https://medicaldevicecourses.com/members/la82/activity/ Activity feed for la82. Fri, 24 Apr 2026 14:14:11 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ebc73f9afaf60076946ff92c112030d8 https://medicaldevicecourses.com/activity/p/12465/ Wed, 15 May 2019 16:56:17 -0400 These results don’t surprise me at all. The social environment that we surround ourselves with has a huge impact on what we do as individuals. Regardless if it is work, school or anything else where motivation is applicable. If I…   Read more»

]]> 984910439e07c8746af6f5c3002bb462 https://medicaldevicecourses.com/activity/p/12464/ Wed, 15 May 2019 16:56:17 -0400 I agree with the above comments, the project managers level of motivation spreads through the team. The spirit of motivation is contagious and very helpful. The project manager needs to show interest, passion and motivation to allow others to act…   Read more»

]]> b1772342f02ca6fc025c134475d1da0b https://medicaldevicecourses.com/activity/p/12463/ Wed, 15 May 2019 16:56:16 -0400 Similar to others, challenge and satisfaction motivate me. The satisfaction of achieving a goal that I have been working toward and challenging myself through the process helps my motivation. For example, for my capstone project, I had to learn an…   Read more»

]]> 7d831803414950fab835d085f15f30ec https://medicaldevicecourses.com/activity/p/12430/ Wed, 15 May 2019 16:55:55 -0400 I have had a similar situation to yours where one team member was replaced by multiple. Do you think it is a good practice for companies to hire more than the needed staff by one or two people ?

]]> a7f90d5356b38cb8ed583fab99792c6c https://medicaldevicecourses.com/activity/p/12421/ Wed, 15 May 2019 16:55:51 -0400 For my capstone project, I haven’t had to put the whole entire system together yet, but for two major parts we encountered a lot of problems while putting them together. The project consists of mainly a hardware part and a…   Read more»

]]> ca929f00e693defb6440bece6f1ca672 https://medicaldevicecourses.com/activity/p/12419/ Wed, 15 May 2019 16:55:50 -0400 I don’t have any experience of my own, but my father owns a company and procurement is a major key to a company’s success. I agree with bb254. The points she mentioned are major points in procurement management. I would…   Read more»

]]> ca0d4932d5a99ec3697492c2e8fc1a35 https://medicaldevicecourses.com/activity/p/12290/ Wed, 15 May 2019 16:54:34 -0400 An example of a risk I am evaluating right now with my team, is power risk, The device we are working on depends on infrared reflection, and according to the Occupational Safety and Health Administration (OSHA) standards, there is a…   Read more»

]]> 4322abb484ec9b74e7426718378ada0f https://medicaldevicecourses.com/activity/p/12289/ Wed, 15 May 2019 16:54:33 -0400 I agree with the previous two comments, things like that I didn’t have any knowledge about until this course, it is very important in cases like this to understand which type of change must occur and how that will affect…   Read more»

]]> d236352eac1524ebd93a06c0084931e2 https://medicaldevicecourses.com/activity/p/12288/ Wed, 15 May 2019 16:54:33 -0400 In my opinion, even if the initiating and planning process was extensive and very detailed, there are always some details, risks or problems that were never apparent until you reach the executing phase. In theory things might fit and seem…   Read more»

]]> 23d9e5a01605eea9dbafa31aa3d3f48f https://medicaldevicecourses.com/activity/p/12185/ Wed, 15 May 2019 16:53:35 -0400 For my capstone project, I found it very important to log every step of the process, Even the small details and changes I made to the entire thing. My team and I started was one intention to the design and…   Read more»

]]> 2947652510fca156895d811d737cfa4c https://medicaldevicecourses.com/activity/p/12183/ Wed, 15 May 2019 16:53:34 -0400 I agree with previous comments about what the overall Engineering Change order is the flow of it and how it is beneficial. Since these comments mostly covered the essentials, I would to alternatively add to the discussion the side effects…   Read more»

]]> df153e1b33d1a045f6e57cb77b2d7327 https://medicaldevicecourses.com/activity/p/12131/ Wed, 15 May 2019 16:53:02 -0400 I agree with dag56. It is very important to keep potential options in the project manager’s mind until it is time to pick for all of the reasons he mentioned. I would like to add that not only in the…   Read more»

]]> ea3185482c553882e5a1bb194347a855 https://medicaldevicecourses.com/activity/p/12130/ Wed, 15 May 2019 16:53:02 -0400 there is a huge range of different challenges that project managers could face. Since a lot have been mentioned, and I have read other posts, a major unforgotten challenge was mentioned in one of the other posts. The challenge is…   Read more»

]]> 82d27b582a65a55bf8c696e378545164 https://medicaldevicecourses.com/activity/p/12129/ Wed, 15 May 2019 16:53:01 -0400 I understand and for the most part agree with both your posts but on the other hand, I have had a personal experience where personal ties to project members with the project managers allowed them to unprofessionally think that it…   Read more»

]]> b3d74f8d2b992c62fa1101c2e23f7477 https://medicaldevicecourses.com/activity/p/12068/ Wed, 15 May 2019 16:52:31 -0400 to reflect on your experience as I had a similar one, where the project I was working on depended on another sector to hand us some chip that will allow us to obtain a signal for us to analyze. Research…   Read more»

]]> b03dbf17810697a4a971309c6e5e4658 https://medicaldevicecourses.com/activity/p/12065/ Wed, 15 May 2019 16:52:29 -0400 I am not really quiet sure how missing a milestone would lead to any success. I agree with other that it greatly depends on the importance of that specific milestone to the project. However, i can’t imagine how having it…   Read more»

]]> de865861614900f1da54481fed2b175a https://medicaldevicecourses.com/activity/p/12063/ Wed, 15 May 2019 16:52:28 -0400 This is my second course with dr. Simon. I previously have taken Medical Devices Development (BME684). The amount of information I learned about the paperwork and all the requirements to carry a project in real life. This has encouraged me…   Read more»

]]> b6506b882e97bcdfe98318c4ccc44807 https://medicaldevicecourses.com/activity/p/11990/ Wed, 15 May 2019 16:51:44 -0400 I agree with you jp582. Relying on others can be problematic. An interesting concept that I had learn from my previous class with dr. Simon, was that the entire department in real like examples is responsible for the shortcoming of…   Read more»

]]> de684c4deb4c4c7900029c7f3dea8fde https://medicaldevicecourses.com/activity/p/11989/ Wed, 15 May 2019 16:51:44 -0400 During a class project, we missed one milestone it delayed the entire project and we had to move faster in other milestones to accommodate for the time lost. The project was an eye tracking device and after accomplishing most of…   Read more»

]]> 99d24eb9a326d9cae4991883bbca2225 https://medicaldevicecourses.com/activity/p/11915/ Wed, 15 May 2019 16:50:59 -0400 This is a very important topic to discuss. The work breakdown structure caught my attention when I was listening to the lecture. I have had many projects where communication and time conflict has been a major issue. However, having a…   Read more»

]]> c470b0cfbc30c0113a275d04684a13ba https://medicaldevicecourses.com/activity/p/11858/ Wed, 15 May 2019 16:50:26 -0400 I agree with all of the above however I would like to add that in certain cases where similar products exist in the market, if the project team spends so much time in that phase it might take longer than…   Read more»

]]> 891d79834acf382d4a11559d5596a0be https://medicaldevicecourses.com/activity/p/11857/ Wed, 15 May 2019 16:50:26 -0400 I agree with what everyone had to say about the consequences of a budget cut. However, I believe that is it very important to understand why the budget is being cut. If it is an overall organizational cut then as…   Read more»

]]> a7b82c602eee38569b11f90ba38e8b87 https://medicaldevicecourses.com/activity/p/11816/ Wed, 15 May 2019 16:50:00 -0400 I agree with everyone’s post. However, I believe communication and the ability for the team to work under pressure is a key to a successful team. You can form a power team of expertise with different backgrounds, but their ability…   Read more»

]]> e1109f929b994f2de1f0828eeffaafcd https://medicaldevicecourses.com/activity/p/11742/ Wed, 15 May 2019 16:49:17 -0400 I completely agree with Chaudhry. According to an article I read regarding the Fitbit regulations decision with FDA, it said that, “According to FDA, the general distinction between a general wellness product and a medical device is whether the product…   Read more»

]]> ea697d683f375342dc4b65d69eab37e4 https://medicaldevicecourses.com/activity/p/11741/ Wed, 15 May 2019 16:49:17 -0400 I strongly agree with you that cutting them in the first place will cause a lot of of other risks. I believe that for those terminally ill patients maybe they should make an exception to specifically approve this certain medication…   Read more»

]]> 717cf20185634be9bd0a1194cc22929b https://medicaldevicecourses.com/activity/p/11725/ Wed, 15 May 2019 16:49:04 -0400 This is a great topic for discussion. Accelerating the process of FDA regulation seems like an ideal solution for many critical patients. Although it seems appealing, I believe that it will cause a lot of risk in terms of the…   Read more»

]]> c633c739c323ecd0ec0fa1b6515d422e https://medicaldevicecourses.com/activity/p/11661/ Wed, 15 May 2019 16:48:31 -0400 My experience with design controls so far was another course I took with Dr. Simon. The class idea was to come up with a project of a medical device and go through all the paperwork and official documents that implementing…   Read more»

]]> c4d4ba00e2e1b13e79b1c71f01803020 https://medicaldevicecourses.com/activity/p/11586/ Wed, 15 May 2019 16:47:53 -0400 I agree with Krp, Pineda and dag56′ posts. I would like to add that although they are similar in the main functionality, I would say a broader project manager is going to face a harder time getting accustomed to all…   Read more»

]]> cbe980d0aa189681c8502b9b342b26bb https://medicaldevicecourses.com/activity/p/11580/ Wed, 15 May 2019 16:47:50 -0400 Hello Roberto, This is a really interesting point. I had that question come up to my mind as I was watching the lecture. With some research I found a clear answer to that concern on the FDA website. A device…   Read more»

]]> 01b72436fa9327caec81e9dd6c38b4c9 https://medicaldevicecourses.com/activity/p/11556/ Wed, 15 May 2019 16:47:37 -0400 I agree with my classmates that your application that you designed for senior project should be classified as a mobile medical app. I couldn’t access your reference link, but I found two links by the FDA that completely breakdown the…   Read more»

]]> 3eed95728fd9fde5d402a595647d516c https://medicaldevicecourses.com/activity/p/11509/ Wed, 15 May 2019 16:45:32 -0400 I believe that a good skill that a project manager should have is giving other team members the spirit of acting as team players in the role of project management. They should have the limited freedom to express their inputs…   Read more»

]]> c4b1cc40244cbd01f9530962fe765863 https://medicaldevicecourses.com/activity/p/11502/ Wed, 15 May 2019 16:45:29 -0400 I have read opinions from other classmates and I agree and disagree with each one of them at different points. I agree that project management basics of being a good leader and other similar skills are uniform in any industry….   Read more»

]]> 65328287babc53a5abb92b560886cbeb https://medicaldevicecourses.com/activity/p/11501/ Wed, 15 May 2019 16:45:29 -0400 I don’t have any experience in the industry yet. However, I feel like a matrix type organizations is more appealing to me. I feel it like it promotes challenge and creativity. Matrix organizations have the ability to sort out the…   Read more»

]]> 54ef64852004fe850bbb792b1454e039 https://medicaldevicecourses.com/activity/p/11371/ Wed, 15 May 2019 16:44:19 -0400 I agree with everyone who mentioned the importance of a written agreement, and I agree with your point Roberto. The only part I would like to comment on is about the condition you set for verbal agreements. I have seem…   Read more»

]]> 01cd5047122489e5fc408f4a48102e3f https://medicaldevicecourses.com/activity/p/11370/ Wed, 15 May 2019 16:44:18 -0400 Hello Roberto, Very interesting topic. Although the example you mentioned might be humanely absurd, but I agree with my classmates. The restrictions are highly important. I come from a country where these kind of gift are not restricted at all…   Read more»

]]> 6d58f277dd13b124c7da2279efb8ea13 https://medicaldevicecourses.com/activity/p/11330/ Wed, 15 May 2019 16:43:58 -0400 When I signed up for this course, I was expecting, as others have mentioned, more of a theory content about medical devices. When I looked at the syllabus and attended the first meeting, I was even more excited about the…   Read more»

]]> c26efdabffcc855d20c9172af1eeac7a https://medicaldevicecourses.com/activity/p/11226/ Wed, 15 May 2019 16:43:06 -0400 I agree with you that this type of organization is good for a start up. on the other hand, as the company grows overall I would prefer to have a company that operates in the matrix way. It promotes innovation…   Read more»

]]> 7eb6c8707151769f4c137d4c463cecf1 https://medicaldevicecourses.com/activity/p/11165/ Wed, 15 May 2019 16:40:27 -0400 I would like to work for a matrix type organization. Matrix type seem flexible to the changes in its environment. Those types of organizations can shift focuses and resources toward major problems and products. It creates a challenging mood in…   Read more»

]]> e8bfc4f2a850d5d0d43c481e17efeb78 https://medicaldevicecourses.com/activity/p/11125/ Wed, 15 May 2019 16:40:07 -0400 Hi, I agree with Irene on using quantitative methods. I found a good research paper on using this method in medical devices. The research says that the method is widely used in pharmaceuticals but it goes over its benefits in…   Read more»

]]> aa86479e082a6aa1ed20c334ba28ac6c https://medicaldevicecourses.com/activity/p/11122/ Wed, 15 May 2019 16:40:05 -0400 Thank you for sharing this! I agree with you. It is a very interesting read. I was researching more on the topic and found another link that lists possible ways on using risk management efficiently and avoiding problems such as…   Read more»

]]> f68f7100308e33ec9659281fc6fc8931 https://medicaldevicecourses.com/activity/p/10964/ Wed, 15 May 2019 16:38:22 -0400 Hello Roberto, I have done some research like my classmates, it was interesting to read that the FDA points out to verification not only in terms of tests. They list guidelines such as analysis and inspections. I agree with my…   Read more»

]]> 995a0821448047c9e4cd5c1d0dad5522 https://medicaldevicecourses.com/activity/p/10963/ Wed, 15 May 2019 16:38:21 -0400 Hi I don’t have an experience with them, but I can imagine if they don’t exist how hard is it to implement a change or realize when a mistake is happening. If you don’t have a review meeting after every…   Read more»

]]> 0a1f89d94be8f0d95f809c9cfb0b7dfd https://medicaldevicecourses.com/activity/p/10961/ Wed, 15 May 2019 16:38:20 -0400 Hello Roberto, This question is very interesting. Many people overlook the importance of meeting minutes. Meeting minutes are very crucial to industries such as medical devices. Things like important dates and details that someone might have not heard, or a…   Read more»

]]> 11741ff47ee1cfa1754b54e7805603d8 https://medicaldevicecourses.com/activity/p/10901/ Wed, 15 May 2019 16:37:43 -0400 You make a great point regarding the dates. Good communications should be kept to makes things move smoothly. Trials as you mentioned is one of the major time consuming factors. If all involved parties are in good synchronization with each…   Read more»

]]> 0c5a6530cc3daf3f222eb0312ed84497 https://medicaldevicecourses.com/activity/p/10864/ Wed, 15 May 2019 16:37:18 -0400 thank you for your reply! To clear my statement, I meant that with the long process and amount of time the company needs to invest in the process of design controls and abiding by it, they mostly use it as…   Read more»

]]> 6fe82d7b3189c2b31861000d3c0cd8e7 https://medicaldevicecourses.com/activity/p/10821/ Wed, 15 May 2019 16:36:54 -0400 Design controls are very essential and useful as others have mentioned. They have listed what they are and their benefits, to avoid repetition, I would like to shift the discussion to a key challenge to design control. The process of…   Read more»

]]> b0ae75832afc6b9e40b2c6b08c69557f https://medicaldevicecourses.com/activity/p/10492/ Wed, 15 May 2019 16:33:58 -0400 Another topic was mentioned about the importance and examples of logging your work throughout a project. In one of the comments someone mentioned that it could get very serious if this information isn’t available when FDA audits the company. Does…   Read more»

]]> 04502ae6020b7fbb7e8ece2dff754588 https://medicaldevicecourses.com/activity/p/10441/ Wed, 15 May 2019 16:33:35 -0400 The process of validation and verification is very important in device development. with that being said, when is the best time to carry out these two important steps during the project’s span ?

]]> 20f125ebbaacf0b39cfeba448d370ba2 https://medicaldevicecourses.com/activity/p/10411/ Wed, 15 May 2019 16:33:21 -0400 The lectures introduce the three types of organizations. Project managers’ roles are specifically mentioned in both matrix and project-based organizations. While other posts discussed the preference of working under one or the other, no one mentions what is best for…   Read more»

]]> 563c6118429f4198f6cffd392ea7e7e6 https://medicaldevicecourses.com/activity/p/10407/ Wed, 15 May 2019 16:33:19 -0400 While researching about one of the discussions posted on the forum about “As far as possible (AFAP)”, I came across the fact that they have changed to this term from ” As low as reasonably practicable (ALARP). I would appreciate…   Read more»

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