https://medicaldevicecourses.com/members/nicoleb/activity/ Activity feed for nicoleb. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 99c8dd3103d71f28de0cd54ae214f87b https://medicaldevicecourses.com/activity/p/18329/ Wed, 15 May 2019 21:47:21 -0400 Business sponsors are a very valuable resource that companies have. Therefore, the relationship between business and sponsor must be a strong one. The relationship mainly revolves around the first stages of project development since a sponsor is deciding on how…   Read more»

]]> 510f8cf3475ce0e5f38de9e9c01f1bc7 https://medicaldevicecourses.com/activity/p/18327/ Wed, 15 May 2019 21:47:20 -0400 I am at a point in my life where I am about to graduate and seek job opportunities. So i feel like currently this class gave me the knowledge i need to find a project manager i would enjoy working…   Read more»

]]> b48916ef5cae7a812bb319200549b0d1 https://medicaldevicecourses.com/activity/p/18326/ Wed, 15 May 2019 21:47:19 -0400 I agree with the overall consensus of the class that says that at first it is easy to receive praise because you are new and upper level management will be impressed by you. Once you set a standard of work…   Read more»

]]> b74e13fdd17b6dd1a60fbbee539cef61 https://medicaldevicecourses.com/activity/p/18254/ Wed, 15 May 2019 21:46:43 -0400 I would personally decide to stay as an engineer. Being a manager requires a lot of organizational, leadership, and people skills. I am not sure that I would enjoy having to deal with those things. I would much rather stay…   Read more»

]]> 706cda061d2ea8805b48b00b5ecc334f https://medicaldevicecourses.com/activity/p/18252/ Wed, 15 May 2019 21:46:42 -0400 My personal motivators for why I want to pursue my career is that I want challenging work that makes a difference. I also want stability, both financially and in my career. I believe that what motivates one to work is…   Read more»

]]> f8598bca82f5c0b337f5eed8c94e342f https://medicaldevicecourses.com/activity/p/18251/ Wed, 15 May 2019 21:46:41 -0400 I think that the main way that a project manager can motivate their team is by being passionate about the project they are working on. I think that this can be achieved by only managing projects that one is truly…   Read more»

]]> e7109b419a565229ef10792d74384b27 https://medicaldevicecourses.com/activity/p/18142/ Wed, 15 May 2019 21:45:44 -0400 I agree that all these factors are important for project success. Primarily, everyone in the project should be able to agree on the project goals. This is important because that way there is no discrepancies of some project members saying…   Read more»

]]> a23ef600c5a128491aacfb0d17fd408f https://medicaldevicecourses.com/activity/p/18109/ Wed, 15 May 2019 21:45:29 -0400 I think that the planning process should be done in a way where vacation and certain absences from employees will not derail the timeline. What I am saying is that there should be some cushion for employees to be absent,…   Read more»

]]> 7431353eacefad6711080e4d155b1b9a https://medicaldevicecourses.com/activity/p/18108/ Wed, 15 May 2019 21:45:28 -0400 Gantt charts are not done for processes like design verification where one task must be completed before moving on to the next. Instead, they are mainly utilized for scheduling parts of the project that can be going on simultaneously. Therefore,…   Read more»

]]> bc21eec5ac7f4db4becb6603ae8098fc https://medicaldevicecourses.com/activity/p/18031/ Wed, 15 May 2019 21:44:49 -0400 I think a good way to really tell verification from validation apart is to think as verification as the theory and validation as the practice. Verification of a device begins with the idea of a project. While validation happens once…   Read more»

]]> 4a18d0b6337d9956941acbbb7e030608 https://medicaldevicecourses.com/activity/p/18030/ Wed, 15 May 2019 21:44:48 -0400 The planning phase of a project is very important, it details where the project is headed. Without a proper plan a project will not have adequate direction and may fail. However, the phases of a project in industry, are most…   Read more»

]]> 55520e0cdfc060eccc3ae0f4876f8612 https://medicaldevicecourses.com/activity/p/17914/ Wed, 15 May 2019 21:43:48 -0400 I think that a challenge a project manager would face, especially with longer term projects, would be how to keep a professional atmosphere. I bring this up because if you are going to be working with someone on a project…   Read more»

]]> fe659593c8c6bb8c72afdf7d5f923198 https://medicaldevicecourses.com/activity/p/17913/ Wed, 15 May 2019 21:43:48 -0400 Working on my capstone project this year, logging in work has been crucial to our success. The project involves both hardware and software that need to work together in order to function. Therefore, the group members working on software must…   Read more»

]]> ddc7391d38413d67392e6e4aa4d3281b https://medicaldevicecourses.com/activity/p/17912/ Wed, 15 May 2019 21:43:47 -0400 I believe that the most important phase of a project is at the end when it is truly tested whether or not the project is successful. What I mean is that if at the end of the day your project…   Read more»

]]> feaf4b0e15f2d0b870bf215ec7613952 https://medicaldevicecourses.com/activity/p/17851/ Wed, 15 May 2019 21:43:15 -0400 I think that answering your question is very dependent on the situation, and ones personal perspective. For example, if a team misses a milestone due lack of preparation and negligence. What I mean to say is due to a lack…   Read more»

]]> d984946634314d005301f816ed66ffb4 https://medicaldevicecourses.com/activity/p/17850/ Wed, 15 May 2019 21:43:15 -0400 Personally, I do not believe it should be too difficult to design a time line. Of course there will be challenges, but for the most part there should be some sort of precedent where a team can look and devise…   Read more»

]]> 064ca3d2cf54866107c50ffdf72bae25 https://medicaldevicecourses.com/activity/p/17849/ Wed, 15 May 2019 21:43:14 -0400 I have not worked in industry but I am currently working on my senior capstone project where we are developing a device and mimicking how the process would occur in industry (having status meetings, design reviews, etc.) My group and…   Read more»

]]> 4a02ea6a92716e33e06ccb7922108331 https://medicaldevicecourses.com/activity/p/17772/ Wed, 15 May 2019 21:42:31 -0400 I think a cost-benefit analysis is important to answer your question. Will the risk cost the company more than it will benefit it? Or vise-versa? If the benefit is greater than the cost than the risk should be taken due…   Read more»

]]> fa7e93bef4d9c6dbf3b56a41256e24b6 https://medicaldevicecourses.com/activity/p/17771/ Wed, 15 May 2019 21:42:31 -0400 You bring up a really good point where you say that a project leader or risk leader develop a strong connection to the project, and therefore continue on with something that is too risky. I think that this a very…   Read more»

]]> 359ad1e6d0349149f1bf49fdeefb6e06 https://medicaldevicecourses.com/activity/p/17770/ Wed, 15 May 2019 21:42:30 -0400 I believe that design input should generally be managed by the marketing team, this is because these individuals have the knowledge to know what is in demand, and therefore will design a product that will sell and make money. However,…   Read more»

]]> 31e8f016da8ed8b92ad2abd2b0cdf696 https://medicaldevicecourses.com/activity/p/17663/ Wed, 15 May 2019 21:41:33 -0400 I am a firm believer that interpersonal skills are crucial in order to succeed in a professional setting. I think that one of the easiest ways to develop these interpersonal skills is by using social media, specifically, linkedin. While a…   Read more»

]]> c4e87c448e17962823fb51581a8955f1 https://medicaldevicecourses.com/activity/p/17662/ Wed, 15 May 2019 21:41:33 -0400 I believe that a good project proposal should include the market gap which you are trying to target with your product. Today’s technology develops incredibly fast, and because of this, there is a device to meet almost any need. However,…   Read more»

]]> a89b2b2af74172763a50a4d9c8c5084b https://medicaldevicecourses.com/activity/p/17661/ Wed, 15 May 2019 21:41:32 -0400 This is a very interesting topic, as I personally had never imagined projects being outright cancelled due to low priority. In all honesty, I do not see any reason why there should be a cancellation of projects, no matter what…   Read more»

]]> 14de6da46ec6d1b912de72c8d886298e https://medicaldevicecourses.com/activity/p/17589/ Wed, 15 May 2019 21:40:52 -0400 The FDA has regulations in place in order to protect the general public. Therefore, the design process of a product is crucial to its success. I believe that in order to ensure a flawless design process the most important step…   Read more»

]]> 403d7bbd5a4146be9aceabcbe5e340a9 https://medicaldevicecourses.com/activity/p/17588/ Wed, 15 May 2019 21:40:52 -0400 Using an unapproved medical device seems to me like an ethical issue. If the device fails the patients health could be put at greater risk. If the device is not given a chance the subjects health might also deteriorate. Modern…   Read more»

]]> 3c4100ed9d17121a3322bdcde43c0c1a https://medicaldevicecourses.com/activity/p/17512/ Wed, 15 May 2019 21:40:09 -0400 This is a very interesting question that most likely has no correct answer. My personal opinion lies within the nature of the product. I think that often times the use of the project is overlooked when considering going through with…   Read more»

]]> 5962158ad3ce0296305a8ef599e9f208 https://medicaldevicecourses.com/activity/p/17510/ Wed, 15 May 2019 21:40:08 -0400 I believe that picking the project team is a crucial step towards the success of a project. As people have stated above, there has to be cohesiveness from a technical and interpersonal standpoint in order for the project team to…   Read more»

]]> ed37ad17d6b5237c78fb45e23a09044a https://medicaldevicecourses.com/activity/p/17509/ Wed, 15 May 2019 21:40:07 -0400 I believe the system is fine as is. During this weeks mini-sim i chose the bluetooth connected glucose meter and pump. Although there has not been a device like this on the market, you can think of this as a…   Read more»

]]> 47187f2e3cb2d6516ff11246a8ad027d https://medicaldevicecourses.com/activity/p/17457/ Wed, 15 May 2019 21:39:40 -0400 I think that overall interpersonal skills are just as valuable as technical skills. I do not think that anyone is capable of doing everything on their own. By default this means that everyone needs help at one point or the…   Read more»

]]> 852b3e1c9819d3be68582f22ed4dd780 https://medicaldevicecourses.com/activity/p/17456/ Wed, 15 May 2019 21:39:40 -0400 I think that a recall on a product with a faulty label depends on the product itself. For example, makeup products have ingredients that have to be approved by the FDA, if a makeup product has a faulty label I…   Read more»

]]> 8ad48e9e5668ee682859eae5dac27782 https://medicaldevicecourses.com/activity/p/17445/ Wed, 15 May 2019 21:39:35 -0400 I do not currently work in industry, and unfortunately during my undergrad I did not get any internship opportunities. I did however shadow an orthopedic surgeon during my time as an undergrad which provided me some direct insight into how…   Read more»

]]> fd970a583279aa40d444d8d8d98e2870 https://medicaldevicecourses.com/activity/p/10795/ Wed, 15 May 2019 16:36:34 -0400 In this weeks lecture Dr. Simon mentions design review meetings which happen at the end of every design stage in order to be able to move to the next stage. In this class we have also learned that staying on…   Read more»

]]> 6a4233ee3318feca850e4faa09910fdf https://medicaldevicecourses.com/activity/p/10778/ Wed, 15 May 2019 16:36:26 -0400 When we met with Dr. Simon in person for the introductory class a portion of the time we spoke about Europe’s new regulatory system, and how it has dethroned the FDA as the “big dog.” My question is, do you…   Read more»

]]> 5ab503f2b188d236e77e01eeb617e9d9 https://medicaldevicecourses.com/activity/p/10244/ Sat, 04 May 2019 15:40:12 -0400 Business sponsors are a very valuable resource that companies have. Therefore, the relationship between business and sponsor must be a strong one. The relationship mainly revolves around the first stages of project development since a sponsor is deciding on how much money to give, aka the budget of the project. Once this is done the sponsor works…[Read more]

]]> 0 cead8c20a3641e30f4cfe6b171661b1a https://medicaldevicecourses.com/activity/p/10242/ Sat, 04 May 2019 15:03:03 -0400 I am at a point in my life where I am about to graduate and seek job opportunities. So i feel like currently this class gave me the knowledge i need to find a project manager i would enjoy working under. In other words i now know how to find a good project manager. In the future i feel like this class will have given me the tools to become a good…[Read more]

]]> 0 855029c670fce0c4790ee7d3c534a376 https://medicaldevicecourses.com/activity/p/10241/ Sat, 04 May 2019 14:58:06 -0400 I agree with the overall consensus of the class that says that at first it is easy to receive praise because you are new and upper level management will be impressed by you. Once you set a standard of work for yourself this praise will decrease as your superiors will be used to the work you do. I feel like this is something that will happen…[Read more]

]]> 0 fea08c8da1b64ab004d41c0de1c05546 https://medicaldevicecourses.com/activity/p/10166/ Sat, 27 Apr 2019 15:32:38 -0400 I would personally decide to stay as an engineer. Being a manager requires a lot of organizational, leadership, and people skills. I am not sure that I would enjoy having to deal with those things. I would much rather stay an engineer and not have to deal with the heavy consequences a manager deals with if a project goes awry.

]]> 0 a24a932f051be210dbecc42efe9110fc https://medicaldevicecourses.com/activity/p/10164/ Sat, 27 Apr 2019 15:20:02 -0400 My personal motivators for why I want to pursue my career is that I want challenging work that makes a difference. I also want stability, both financially and in my career. I believe that what motivates one to work is very personal to each person and can not be encompassed in a multiple choice question study. Which explains these results. I do not…[Read more]

]]> 0 62a3e79fab18922f375163d50774affb https://medicaldevicecourses.com/activity/p/10163/ Sat, 27 Apr 2019 15:13:26 -0400 I think that the main way that a project manager can motivate their team is by being passionate about the project they are working on. I think that this can be achieved by only managing projects that one is truly excited about. By leading a project that one is excited and passionate about you can one find individuals to work on your team that…[Read more]

]]> 0 dcdae10777a02c9acd00f7716b167412 https://medicaldevicecourses.com/activity/p/10052/ Sun, 14 Apr 2019 22:36:06 -0400 I agree that all these factors are important for project success. Primarily, everyone in the project should be able to agree on the project goals. This is important because that way there is no discrepancies of some project members saying more or less could have been done. Communication is crucial in all aspects. From being able to build…[Read more]

]]> 0 975d2dc8129e239a7298db3b3f173d93 https://medicaldevicecourses.com/activity/p/10019/ Wed, 10 Apr 2019 19:17:13 -0400 I think that the planning process should be done in a way where vacation and certain absences from employees will not derail the timeline. What I am saying is that there should be some cushion for employees to be absent, even unplanned absences. For example, for an employee with children it should be taken into consideration that kids get sick.…[Read more]

]]> 0 b172b14c1fb64b7b9c8d19a0a9fa3e35 https://medicaldevicecourses.com/activity/p/10018/ Wed, 10 Apr 2019 19:09:04 -0400 Gantt charts are not done for processes like design verification where one task must be completed before moving on to the next. Instead, they are mainly utilized for scheduling parts of the project that can be going on simultaneously. Therefore, you can have tasks in different categories going on at the same time.

]]> 0 b3860db359ce78df490aa0d4c832c1b9 https://medicaldevicecourses.com/activity/p/9934/ Tue, 26 Mar 2019 00:17:40 -0400 In this weeks lecture Dr. Simon mentions design review meetings which happen at the end of every design stage in order to be able to move to the next stage. In this class we have also learned that staying on track with the timeline is crucial in project management. For those of you who work/have worked in industry. Have you ever had any instances…[Read more]

]]> 0 8c0bf807bf1d281ebf059083164bd2fe https://medicaldevicecourses.com/activity/p/9933/ Tue, 26 Mar 2019 00:10:13 -0400 I think a good way to really tell verification from validation apart is to think as verification as the theory and validation as the practice. Verification of a device begins with the idea of a project. While validation happens once the project is already produced and it is time to test if it really works.

]]> 0 0f9d46c8c9d45a7db26f0f2b41e21447 https://medicaldevicecourses.com/activity/p/9932/ Mon, 25 Mar 2019 23:58:39 -0400 The planning phase of a project is very important, it details where the project is headed. Without a proper plan a project will not have adequate direction and may fail. However, the phases of a project in industry, are most likely not as defined as they are in our class. What I mean is that there is probably some blending together of the phases.…[Read more]

]]> 0 5439539ca350f84c72b95d1a655eea64 https://medicaldevicecourses.com/activity/p/9813/ Sat, 09 Mar 2019 20:29:17 -0500 I think that a challenge a project manager would face, especially with longer term projects, would be how to keep a professional atmosphere. I bring this up because if you are going to be working with someone on a project for an extended period of time, it is difficult to just keep conversation to just work related stuff. Forming friendships, I…[Read more]

]]> 0 02f5151e4e8a6fec29cbbfa78344a72f https://medicaldevicecourses.com/activity/p/9812/ Sat, 09 Mar 2019 20:18:19 -0500 Working on my capstone project this year, logging in work has been crucial to our success. The project involves both hardware and software that need to work together in order to function. Therefore, the group members working on software must keep an accurate log of what they are doing in order for the group members working on hardware to be able…[Read more]

]]> 0 71ee613ec269832c60f736bfdb960697 https://medicaldevicecourses.com/activity/p/9811/ Sat, 09 Mar 2019 20:08:13 -0500 I believe that the most important phase of a project is at the end when it is truly tested whether or not the project is successful. What I mean is that if at the end of the day your project yields a product that does not sell, does not work, etc. Then all the steps in project management were essentially a waste.

]]> 0 a06c6b0a3829cb2a2a7f9ffc2cfc0dd5 https://medicaldevicecourses.com/activity/p/9748/ Sat, 02 Mar 2019 20:20:28 -0500 I think that answering your question is very dependent on the situation, and ones personal perspective.
For example, if a team misses a milestone due lack of preparation and negligence. What I mean to say is due to a lack of preparation. Then this is most definitely not a ” link to future success” . This is simply a failure, a misuse of company…[Read more]

]]> 0 82224119bbb4a0122557c0082ef05a82 https://medicaldevicecourses.com/activity/p/9747/ Sat, 02 Mar 2019 20:09:11 -0500 Personally, I do not believe it should be too difficult to design a time line. Of course there will be challenges, but for the most part there should be some sort of precedent where a team can look and devise an accurate time line. Also, a good rule of time is to add time on a task that might be more difficult because it is always better to…[Read more]

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