Medical Device Courses | djr32 | Activity https://medicaldevicecourses.com/members/djr32/activity/ Activity feed for djr32. Fri, 24 Apr 2026 14:09:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 10ae7cc1b8cf4c5af97862880497827a djr32 replied to the topic "Engineer vs. Manager" - https://medicaldevicecourses.com/activity/p/12545/ Wed, 15 May 2019 16:57:01 -0400 I would personally like to have my end goal to be a manager, but I first would want to get a couple of years working as an engineer to understand how the industry actually works. This semester we learned many…   Read more»

]]> d2b7c10cbccfe93356a384bfee8f8759 djr32 replied to the topic "Why do people work?" - https://medicaldevicecourses.com/activity/p/12529/ Wed, 15 May 2019 16:56:47 -0400 No, I’m not so surprised by these results and kind of expected it. As Confucius put it, “Choose a job you love and you will never have to work a day in your life”. For someone to enjoy working for…   Read more»

]]> 11bf522ccc79368097866f2ca980146e djr32 replied to the topic "Discussion Topic: Costs and managing your investment" - https://medicaldevicecourses.com/activity/p/12357/ Wed, 15 May 2019 16:55:16 -0400 The rate of return is specific to a company and it is related how the company gets its funding for projects [1]. Moreover, it is the rate of return that the investor expects or the cost of borrowing money [1]….   Read more»

]]> a4be69a69ee54c630b04c711f956a444 djr32 replied to the topic "Discussion Topic: Scope creep....when your project changes" - https://medicaldevicecourses.com/activity/p/12352/ Wed, 15 May 2019 16:55:13 -0400 My capstone project AudIQ was about to suffer from a small scope creep, which is when the changes, continuous or uncontrolled growth in a project’s scope. Before the development of the mobile application, we had laid out our customer need…   Read more»

]]> a25afc613135f4c101b907eeebfb5641 djr32 replied to the topic "Device Class Confusion" - https://medicaldevicecourses.com/activity/p/12263/ Wed, 15 May 2019 16:54:18 -0400 My capstone project was one that we were not sure if it would even go through FDA regulation. My capstone project is a mobile application that helps train users to discriminate auditory cue, such as discriminating pitch. We were also…   Read more»

]]> 6e486a04ff983a38e66c9bbe8c1c2c0b djr32 replied to the topic "Design Review Meeting" - https://medicaldevicecourses.com/activity/p/12153/ Wed, 15 May 2019 16:53:20 -0400 I took apart in a mock design review meeting for my senior capstone course. In my class, we were assigned roles of the scribe, moderator, reader, and authors. A couple of weeks before the design review, each of us had…   Read more»

]]> 2be3b439bd8def8b08e1d776275e2c97 djr32 replied to the topic "Underestimating Task Duration" - https://medicaldevicecourses.com/activity/p/12096/ Wed, 15 May 2019 16:52:45 -0400 Some methods that a project manager can develop in order to properly account for employees underestimating task duration are one holding weekly meetings towards the end of the week to check on the progress of the project. This ensures if…   Read more»

]]> a7c64cd87c59ab1c56179cadd1c0790d djr32 replied to the topic "PM: Quality Assurance Process" - https://medicaldevicecourses.com/activity/p/12091/ Wed, 15 May 2019 16:52:43 -0400 Some tasks that I would need to perform to obtain an accurate assessment of quality assurance of my project is to make sure thorough research has been done on the project. I would also have to make sure that work…   Read more»

]]> cde59dd27a3ba23dab678e4a0809cc8d djr32 replied to the topic "Benefits of this course" - https://medicaldevicecourses.com/activity/p/12005/ Wed, 15 May 2019 16:51:53 -0400 I would have to agree with you. I’m an undergraduate BME student and this is my first time taking the course with Dr. Simon. The only time learned about FDA regulation was in BME 304 Introduction to Biomaterial course with…   Read more»

]]> 4347558456e4fb860d056e7178eb2823 djr32 replied to the topic "Risk Management" - https://medicaldevicecourses.com/activity/p/11835/ Wed, 15 May 2019 16:50:13 -0400 A medical device is my capstone project, AudIQ, which is a mobile application that trains people with hearing aid’s auditory cues. One possibility of risk of the product is the application does not control the level of sound it outputs…   Read more»

]]> 204b52cfb438c25905d98255011ad678 djr32 replied to the topic "Discussion Topic: The critical path" - https://medicaldevicecourses.com/activity/p/11834/ Wed, 15 May 2019 16:50:12 -0400 A time when an extraneous task suddenly wound up on the critical path for the project is the discovery of Scotchgard stain repellent. Patsy Sherman, a researcher, who worked at 3M company as a chemist was assigned to work on…   Read more»

]]> 80f5a8b067c57520268296d3f0317aba djr32 replied to the topic "Discussion Topic: Design and Process Verification" - https://medicaldevicecourses.com/activity/p/11832/ Wed, 15 May 2019 16:50:11 -0400 Verification means to check if the inputs and outputs are equal to each other and to verify each output with a verification protocol. To an extent, it is a rigid rule that Verification takes place during the execution phase of…   Read more»

]]> 1034e090fb3f5e5a4d4a7a8832cb8350 djr32 replied to the topic "Combination Products" - https://medicaldevicecourses.com/activity/p/11552/ Wed, 15 May 2019 16:47:35 -0400 The necessary regulation to get FDA approval of a combination product is first the company has to request for designation (RFD), in which companies have to outline the rationale of the product. Then, the company has to submit the “pre”pre-investigational…   Read more»

]]> 18189c469fd1f5306fc0c975e559a750 djr32 replied to the topic "Discussion Topic: The 510k Process" - https://medicaldevicecourses.com/activity/p/11478/ Wed, 15 May 2019 16:45:17 -0400 One of the critiques the IOM said about the 510 (K) process was that it lacked the legal basis to be reliable of the safety and effectiveness of moderate -risk class II devices. The reason why the 510(K) lack safety…   Read more»

]]> f717e99489424a5495d52907867e0df7 djr32 replied to the topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/11475/ Wed, 15 May 2019 16:45:16 -0400 The kind of organization I feel that I would be most suited for is project-based one, which an organizational structure when a company’s department and personnel are organized around a particular project. One of the main reason is that I…   Read more»

]]> 0d0d9e54b195380cc7754ff8e4ea349b djr32 replied to the topic "Discussion Topic: Projects of all types" - https://medicaldevicecourses.com/activity/p/11473/ Wed, 15 May 2019 16:45:15 -0400 I think project management differs in different industries is in terms of regulations involved on a project. For instance, projects in the biomedical industries need to take into consideration the FDA regulations, such as 510(K) clearance. While construction site has…   Read more»

]]> 33d3988f889446d48357912cc19188d6 djr32 posted a new topic "Bartleby: The Scrivener" - https://medicaldevicecourses.com/activity/p/10526/ Wed, 15 May 2019 16:34:15 -0400 In my Hum102 class, I read the short story Bartleby: The Scrivener by Herman Melville. In the story, Bartleby was a new scrivener hired by a Manhattan lawyer. Bartleby produced the large volume of high-quality of work compared to the…   Read more»

]]> 7f02f7e57e22ad4232535a4fe665f884 djr32 posted a new topic "Clinical Trials Experience" - https://medicaldevicecourses.com/activity/p/10518/ Wed, 15 May 2019 16:34:12 -0400 This week lecture on clinical trial protocol, specifically the planning stage, reminds of the experiments I had to conduct for my sociology class. My professor had gotten IRB approval for the entire class to conduct field research. We were told…   Read more»

]]> fe683481d13d6d49a74af3685cdf6284 djr32 posted a new topic "What’s Your Motivator?" - https://medicaldevicecourses.com/activity/p/10517/ Wed, 15 May 2019 16:34:11 -0400 My biggest motivator is competition. I remember in Dr. Mantilla’s engineering physiology lab (BME 363) I got motivated by my colleagues answering Dr. Mantilla’s questions on physiology. Therefore, I would be read up on the physiology chapter every night before…   Read more»

]]> 0d2eceb23e6c9dab8ee942e2417a9fa1 djr32 posted a new topic "Let's Be Motivated!!!" - https://medicaldevicecourses.com/activity/p/10516/ Wed, 15 May 2019 16:34:11 -0400 Suppose you are a project manager in a medical industry. What are some ways you would motivate the team members you are managing? Does a project manager’s level of motivation affect the team’s productivity and motivation level? Explain.

]]> 142f8b68166ea77ed2cbec9cd49a0113 djr32 posted a new topic "Integration PM" - https://medicaldevicecourses.com/activity/p/10505/ Wed, 15 May 2019 16:34:04 -0400 For my capstone, we had one main project of developing a mobile application. However, within this one project, we had different mini projects which were put together at the end to become one mobile application. One project was developing the…   Read more»

]]> dfecb43c5a8f432eeb7a699001f2071c djr32 posted a new topic "Combination Product" - https://medicaldevicecourses.com/activity/p/10497/ Wed, 15 May 2019 16:34:00 -0400 A while ago we studied about combination device, which may include two or more separate products packaged together or includes products sold separately but intended for use with another type of product. Find a combination device and explain what it…   Read more»

]]> e17930d1c5b74dd62da2b46a6b279623 djr32 posted a new topic "FDA Recall...Now What?" - https://medicaldevicecourses.com/activity/p/10496/ Wed, 15 May 2019 16:34:00 -0400 On March 31 of this year, the FDA recalled Mylan’s EpiPen and EpiPen Jr Autoinjector products used for emergency treatment of severe allergic reactions. The product is recalled because of a defective part that could result in the device’s failure…   Read more»

]]> f6b20fd7078e27c4d5f4445f1ecfa2bf djr32 posted a new topic "Cost Analysis of Project" - https://medicaldevicecourses.com/activity/p/10487/ Wed, 15 May 2019 16:33:56 -0400 In this week’s lecture, we learned about planned value and actual cost. Planned value is the value of the work you are supposed to have on a certain date. While the actual cost is the cost of the project actually…   Read more»

]]> d4adc17146ded713fb2279bca4091f3f djr32 posted a new topic "Importance of Logging Work" - https://medicaldevicecourses.com/activity/p/10486/ Wed, 15 May 2019 16:33:55 -0400 According to the lecture for this week, logging work is important because it can be usefully when new employees come to work on the project or when starting a new project, logs can help as a guidance of not making…   Read more»

]]> 3e1f085bd91a4dac9b29de88f208d396 djr32 posted a new topic "Challenges PM face" - https://medicaldevicecourses.com/activity/p/10480/ Wed, 15 May 2019 16:33:53 -0400 What is one challenge project managers face when handling a project? How would the project manager handle those challenge?

]]> c63dbb47953eccb5cb6b447c6f19dbaf djr32 posted a new topic "Are Missed Milestones really Bad?" - https://medicaldevicecourses.com/activity/p/10470/ Wed, 15 May 2019 16:33:49 -0400 We all know missing a milestone in a project is the worst thing that can happen. Not only are we set back our project a couple of weeks, months or maybe years, but the company loses money. Missing a milestone…   Read more»

]]> c0abb075c91dfc30c3f0377efb4a15c4 djr32 posted a new topic "In the Shoes of a Project Manager" - https://medicaldevicecourses.com/activity/p/10469/ Wed, 15 May 2019 16:33:48 -0400 In last week’s lecture, we learned about the term Work Breakdown Structure (WBS), which a hierarchical breakdown of tasks performed for the project and we learned about the importance of a Gantt Chart. Suppose you are the project manager in…   Read more»

]]> 7fe9d42f349d420323b2e67bdf98884c djr32 posted a new topic "Revising a Gantt Chart" - https://medicaldevicecourses.com/activity/p/10461/ Wed, 15 May 2019 16:33:44 -0400 In 2015, the FDA approved the ReShape Integrated Dual Balloon System. This is a device that is a weight-loss system of a gastric balloon that occupies in the stomach. The system consists of two attached balloons that are filled and…   Read more»

]]> dde20869736e68abc2ed1f82ce1682e6 djr32 posted a new topic "Missing a Milestone Experience" - https://medicaldevicecourses.com/activity/p/10460/ Wed, 15 May 2019 16:33:44 -0400 This week we learned about the importance of a Gantt chart and how it allows project managers to highlight the critical path of a project. Think of a project that followed a specific Gantt chart. Share a time when you…   Read more»

]]> e05986c2a05eaa90998251e855772fbb djr32 posted a new topic "Experience Breaking Down A Project" - https://medicaldevicecourses.com/activity/p/10459/ Wed, 15 May 2019 16:33:44 -0400 In this week’s lecture, we learned about the term Work Breakdown Structure (WBS), which a hierarchical breakdown of tasks performed for the project. I have not yet had the opportunity to work in industry, but I did take part in…   Read more»

]]> 588205c236cc19c861f4dd92828bd293 djr32 posted a new topic "LifeVest Wearable Cardioverter Defibrillator" - https://medicaldevicecourses.com/activity/p/10450/ Wed, 15 May 2019 16:33:39 -0400 Zoll LifeVest is a wearable cardioverter defibrillator to monitor and treat dangerous abnormally fast heart rhythms. These abnormal rhythms can lead to a complete absence of heartbeat and death if not treated. Thus the LifeVest treats abnormal rhythms by applying…   Read more»

]]> e1b82e3c1a50ecc213653e1743b9e740 djr32 posted a new topic "General Wellness Product" - https://medicaldevicecourses.com/activity/p/10449/ Wed, 15 May 2019 16:33:39 -0400 According to the FDA, general wellness products are “(1) intended for maintaining or encouraging a general state of health or a healthy activity or (2) an intended use that related the role of a healthy lifestyle with helping to reduce…   Read more»

]]> fdce306a9990e8bf00750824824b2e67 djr32 posted a new topic "Fitbit: A Medical-Grade Device?" - https://medicaldevicecourses.com/activity/p/10448/ Wed, 15 May 2019 16:33:38 -0400 Fitbit is a consumer product that has the intention of tracking one’s daily fitness, heart rate, and blood pressure. However, there are people who filed a lawsuit against this company. The plaintiff David Urban bought a Fitbit PurePulse Tracker to…   Read more»

]]> 5656f6e196f62fe4cf9bd1c2b10199b9 djr32 posted a new topic "Toxic Medicine" - https://medicaldevicecourses.com/activity/p/10440/ Wed, 15 May 2019 16:33:35 -0400 In the article, FDA: Toxic Belladonna In Homeopathic Teething Product, the FDA found that Hyland’s homeopathic teething products had belladonna, which is a toxic chemical, a level far exceeding the amount claimed on the label and asked the Standard Homeopathic…   Read more»

]]> 0ee8c0259d843eb116e2afd9b7a11d2c djr32 posted a new topic "Experience with Design Control" - https://medicaldevicecourses.com/activity/p/10439/ Wed, 15 May 2019 16:33:34 -0400 From this week’s lecture, there are multiple steps in a project cycle. Describe a time when you took part in a project in industry or in school. What design controls did you take part in the project? Was your experience…   Read more»

]]> 293558d238a17a268c2e8a5e2eed2910 djr32 posted a new topic "Initiating a Project Idea" - https://medicaldevicecourses.com/activity/p/10438/ Wed, 15 May 2019 16:33:34 -0400 From the lecture, there are 9 parts to design controls. Why is initiating a project idea the hardest part of project development? How does business and market research play an important role when initiating a project idea? What are some…   Read more»

]]> aaacba5898c5067ced3de91fc14a0f42 djr32 posted a new topic "Meat without Murder" - https://medicaldevicecourses.com/activity/p/10428/ Wed, 15 May 2019 16:33:30 -0400 A Brooklyn startup company, Modern Meadows, has a technique to develop meat without killing any animals. The process they use to make this meat is by incorporating fetal bovine serum, which is the blood drawn from the fetus of a…   Read more»

]]> 4600a12c70e291f06653092a6677a265 djr32 posted a new topic "Mobile Medical Applications" - https://medicaldevicecourses.com/activity/p/10427/ Wed, 15 May 2019 16:33:29 -0400 When you open your Google play store or Apple Store, you can find an app for everything, even things related for medical purposes, such as an app that measures blood pressure. Moreover, the FDA has regulation for apps that are…   Read more»

]]> 1d02fa50bdc805e5d001db575382cd4a djr32 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2467/ Wed, 26 Apr 2017 16:58:28 -0400 I would personally like to have my end goal to be a manager, but I first would want to get a couple of years working as an engineer to understand how the industry actually works. This semester we learned many important concepts of FDA regulation and how the project management process works. This is important background basis for a project…[Read more]

]]> 0 8c459b6a17299b957fb06dfdac834ce1 djr32 started the topic Bartleby: The Scrivener in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2434/ Mon, 24 Apr 2017 20:14:31 -0400 In my Hum102 class, I read the short story Bartleby: The Scrivener by Herman Melville. In the story, Bartleby was a new scrivener hired by a Manhattan lawyer. Bartleby produced the large volume of high-quality of work compared to the other two scriveners. The lawyer was very impressed by his work because he was a reliable worker. However, one day,…[Read more]

]]> 0 a1eecedc47c5e02539ea4407c20c50d8 djr32 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2433/ Mon, 24 Apr 2017 19:30:57 -0400 No, I’m not so surprised by these results and kind of expected it. As Confucius put it, “Choose a job you love and you will never have to work a day in your life”. For someone to enjoy working for another person, the work should allow them to grow and challenge them. It is like watching a movie. People will go watch a movie that they like and w…[Read more]

]]> 0 184409ebc2b616a7d3e2f6321a25383f djr32 started the topic Clinical Trials Experience in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2329/ Wed, 19 Apr 2017 04:38:46 -0400 This week lecture on clinical trial protocol, specifically the planning stage, reminds of the experiments I had to conduct for my sociology class. My professor had gotten IRB approval for the entire class to conduct field research. We were told to come up with a sociological question and conducts interviews on campus and record our findings. The…[Read more]

]]> 0 208f672092daa66ba8b2a16a7c6ecd71 djr32 started the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2322/ Tue, 18 Apr 2017 03:39:40 -0400 My biggest motivator is competition. I remember in Dr. Mantilla’s engineering physiology lab (BME 363) I got motivated by my colleagues answering Dr. Mantilla’s questions on physiology. Therefore, I would be read up on the physiology chapter every night before his class, just so I would get participation points and keep up with my colleagues.

W…[Read more]

]]> 0 6ba83a2ad2acf5a469ea4f6da1eb3e52 djr32 started the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2321/ Tue, 18 Apr 2017 03:19:28 -0400 Suppose you are a project manager in a medical industry. What are some ways you would motivate the team members you are managing? Does a project manager’s level of motivation affect the team’s productivity and motivation level? Explain.

]]> 0 fb5d9f3ee470a7eedbf5d0c7e87afb2f djr32 started the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2320/ Tue, 18 Apr 2017 03:19:28 -0400 Suppose you are a project manager in a medical industry. What are some ways you would motivate the team members you are managing? Do you think a project manager’s level of motivation on a specific project plays a role of how much the team is motivated?

]]> 0 e71dac53224f368c612d62c70fa41e2e djr32 replied to the topic Discussion Topic: Costs and managing your investment in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2213/ Wed, 12 Apr 2017 02:13:16 -0400 The rate of return is specific to a company and it is related how the company gets its funding for projects [1]. Moreover, it is the rate of return that the investor expects or the cost of borrowing money [1]. Other words, to determine R one would need to consider how much debt a company has or how much it owes, and how much money it gets from…[Read more]

]]> 0 feeb04a69163ea96581b31a65a37ba56 djr32 replied to the topic Discussion Topic: Scope creep....when your project changes in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2205/ Mon, 10 Apr 2017 20:03:20 -0400 My capstone project AudIQ was about to suffer from a small scope creep, which is when the changes, continuous or uncontrolled growth in a project’s scope. Before the development of the mobile application, we had laid out our customer need for the project and then prioritize the customer need which is most important to accomplish. For instance, o…[Read more]

]]> 0 41d324d2d7246f822276d06a370d75d9 djr32 started the topic Integration PM in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2204/ Mon, 10 Apr 2017 19:57:30 -0400 For my capstone, we had one main project of developing a mobile application. However, within this one project, we had different mini projects which were put together at the end to become one mobile application. One project was developing the three training games on the user interface side. Another project was establishing a communication between…[Read more]

]]> 0 9d0fa339ea3a70c719cb091da2af3676 djr32 replied to the topic Device Class Confusion in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2092/ Mon, 03 Apr 2017 15:05:00 -0400 My capstone project was one that we were not sure if it would even go through FDA regulation. My capstone project is a mobile application that helps train users to discriminate auditory cue, such as discriminating pitch. We were also asked the question in my capstone class what class would our project fall under for the FDA. So, my team and I were…[Read more]

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