

]]> a3e6456eaa7e69373c24ab0a2063e301 https://medicaldevicecourses.com/activity/p/31090/ Mon, 17 Mar 2025 01:45:31 -0400 I am surprised to see that no one is focusing on developing technical skills and familiarization with industry-specific standards and regulatory boards. Personal development is about much more than personality and traits, but development within the actual area of work…   Read more»

]]> cbb650fccf9a58a594e38bbef5ba7d5c https://medicaldevicecourses.com/activity/p/31086/ Mon, 17 Mar 2025 01:19:16 -0400 Unfortunately, without regulatory compliance there is no innovation. I do not necessarily agree that there is a balancing of innovation and regular compliance. Regulatory compliance is far more important than innovation, as with any violations a project or company can…   Read more»

]]> 2ac0bd2bb71eeb5d5f933971e192e0a1 https://medicaldevicecourses.com/activity/p/31082/ Mon, 17 Mar 2025 00:41:40 -0400 I personally feel as in person meetings are essential to success. Emails simply cannot get important information across. We live in an age where many young people barely check their email, and when they do they skim it as it…   Read more»

]]> 1fbcd924d12401702f3fcb2d3d42048c https://medicaldevicecourses.com/activity/p/30924/ Mon, 03 Mar 2025 04:08:25 -0500 One of the best ways to manage your inbox is built directly into every major email provider and/or manager. I have not seen many people use this function personally, but you can create customizable folders and filters using “rules.” For…   Read more»

]]> 0fb38a6c4952607cacdf35f90df8e25d https://medicaldevicecourses.com/activity/p/30921/ Mon, 03 Mar 2025 03:47:27 -0500 I believe it is more important to consider money during the planning phase. I say this because without money, there is no project and deadlines don’t matter. You can be given 2 years to replace a broken fridge, but if…   Read more»

]]> 9fd608122166eb11d86ca00c95af3662 https://medicaldevicecourses.com/activity/p/30919/ Mon, 03 Mar 2025 03:29:00 -0500 Maintaining the critical path is just as important as it sounds, it is absolutely critical to the success of the project. I was the dedicated “Project Manager” for my BME capstone team during my time as an undergrad. Although the…   Read more»

]]> cd90dbee1dc3b12aee9b26398bb76b03 https://medicaldevicecourses.com/activity/p/30852/ Mon, 24 Feb 2025 07:47:28 -0500 @sn64 Hey! The first step would be to establish a framework, defining a clear tiered approach to classify the changes. Then I would ensure that there is a clear documentation and tracking system in place to ensure proper documentation and…   Read more»

]]> 5a5d44f3e8e69e31b3e24cd83dc2b70d https://medicaldevicecourses.com/activity/p/30851/ Mon, 24 Feb 2025 07:06:53 -0500 I believe the most present risk in the majority of projects would have to be a schedule risk. This is because of the immense number of factors that can all affect the schedule of the project at any given moment….   Read more»

]]> 2cdcd46ab7a3caf1450119681fe54d43 https://medicaldevicecourses.com/activity/p/30850/ Mon, 24 Feb 2025 06:17:26 -0500 Hello! My name is Sean Caswell and I am doing my master’s in BME at NJIT! I look forward to connecting with you all!
Here is my LinkedIn -> Sean Caswell | LinkedIn

]]> fe0f7e9b90fcd5bea5621a30318198a7 https://medicaldevicecourses.com/activity/p/30745/ Sun, 16 Feb 2025 22:59:50 -0500 One important nuance I have always noticed is that it has never been “Nature or Nurture” but rather “Nature vs Nurture.” It is not black or white, it is more comparable to grayscale. I think of it as a large…   Read more»

]]> 0c655fc8ce7a93a0a2692007ec28c203 https://medicaldevicecourses.com/activity/p/30743/ Sun, 16 Feb 2025 22:42:18 -0500 I personally believe that testing in extremes is important. For example, say the labels were only tested for what was deemed “practical application” and tests were never conducted on bottles wet for the time period. The labels pass without issue…   Read more»

]]> de2adc30e2c04b81fe90caaedea001f7 https://medicaldevicecourses.com/activity/p/30741/ Sun, 16 Feb 2025 21:55:06 -0500 Fortunately, my group did not seem to run into any issues. However, we did run into a similar situation where everyone seemed to have a slightly different background. I believe it helped us as well. Our group was able to…   Read more»

]]> a3ee73d665aa204e4422fbf88a74a447 https://medicaldevicecourses.com/activity/p/30657/ Mon, 10 Feb 2025 05:08:45 -0500 A Design History File (DHF) is essential for regulatory compliance, but a massive part of good project management as well. Any issues with regulatory boards will have drastic implications for the company in question. One of the best ways I…   Read more»

]]> c7b9f0af3390bb53431849f5453dc671 https://medicaldevicecourses.com/activity/p/30656/ Mon, 10 Feb 2025 04:56:55 -0500 I believe the best way to handle Design Change Requests is to plan for them in the first place. Obviously no one wants to plan for something to go wrong, but good project management will always plan for setbacks and…   Read more»

]]> bd20d914048fe5a28b9c210172f18a12 https://medicaldevicecourses.com/activity/p/30564/ Mon, 03 Feb 2025 01:43:25 -0500 I think this common practice clearly limits the potential for innovation in the medical field. The most obvious reasons to me are rooted in financial capacity and resources. Innovation and new devices and treatments are essential to the medical field…   Read more»

]]> 6bf410df88a520369b4d4aade2ab18e0 https://medicaldevicecourses.com/activity/p/30562/ Mon, 03 Feb 2025 01:09:19 -0500 Many devices exist in a sort of “grey area” where they could potentially be classified as one class or another, or at the very least experience overlap when it comes to the governing sub-agency of the FDA (CBER, CDER, CDRH)….   Read more»

]]> 68d34a01af0e03dbd4c842f682e4ffc6 https://medicaldevicecourses.com/activity/p/30558/ Sun, 02 Feb 2025 23:56:35 -0500 Understanding the differences between these pathways is essential to Project Management since they drastically effect the timelines and requirements for projects that fall under them. Typically, a PMA will take the longest and it is required for any Class III…   Read more»

]]> 78bce47ae70ded1bc4f5b2444e85dcf0 https://medicaldevicecourses.com/activity/p/30487/ Mon, 27 Jan 2025 04:27:32 -0500 Balancing the values between stakeholders and customers is what I would call being stuck between a rock and a hard place. In a perfect world, all values would align in perfect harmony. However, as anyone can assume this is almost…   Read more»

]]> bc0923178a69e01b9ec63d8b61d8b7ef https://medicaldevicecourses.com/activity/p/30482/ Mon, 27 Jan 2025 03:38:41 -0500 I believe there are three keys to effective communication: speed, detail, and situational awareness.  Firstly, effective communication must happen as soon as possible. As soon as a need for communication is identified, I strongly believe an attempt at said communication…   Read more»

]]> 0abd8a5013f02fb9e8b286ef11b3ff9d https://medicaldevicecourses.com/activity/p/30478/ Mon, 27 Jan 2025 03:00:51 -0500 You’ve certainly nailed the importance of Project Managment! To answer your proposed question, my experience definitely leads me to believe that rules and regulations are by far the biggest hurdle in any medical industry, including when it comes to medical…   Read more»

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