https://medicaldevicecourses.com/members/magstiff/activity/ Activity feed for tm422. Fri, 24 Apr 2026 23:46:26 -0400 https://buddypress.org/?v= en-US 30 hourly 2 3ed7d01d0c7e15da2615ba0ee6a1fd85 https://medicaldevicecourses.com/activity/p/31454/ Mon, 28 Apr 2025 19:54:09 -0400 @sn64 I completely agree with your points! eClinical platforms and eConsent are growing and modernizing clinical trials. Real-time risk-based monitoring (RBM) could be a real game-changer for identifying issues early and improving overall study quality. I also like how you…   Read more»

]]> f2bc14e74d29214c2329a41770355eda https://medicaldevicecourses.com/activity/p/31453/ Mon, 28 Apr 2025 19:38:22 -0400 Throughout this semester in BME 682, we explored various subjects related to industry stages, project creation, and adhering to deadlines. These topics definitely significantly assisted me in considering my future direction. To answer your question, if I had a choice,…   Read more»

]]> 41b68c361fa74dc08932308c7ed18417 https://medicaldevicecourses.com/activity/p/31452/ Mon, 28 Apr 2025 19:32:02 -0400 This is an awesome question. I feel that one of my biggest motivators is competition as well. The drive to continuously improve was fostered during my time in the military. I found that some parts of that were carried into…   Read more»

]]> 395c613f6feba54a940a64aeea0610c9 https://medicaldevicecourses.com/activity/p/31372/ Tue, 22 Apr 2025 15:53:59 -0400 If I’m leading a team in my medical device company, I’m maintaining a positive atmosphere and ensuring the objective is clear. To begin with, I would ensure that everyone understands their contributions truly count and give credit where it is…   Read more»

]]> beebe9983465e8dbf0b7eb989543caca https://medicaldevicecourses.com/activity/p/31371/ Tue, 22 Apr 2025 15:47:34 -0400 I believe that while job satisfaction is often glorified as the key to retaining your employees and promoting productivity, it is quite idealistic. In my experience, compensation frequently outweighs satisfaction, especially in high pressure fields. You can love your job…   Read more»

]]> 3b49f4d08e73840b04a92e259b8d5093 https://medicaldevicecourses.com/activity/p/31370/ Tue, 22 Apr 2025 15:34:45 -0400 I believe that clinical trial teams can find a good balance between following the protocol and keeping patients safe by treating their given protocol as a flexible guide rather than a strict rulebook. I know this is not a conventional…   Read more»

]]> aeee06ecaab6eb5e2d1f26335913e7d1 https://medicaldevicecourses.com/activity/p/31291/ Tue, 15 Apr 2025 15:40:59 -0400 @eowinomsm-edu Hi there. I agree with you! What’s intriguing is that the budget not only indicates the financial condition of a project; it also actively influences the project’s character. In other words, it functions as a framework behind the framework….   Read more»

]]> 09c66926e19eb53317aaad638acbb0ec https://medicaldevicecourses.com/activity/p/31290/ Tue, 15 Apr 2025 15:25:49 -0400 In my opinion, although both communication and technical abilities hold value, superior communication skills are more crucial for project managers. It was discussed in class that the main responsibility of a project manager is to organize teams, synchronize stakeholders, oversee…   Read more»

]]> 59975a70760d90a95109d30f1e3a11d2 https://medicaldevicecourses.com/activity/p/31289/ Tue, 15 Apr 2025 15:21:52 -0400 In my experience in industry, missing deadlines can mean the difference between a successful and failing project. Yes, I believe there should be some kind of consequence for going over project deadlines or budgets. More specifically, it should be a…   Read more»

]]> 927f983a07bf1302bd360e104735c465 https://medicaldevicecourses.com/activity/p/31219/ Tue, 08 Apr 2025 01:40:20 -0400 @benjaminrofail Hi Ben! You’ve made a good point— change fatigue is indeed a reality, particularly in regulated settings such as medical device development, where alterations in documentation and design are frequently unavoidable. I experienced this myself firsthand when I was…   Read more»

]]> 1bc421a90ba3ac4666c070096a15e652 https://medicaldevicecourses.com/activity/p/31218/ Tue, 08 Apr 2025 01:28:58 -0400 @ms3548 In my experience, working in the medical device industry, one of the biggest challenges was ensuring that data from labs outside our immediate workplace aligned with our internal expectations. This is especially true during verification and biocompatibility testing. We…   Read more»

]]> 30c916bf70e89f28f513d35bcb2fbc9c https://medicaldevicecourses.com/activity/p/31217/ Tue, 08 Apr 2025 01:08:35 -0400 In my time working in industry, I know that things may get fast paced rather quickly. Especially when multiple departments are involved, communication can make or break a timeline. From formal documentation like meeting minutes and design reviews to more…   Read more»

]]> 492e38984cd88bbbb3a996bffa2f99ec https://medicaldevicecourses.com/activity/p/31145/ Wed, 26 Mar 2025 22:20:34 -0400 @sa2847 I agree with you! On top of this, project managers can also manage their inboxes more efficiently by setting specific times during the day to respond to emails. I personally enjoy utilizing filters and folders to organize my messages….   Read more»

]]> c417b08968c615b6bc0b8b62135aa58b https://medicaldevicecourses.com/activity/p/31143/ Wed, 26 Mar 2025 22:12:50 -0400 From a medical device intern’s perspective, I believe that hiring from within the company is often the better choice, especially for roles that require deep understanding of internal processes. Many tasks, even for the same role at different institutions, have…   Read more»

]]> 2325dbda6f9e5c2c57f616776401d252 https://medicaldevicecourses.com/activity/p/31142/ Wed, 26 Mar 2025 22:07:04 -0400 In my opinion, preventing change fatigue while maintaining a strong change control process in medical device development can be done by teams implementing a prioritization system that categorizes changes by the risk and impact. In my experience in medical device…   Read more»

]]> 26a5739bbf266fbcdbaf5a513a4e7457 https://medicaldevicecourses.com/activity/p/31025/ Mon, 10 Mar 2025 19:13:57 -0400 @ms3548 Although collaborations can offer advantages, they are not always the most efficient or economical method. Working in industry has taught me that collaborations such as the one between BoneFix and FactoSet bring about intricacies that may actually hinder decision-making…   Read more»

]]> 80525db79ab6e07e92c743247d791b73 https://medicaldevicecourses.com/activity/p/31024/ Mon, 10 Mar 2025 19:05:32 -0400 @cs22 I fully agree with you—jeopardizing the integrity of experimental data can lead to much graver outcomes than merely delaying a project. I noticed that if inadequate experimentation results in unnoticed design defects, the problem might not emerge until significantly…   Read more»

]]> 45490e3c6a4c1e1ea32dd126aa94fb23 https://medicaldevicecourses.com/activity/p/31023/ Mon, 10 Mar 2025 19:00:18 -0400 @sa2847 In root cause analysis (RCA), defining the issue, setting timeframes, and identifying locations are crucial, but I believe that this method is sometimes overly strict and fails to encompass the full depth of an effective RCA. In my experience…   Read more»

]]> 36604b476b38f8a9865a993db939b1cd https://medicaldevicecourses.com/activity/p/30954/ Tue, 04 Mar 2025 16:57:04 -0500 @kellyepcarter I see where you’re coming from, and I have to disagree with the original definition of success. An important thing to note is that even though the project may check all the boxes in terms of budget, timeline, and…   Read more»

]]> c26701a83dc06357f9bdc78764b84bdf https://medicaldevicecourses.com/activity/p/30953/ Tue, 04 Mar 2025 16:52:40 -0500 @jo277 Hi there, that is a really excellent observation. I noticed in my industry internship that managing change in validated processes can be highly intricate, especially when trying to balance efficiency and compliance. Implementing an effectiveness assessment is essential to…   Read more»

]]> 532efb6fafc32758852cb74fab00955c https://medicaldevicecourses.com/activity/p/30952/ Tue, 04 Mar 2025 15:57:50 -0500 @arianaburch I agree with you! Well said. Allocating time not only properly enables comprehensive development, it also guarantees that the product adheres to quality benchmarks. In my experience with industry, although obtaining investments may be really important, a thoroughly developed…   Read more»

]]> 427ae09ba3d8eb35507871a635f73955 https://medicaldevicecourses.com/activity/p/30881/ Wed, 26 Feb 2025 20:32:15 -0500 I believe the question depends on what you mean by “valid.” There is no doubt that the Google PMP certification (Google Project Management Professional Certificate) serves as a strong entry-level qualification. This is especially true for individuals who are new…   Read more»

]]> efe39e7adb6427b727e4adb20aa4ff0f https://medicaldevicecourses.com/activity/p/30880/ Wed, 26 Feb 2025 20:28:27 -0500 @mirna-cheikhali I understand the argument that schedule risk is common, but I would actually argue that financial risk is truly the primary concern in many industries. Delays are certainly an issue, yet in many situations, they can be handled. Teams…   Read more»

]]> 0c2f391e4113f9b50896981ffdad9434 https://medicaldevicecourses.com/activity/p/30879/ Wed, 26 Feb 2025 20:24:58 -0500 @sn64 Hi sn64! I agree with you- keeping abreast of regulatory trends is an evolving and complex endeavor. A noteworthy aspect to reflect on is the growing importance of AI and machine learning in regulatory intelligence. My company that I…   Read more»

]]> 1dd8d0aa77b4f66943d8fcafc46b5527 https://medicaldevicecourses.com/activity/p/30775/ Mon, 17 Feb 2025 22:43:49 -0500 Missing a milestone is seen often as a setback, but it can also serve as an important indicator that the project timeline did not accurately reflect the work that was listed for a given project. I have noticed in my…   Read more»

]]> ec73044a32b5965fd634fbc5c480c6a4 https://medicaldevicecourses.com/activity/p/30774/ Mon, 17 Feb 2025 22:37:59 -0500 @devdesai Hi there! You made a great point about how it is important to incorporate slack into a project’s timeline. Slack helps account for expected delays like vacation and unexpected issues that might arise. Having extra time as a buffer…   Read more»

]]> 3d6b9c2b8a6721d3ab6c2f8bd772287b https://medicaldevicecourses.com/activity/p/30773/ Mon, 17 Feb 2025 22:32:55 -0500 Hi everyone! My name is Tiffany Magno, and I am pursuing both my BS and MS in BME at NJIT. A fun fact about me is I am also in the military!  Tiffany Magno | LinkedIn I look forward to…   Read more»

]]> 7e48bb2e854d8e84c3dea7018be49d33 https://medicaldevicecourses.com/activity/p/30669/ Mon, 10 Feb 2025 21:10:31 -0500 @sn64 Hi sn64! I recently learned about a tool used at work to facilitate analysis regarding regulatory classification. The company one of my professors work for uses an AI-powered regulatory decision matrix for this process. The tool streamlines analysis by…   Read more»

]]> 9b5d9c2f9a953f80d45c101fa37fe36e https://medicaldevicecourses.com/activity/p/30668/ Mon, 10 Feb 2025 20:57:32 -0500 @amm7 I agree that finding the right balance between tight and loos specification is very important however I would also like to note that beyond functionality is the impact on long term performance and regulatory compliance. What do I mean…   Read more»

]]> 23786166e0269789f5d7fc75ceb42d32 https://medicaldevicecourses.com/activity/p/30667/ Mon, 10 Feb 2025 20:53:09 -0500 @archishak Hi there! While project management skills can be beneficial in many fields, I would actually argue against your post that a deep understanding of project management is not always necessary to contribute effectively to a project’s success. Many professionals…   Read more»

]]> 84c78fb14096c8b40e4041f4d1c9fbe9 https://medicaldevicecourses.com/activity/p/30610/ Thu, 06 Feb 2025 01:54:47 -0500 @anthony Hi Anthony! That is a very valid concern. The endorsement of Abilify MyCite highlights an important disparity between regulatory adherence and real-world clinical usefulness. Although the FDA’s responsibility is to confirm safety and adequate effectiveness, it does not always…   Read more»

]]> d7e975c4c2f268d3642772ca46b7e53a https://medicaldevicecourses.com/activity/p/30609/ Thu, 06 Feb 2025 01:48:13 -0500 @bryan-xavier Hi Bryan! I certainly agree. Utilizing a traceability matrix is a fantastic method to keep organization in the Design History File (DHF), I found it quite useful when organizing one for a previous semester project. It guarantees a systematic…   Read more»

]]> e6fcce1dde6d5c9a3790ff06c4748085 https://medicaldevicecourses.com/activity/p/30608/ Thu, 06 Feb 2025 01:41:25 -0500 @mjc22 Hi there! I agree with you that filing for FDA approval of a misclassified device can cause major hinderances to the entire process. I can recount a personal experience with this. While I was interning in a small startup…   Read more»

]]> 26593b63cf3e5a97cf4299126b10126d https://medicaldevicecourses.com/activity/p/30513/ Tue, 28 Jan 2025 19:04:55 -0500 @sn64 Hey sn64! Although empathy and comprehension are essential characteristics for a project manager, I would also like to make note that altering goals or reallocating tasks shouldn’t be the initial strategy in such scenarios. The main duty of a…   Read more»

]]> af35769430024ae744fb0226748697e1 https://medicaldevicecourses.com/activity/p/30512/ Tue, 28 Jan 2025 19:02:48 -0500 96441729bc8201130b1d77acf40cfcda https://medicaldevicecourses.com/activity/p/30511/ Tue, 28 Jan 2025 19:01:57 -0500 @benjaminrofail Hi Ben! You make a good point about how conflicts can either strengthen or weaken a team, depending on how they are handled. I agree that overcoming disagreements through clear communication and discussion fosters camaraderie. I can personally attest…   Read more»

]]> c7d63bffe31ff2f3791c6f939d8bdcb4 https://medicaldevicecourses.com/activity/p/30510/ Tue, 28 Jan 2025 18:55:24 -0500 I find that collaborating in teams of varying sizes presents distinct benefits and challenges. During my time in the military, I noticed that small teams typically offer efficient communication and quicker decision-making, yet might lack a range of expertise, while…   Read more»

]]> 6e8d033e35cd34450ac43431dace7c1d https://medicaldevicecourses.com/activity/p/30441/ Sat, 25 Jan 2025 13:04:27 -0500 When presented with new technology during a project, a project manager should carefully evaluate their possible effects by considering their compatibility with project objectives. This evaluation includes performing a detailed cost-benefit analysis, taking into account aspects such as increased efficiency,…   Read more»

]]> b1f957b5e14629571a69df1f65957d8a https://medicaldevicecourses.com/activity/p/30440/ Sat, 25 Jan 2025 12:58:06 -0500 During the lecture, we explored different organizational structures, and I think the leadership style—whether it be hands-off or micro-managing—significantly impacts a project’s success. Based off my previous work experience, I personally favor collaborating with a leader who takes a hands-off…   Read more»

]]> f064f1e74ce6650d00c83771852e4eb6 https://medicaldevicecourses.com/activity/p/30439/ Sat, 25 Jan 2025 12:52:36 -0500 @ms3548 This is a thoughtful question! I think that Agile approaches are very efficient in handling changing project objectives since they prioritize flexibility and teamwork. By dividing the project into smaller, time-limited sprints, Agile enables teams to reevaluate priorities and…   Read more»

]]> 5a6c6818c9b07df393f8e35aaca5f369 https://medicaldevicecourses.com/activity/p/30285/ Tue, 26 Nov 2024 19:26:43 -0500 Hi Roberto, I agree with you that these situations can feel awkward especially when the intent is simply to show professional gratitude. One way to address this awkwardness might be to have clear communication up front. I would have had…   Read more»

]]> 02ddc0fb0378dfd22cea9a60bf4f1ef5 https://medicaldevicecourses.com/activity/p/30284/ Tue, 26 Nov 2024 19:21:37 -0500 @cef3 You make a valid point however, I would argue that even legal action seems unlikely, having a contract is still strongly beneficial. A contract ensures that all parties are on the same page regarding stated terms, reducing any misinterpretations…   Read more»

]]> ac0cfeec81efd54ab865897e2cdd930b https://medicaldevicecourses.com/activity/p/30283/ Tue, 26 Nov 2024 19:17:01 -0500 @cef3 You make a good point! An NDA is surely an important piece in the early stages of development especially when engaging with collaborators to collect necessary data. Without an NDA, it is true that there is significant risk that…   Read more»

]]> f1b0da4e077232fe6cc0c7baa59a7c72 https://medicaldevicecourses.com/activity/p/30282/ Tue, 26 Nov 2024 19:08:44 -0500 It is clear from our class lectures that organizational development (OD) is very important in assisting medical device manufacturing companies to integrate cutting-edge technologies. In fields regarding AI and IoT, OD helps in ensuring these advancements are in line with…   Read more»

]]> 4bf5ca15ea1d215952ac4dd433f0ad71 https://medicaldevicecourses.com/activity/p/30221/ Wed, 20 Nov 2024 19:43:53 -0500 Based off my experience in industry, I believe that the ideal organizational layout varies based on the company’s objectives. A flexible approach such as “everyone does all tasks” is suitable for small businesses as it promotes agility and multitasking, and…   Read more»

]]> 57db1b5e844cc560fdc12d9d7bf3a9ee https://medicaldevicecourses.com/activity/p/30220/ Wed, 20 Nov 2024 19:32:51 -0500 I believe I have the potential to succeed in both positions in the long run, but I envision myself beginning in middle management. Middle management is primarily responsible for task execution and ensuring the effective implementation of the company’s vision,…   Read more»

]]> b6d58ae4999773862dfcb67612555e67 https://medicaldevicecourses.com/activity/p/30219/ Wed, 20 Nov 2024 19:19:31 -0500 That’s an awesome question! In order to build a successful project team, I feel that I must prioritize selecting members with the required knowledge and abilities for their respective positions, in addition to their ability to work together effectively and…   Read more»

]]> f2110f1aff91857c5887bf6a0bebc4ae https://medicaldevicecourses.com/activity/p/30160/ Thu, 14 Nov 2024 19:54:59 -0500 Hi Savannah! Those are great questions. Compliance with ISO, FDA, and ASTM standards can be expensive as it involves a good amount of resources, expert cooperation, and continuous updates. Based off my previous work experience, I understand that these are…   Read more»

]]> 973d20c677027d3d940474eaf98d027c https://medicaldevicecourses.com/activity/p/30157/ Thu, 14 Nov 2024 17:01:26 -0500 Risk management is certainly a crucial aspect of the planning stage, particularly in the area of medical device development. I worked in medical device development for quite some time and what I noticed was incorporating risk management early enables teams…   Read more»

]]> 7537af250cfae00fa2ac02bb66002da2 https://medicaldevicecourses.com/activity/p/30156/ Thu, 14 Nov 2024 16:57:36 -0500 Based off my experience working in a medical device company for dental implants, conducting a risk management evaluation for a medical device offers many important advantages! One of the most commonly observed is the increase of safety for patients and…   Read more»

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