https://medicaldevicecourses.com/members/jonwil123/activity/ Activity feed for jonwil123. Sat, 25 Apr 2026 02:14:09 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e1f4b37343c2abb57c24a3d8c9c0f9a1 https://medicaldevicecourses.com/activity/p/22372/ Sun, 02 May 2021 17:38:53 -0400 This class was very interesting and super informative for my future endeavors. What I found the most helpful and interesting were both the Mini-Simulations and the Simulations themselves. The mini-Sims gave me a chance to apply my knowledge and get…   Read more»

]]> 5144940d63ac0375a9e5c7534a80e046 https://medicaldevicecourses.com/activity/p/22371/ Sun, 02 May 2021 17:19:05 -0400 As stated in the question, we were introduced to a few different qualities a manager needs to have to be successful and effective. Among these were interpersonal skills, organization and crisis management. I have a very easy going and friendly…   Read more»

]]> e5819947b24c0e86a4f24b524d4d2f1a https://medicaldevicecourses.com/activity/p/22370/ Sun, 02 May 2021 16:59:31 -0400 If I was given the choice between a management role and an engineering/tech/scientist role, I would definitely choose to be in the engineering/tech/scientist role. I would choose this role because I love getting my hands dirty and doing what needs…   Read more»

]]> f1ac5086a03254551675213a21490cdb https://medicaldevicecourses.com/activity/p/22252/ Fri, 23 Apr 2021 15:15:58 -0400 From the list of roles of a clinical project team, they all had their interesting aspects but the roles that grabbed my attention were the “Clinical Research Organizations (CROs)” or the Laboratories. These, mainly, because I enjoy hands on work….   Read more»

]]> 8dbb3370e3553f654dcedc6198244d72 https://medicaldevicecourses.com/activity/p/22251/ Fri, 23 Apr 2021 14:49:27 -0400 So looking at this issue at face value, I would 100% agree with you here, they don’t seem to correlate at all. If what motivates people to work is exciting/challenging work, then leaving a job because you aren’t getting recognition…   Read more»

]]> 4869785d80c273ffef554b20adae4758 https://medicaldevicecourses.com/activity/p/22250/ Fri, 23 Apr 2021 14:22:26 -0400 Looking at the results of what motivates people to stay and continue working, I had mixed thoughts there were some things in places that I would guess and there were others that I thought were on par. For example, I…   Read more»

]]> 700629f554d7db4cddac2732537e2487 https://medicaldevicecourses.com/activity/p/22176/ Mon, 19 Apr 2021 02:36:32 -0400 Simply put, according to the lecture, Quality Assurance is making sure that the project has the procedures and the people to handle the project standards, while Quality Control is the act of measuring compliance with all of these standards. More…   Read more»

]]> 15be40df5a69ce9b0daa82bed39c4280 https://medicaldevicecourses.com/activity/p/22175/ Mon, 19 Apr 2021 02:19:41 -0400 Communication is extremely important in, not only project management but, in life in general. In regards to your questions, for the first question of who should do the communication on a project dependent on the organization set-up, I believe its…   Read more»

]]> 026a943936787e2c2a13bb6c8d3a9826 https://medicaldevicecourses.com/activity/p/22173/ Mon, 19 Apr 2021 02:06:49 -0400 If someone on the team changes positions to a different job, that could cause problems when it comes time to complete a project. Especially if the part that person is working on is important and critical to the completion. In…   Read more»

]]> 08eca06a4856b604eb07fa8a7b3bb075 https://medicaldevicecourses.com/activity/p/21930/ Mon, 29 Mar 2021 03:14:06 -0400 Overall, change controls are influencing factors that create change to ensure beneficial results. Change controls are to determine that change has occurred as well as manage the change as it happens. The inputs or requirements to change control are the…   Read more»

]]> 0e9815aecddc05cf167d1849917a853a https://medicaldevicecourses.com/activity/p/21926/ Mon, 29 Mar 2021 02:52:38 -0400 Fortunately, during the miniSim, all time conflicts were resolved in a pleasant manner, however, this is not always the case. If there is a situation where the conflict is not resolved calmly or there is no simple way of satisfying…   Read more»

]]> 7db08282f699bad92855318f7ba061b5 https://medicaldevicecourses.com/activity/p/21923/ Mon, 29 Mar 2021 02:38:48 -0400 Closing phase is the final phase in the project life cycle, after Monitoring and Controlling phases, to formally recognize project completion. As stated in the lecture, during this phase, all contracts are closed, all payments are made to whomever must…   Read more»

]]> a9f3e3b7b9725bc75cdb068e9c79c062 https://medicaldevicecourses.com/activity/p/21754/ Mon, 15 Mar 2021 01:45:49 -0400 This is a very good question. Design validation is an important factor in some, not all, projects. From the lecture, we see that, for many devices, validation means that the product will be used in living people, in a cadaver…   Read more»

]]> e2bb85f8f9f0a3005cc62dba7024c175 https://medicaldevicecourses.com/activity/p/21751/ Mon, 15 Mar 2021 01:34:26 -0400 Design verification checks that the inputs are equal to the corresponding and correct outputs. Each input has an output and each output must be verified. This is typically a necessary step in the executing phase. Design validation checks that the…   Read more»

]]> 19199d746843c4c3564a733a3f41ace1 https://medicaldevicecourses.com/activity/p/21749/ Mon, 15 Mar 2021 00:58:01 -0400 I don’t entirely agree with the statement provided. I do agree that blunders in the areas of information distribution, solicitation, source selection, and managing vendor relations can definitely cause the project at hand to fail. While I do believe that…   Read more»

]]> c5f3ebe6c7c6fc57c1322e77947c356b https://medicaldevicecourses.com/activity/p/21471/ Mon, 01 Mar 2021 03:18:58 -0500 There are many uses for a Gantt chart. Specifically, to help visualize all of the task in a project, no matter how complex. As the project becomes more complex, there will be more and more subcategories. This makes the Gantt…   Read more»

]]> 412c4ef5ba6a99ead8ca23ff2e87ec40 https://medicaldevicecourses.com/activity/p/21469/ Mon, 01 Mar 2021 03:02:46 -0500 I believe, like many people in this discussion, that every phase has its own part to play in device development and all phases are important. However, if I had to choose one, it would definitely be the initiating/planning phase. This…   Read more»

]]> 63c9fc4cd97c316bfec5fdad32224751 https://medicaldevicecourses.com/activity/p/21467/ Mon, 01 Mar 2021 02:54:26 -0500 This is a very good question and I have to agree with hjp39. This question would be properly answered by someone with experience and I am not that. However, I will use the knowledge I have to answer to the…   Read more»

]]> aaf21cbd793daf4a772aad712af80ce1 https://medicaldevicecourses.com/activity/p/21414/ Mon, 22 Feb 2021 03:49:57 -0500 It is true that when I see the word “Risk”, I think of negative possibilities. However, that is not always the case. Risk is only the probability of hazard occurring. The biggest example of how risk has resulted in negative…   Read more»

]]> 04afa317bd9d72f20e078b235b1dce2c https://medicaldevicecourses.com/activity/p/21408/ Mon, 22 Feb 2021 03:33:34 -0500 As a PM, the most important thing is to develop a comfortable environment or network for your team members. It is important for these people to be comfortable with, not only you but also with their other team members. This…   Read more»

]]> 9a8497d6ca0660a3022db4801020cc8d https://medicaldevicecourses.com/activity/p/21404/ Mon, 22 Feb 2021 03:21:27 -0500 I am currently a first year graduate student and this is the second class I have taken with Dr. Simon. I took Medical Devices Development (BME684) last semester and I enjoyed that class so much that I decided to take…   Read more»

]]> 2ec669d39eaa9b5df99ce7f959c53568 https://medicaldevicecourses.com/activity/p/21290/ Sun, 07 Feb 2021 20:24:26 -0500 While the pros and cons of each organizational structures are covered pretty well in the lecture, I will go over it for the sake of the discussion. The first type of organizational structure was the functional organization. The pros were…   Read more»

]]> 4b276bcedc9f15101dabdc1ad6065f5d https://medicaldevicecourses.com/activity/p/21289/ Sun, 07 Feb 2021 19:38:12 -0500 This is honestly not an easy question in my opinion. If someone is introverted and quiet, their team may see this as the manager being withdrawn and impersonal, as well as a poor communicator. Personally, I think it is important…   Read more»

]]> 264dae9666d468fc20f1a5bd0fcdd185 https://medicaldevicecourses.com/activity/p/21288/ Sun, 07 Feb 2021 19:25:50 -0500 If I had to choose a project team, I would want members who are eager to learn and grow as well as passionate about the project that needs to be done. While it is important to have people who are…   Read more»

]]> 8cd5a03a96f1fb98d98c3b05f931390c https://medicaldevicecourses.com/activity/p/21242/ Mon, 01 Feb 2021 02:45:29 -0500 Project Management will definitely differ from job to job. I don’t think you can take a great project manager from medical device development and throw them into a construction site or a software building company. This is because these different…   Read more»

]]> 22163f67db226d9d6719ce24f10bb981 https://medicaldevicecourses.com/activity/p/21240/ Mon, 01 Feb 2021 02:29:56 -0500 Initiating a project idea is the hardest part of project development because this is the part where a rough outline of everything is required. You need to provide an outline of what the device does, when the device will be…   Read more»

]]> d99501f378986d2b524180b76d491f9c https://medicaldevicecourses.com/activity/p/21239/ Mon, 01 Feb 2021 02:15:32 -0500 I believe there are a lot of skills that are important for a project manager to have in order to succeed. Mainly, communication skills and time management skills. I think it also depends on what you consider successful. Success could…   Read more»

]]> 585e9eb0a7a996e3f5cff3509edc6779 https://medicaldevicecourses.com/activity/p/21152/ Mon, 25 Jan 2021 04:56:26 -0500 I believe that your app should be considered a mobile medical app based on the definition you provided. I believe this because, you said that your app allows it users to “retrain their auditory cues” and identify which frequencies can…   Read more»

]]> 786c98923abac2ea8da565ff78918150 https://medicaldevicecourses.com/activity/p/21151/ Mon, 25 Jan 2021 04:39:44 -0500 I love this question because I have always thought about this. Personally, I believe the system is backwards. If I am going to school to be an engineer, my value should be placed on my ability to engineer what is…   Read more»

]]> b6c3b712598a53e39dcfb68f26d7666a https://medicaldevicecourses.com/activity/p/21150/ Mon, 25 Jan 2021 04:30:56 -0500 Due to COVID-19, its becoming increasingly more difficult to get ahold of people when you really need them. Personally, I’m the type of person who typically doesn’t like to overdo phone calls and emails and things like that. Fortunately, I…   Read more»

]]> f694e325efde683bef6d89ca2cddec5f https://medicaldevicecourses.com/activity/p/21074/ Mon, 30 Nov 2020 04:33:59 -0500 The difference between a patent and a NDA is that a patent is a federal document proving ownership of an idea, while an NDA is a contract between two people. In other words, NDA’s recognize the people whose signatures are…   Read more»

]]> 472092e89f6b87c2c8ed4318a36fd9f9 https://medicaldevicecourses.com/activity/p/21073/ Mon, 30 Nov 2020 04:21:09 -0500 This class was extremely informational. I really enjoyed the amount of different topics we delved into. During undergrad at NJIT, I feel like the only course that really introduced me to industry-related topics was capstone, since it involved working on…   Read more»

]]> efdf971770214479dc8aac04e9610e10 https://medicaldevicecourses.com/activity/p/21072/ Mon, 30 Nov 2020 04:15:07 -0500 A verbal contract can include any agreement with words, which includes both oral and written agreements. Because of this, we should compare written contacts to spoken contracts. In every sense, a written contract is the most reliable contract when starting…   Read more»

]]> b4ad7fbffdeee53108816502b2c5209a https://medicaldevicecourses.com/activity/p/20996/ Mon, 23 Nov 2020 00:04:26 -0500 In my opinion, it is tough to say which organizational structure is best and which one is the most effective. I believe it depends on the type and size of company that is being used. If they are the same…   Read more»

]]> b383969a103e912eb3f5266ab1f356c5 https://medicaldevicecourses.com/activity/p/20927/ Sun, 15 Nov 2020 22:49:32 -0500 For high severity risks, I would choose avoidance since that kind of severity of the risk is high any way to completely eliminate these risks would be necessary. For low severity risks, I would use mitigation or acceptance if the…   Read more»

]]> fadf640b9d6c6f26f845b4a1822395e2 https://medicaldevicecourses.com/activity/p/20924/ Sun, 15 Nov 2020 22:20:42 -0500 This is tough because the important word you used was “residual”. These companies do all they can in the risk management to avoid having these risks out there. Unfortunately, there is only so much a company can do to a…   Read more»

]]> 070b0297859657d4ec556f6920dae06c https://medicaldevicecourses.com/activity/p/20920/ Sun, 15 Nov 2020 22:09:02 -0500 This is a great question. In terms of medical devices, I feel like there are a lot of examples of devices in which we need to accept the risks. For example, as stated in the lecture with surgical tools, we…   Read more»

]]> 559dd9b63509429a4770199a6afd09fc https://medicaldevicecourses.com/activity/p/20877/ Mon, 09 Nov 2020 04:49:58 -0500 While similar in many ways, Verification and Validation are used to check different components of a device. More specifically, verification checks that all inputs are equal to their corresponding outputs. This is done through making a test, doing that test,…   Read more»

]]> 15879545161265cfec13c8b59c690121 https://medicaldevicecourses.com/activity/p/20875/ Mon, 09 Nov 2020 04:40:00 -0500 So I do not have much experience with meetings and meeting minutes so I can only speak theoretically. I can definitely see why documenting meeting minutes would be important. There are instances where some people may not think you are…   Read more»

]]> f43c09a3d97a4892e29f002e76dff676 https://medicaldevicecourses.com/activity/p/20872/ Mon, 09 Nov 2020 04:34:23 -0500 I believe every part of the DDP is very important in their own way. However, if I had to choose one to be the most important it would have to be the scope management plan. I chose this because it…   Read more»

]]> 8ad36b815b1dfe6a792968401989d242 https://medicaldevicecourses.com/activity/p/20814/ Thu, 05 Nov 2020 20:28:47 -0500 This video was absolutely hilarious while getting its point across. It shows how when people don’t understand the project they go off on tangents that are impossible to pinpoint. This makes completing the project incredibly difficult. They rely on the…   Read more»

]]> 170b10829cec27a6687d2f79583480c9 https://medicaldevicecourses.com/activity/p/20813/ Thu, 05 Nov 2020 20:17:40 -0500 Some colors that I notice a lot are blue, green, and white. I think these are great colors for companies to use. These colors all draw the eye very quickly. For example, when I think Apple, I think white. White…   Read more»

]]> f17e8573d70331d4060227383013db16 https://medicaldevicecourses.com/activity/p/20812/ Thu, 05 Nov 2020 20:09:44 -0500 This is an interesting topic you raise. I believe that there is a factor of manipulation needed to really promote a product and sell it to a person. However, I do not think it is a bad kind of manipulation….   Read more»

]]> e1d927386b1d25093dfdd85affcde6c0 https://medicaldevicecourses.com/activity/p/20650/ Sun, 18 Oct 2020 19:01:14 -0400 I would, definitely, not turn down a job based on the type of business it is. If they are willing to hire me I would gladly join them. At the end of the day, no matter where you are, experience…   Read more»

]]> e1b713aaf401e9e28b67776394346254 https://medicaldevicecourses.com/activity/p/20649/ Sun, 18 Oct 2020 18:50:55 -0400 From the lecture, we saw that a sole proprietorship cannot be passed down or sold according to the law. Once the owner of that sole proprietorship dies, the business dies with them. Im sure there are ways around this that…   Read more»

]]> db4c556eada2973f16b0e2cc9aedda13 https://medicaldevicecourses.com/activity/p/20648/ Sun, 18 Oct 2020 18:38:50 -0400 I, personally, don’t see myself getting involved in a partnership or starting a business in general. Although there is less risk financially and there is a larger system of support, people will always butt heads and internal conflict is a…   Read more»

]]> 5140d9de4dc6b8fecc009dc330d26d2e https://medicaldevicecourses.com/activity/p/20515/ Fri, 02 Oct 2020 19:14:02 -0400 Unfortunately, it is the job of the quality department to make sure all other departments are following procedure and doing what they are supposed to be doing. While this may cause some bad relations, the way to improve these relations…   Read more»

]]> d05d5941d5edc00c2fac0c9eff2b0f60 https://medicaldevicecourses.com/activity/p/20514/ Fri, 02 Oct 2020 18:58:17 -0400 Now this is something that has bothered me for a long time. I have always said that, while physicians and big pharma are here to assess and relieve our ailments, at the end of the day it’s all about money….   Read more»

]]> dc7fe16c0aa38ac860f77755ee263085 https://medicaldevicecourses.com/activity/p/20513/ Fri, 02 Oct 2020 18:28:57 -0400 This is a great discussion topic. I have always been a huge supporter of the saying “measure twice, cut once”. In other words, be absolutely, positively sure of what you’re doing before you do it so you don’t have to…   Read more»

]]> 52180c3ac25bf46ace79256d34544889 https://medicaldevicecourses.com/activity/p/20450/ Sun, 27 Sep 2020 00:58:56 -0400 I do see what you mean but I understand the purpose of the 510(k) form. Ive said before, science and medicine is always changing along with our understanding of the body and devices. A device will never last forever and…   Read more»

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