https://medicaldevicecourses.com/members/jb678/activity/ Activity feed for jb678. Fri, 24 Apr 2026 20:02:28 -0400 https://buddypress.org/?v= en-US 30 hourly 2 283023c4769b0db01e4377953df1ec17 https://medicaldevicecourses.com/activity/p/18322/ Wed, 15 May 2019 21:47:17 -0400 Projects generally have multiple tasks going on at one time. With this being said it would definitely be possible for the project to have multiple priorities going on at one time. There will be tasks that have a greater priority…   Read more»

]]> becc7e4da6b140cec6b826bc7e0d20e8 https://medicaldevicecourses.com/activity/p/18321/ Wed, 15 May 2019 21:47:16 -0400 A team is going to follow their project manager’s examples. Therefore if he is lackadaisical his team is most likely going to slack off on assignments, thus causing a cascade of issues. It is important for a project manager to…   Read more»

]]> 1022747acdb9060e86c43516cbecd30d https://medicaldevicecourses.com/activity/p/18320/ Wed, 15 May 2019 21:47:16 -0400 The two survey answers seem unrelated to me. I say this because you can love your job without being praised. Everyone wants to feel appreciated and receive recognition, but if you truly love what you’re doing do you really need…   Read more»

]]> 92edfc10a68def56fc1bb064c9ffd7b7 https://medicaldevicecourses.com/activity/p/18264/ Wed, 15 May 2019 21:46:48 -0400 I am a little surprised that percentage for benefits, meaningful work, and being recognized are the lowest. One of the most famous saying is “do a job you love and you’ll never work a day in your life”. Which I…   Read more»

]]> 06c80ceebac9795787d7b8638eea302e https://medicaldevicecourses.com/activity/p/18263/ Wed, 15 May 2019 21:46:47 -0400 No one has all of the answers, and most people are learning as they go along. In the mini-sims I always tried to gather up as much information as I can and make a sort of informed “gut” decision. It…   Read more»

]]> b291370a72b7245f13b5b676ef0c33c0 https://medicaldevicecourses.com/activity/p/18262/ Wed, 15 May 2019 21:46:46 -0400 I believe for myself personally I would need improvement in the risk management portion of project management. It seems as though it is something that may come with experience. One can obviously count for all of the expected risks, but…   Read more»

]]> eef8c65a83bf1c8a42cfef7c8d4ba686 https://medicaldevicecourses.com/activity/p/18194/ Wed, 15 May 2019 21:46:10 -0400 In almost all cases it is the project manager’s sole responsibility to make sure that everyone is talking regardless of organization. The title the person hold is “project manager” meaning that they must manage what is going on within the…   Read more»

]]> 04cab7a258049cfd9074bf2b90409ad7 https://medicaldevicecourses.com/activity/p/18193/ Wed, 15 May 2019 21:46:10 -0400 Using the minisim as an example. The product that was being made required a specific amount of friction in order for the product to work. Specifications should most certainly be followed to a t when a final product is being…   Read more»

]]> eaadce7a57f9379ed821971534473425 https://medicaldevicecourses.com/activity/p/18192/ Wed, 15 May 2019 21:46:09 -0400 Reactive management is most certainly not a bad thing if it required. Hopefully, it will not be required as a good PM should be able to account for any delays or foreseeable issues. Usually reactive management is characterized by a…   Read more»

]]> 2d1bff62a93ec3c03e9fc465cf678168 https://medicaldevicecourses.com/activity/p/18120/ Wed, 15 May 2019 21:45:34 -0400 EV, SV, and CV are mainly used as estimates so that the PM and stake holders can know where the project is at, and how it is doing. These values allow the PM to adjust, and make changes so that…   Read more»

]]> d9d5191f8ae5f8e410ae5f0186960d74 https://medicaldevicecourses.com/activity/p/18119/ Wed, 15 May 2019 21:45:33 -0400 If I had to choose between the two possible cases I myself would go with scenario 2. It is better to be behind schedule but under budget, than ahead of schedule and over budget. I say this because you can…   Read more»

]]> 540f79ba4239c835fd86db673c2d127e https://medicaldevicecourses.com/activity/p/18118/ Wed, 15 May 2019 21:45:33 -0400 I believe by growth you mean scope creep. Scope creep generally refers to changes or uncontrolled growth in a project’s scope. This can involve poor change control, lack of initial identification of tasks in the project, etc. I do not…   Read more»

]]> c8481b49d411f8aa3ba4400a57b1575a https://medicaldevicecourses.com/activity/p/18041/ Wed, 15 May 2019 21:44:54 -0400 When determining a schedule human factors should already be taken into account. I believe that a good project manager should already have sick days, and vacations accounted for. The most dangerous waste of resources would obviously be what cannot be…   Read more»

]]> f520a44db27c305b42f381daac56ff4f https://medicaldevicecourses.com/activity/p/18040/ Wed, 15 May 2019 21:44:53 -0400 Both variance types are crucial when trying to stay within the scope of the project. Schedule variance is calculated by subtracting the planned value out from the earned value (EV-PV). Schedule variance gives the PM an idea of where they…   Read more»

]]> f1e496567d8200c606bf663b5b688ce9 https://medicaldevicecourses.com/activity/p/18039/ Wed, 15 May 2019 21:44:53 -0400 I do not have experience with industrial projects, however I have been on a surgical research team. While on this team we went over the DDP of the project, and covered all tasks required. While working on our project it…   Read more»

]]> 21b89a140aa5b197de6ec973c68445d8 https://medicaldevicecourses.com/activity/p/18001/ Wed, 15 May 2019 21:44:31 -0400 manolo the issue with what you are asking is that ISO are regulations that must be required. Different devices need these regulations or else they will run into issues with the FDA. The FDA could then stop these companies from…   Read more»

]]> 6a787483ab1e9664cf20df695d44a699 https://medicaldevicecourses.com/activity/p/17998/ Wed, 15 May 2019 21:44:30 -0400 No, personally I do not believe it is ever okay to shorten time frames if it means risk will be increased. In the simulation there was an option to shorten testing, and it was all luck that the FDA over…   Read more»

]]> 8fd8d4596df5fd9fd556e8e30c873b83 https://medicaldevicecourses.com/activity/p/17988/ Wed, 15 May 2019 21:44:25 -0400 As most responses in this thread indicate, talking to the vendor directly to let them know the issue would be the simplest way of dealing with any problems in regards to the product they are providing. In the original example…   Read more»

]]> 6e08c2bbb672aa25bb381176a142af88 https://medicaldevicecourses.com/activity/p/17908/ Wed, 15 May 2019 21:43:45 -0400 Like previous posts have mentioned, having a full scope of the project is key to completing the project in the proper time frame. Risk analysis is involved in multiple areas of a project, and runs directly parallel with the design…   Read more»

]]> 054ff6cbd508999e782226aac62aa054 https://medicaldevicecourses.com/activity/p/17867/ Wed, 15 May 2019 21:43:24 -0400 @ manolo, I am curious as to what you mean by “overcommunication”. I agree with you that being pestered by someone constantly can become quite a nuisance, however, I would only say that this would extend to coworkers or subordinates….   Read more»

]]> 73b1dbaa56f2999103ae4d5fd3e78a2a https://medicaldevicecourses.com/activity/p/17842/ Wed, 15 May 2019 21:43:11 -0400 The company being told to cease operations goes to show that not following these requirements are more than proof of the consequences, are they not? You’re right in that a company can decide to not follow requirements in attempt to…   Read more»

]]> 21b33299b8354de9e927b5b762046035 https://medicaldevicecourses.com/activity/p/17841/ Wed, 15 May 2019 21:43:10 -0400 I believe the simplest remedy to the situation proposed would be to have the project manager hold a meeting with each team member, and ask them how long they think it will take them to complete the project. If the…   Read more»

]]> adb40380b56f5d6cb9669d64436c0d30 https://medicaldevicecourses.com/activity/p/17759/ Wed, 15 May 2019 21:42:25 -0400 It is hard to understand what you fully mean by your question Ryan. To fully grasp the concept of your question I would like to know what you mean by personal connection? The most severe case I could imagine would…   Read more»

]]> 2f58028b60cf104a6d8230a4383a4d7a https://medicaldevicecourses.com/activity/p/17758/ Wed, 15 May 2019 21:42:24 -0400 There are many types of ISO requirements. ISO is an acronym for International Organization for Standardization. The one that Dr. Simon discussed in this weeks lecture refers directly to the application of risk management to medical devices. There are many…   Read more»

]]> 81904b873695223aa1688e17ee990488 https://medicaldevicecourses.com/activity/p/17757/ Wed, 15 May 2019 21:42:23 -0400 I would have to say that the pros and cons of a single, or separate team would vary dependent upon the project. If it were a small project with low risk then there would be more pros in the favor…   Read more»

]]> 4938c985d8accc53b2a130b8775a45f4 https://medicaldevicecourses.com/activity/p/17696/ Wed, 15 May 2019 21:41:52 -0400 As many others have stated in this thread, good interpersonal skills are an extremely beneficial trait to possess. However, I do not agree with the statement that it is 70% interpersonal, and 30% knowledge. Interpersonal skills are important because having…   Read more»

]]> 0e9f9ccfde4507187745f9fbd045c3ff https://medicaldevicecourses.com/activity/p/17695/ Wed, 15 May 2019 21:41:51 -0400 When dealing with experiment failure I believe it is necessary to take a step back, and reflect on what could have gone wrong. Errors cannot be fixed without first knowing what the problem is. Brainstorming, and working through the process…   Read more»

]]> 168c4a9791938dee50e694803662c398 https://medicaldevicecourses.com/activity/p/17608/ Wed, 15 May 2019 21:41:01 -0400 I did an internship at a project based organization. I enjoyed my time there, and working with the team was a breeze. Project ideas are very easily announced, and discussed about in the workplace. It was a fairly small team…   Read more»

]]> ec27d80a2c3e1fdad0c03db65ddec81d https://medicaldevicecourses.com/activity/p/17607/ Wed, 15 May 2019 21:41:00 -0400 I agree with you that there would be more pros to creating a universal regulation process than there would be cons. In regards to which countries would use these processes, I believe it would have to be something that were…   Read more»

]]> a07d97cbc9d34445efb191fb35a443cd https://medicaldevicecourses.com/activity/p/17605/ Wed, 15 May 2019 21:41:00 -0400 During my internship I worked on the Verification process of a product. It was heavily research based, and was in its early stages of testing. I think I would like to stay in the design verification phase for a few…   Read more»

]]> 87bab8cd092e93a9640d429441aefb82 https://medicaldevicecourses.com/activity/p/17528/ Wed, 15 May 2019 21:40:17 -0400 I agree that this system is fine as it is. I do not believe that more classes need to be created. As stated before this system runs entirely on risk and safety of the product. In the mini-sim the LAA…   Read more»

]]> d9dd28a7c0dfbcb89e4f70a6a67dc6c9 https://medicaldevicecourses.com/activity/p/17527/ Wed, 15 May 2019 21:40:17 -0400 I would agree with the participants statements who posted before me. The FDA already has set regulations and guidelines that are established to aid companies with the creation of their devices. Most devices have to go through rigorous testing, and…   Read more»

]]> 917ee105bc27e16b75b1a38e1a6cb75b https://medicaldevicecourses.com/activity/p/17516/ Wed, 15 May 2019 21:40:11 -0400 No, not all products require a 510k, but all devices getting a 510k are a medical devices. If the device is something non-invasive, and simple such as that of a band aid, it would be classified as a class I…   Read more»

]]> e9e77423e8c82c6f424d3fd6f995ae43 https://medicaldevicecourses.com/activity/p/17455/ Wed, 15 May 2019 21:39:40 -0400 I do not believe that a faulty label on a batch of drugs would cause for an entire recall of the product as that would be extremely expensive for the company. Instead I believe the company would release a large…   Read more»

]]> 66d01b0da25e7e68e47cb8e0322f5e7e https://medicaldevicecourses.com/activity/p/17453/ Wed, 15 May 2019 21:39:39 -0400 I do believe that interpersonal skills are valued more heavily than that of technical skills. I say this because when I think of a person going for a job they first need to apply by sending out their list of…   Read more»

]]> 1498616136b55c966a4702e027959b35 https://medicaldevicecourses.com/activity/p/17451/ Wed, 15 May 2019 21:39:38 -0400 I am not currently employed in industry work as I am heavily focused on completing my school work. Though I have yet to fully immerse myself into the industrial world, I believe I would do well beginning in a functional…   Read more»

]]> a7e64774cc364668eccb4ec4e8995644 https://medicaldevicecourses.com/activity/p/10793/ Wed, 15 May 2019 16:36:33 -0400 So far we have learned that there are numerous phases that a project must go through in order to be completed properly, and on time. Phases such as: Design Controls, creating a project proposal, initiating a DDP, etc. My question…   Read more»

]]> 31d5bf6c0acf41c1d55ef040b1aaabab https://medicaldevicecourses.com/activity/p/10792/ Wed, 15 May 2019 16:36:32 -0400 Hello everyone, as we progress through the semester and learn more about project management we see many real world applications. My question is more of a personal one, but one I am very curious of. For those already in the…   Read more»

]]> 90e666d734667a92ff3e3ea15bf2020c https://medicaldevicecourses.com/activity/p/10237/ Fri, 03 May 2019 17:52:06 -0400 Projects generally have multiple tasks going on at one time. With this being said it would definitely be possible for the project to have multiple priorities going on at one time. There will be tasks that have a greater priority than others, of course. However, it is crucial to determine which tasks are more important, and which will take longer.…[Read more]

]]> 0 aa56d2e0645921808574645bc1f9a088 https://medicaldevicecourses.com/activity/p/10236/ Fri, 03 May 2019 17:43:43 -0400 A team is going to follow their project manager’s examples. Therefore if he is lackadaisical his team is most likely going to slack off on assignments, thus causing a cascade of issues. It is important for a project manager to be communicative with his team, neat, and enthusiastic about all aspects of the project. Team motivation can be as simple…[Read more]

]]> 0 a25430f1d21bdcee6eb596d252f05685 https://medicaldevicecourses.com/activity/p/10235/ Fri, 03 May 2019 17:28:31 -0400 The two survey answers seem unrelated to me. I say this because you can love your job without being praised. Everyone wants to feel appreciated and receive recognition, but if you truly love what you’re doing do you really need to be praised for everything that you do? Obviously one needs recognition in order to move up in their career path,…[Read more]

]]> 0 72c9276e3349bb3e6a16f6ac6419aef5 https://medicaldevicecourses.com/activity/p/10176/ Sun, 28 Apr 2019 01:46:12 -0400 I am a little surprised that percentage for benefits, meaningful work, and being recognized are the lowest. One of the most famous saying is “do a job you love and you’ll never work a day in your life”. Which I would imagine would coincide with meaningful work, but I suppose that being challenged or excited by your work is more of the same towards…[Read more]

]]> 0 800dcee9a7def462efcba7c7335ed83d https://medicaldevicecourses.com/activity/p/10175/ Sun, 28 Apr 2019 01:13:37 -0400 No one has all of the answers, and most people are learning as they go along. In the mini-sims I always tried to gather up as much information as I can and make a sort of informed “gut” decision. It is always good to communicate with the people you are working with as they may know something that you do not. For example Mini-sim 2 had two possible…[Read more]

]]> 0 0b258257dec720e4059be7381584a9ce https://medicaldevicecourses.com/activity/p/10174/ Sun, 28 Apr 2019 00:58:52 -0400 I believe for myself personally I would need improvement in the risk management portion of project management. It seems as though it is something that may come with experience. One can obviously count for all of the expected risks, but it is the unexpected that comes with having experience. It is very hard to expect to unexpected until it has…[Read more]

]]> 0 9f06bc6a96a92c88c24d8e20e179de50 https://medicaldevicecourses.com/activity/p/10104/ Sun, 21 Apr 2019 02:23:26 -0400 In almost all cases it is the project manager’s sole responsibility to make sure that everyone is talking regardless of organization. The title the person hold is “project manager” meaning that they must manage what is going on within the project. This includes the tasks that are required, and the people working on the project. A team sport is a…[Read more]

]]> 0 68ab06c410e5df9dde2ebca9a2e62e47 https://medicaldevicecourses.com/activity/p/10103/ Sun, 21 Apr 2019 02:11:25 -0400 Using the minisim as an example. The product that was being made required a specific amount of friction in order for the product to work. Specifications should most certainly be followed to a t when a final product is being worked on. Deviations of specifications can cause many issues in a product or even failure; which is not a desired outcome…[Read more]

]]> 0 252ccffaecd45e15b1b22d2b21c22089 https://medicaldevicecourses.com/activity/p/10102/ Sun, 21 Apr 2019 01:48:11 -0400 Reactive management is most certainly not a bad thing if it required. Hopefully, it will not be required as a good PM should be able to account for any delays or foreseeable issues. Usually reactive management is characterized by a lack of proper planning. Reactive management is also referred to as “firefighting”; which means that the manager has…[Read more]

]]> 0 1c91cb5558ff9bc22794b05fd74b2307 https://medicaldevicecourses.com/activity/p/10030/ Sun, 14 Apr 2019 01:35:43 -0400 EV, SV, and CV are mainly used as estimates so that the PM and stake holders can know where the project is at, and how it is doing. These values allow the PM to adjust, and make changes so that the project can be successful. As Jdc stated previously, Earned Value is dependent upon the percentage of work completed multiplied by the original budget…[Read more]

]]> 0 7882ecab5e765af5a2f58f54de77c339 https://medicaldevicecourses.com/activity/p/10029/ Sun, 14 Apr 2019 00:58:10 -0400 If I had to choose between the two possible cases I myself would go with scenario 2. It is better to be behind schedule but under budget, than ahead of schedule and over budget. I say this because you can always work harder or get more people to work on the project if you have the money to spare, rather than being behind schedule and over the…[Read more]

]]> 0 d0b83ddebb235b4c66c3f670698e8019 https://medicaldevicecourses.com/activity/p/10028/ Sat, 13 Apr 2019 23:59:29 -0400 I believe by growth you mean scope creep. Scope creep generally refers to changes or uncontrolled growth in a project’s scope. This can involve poor change control, lack of initial identification of tasks in the project, etc. I do not believe that there is any actual way of controlling scope creep as it is bound to happen, especially to large…[Read more]

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