https://medicaldevicecourses.com/members/lurongyang/activity/ Activity feed for lurongyang. Sat, 25 Apr 2026 00:06:59 -0400 https://buddypress.org/?v= en-US 30 hourly 2 a7f0456bdbbef55ff5444d3b41499079 https://medicaldevicecourses.com/activity/p/17365/ Wed, 15 May 2019 21:38:52 -0400 Even though Non-Disclosure Agreement could have a perpetual time limit and should be theoretically protective to the commercial secrets between the two parties or within the company or institute. However, this is not powerful as a patent since it is…   Read more»

]]> 165062372426e4a0f74426478a96dd6c https://medicaldevicecourses.com/activity/p/17364/ Wed, 15 May 2019 21:38:52 -0400 I think most of these regulations mentioned regarding gift giving to physician are reasonable. The first topic I do feel a little bit rigid because it is not consistent with basic courtesy, which in normal situation, people would at least…   Read more»

]]> 0e7e2da3a5cd21fd27c91b5aee733c45 https://medicaldevicecourses.com/activity/p/17363/ Wed, 15 May 2019 21:38:51 -0400 I think there are some significant differences between Verbal Agreement & Oral Agreement. Let’s firstly suppose we take the form of verbal agreement, then we need to consider how the two parties should make the verbal statement on agreement in…   Read more»

]]> ebe891d0cb730013f7c04a3398accf4c https://medicaldevicecourses.com/activity/p/17240/ Wed, 15 May 2019 21:37:52 -0400 Even though I haven’t involved in any types of organizations mentioned in this week’s course, I have a preference to choose project-based organization as my ideal type of company to work for in the future. Here are my reasons. First…   Read more»

]]> 072fac02fabd9fa3900fedff21dff60a https://medicaldevicecourses.com/activity/p/17239/ Wed, 15 May 2019 21:37:52 -0400 In terms of forming a project team, I think it’s important to always find people who are qualified enough to participate their roles in the project, and meanwhile, have a good sense of collaboration and moderate subordination. It’s always all…   Read more»

]]> 7f0fa9f99691534f9c7294cd8ceb8253 https://medicaldevicecourses.com/activity/p/17238/ Wed, 15 May 2019 21:37:51 -0400 To start with the question: would it be more challenging to work as a project manager in either Matrix or Project-based organization? I think it will be so, based on more documents needed to practice the project management. For example,…   Read more»

]]> d48ae6c55814cf015ead736e59b54dfb https://medicaldevicecourses.com/activity/p/17134/ Wed, 15 May 2019 21:36:56 -0400 To identify and prioritize the risks for a project, you need to start with looking up in the design history files for other similar projects for reference. This will cost less time when you hold meetings to have every member…   Read more»

]]> 9c6a29453306e90706712dee34290e56 https://medicaldevicecourses.com/activity/p/17132/ Wed, 15 May 2019 21:36:55 -0400 These are very common causes for risk management mistakes. But in essence, these mistakes are due to lack of comprehensive knowledge of risk management. Here I wanna add one more mistake that could occur in risk management, which is the…   Read more»

]]> 703900667b59cae7b63759829ef52230 https://medicaldevicecourses.com/activity/p/17130/ Wed, 15 May 2019 21:36:54 -0400 To run a risk management meeting, always follow the cycle of assess-evaluate-manage-measure. First thing you should do is to have quality member gather all members in the project team, because it is important to make everyone get the information of…   Read more»

]]> 9d3e552559f37564b5bc8b143e69b8f8 https://medicaldevicecourses.com/activity/p/17097/ Wed, 15 May 2019 21:36:37 -0400 Design review meetings are very necessary for ensuring that the present design meets the project objectives, because without doing so, nobody would attentively look for a possible deviations that could have occurred within the design part. Besides, these meetings are…   Read more»

]]> c85e3327443013f08707416d45ece71f https://medicaldevicecourses.com/activity/p/17095/ Wed, 15 May 2019 21:36:36 -0400 If the deviation happens, firstly we need to locate which one or multiple parts could possibly contribute to the failure of verification. This is very important and may be highly related to small decisions such as design dimensions, wrong analytical…   Read more»

]]> feb3387c82d1efbc3fcb37bb8844b51b https://medicaldevicecourses.com/activity/p/17092/ Wed, 15 May 2019 21:36:34 -0400 For Design Development Plan (DDP), I think the two most important parts are quality management plan and scope management plan. Because the quality management plan will tell you how to evaluate the difference between the actual outcome and the desired…   Read more»

]]> b01e1935361e09bcd6b51b7330a813c8 https://medicaldevicecourses.com/activity/p/16945/ Wed, 15 May 2019 21:35:20 -0400 Verification is one of the most important steps in the design control, that it not only can address the questions of whether this is effective enough to do what potential customers want it to be, but also confirms that to…   Read more»

]]> 725e0e739eb599a920511e818dc705a2 https://medicaldevicecourses.com/activity/p/16944/ Wed, 15 May 2019 21:35:19 -0400 The minutes in the meetings are very important because of they often specify how the team members are assigned their works and the deadlines, so that the responsibilities will be clear for the members to bear in mind. For instance,…   Read more»

]]> a7d3d5977e298567ee926187081a46ba https://medicaldevicecourses.com/activity/p/16943/ Wed, 15 May 2019 21:35:19 -0400 Design Control is a broad definition of illustrating how you monitor the design process before it goes to the FDA for auditing. There are overall 9 files that should be accomplished: Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes,…   Read more»

]]> 1e80cbfd42d660efc4a663a8787f0dea https://medicaldevicecourses.com/activity/p/16854/ Wed, 15 May 2019 21:34:33 -0400 I think placebo group is the only scientific way to prove a drug is actually working on the human body. Since it is no longer a mystery that a psychological effect called “placebo effect” is proved to be statistically effective…   Read more»

]]> 08bf997485c5c8191653056ade550683 https://medicaldevicecourses.com/activity/p/16853/ Wed, 15 May 2019 21:34:33 -0400 It is very important to make sure that every pharmaceutical drugs should go through the clinical trials multiple multiple times with sampling subjects more and more extensively before they are put into the market. This is because every drugs has…   Read more»

]]> 690041fe267211eacbdf8e6981c6a98d https://medicaldevicecourses.com/activity/p/16852/ Wed, 15 May 2019 21:34:32 -0400 It’s not that confusing actually, it will be easier to understand this rule when you think of this as a clinical researcher. One of the most important reasons is that there is always an overall objective you wish to confirm…   Read more»

]]> 593a91fe11756f553120380f54f122e6 https://medicaldevicecourses.com/activity/p/16743/ Wed, 15 May 2019 19:42:10 -0400 When designing the brand for a food company or a franchise, the color red is most commonly used because according to some researches, the color red does interact with customer’s decision by evoking more impulsive emotions and demands. Of course,…   Read more»

]]> 9e87ceac4b05c8842d28c65ea6184699 https://medicaldevicecourses.com/activity/p/16741/ Wed, 15 May 2019 19:42:09 -0400 With respect to clever uses of participation that used as a marketing strategy by some companies, I did witnessed some successful tricks that actually works for finding potential customers, and even driving them to ask for the product actively. For…   Read more»

]]> 86a9604d73e60d497304627ebf301799 https://medicaldevicecourses.com/activity/p/16739/ Wed, 15 May 2019 19:42:08 -0400 I think one of the most important reasons why these companies never put ads on television is that they occupy the most of the market share in that area, almost monopolized in its most cutting-edge technology development that not many…   Read more»

]]> 177d77e21daa4a9f40bf3d5d56cf876b https://medicaldevicecourses.com/activity/p/16636/ Wed, 15 May 2019 19:41:08 -0400 Sole proprietorship cannot shift its owner according to the law, the business will die with the owner. One way to do this is change the category to a Limited Liability Partnership which allows limited members to hold the company’s share….   Read more»

]]> 6dec9dddb39769516f2e511c091029c8 https://medicaldevicecourses.com/activity/p/16635/ Wed, 15 May 2019 19:41:07 -0400 In this course, companies including Limited Liability Company vs Corporation vs Sole Proprietorship vs partnership are classified based on the way of operating business, how many people own the business, and how the company relates to the owners. It’s all…   Read more»

]]> 077083d2777b0b11b3c36f1d56c97d07 https://medicaldevicecourses.com/activity/p/16634/ Wed, 15 May 2019 19:41:07 -0400 S-corps, in my opinion, are those companies who only allows a few members to have a say in running business, the corporate cannot be publicly traded and have thousands of stakeholders like C-corps, but could only be taxed once, which…   Read more»

]]> 7c9e35eee65b0d52e5373ab78ce74d20 https://medicaldevicecourses.com/activity/p/16513/ Wed, 15 May 2019 19:39:55 -0400 I think there should be a intermediator who can talk between and has fair amount of the knowledge on both side to help them agree to a somehow acceptable level. That being said, everyone needs to compromise for whatever the…   Read more»

]]> e5b2fe09f4d96efb7c3de2c4d773b4ec https://medicaldevicecourses.com/activity/p/16511/ Wed, 15 May 2019 19:39:54 -0400 Quality control is not only a matter of saving money, actually. I think it will bring much more profitable good to the company if they did great job on quality control. First, quality control is defined with the acceptance criteria…   Read more»

]]> 1648568f752ee67c16a04b9d6440cda0 https://medicaldevicecourses.com/activity/p/16510/ Wed, 15 May 2019 19:39:54 -0400 As mentioned in the lecture, the ways we can do for effectively monitoring product quality and collaboration between different departments is to simply make strict principles and rules to comply with. In a big company, there are a lot of…   Read more»

]]> 7617a8454f354b14f9e8e3737ea53d5a https://medicaldevicecourses.com/activity/p/16334/ Wed, 15 May 2019 19:38:15 -0400 I think this is the exact pitfall where a project manager cannot control the schedule, performance and a lot of details about the animal study. Most important one of them is the requirement of the animal that is appropriate for…   Read more»

]]> 684583b2606b2fc57af538799f089cbd https://medicaldevicecourses.com/activity/p/16329/ Wed, 15 May 2019 19:38:12 -0400 In my opinion, it is not humanitarian at all to take any animal experiment. Since their lives will get hurt and killed anyway when it comes to the pre-clinical research and people just wanna get rid of the germs,toxins or…   Read more»

]]> a646549dbe5cb6a9e00068cd84bf62a4 https://medicaldevicecourses.com/activity/p/16325/ Wed, 15 May 2019 19:38:09 -0400 I always think research for the future in academia is more important since the outcome would be openly seen by the public and it’s always good for the further development of the technology, not always about the money. Sometimes money…   Read more»

]]> d9bef72fa807c8af21841efcf2b42a13 https://medicaldevicecourses.com/activity/p/16105/ Wed, 15 May 2019 19:17:07 -0400 Diverse major like BME is less known and demanded than computer science and mechanical engineering for sure. But that doesn’t mean we should only focus on the downside of its diverse nature. Instead, I think BME is significantly useful in…   Read more»

]]> 5b42b3fae0f243d2238e546fc0b8c6b6 https://medicaldevicecourses.com/activity/p/16104/ Wed, 15 May 2019 19:17:06 -0400 For my experience, I will start with that in academia because that defines basically all of my past work experience. As you may get to know me in the post of my self-introduction. I used to work as an intern…   Read more»

]]> c8dfc33e87dd71e66878c6fbb613b33f https://medicaldevicecourses.com/activity/p/16103/ Wed, 15 May 2019 19:17:06 -0400 I think in reality they are both important. 70:30 seems a fair proportion for me in terms of studying both academic skills enough for basically knowing where I am in the overall knowledge network of the BME-related subjects and practical…   Read more»

]]> c87cad457dcdefe98a636caa3a4c8b60 https://medicaldevicecourses.com/activity/p/9201/ Sun, 02 Dec 2018 06:21:10 -0500 Even though Non-Disclosure Agreement could have a perpetual time limit and should be theoretically protective to the commercial secrets between the two parties or within the company or institute. However, this is not powerful as a patent since it is not protected by the official government and thus, cannot protect your secret, for example, a…[Read more]

]]> 0 a8e45c32783e3afdcbc875e00e08a7f1 https://medicaldevicecourses.com/activity/p/9200/ Sun, 02 Dec 2018 06:04:48 -0500 I think most of these regulations mentioned regarding gift giving to physician are reasonable. The first topic I do feel a little bit rigid because it is not consistent with basic courtesy, which in normal situation, people would at least buy their friend a meal along with his/her family. However, this meal is also purposeful because it’s interest…[Read more]

]]> 0 2d1d50127925bbb24be1c6a1131f937a https://medicaldevicecourses.com/activity/p/9199/ Sun, 02 Dec 2018 05:45:59 -0500 I think there are some significant differences between Verbal Agreement & Oral Agreement. Let’s firstly suppose we take the form of verbal agreement, then we need to consider how the two parties should make the verbal statement on agreement in an official way. This is not easy since many issues including whether the recordings are allowed by the…[Read more]

]]> 0 ef3c19f37981e36f83e7f085ae1807af https://medicaldevicecourses.com/activity/p/9063/ Thu, 22 Nov 2018 02:51:09 -0500 Even though I haven’t involved in any types of organizations mentioned in this week’s course, I have a preference to choose project-based organization as my ideal type of company to work for in the future. Here are my reasons. First of all, the work environment would be more agreeable since everyone don’t have to put more energy on the possible…[Read more]

]]> 0 a51a0842f6a7260436bc492bb4b9c523 https://medicaldevicecourses.com/activity/p/9062/ Thu, 22 Nov 2018 02:36:00 -0500 In terms of forming a project team, I think it’s important to always find people who are qualified enough to participate their roles in the project, and meanwhile, have a good sense of collaboration and moderate subordination. It’s always all about finding the balance over these two qualities from a competent before recruiting one in the team.…[Read more]

]]> 0 0061fe8f9648d2021d0a5369402fa70a https://medicaldevicecourses.com/activity/p/9061/ Thu, 22 Nov 2018 02:22:28 -0500 To start with the question: would it be more challenging to work as a project manager in either Matrix or Project-based organization? I think it will be so, based on more documents needed to practice the project management. For example, aside from Project Management Plan; Risk Management Plan, there are also Preliminary Gantt Chart, WBS, Network…[Read more]

]]> 0 7474974fb27d0981b32eb3b025ed5590 https://medicaldevicecourses.com/activity/p/8953/ Fri, 16 Nov 2018 19:55:24 -0500 To identify and prioritize the risks for a project, you need to start with looking up in the design history files for other similar projects for reference. This will cost less time when you hold meetings to have every member brainstorm the risks within their job duties. However, more effort still needs to be put on the risks related to highly…[Read more]

]]> 0 9e50d539822daf94153b33b44f21ad12 https://medicaldevicecourses.com/activity/p/8951/ Fri, 16 Nov 2018 19:44:39 -0500 These are very common causes for risk management mistakes. But in essence, these mistakes are due to lack of comprehensive knowledge of risk management. Here I wanna add one more mistake that could occur in risk management, which is the overestimation or underestimation of a potential risk by misunderstanding its occurrence mechanism, possibility,…[Read more]

]]> 0 a64b53a591c2edbff54b8ac056928cd4 https://medicaldevicecourses.com/activity/p/8949/ Fri, 16 Nov 2018 19:15:23 -0500 To run a risk management meeting, always follow the cycle of assess-evaluate-manage-measure. First thing you should do is to have quality member gather all members in the project team, because it is important to make everyone get the information of potential risks. Second thing is brainstorming the risks that could happen in the product, product…[Read more]

]]> 0 54cc73bac9035302f9bcbb85b34f51ab https://medicaldevicecourses.com/activity/p/8910/ Mon, 12 Nov 2018 02:31:10 -0500 Design review meetings are very necessary for ensuring that the present design meets the project objectives, because without doing so, nobody would attentively look for a possible deviations that could have occurred within the design part. Besides, these meetings are helpful for facilitating the process of the design corrections if anything wrong…[Read more]

]]> 0 11c7aecf5d4a391de809ec4bdcd65e3f https://medicaldevicecourses.com/activity/p/8908/ Mon, 12 Nov 2018 02:09:42 -0500 If the deviation happens, firstly we need to locate which one or multiple parts could possibly contribute to the failure of verification. This is very important and may be highly related to small decisions such as design dimensions, wrong analytical method, data collection mistake, and etc. In general, different corrections apply to different…[Read more]

]]> 0 db5e7b2f759a7fd8b677717112dfc7bb https://medicaldevicecourses.com/activity/p/8905/ Mon, 12 Nov 2018 01:54:17 -0500 For Design Development Plan (DDP), I think the two most important parts are quality management plan and scope management plan. Because the quality management plan will tell you how to evaluate the difference between the actual outcome and the desired outcome, so as to provide the right direction to apply changes and make the project back on track.…[Read more]

]]> 0 ab4aa21cd512ea7f9f5f070dfa2857b8 https://medicaldevicecourses.com/activity/p/8753/ Fri, 02 Nov 2018 19:26:37 -0400 Verification is one of the most important steps in the design control, that it not only can address the questions of whether this is effective enough to do what potential customers want it to be, but also confirms that to what extent of adverse environment can this medical device functionally work, and will it have safety check to avoid injury to…[Read more]

]]> 0 bfcb969fa9962e0e98aeb536561efe75 https://medicaldevicecourses.com/activity/p/8752/ Fri, 02 Nov 2018 19:11:27 -0400 The minutes in the meetings are very important because of they often specify how the team members are assigned their works and the deadlines, so that the responsibilities will be clear for the members to bear in mind. For instance, if you are gonna write about how you will make a bone implant design works, many small details should be taken…[Read more]

]]> 0 4b825541524d322515b0eb9a389d302b https://medicaldevicecourses.com/activity/p/8751/ Fri, 02 Nov 2018 18:59:20 -0400 Design Control is a broad definition of illustrating how you monitor the design process before it goes to the FDA for auditing. There are overall 9 files that should be accomplished: Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes, and Design History File.
From the perspective of a company, this is a very…[Read more]

]]> 0 4232c91571ca584c1eab94cdd414b91f https://medicaldevicecourses.com/activity/p/8657/ Sat, 27 Oct 2018 06:03:04 -0400 I think placebo group is the only scientific way to prove a drug is actually working on the human body. Since it is no longer a mystery that a psychological effect called “placebo effect” is proved to be statistically effective for relieving symptoms of a disease, we will never know this drug is effective because of this effect or it actually does…[Read more]

]]> 0 c1bcd5de82e0f7ecdcb033fab53bcb1a https://medicaldevicecourses.com/activity/p/8656/ Sat, 27 Oct 2018 05:46:18 -0400 It is very important to make sure that every pharmaceutical drugs should go through the clinical trials multiple multiple times with sampling subjects more and more extensively before they are put into the market. This is because every drugs has its specific effectiveness and toxicity functions to its dose. If we don’t do clinical test, we will…[Read more]

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