https://medicaldevicecourses.com/members/jp582/activity/ Activity feed for jp582. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b1257f33db89c91e6cacd7c4929642cb https://medicaldevicecourses.com/activity/p/12552/ Wed, 15 May 2019 16:57:04 -0400 I completely agreed with hiren rana. I also heard this through my internship at hospital dealing with medical instruments such as calibrating, perform testing and problem solving on devices. I was surprised by knowing that there are places where manager…   Read more»

]]> ac3ee135103079925461b474f5f97533 https://medicaldevicecourses.com/activity/p/12528/ Wed, 15 May 2019 16:56:47 -0400 I expected fair pay and benefits should slightly be higher. I am surprised by number that only 32% and 22% people’s motivation fair pay and benefits. In my opinion, if the fair pay and benefits are not satisfying to the…   Read more»

]]> b00c401e9e14bd908e1e7103b6a3de6f https://medicaldevicecourses.com/activity/p/12509/ Wed, 15 May 2019 16:56:38 -0400 I would like add to above post. The sponsor is responsible for initially determining if the change meets the statutory criteria. This determination should be made by the person in the company responsible for such decisions, and should be based…   Read more»

]]> e61da054995d5cc9543ed9ce079138af https://medicaldevicecourses.com/activity/p/12452/ Wed, 15 May 2019 16:56:10 -0400 Team members are the main and the most important resource of each company. For achieving successful results, each leader needs to have a motivation strategy to create and maintain the spirit of enthusiasm among employees. If I would be a…   Read more»

]]> b5e791abcdf6094bf7de7fcb2e0d198f https://medicaldevicecourses.com/activity/p/12451/ Wed, 15 May 2019 16:56:10 -0400 Challenges motivate me the most. Challenges are not that many people enjoy because low odds of success with big sacrifices of time, effort and sometime money. However, I like challenges because it helps build my skill, inspires courageous acts, and…   Read more»

]]> 1734e4652b8a3b412ba1fd97678689d7 https://medicaldevicecourses.com/activity/p/12429/ Wed, 15 May 2019 16:55:55 -0400 Choosing a vendor can be as simple as asking friends who they use for their business. Other, I would take certain steps to choose right vendor such as document my organization needs, identify the sources- do my own research, measuring…   Read more»

]]> 2df38824e5c43ac42382ecbbcd780bad https://medicaldevicecourses.com/activity/p/12367/ Wed, 15 May 2019 16:55:21 -0400 Preliminary Hazard Analysis is a tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of…   Read more»

]]> 5de3c29483c723c91fbb9b01aa2cdefa https://medicaldevicecourses.com/activity/p/12366/ Wed, 15 May 2019 16:55:20 -0400 The rate of return (R) is used as the discount rate for future cash flows to account for the time value of money. Companies may often have different ways of identifying the discount rate. Common methods for determining the discount…   Read more»

]]> 23737c601b29f18ab0b52e381be3d921 https://medicaldevicecourses.com/activity/p/12271/ Wed, 15 May 2019 16:54:23 -0400 Combination product is a product composed of any combination (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic). Infuse bone graft is a combination product which consists a protein that is found in everyone’s body and a natural carrier for delivery. Infuse bone…   Read more»

]]> 77df9290f37dafc1a9677f7953bd9a86 https://medicaldevicecourses.com/activity/p/12270/ Wed, 15 May 2019 16:54:22 -0400 Mechanical failure could be one of a product risk. Several things I would like to do to evaluate and manage risk for example I would assess the potential effects of the risk on my project then develop a plan to…   Read more»

]]> e5c1f7b6fedce2648e99eea0433dec6b https://medicaldevicecourses.com/activity/p/12265/ Wed, 15 May 2019 16:54:19 -0400 Last year in medical device course, I submitted a project proposal on device called “Indirect Video Laryngoscope”. The purpose of that device is to make the process of intubation easier and quicker to perform. It can also be used for…   Read more»

]]> e0f9f6ae519fb1f5012eb32189838bfd https://medicaldevicecourses.com/activity/p/12163/ Wed, 15 May 2019 16:53:25 -0400 I was working on my class project; at the beginning, I had to estimate project cost. I calculated the total project budget should not cost more than $90. However, by the time I finished my project, it ended up cost…   Read more»

]]> 1d9df6350973a2bcbc46f9bea3c62fc0 https://medicaldevicecourses.com/activity/p/12161/ Wed, 15 May 2019 16:53:23 -0400 Monitoring and controlling a project is a process to track, review and revise the project activities which can be done by project manager to ensure the project is on right track and creates the deliverables in accordance with the project…   Read more»

]]> 561877c5ffc575248784cf1772abbf50 https://medicaldevicecourses.com/activity/p/12112/ Wed, 15 May 2019 16:52:53 -0400 One challenge project manager face is lack of accountability. A project manager always should clearly state or define each team member’s rules and responsibilities which includes managing the expectations of stakeholders who are financing the project but not involved directly…   Read more»

]]> aa7d3ee8f475239477cdb28ca4ec1a55 https://medicaldevicecourses.com/activity/p/12105/ Wed, 15 May 2019 16:52:50 -0400 There are various obstacles come across if you are taking a company globally. As my other classmates discussed in above posts, I would like to add some points. 1.Be aware of national and religious holidays- holidays might affect a team…   Read more»

]]> 5f62dd106a1a0e8fe783394e1bfba000 https://medicaldevicecourses.com/activity/p/12017/ Wed, 15 May 2019 16:52:01 -0400 Time estimation is important can be used to organize and structure all projects. Using good time estimation techniques may save time, and money. First, project manager should familiar with the task to be carried out and understand the project outcomes…   Read more»

]]> 737d57272e01e61b0f42f9c53e8f0636 https://medicaldevicecourses.com/activity/p/12016/ Wed, 15 May 2019 16:52:00 -0400 Missing a milestone is not bad at once; however, missing more than 2 milestones lead to significant reductions in customer satisfaction and confidence which is bad for company’s reputation. It could be avoid by examining key possibilities in detail that…   Read more»

]]> 54bbd9d0625812057610012b3540a28d https://medicaldevicecourses.com/activity/p/12010/ Wed, 15 May 2019 16:51:57 -0400 Time management is crucial for any project. If I would be a project manager for this week’s simulation, I would like each team members to read simulation’s instruction and find related articles that help towards this simulation at least by…   Read more»

]]> fe80b9d2dd9f9cb8695b9bc33cccc2c3 https://medicaldevicecourses.com/activity/p/11931/ Wed, 15 May 2019 16:51:08 -0400 I was working on my class project called “Quadruped Spider robot” which was built in 3D printer and powered by Arduino. Many obstacles came across during the project which caused a delay. The main issue was 3D printing parts which…   Read more»

]]> e30313231ec4762cfac390c5c52fe0cc https://medicaldevicecourses.com/activity/p/11919/ Wed, 15 May 2019 16:51:01 -0400 Work breakdown structure (WBS) helps improve the future project estimation, has better control executing the project, and also helps speeding up the project process. In my opinion, WBS won’t work in some environment, especially in learning process, where everyone should…   Read more»

]]> 51a45b1a6fdc6d2fb6bd50fcbbdb215f https://medicaldevicecourses.com/activity/p/11918/ Wed, 15 May 2019 16:51:00 -0400 This topic is very interesting. I think this is the most common problem while working in team. I have experienced this situation many times due to lack of communication, delay in replying and most important when the team members rely…   Read more»

]]> 0611172120c2608c55fe151605a787d6 https://medicaldevicecourses.com/activity/p/11856/ Wed, 15 May 2019 16:50:25 -0400 I agree with jvv6, it completely depends on the project if someone has previous experience with similar project can start with minimal information about new project with confident. However, if the project is new then required lot of research and…   Read more»

]]> 4da9531344d69d1e01cfe2b48c788a80 https://medicaldevicecourses.com/activity/p/11855/ Wed, 15 May 2019 16:50:24 -0400 sorry i posted on wrong place

]]> 8edf0b80bfdf44f170cefd56fcb2f8c9 https://medicaldevicecourses.com/activity/p/11836/ Wed, 15 May 2019 16:50:14 -0400 Last semester in medical device course, I worked on a medical device project called Automated Chest compression machine and my role was to analyze the risk. The most common risk in this device is bone breakage (sternum, and ribs) and…   Read more»

]]> 0f1862cf8b5fcf19235bbdc0eb5ef71e https://medicaldevicecourses.com/activity/p/11749/ Wed, 15 May 2019 16:49:22 -0400 I want to add some pros and cons of FDA regulations Pros-increase public awareness and education regarding the dangers and misuse and over prescribing drugs, FDA plays a “gate keeper” role for consumers, and overall public safety by checking that…   Read more»

]]> d3d222c356f326fa8653cba184655855 https://medicaldevicecourses.com/activity/p/11748/ Wed, 15 May 2019 16:49:21 -0400 Many people want to change their unhealthy lifestyle, especially college students who do not have time for exercise and eat without counting calories. There is general wellness device called Withings pulse Ox can help someone be more active and improve…   Read more»

]]> 5658cb28bd14dee93ce9ef1a52137117 https://medicaldevicecourses.com/activity/p/11747/ Wed, 15 May 2019 16:49:20 -0400 I agreed with above posts that fitbit should not consider for FDA approval unless if fitbit claims to treat or diagnose other specific diseases then definitely need a FDA approval and I believe it considers as a class II device…   Read more»

]]> 7b5264c6e83f70432c15da1420bc9b6d https://medicaldevicecourses.com/activity/p/11667/ Wed, 15 May 2019 16:48:34 -0400 Design verification and validation are the procedure to check during medical device development process that the product meets the specific requirements and error free. Design verification is testing that the design output meets the design input and requirements you have…   Read more»

]]> f9650386e51da3b0df0d0d5a2c6538f1 https://medicaldevicecourses.com/activity/p/11560/ Wed, 15 May 2019 16:47:39 -0400 First of all, person/company needs to find out if this product even required RFD because not all product required RFD submission. The necessary step to take before submitting RFD with a better understanding of how the product works and then…   Read more»

]]> 561018437e1e4ae98e55c7042e972527 https://medicaldevicecourses.com/activity/p/11557/ Wed, 15 May 2019 16:47:38 -0400 Hello, I think during capstone project the application your team developed is considered to be mobile medical app because it allows people to retain their auditory stimuli. Furthermore, mobile medical application is something that can help people manage their own…   Read more»

]]> 5eaaf9af7e6148ecc257861ab8d08c32 https://medicaldevicecourses.com/activity/p/11538/ Wed, 15 May 2019 16:47:27 -0400 To be a good project manager, I think project manager should have certain skills in order to be effective and successful. I agreed with above posts that communication skill is very important to transfer information relate to any changes and…   Read more»

]]> df11cb8d98a3aa6b62c72bcf06b69f33 https://medicaldevicecourses.com/activity/p/11526/ Wed, 15 May 2019 16:45:42 -0400 Design validation is required to verify if user needs and intended uses are met; it can improve the launch success and reduce the chances of product recalls. In simple words, Validation is to check that you have made the device…   Read more»

]]> b540cded420dd53729794e900173079b https://medicaldevicecourses.com/activity/p/11525/ Wed, 15 May 2019 16:45:41 -0400 Hello, I would like to work in a matrix type organization. Matrix organization is a mixture of functional and projectized organization structure which helps employees to perform well, allows enhanced growth and career development. Matrix organization has some advantages such…   Read more»

]]> 5da01e66804dd54deeb3f34eec36cabc https://medicaldevicecourses.com/activity/p/11390/ Wed, 15 May 2019 16:44:31 -0400 Hey Roberto, The topic is very interesting. Lamiaa has a good example why it is necessary. I understand, it is very competitive to bring something new in the market, and it makes sense that owners or company considered every angle…   Read more»

]]> 0ee8a7356e92dda7cf6dce0201c7446a https://medicaldevicecourses.com/activity/p/11329/ Wed, 15 May 2019 16:43:58 -0400 Before taking this course, I had hard time figuring out what I could do as a biomedical engineers when I will be looking for industry based jobs. I have gained bit of knowledge now to know how industry works and…   Read more»

]]> 093676a2fa93d29fe4d0b3a5d4b6817c https://medicaldevicecourses.com/activity/p/11267/ Wed, 15 May 2019 16:43:28 -0400 Very interesting question. To be successful in the project, culture organization has a huge impact on your success rate. Your organization structure can help or hurt project success, it is easier to change organization structure than culture organization for a…   Read more»

]]> c20b24b713ca703f10b3f5f55342f638 https://medicaldevicecourses.com/activity/p/11240/ Wed, 15 May 2019 16:43:13 -0400 Hello, There is a recent Gallup survey article about revisiting the matrix organization published on January 2016 which involved 4000 US employees highlighted some benefits in matrix organization. Survey categorized as matrixed, slightly matrixed, non-matrixed, supermatrixed employees working in such…   Read more»

]]> b2913a4a2381348609e629a518be624d https://medicaldevicecourses.com/activity/p/11221/ Wed, 15 May 2019 16:43:03 -0400 While forming a project team, mistakes I would try to avoid are not been cooperative, lack of communication and effort. I think I would like to work with people who I am familiar with, it is always easy to communicate…   Read more»

]]> 2f7ca8281f528f2d0458e191809a599f https://medicaldevicecourses.com/activity/p/11110/ Wed, 15 May 2019 16:39:59 -0400 I agreed with above discussions. I think it is very important for doctors, surgeons or who else is involve in using that device to have a training or at least instructions have been read before using any new medical device…   Read more»

]]> 7c3efd33ac02d7a707a64fa1a5c12cff https://medicaldevicecourses.com/activity/p/10930/ Wed, 15 May 2019 16:38:02 -0400 Design transfer is the process in which the device design is translated into production, distribution, and installation specification. Some of the common problem during Design transfer include • Product developers do not have a finalized design. • Manufacturing processes have…   Read more»

]]> 2d00e5371d29b5b48741791cbb812a2d https://medicaldevicecourses.com/activity/p/10928/ Wed, 15 May 2019 16:38:01 -0400 Design verification and validation are the procedure to check during medical device development process that the product meets the specific requirements and error free. Design verification is testing that the design output meets the design input and requirements you have…   Read more»

]]> b0cd3f656fd6d5c6cc54dc4e41f38697 https://medicaldevicecourses.com/activity/p/10927/ Wed, 15 May 2019 16:38:01 -0400 Design input is the key point of medical device. If design input defined well during product development, it makes the rest of product development easier. Some sources state that establishing design input can take easily up to 30% of the…   Read more»

]]> dd3d9e8e659402f27e0f459221591481 https://medicaldevicecourses.com/activity/p/10815/ Wed, 15 May 2019 16:36:50 -0400 Design development plan(DDP) is a plan written by project manager, and it defines and describes all important aspects needed for the project. I think final scope statement is the most important part of DDP to provide understanding of project strategy,…   Read more»

]]> 16946dff63ab67b1e83f8149ba3308c7 https://medicaldevicecourses.com/activity/p/10811/ Wed, 15 May 2019 16:36:48 -0400 Design control is required by FDA to check the medical device you design and develop is safe to use before you bring the product to market. Design Control is a procedure while developing a medical device to meet with specification…   Read more»

]]> 1ce4afe0124e17de1b4becf6c1cacaed https://medicaldevicecourses.com/activity/p/10529/ Wed, 15 May 2019 16:34:19 -0400 As we have all heard about six sigma either through Dr. Simon’s lecture or outside. Six sigma is a technique intended to improve business processes by reducing the probability of error or defect will occur. I would like to know…   Read more»

]]> a0d76c868772e641b09d5fc5e60b2c26 https://medicaldevicecourses.com/activity/p/10489/ Wed, 15 May 2019 16:33:57 -0400 Hello Everyone, In this week’s lecture, Dr. Simon talked about different kinds of changes during monitoring and control phase. One of the change is Engineering change order which is a packet of documentation includes proposed change, list the parts or…   Read more»

]]> f646fe3a660f7b00a21f6d4455636170 https://medicaldevicecourses.com/activity/p/10457/ Wed, 15 May 2019 16:33:43 -0400 Hello everyone, Budget cut is the most common issue during the project, and it happens too often. It has negative impacts on staff of cutbacks, reorganization and sometime layoffs. In my opinion, sometime working under budget helps in situation later…   Read more»

]]> 3135a993d9c725abdbd020046d1e5c37 https://medicaldevicecourses.com/activity/p/10437/ Wed, 15 May 2019 16:33:33 -0400 Hello Everyone, It is critical to know which steps can be taken to successfully go through project initiating phase as quickly and efficiently as possible. To be a good project manager, you should know how to initiate projects successfully, get…   Read more»

]]> 27278f53329521614e81879cf696e968 https://medicaldevicecourses.com/activity/p/10430/ Wed, 15 May 2019 16:33:31 -0400 Hello Everyone, Human Factors study considered users to assess the adequacy of the combination product user interface design to eliminate or mitigate potential use-related hazards. Human factors study is perform to consider the complexity of the combination product and the…   Read more»

]]> c5d631483f071e536ffd2abb0c5f438b https://medicaldevicecourses.com/activity/p/10419/ Wed, 15 May 2019 16:33:25 -0400 Hello Everyone, As we all have little idea of legal aspects and how it works. We know outside of court settlement is best option which saves time and money, get more privacy and become less stressful. There are two types…   Read more»

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