https://medicaldevicecourses.com/members/noahyoussef/activity/ Activity feed for noahyoussef. Sat, 25 Apr 2026 04:09:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7037fd793d9c1d767135d888e97213e9 https://medicaldevicecourses.com/activity/p/29308/ Sun, 14 Apr 2024 14:06:44 -0400 For the mini-SIM, I opted to have one alternative vendor. This choice was the more financially favorable option and delayed the project less; however, there was more risk with having only one alternative vendor. Yet, I justified taking on this…   Read more»

]]> 61ca3d38e68fdcc2314ccea5a69659f5 https://medicaldevicecourses.com/activity/p/29307/ Sun, 14 Apr 2024 14:03:46 -0400 In smaller projects, quality control may be a constant process rather than having an entire team dedicated to that sector. For instance, for smaller projects, each member of the team can review the work of other team members, serving as…   Read more»

]]> 9c0eb772d3a617b553c791cd5ebe3b32 https://medicaldevicecourses.com/activity/p/29306/ Sun, 14 Apr 2024 14:01:01 -0400 I agree with some of the above responses. It is possible to cultivate a strong, collaborative team environment even while using a lower budget. A lot of team-building activities do not require a high budget, just time and effort. It…   Read more»

]]> 306579b5e912444a28c521576a688aec https://medicaldevicecourses.com/activity/p/29255/ Mon, 08 Apr 2024 02:00:00 -0400 I think it is a good practice to hire a blend of both particular field experts and versatile employees. In order for a project to have success, the team needs to be able to adapt and adjust to particular changes….   Read more»

]]> 743b16976ac7ed62d47625a0af3dddd4 https://medicaldevicecourses.com/activity/p/29251/ Mon, 08 Apr 2024 00:25:15 -0400 I agree with many of the other responses regarding the fact that the project planning/initiation stage is the most important aspect. If this stage is rushed or not completed properly, then the rest of the project will fail. I’d also…   Read more»

]]> 7037979e37bccdabc63a761246d6b813 https://medicaldevicecourses.com/activity/p/29246/ Sun, 07 Apr 2024 23:48:08 -0400 While not talked about much in the course, one aspect of medical device development (especially for devices that require clinical trials) that needs to be monitored is documentation. There are so many different forms of documentation including protocols, informed consent…   Read more»

]]> cce6cde42437b1fddafc4a6ffa68ea61 https://medicaldevicecourses.com/activity/p/29186/ Sat, 23 Mar 2024 16:36:11 -0400 In addition to the questions mentioned above, other key questions that can be asked include: When did the issue first occur? Where does the issue occur? Who is involved or affected? How frequently does the issue occur? What are the…   Read more»

]]> f226b4761b41a1648023d22f0db94453 https://medicaldevicecourses.com/activity/p/29185/ Sat, 23 Mar 2024 16:31:18 -0400 I agree with the above statements, especially with the fact that the first step in finding a solution is to find the root cause of the schedule variance. However, it may be hard to retroactively fix this issue and get…   Read more»

]]> 3d85135fdf1d46637891baba2698a97c https://medicaldevicecourses.com/activity/p/29165/ Tue, 19 Mar 2024 21:06:48 -0400 I think the success of a project depends on the initial goals set out during project initiation/planning. If the outcomes of the project meet these goals, then the project is successful. If the project is unable to meet the aforementioned…   Read more»

]]> 81abd5aadc6a3da1f703cabbd31b0e26 https://medicaldevicecourses.com/activity/p/29135/ Mon, 11 Mar 2024 02:13:21 -0400 Personally, I prefer communication via Teams as it is more convenient to have quick, simple chats in comparison to email. For a quick question, teams tends to generate a much quicker response than email threads. In terms of email management,…   Read more»

]]> 80058ea27d62e0a938b6140340c411de https://medicaldevicecourses.com/activity/p/29134/ Mon, 11 Mar 2024 02:09:25 -0400 Navigating dynamics with multiple project managers can be challenging but manageable with clear communication, coordination, and a structured approach. The best way to overcome the potential challenges of having multiple managers is to establish clear roles among the project managers….   Read more»

]]> b2d60cf6136746fcca0e17e10de9075a https://medicaldevicecourses.com/activity/p/29133/ Mon, 11 Mar 2024 02:05:37 -0400 Risks are not necessarily harmful, as long as they are properly assessed and discussed within a team. Shortening a project timeline may incur some risk, but discussions should be had to determine if the benefits far outweigh the risks. The…   Read more»

]]> a8d7c3ac3aa4b21920441abd788bdbf4 https://medicaldevicecourses.com/activity/p/29021/ Sun, 25 Feb 2024 20:49:07 -0500 One challenge that project managers face is the fact that they may need to confront or address team members when work is not being performed on time or to the level that is expected. These conversations can often be awkward…   Read more»

]]> bf1dde873dfcd79dbb9d4fd9b25f8888 https://medicaldevicecourses.com/activity/p/29020/ Sun, 25 Feb 2024 20:44:42 -0500 As part of a project team in the past, the biggest issue we had with project planning was not setting clear team member roles/expectations. Because of this, there were many delays in getting work completed. Team members were unsure of…   Read more»

]]> 37e4c70a0152e3087c80852084baf127 https://medicaldevicecourses.com/activity/p/29019/ Sun, 25 Feb 2024 20:41:20 -0500 In industry, finances control everything and the stakeholders are the primary means by which a project is funded. Thus, stakeholders hold a significant amount of power. If stakeholders want a project to be completed in a specific manner or on…   Read more»

]]> cf16eae324ab599c9d02cca9eedc323a https://medicaldevicecourses.com/activity/p/28947/ Sun, 18 Feb 2024 13:01:20 -0500 In general, estimates of budgets are usually obtained from thorough market research. Even if a product is not exactly the same as previous products, a rough estimate can be obtained by looking at factors such as market size, market share,…   Read more»

]]> d4569a19cc9c6c61970e4ede40f8a366 https://medicaldevicecourses.com/activity/p/28946/ Sun, 18 Feb 2024 12:57:27 -0500 I recently worked on a Capstone Project where we had to design and construct a medical device. After completing the project, the biggest lesson I learned was to be more proactive. Instead of waiting for due dates/deadlines, it would have…   Read more»

]]> 171eb4e7b3a73d81819fe1ddadde49c7 https://medicaldevicecourses.com/activity/p/28945/ Sun, 18 Feb 2024 12:54:32 -0500 In my experience, poor project planning leads to 2 issues: oversights and delays. When a project is not properly organized from the onset, work is often not delegated properly. Because of this, delays often occur. For instance, if the DID…   Read more»

]]> 8a136f44561c9f27eadddb5d983460f8 https://medicaldevicecourses.com/activity/p/28887/ Sun, 11 Feb 2024 14:36:57 -0500 In general, I do not think there is a major difference between a project manager with an academic background and one with more professional experience. An individual can develop expertise on a given subject through both academics and real-world experiences….   Read more»

]]> ab0cac374d67be8dc280268299794ab1 https://medicaldevicecourses.com/activity/p/28886/ Sun, 11 Feb 2024 14:28:18 -0500 Some individuals are born or inherit traits that are favorable to being a leader. However, not all of these individuals use these traits to lead. Sometimes you meet an individual who is a strong communicator, but they do not use…   Read more»

]]> f670bf57bd3ca178b4d8c2c24fccb718 https://medicaldevicecourses.com/activity/p/28885/ Sun, 11 Feb 2024 14:24:30 -0500 As stated in previous posts, I believe there are pros and cons to both in-person and online project management. While it is more convenient and cheaper to have an online project manager, communication is certainly not as effective in an…   Read more»

]]> 2c48fba39740bfd4d4d581c400d985cf https://medicaldevicecourses.com/activity/p/28809/ Sun, 04 Feb 2024 18:37:28 -0500 The PDCA cycle is an essential aspect of successful biomedical engineering projects. While each respective department may have its own PDCA cycle, the “check” aspect can involve members of different specialties. For instance, in a pharmaceutical company, clinical trial protocols…   Read more»

]]> df4c90fb06ec8379cadb71a34594403d https://medicaldevicecourses.com/activity/p/28803/ Sun, 04 Feb 2024 17:55:12 -0500 Sub plans are important in project management, especially in cases where specific details of a specific aspect of a project need to be expanded. For instance, a project management plan usually includes an executive summary, a Gantt Chart, a risk…   Read more»

]]> 171f5370da31110a532ed21cb95ea51b https://medicaldevicecourses.com/activity/p/28802/ Sun, 04 Feb 2024 17:36:48 -0500 Verification and validation are similar processes but with different goals. Verification relies on testing the design requirements/specifications to ensure that the product is built/functions as designed. Validation is testing to ensure that the customer’s requirements or needs are met. For…   Read more»

]]> 601f3c63081d92d7ac35e85063d54728 https://medicaldevicecourses.com/activity/p/28734/ Sat, 27 Jan 2024 18:07:47 -0500 I do believe there is some ambiguity in the classification of medical devices, especially when considering combination products. However, I’d make the argument that it is better to “overclassify” than “underclassify” the device. For the example of mouthwash with fluorine,…   Read more»

]]> 325695e7612dfa2d10dc772f33da90f4 https://medicaldevicecourses.com/activity/p/28733/ Sat, 27 Jan 2024 18:01:55 -0500 Misclassifying a medical device will shift the project’s overall timeline as different testing or steps would be necessary. For instance, if a Class II device is reclassified as a Class III device, a PMA must be filed and a human…   Read more»

]]> b02d23b8fbe3199c6623200ef746697e https://medicaldevicecourses.com/activity/p/28732/ Sat, 27 Jan 2024 17:57:55 -0500 Reclassification can happen if there are changes made after undergoing testing. For instance, imagine that a traditional hip implant is being tested. During this testing, the researchers note that the implant is loose at the bone-implant interface. Thus, to improve…   Read more»

]]> 12d47758b092252b7b3da10c7c99793a https://medicaldevicecourses.com/activity/p/28670/ Mon, 22 Jan 2024 01:50:31 -0500 A lack of funding is not a positive sign when proposing a new project. While the project may have patent potential, you need to ask yourself why there has not been funding for the project. Is the project unrealistic? Is there…   Read more»

]]> 1222fe7257ffeeacac365f69b860bbb6 https://medicaldevicecourses.com/activity/p/28669/ Mon, 22 Jan 2024 01:34:24 -0500 I think the size of a given project team is highly dependent on the scale of the project being worked on. However, in terms of medical devices and biomedical engineering products, I do believe that there should be at least…   Read more»

]]> 4ae3b3311fe29424d237802a080b4980 https://medicaldevicecourses.com/activity/p/28666/ Mon, 22 Jan 2024 01:21:13 -0500 @afshinsadri Thank you for your explanation of both preventative maintenance and preserve maintenance, as I had never heard of these terms before. This aspect of project management seems especially important in biomedical engineering, where consumers have to balance cost with…   Read more»

]]> 317a2a634de11a8fd01dd96b9bbc7935 https://medicaldevicecourses.com/activity/p/28586/ Sun, 03 Dec 2023 21:30:46 -0500 I don’t believe giving lavish gifts like the “old days” is permissible or appropriate in the modern pharmaceutical industry. As stated above, these gifts result in bias where physicians recommend products based on gift-giving rather than what is best for…   Read more»

]]> c924c0910a5fccb9f61f92b15ec607f3 https://medicaldevicecourses.com/activity/p/28585/ Sun, 03 Dec 2023 21:08:27 -0500 While these rules or regulations may seem like they are too restrictive, they are necessary for the integrity of the pharmaceutical/medical device industry. While it is appropriate to pay for a physician’s dinner when taking them out for dinner to…   Read more»

]]> 15f4d03f00dfb2c370632128723cd09d https://medicaldevicecourses.com/activity/p/28584/ Sun, 03 Dec 2023 20:26:10 -0500 In most scenarios, verbal contracts are legally binding. However, it is often hard to prove these contracts without written documentation. This can lead to parties not abiding by the contracts. Several measures can be taken to prevent this from occurring…   Read more»

]]> 5fd294b49df1be73a72f555610d57e74 https://medicaldevicecourses.com/activity/p/28532/ Sun, 26 Nov 2023 19:40:48 -0500 The most effective type of organizational structure depends on the type of project being worked on and the available assets. For instance, a Matrix or Functional organization may be better for a smaller company because the entire team is composed…   Read more»

]]> 716236251d394600baa01c46fa0d6ebc https://medicaldevicecourses.com/activity/p/28531/ Sun, 26 Nov 2023 19:27:31 -0500 For the project manager, it would definitely be easier to work in a project-based organization than a Matrix organization. In a project-based organization, the project manager only needs to work with their assigned project team and does not need to…   Read more»

]]> 6fe02eae9d1dd478f1f00be0878906f4 https://medicaldevicecourses.com/activity/p/28529/ Sun, 26 Nov 2023 19:12:43 -0500 As stated in other responses, I think communication and setting expectations are of utmost importance. When a new manager is assigned to a team, it is important that this manager gets to know every member of the team, their habits,…   Read more»

]]> bbc64b6218b05bc6976485b21867bfaa https://medicaldevicecourses.com/activity/p/28502/ Mon, 20 Nov 2023 02:12:28 -0500 The pros of a risk assessment far outweigh the cons. On the surface level, the cons are that these plans may result in the project taking a longer time and greater expenses. However, in the long run, these plans actually…   Read more»

]]> 484d663886bce876ff33d2016367519b https://medicaldevicecourses.com/activity/p/28501/ Mon, 20 Nov 2023 02:09:25 -0500 Risk assessment is an essential part of the planning phase. All potential risks must be discussed so a thorough, well-thought out plan can be constructed. By doing so, the plan will run more smoothly when enacted and the risks will…   Read more»

]]> 90220cdbf8e56963725e90ed5a422c2f https://medicaldevicecourses.com/activity/p/28500/ Mon, 20 Nov 2023 02:06:25 -0500 While it may seem that companies tend to outweigh reward more than risk (due to media headlines and such), I believe that most companies outweigh the risk more. First of all, liability is of utmost important in the biotechnology industry….   Read more»

]]> 3243de35c557823e98c5da0ae8a01fce https://medicaldevicecourses.com/activity/p/28441/ Mon, 13 Nov 2023 02:47:40 -0500 I belive that both inputs and specifications have their intended purposes. In terms of actually constructing a device, it is impossible to do so based on solely inputs. Specifications are needed for the actual construction of the device and for…   Read more»

]]> fbe1ddf37275af67ae94e5fecce78c9f https://medicaldevicecourses.com/activity/p/28439/ Mon, 13 Nov 2023 02:42:23 -0500 I do believe these columns are enough as they allow for the entire design process to be visualized without overly complicating it. I think the most useful aspect of a Design Matrix is that it tends to be easy to…   Read more»

]]> 9cdbc14ff0d9e436b4a09d5e357be7fa https://medicaldevicecourses.com/activity/p/28437/ Mon, 13 Nov 2023 02:38:27 -0500 In general, clinical trials for both medical devices and drugs have the same end goal, to prove the safety and efficacy of these products for their given purposes. However, as many indicated above, the process of proving the safety and…   Read more»

]]> 29c182354aeed71243f8b7d34a2f02b7 https://medicaldevicecourses.com/activity/p/28384/ Mon, 06 Nov 2023 03:21:10 -0500 In terms of validation, I believe that the key is to always go back to the customer. By definition, validation is the process of ensuring that the device meets all of the customer’s needs. If the device fails in a certain…   Read more»

]]> 15ef6b1480babe4dc21aacf279ae2896 https://medicaldevicecourses.com/activity/p/28383/ Mon, 06 Nov 2023 03:16:24 -0500 Why seemingly similar and first-glance, validation and verification are quite different terms. Validation is the process of ensuring that a device meets the predetermined customer needs while verification is the process of ensuring that the physical aspects of the device…   Read more»

]]> 3602126d5a92b056e584de317b4d432c https://medicaldevicecourses.com/activity/p/28382/ Mon, 06 Nov 2023 03:06:19 -0500 The most important part of meeting minutes is that they lay out deliverables for each team member and when those deliverables are supposed to be accomplished. Especially in a project with a lot of moving parts, it is important to…   Read more»

]]> e968fe75e02863db5b2e98208fa86534 https://medicaldevicecourses.com/activity/p/28336/ Mon, 30 Oct 2023 01:30:24 -0400 If I were to work in clinical trials, I’d like the role of working patient advocacy. I think one of the most overlooked aspects of clinical trials is the individual patients involved. Patient advocacy is being the “voice” of the…   Read more»

]]> 7fb95df0faadd038d5af4c044b68cbc2 https://medicaldevicecourses.com/activity/p/28335/ Mon, 30 Oct 2023 01:25:53 -0400 I never realized that for rare diseases, sometimes clinical trials are the only means of getting treatment. Some of these diseases are very niche and do not have approved drugs, so the only drugs available are experimental products. Are patients…   Read more»

]]> 0a2611dff65ac7c97140b3b2f9b2e006 https://medicaldevicecourses.com/activity/p/28334/ Mon, 30 Oct 2023 01:19:31 -0400 Clinical Trials (in all of the different stages) require a lot of data to display two aspects of the drug: safety and efficacy. If the “drug” has no adverse effects and the data displays positive symptom relief, then it would…   Read more»

]]> 55ab1f13647d79251fcc57e558cd7308 https://medicaldevicecourses.com/activity/p/28275/ Mon, 23 Oct 2023 00:54:22 -0400 I believe the method of marketing and advertising depends on the medical device being marketed. Some devices/drugs have a much broader demographic, so selective marketing may not be needed in order to reach the target consumers. For instance, diabetes affects…   Read more»

]]> bd2df23c78bd85f4d0dbb80a8b3a8735 https://medicaldevicecourses.com/activity/p/28270/ Mon, 23 Oct 2023 00:33:14 -0400 If possible and it does not delay graduation, I believe getting a minor in business or marketing is beneficial. This minor will expose you to topics and skills needed in a biomedical engineering career, such as customer satisfaction, cost minimization,…   Read more»

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