https://medicaldevicecourses.com/members/justinjts/activity/ Activity feed for Justinjett. Sat, 25 Apr 2026 01:02:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 a1d094cb67cf62e762ae92513cb13e6a https://medicaldevicecourses.com/activity/p/23751/ Sat, 16 Oct 2021 23:48:42 -0400 Posted by: @savery115 A small part of the lecture reviewed Upper Management vs Middle Management. Upper Management people are strategic and tend to set the groundwork and vision for what the company could be. Middle Management people are tactical and…   Read more»

]]> a00988178a4a31102e00a0fadd33d00f https://medicaldevicecourses.com/activity/p/23750/ Sat, 16 Oct 2021 23:41:23 -0400 Posted by: @amd29 Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird.Personally, after experiencing with the Functional Organizational type in…   Read more»

]]> 8f7540cbeb3e9ddf7b6a2488262ada7d https://medicaldevicecourses.com/activity/p/23716/ Thu, 14 Oct 2021 04:20:44 -0400 Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project according to their expertise/role. How would…   Read more»

]]> 4e86a2348823e23edb10b6c3d78a17b5 https://medicaldevicecourses.com/activity/p/23653/ Sat, 09 Oct 2021 22:27:06 -0400 Posted by: @tulikadasp To make sure medical devices remain safe and effective once it’s on the market – medical post-market surveillance (PMS) is done. It a system that provides continuous feedback about a device on the market in order to…   Read more»

]]> 369ea34982dda0c0d6a30c2cd5143c31 https://medicaldevicecourses.com/activity/p/23652/ Sat, 09 Oct 2021 22:14:40 -0400 Posted by: @traceymraw Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the past? Which do you find the most beneficial or…   Read more»

]]> f64f1aaee3b9bf72f2993042722dc72a https://medicaldevicecourses.com/activity/p/23629/ Thu, 07 Oct 2021 03:20:03 -0400 Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?  In the medical field from the developer side an instance when accepting the risk…   Read more»

]]> 23d981e696564927d24591c9461203d0 https://medicaldevicecourses.com/activity/p/23562/ Sun, 03 Oct 2021 00:06:01 -0400 Posted by: @la82 As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the process and if it is…   Read more»

]]> 95dd0b941e9bea8d9c53a6bf61251da4 https://medicaldevicecourses.com/activity/p/23559/ Sat, 02 Oct 2021 22:17:16 -0400 ac0d40be26bc3ab574192ae6d2a22eaf https://medicaldevicecourses.com/activity/p/23558/ Sat, 02 Oct 2021 22:11:29 -0400 Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Before this, when I was…   Read more»

]]> 77136c6177cfba4541d418782e4b8045 https://medicaldevicecourses.com/activity/p/23523/ Thu, 30 Sep 2021 03:07:47 -0400 Posted by: @smk45 While watching this week’s lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs align with the design inputs….   Read more»

]]> 3d97ef2adc1cf86c0b86424f8e9e6b79 https://medicaldevicecourses.com/activity/p/23481/ Sun, 26 Sep 2021 02:53:36 -0400 Posted by: @jr377 This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a current “compassionate use” framework, but…   Read more»

]]> 6af4cea80e68f6d0aa96d9c2a526f171 https://medicaldevicecourses.com/activity/p/23480/ Sun, 26 Sep 2021 02:50:40 -0400 Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

]]> aa546d193eb94cbe2bee5533496ea532 https://medicaldevicecourses.com/activity/p/23427/ Thu, 23 Sep 2021 03:15:52 -0400 Posted by: @alexandrabuga Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research.  Lacks was the unknowing…   Read more»

]]> 65497eaa6babbfb46229bf94b87fbca0 https://medicaldevicecourses.com/activity/p/23372/ Sat, 18 Sep 2021 21:09:21 -0400 Posted by: @llefevre It is estimated that globally, the market for Clinical Trials is in upwards of $44 Billion as of 2020 and is expected to grow by approx 6% over the next 7 years, mostly fueled by the need…   Read more»

]]> 0ce3e6a5a5ecd9a523e407f239bd70df https://medicaldevicecourses.com/activity/p/23371/ Sat, 18 Sep 2021 20:44:31 -0400 Posted by: @manolo Dr. Simon touched upon Branding when going over the Facets of Marketing. The coloring is an important component to think about when branding a product/company. What kind of coloring do you notice companies are using and why…   Read more»

]]> 6067ba9392fa289b8664477bbdf5a0cc https://medicaldevicecourses.com/activity/p/23370/ Sat, 18 Sep 2021 20:39:28 -0400 Posted by: @amd29 Prof. Simon has made it simple; he seems to definei) Marketing: — as being able to have the customer believe that what you – the marketing agent – areoffering is what they truly need ii) Sales: —-…   Read more»

]]> c20b8c991b92620846551a84d59cc96c https://medicaldevicecourses.com/activity/p/23309/ Mon, 13 Sep 2021 01:08:47 -0400 Posted by: @sahitya-sadineni Part of FDA’s mission statement is providing safety and protecting the public health in the use of drugs, medical devices, and etc.. The second part of the mission statement states that they are “advancing the public health…   Read more»

]]> cd77910dd9878df4b635382157a36e53 https://medicaldevicecourses.com/activity/p/23308/ Mon, 13 Sep 2021 01:08:46 -0400 Posted by: @hzy2 Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. Following implantation, these women started to…   Read more»

]]> 7e5513d5f11899f630df886448845795 https://medicaldevicecourses.com/activity/p/23216/ Wed, 08 Sep 2021 12:06:57 -0400 Posted by: @karen-immanuel Hello all, I was just curious as to what level of education is best before getting into industry. My thoughts are that BS is good enough to employ you with basic skills and knowledge. Later, you can…   Read more»

]]> 976a29e724647ac22666bb8a4b164247 https://medicaldevicecourses.com/activity/p/23215/ Wed, 08 Sep 2021 12:06:56 -0400 Posted by: @sseal98 With the increasing integration of computers to our daily lives as well as into the medical device and biomedical engineering discipline, should it be required from students in BME to take advanced coding techniques in different languages…   Read more»

]]> 064e4bda5cf6cca54ae56ca7bb1821b9 https://medicaldevicecourses.com/activity/p/23214/ Wed, 08 Sep 2021 12:06:56 -0400 Posted by: @hjp39 With the way everything is headed now, several departments have gone full time remote such as complaint handling, some regulatory positions, and even few Quality Engineer positions in my company. I am aware that this question may…   Read more»

]]> fa79bd71ac0225cc2099c8476c35f6ea https://medicaldevicecourses.com/activity/p/23213/ Wed, 08 Sep 2021 12:06:54 -0400 Posted by: @hruship101 Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the…   Read more»

]]> 9a7f902eafb8a314d11b3ff5df1077c2 https://medicaldevicecourses.com/activity/p/23189/ Tue, 07 Sep 2021 01:06:13 -0400 The areas that are important to me would be; The budget amount they are requesting. The budget break down. The price research and comparisons and the purpose for each expense that they are requesting funds for. Also find it interesting…   Read more»

]]> 462bea0a5d8fb5ec4ca9f4c0b2f262aa https://medicaldevicecourses.com/activity/p/23188/ Tue, 07 Sep 2021 01:06:12 -0400 The animal variety can influence the reproducibility of a pre-clinical research because the models are different. How a medication works in on animal may not work the same way in another animal. This is one the major challenges that pharmaceutical…   Read more»

]]> e4428a7bfe8866f51c4c16af5d7af29f https://medicaldevicecourses.com/activity/p/23187/ Tue, 07 Sep 2021 01:06:12 -0400 Another great way to help is to put more funding into the development of alterative testing models. A great example would be organ on chips. This is a type of biotechnology they is able to replication human organ responses to…   Read more»

]]> 3a333c7c26f49c65e199755177b0d8ba https://medicaldevicecourses.com/activity/p/23071/ Tue, 24 Aug 2021 17:30:25 -0400 When considering the three types of organizations in project management I would prefer matrix organization. I choose this being in the form of organization because it is more hands on for those involved. You get a chance to see how…   Read more»

]]> 61f1aa450f0483cc9db2f9519c29f530 https://medicaldevicecourses.com/activity/p/23065/ Tue, 24 Aug 2021 17:30:21 -0400 @tlstrickland Hey Tia, I really enjoyed your explanation on why matrix organization would be your preferred organization you would work under. What really stood out about what you said in your post that that when you have multiple bosses you…   Read more»

]]> fef00b1c9cb42a44a3ffd47f93afed48 https://medicaldevicecourses.com/activity/p/23054/ Tue, 24 Aug 2021 17:29:34 -0400 In case of an emergency certain medication and medical device for very rare disease can be used if they have not yet been approve but the patient must have exhausted all other forms of treatments. A physician and not used…   Read more»

]]> a6e1a6d3785efb55f01b1e9c3e148a19 https://medicaldevicecourses.com/activity/p/23049/ Tue, 24 Aug 2021 17:29:31 -0400 @sfrancis  Hey Francis, Great post! Your choice of the three core competencies are really good picks. However, to effective use those skills do you think that a fourth skills might be necessary, such as communication skills. I state this one…   Read more»

]]> 13c7ae3eb20af36fc42ba6308041242c https://medicaldevicecourses.com/activity/p/23048/ Tue, 24 Aug 2021 17:29:30 -0400 @arianaburch  Hey Ariana, I really enjoyed reading your post and getting to see your view point on what skills you think a manager should possess. However, I want to challenge you to define more about what extacly communication skills are….   Read more»

]]> 47dbfd6b064c6991f59ca8e9569a00ea https://medicaldevicecourses.com/activity/p/23044/ Tue, 24 Aug 2021 17:29:16 -0400 If a device has been processed under a 510K then yes it would be considered a medical device. There are different classes of medical devices some be a simply as a medical band aid or medical tape are as advance…   Read more»

]]> bbb6caf176a9e785fbf137efd90a38e7 https://medicaldevicecourses.com/activity/p/23037/ Tue, 24 Aug 2021 17:29:12 -0400 I work in a diagnostic lab testing mostly covid samples it is very impart we record different part of the process. A time that this was important was when a plate of samples was mislabeled on a PCR machine and…   Read more»

]]> d636e420156f35013f86bd657278d2a7 https://medicaldevicecourses.com/activity/p/23034/ Tue, 24 Aug 2021 17:28:08 -0400 Posted by: @devarshi-joshi According to me the most important 5 success factors are:1)Agreeing on the project goals2)Effective Communication3)Develop clearly defined plans with assigned responsibilities.4)Managing project scope effectively.5)Making sure of management support. So how are these factors individually important for a…   Read more»

]]> 4a56ead48acf4c1eea46994080f706e0 https://medicaldevicecourses.com/activity/p/23033/ Tue, 24 Aug 2021 17:28:08 -0400 Posted by: @devarshi-joshi After the development of team how do the execution process works or what does it do during the absence or vacation of an employee or with an personal problem? After the development of the team if a…   Read more»

]]> 1f259af12d01803b58f8b36fa47e7045 https://medicaldevicecourses.com/activity/p/23029/ Tue, 24 Aug 2021 17:28:03 -0400 Posted by: @mejefferson During the planning phase of project management, both time and money are crucial. Timewise, the longer your product takes to develop, the more money you will have to seek from investors yet your product will have a…   Read more»

]]> 5d3a52cd25bf44cae684588c79f8d958 https://medicaldevicecourses.com/activity/p/23022/ Tue, 24 Aug 2021 17:26:57 -0400 Posted by: @ap962 The end of the Monitoring and Controlling Phase is marked by the Closing Phase. What are steps that need to be followed to ensure that phase is carried out effectively? Doing the closing phase it is important…   Read more»

]]> 530dc5b4a0fa51be12621e79533026ea https://medicaldevicecourses.com/activity/p/23015/ Tue, 24 Aug 2021 17:26:19 -0400 Well if I was the project manager in this case I would have planned for 2 to 3 employees leaving during the course of this project. So, them taking a vacation should not effect the over all progression of the…   Read more»

]]> bcd9fe6930047df46c36014c3a1ea0bd https://medicaldevicecourses.com/activity/p/23014/ Tue, 24 Aug 2021 17:26:18 -0400 @sfrancis  Francis, Great reply to the post. It is really amazing to see that you actual have real world experience with this. Because it is easy to give a test book answer to this problem to to actually have to…   Read more»

]]> 989a7b9416ad54a2a938bfc17b9afe7c https://medicaldevicecourses.com/activity/p/23004/ Tue, 24 Aug 2021 17:25:31 -0400 Quality assurance is the combination of administrative and procedural activities implemented in a quality system that are meant to ensure that a goal is completed are a project is fulfilled. While quality control is more so meant to serve as a…   Read more»

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