https://medicaldevicecourses.com/members/ps689/activity/ Activity feed for ps689. Fri, 24 Apr 2026 18:41:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 f51ac3d3bcfb8b57e8a9c5ca799681de https://medicaldevicecourses.com/activity/p/23946/ Sun, 07 Nov 2021 13:03:54 -0500 All device changes, no matter how minor or major, should be documented and controlled. If you were to do device modifications or improvements, it is a good way to keep track of design changes that did not work. Furthermore, a…   Read more»

]]> f746c39f281300e245729a86793599d5 https://medicaldevicecourses.com/activity/p/23945/ Sun, 07 Nov 2021 13:03:01 -0500 As many have mentioned before me, it might be the most helpful to work backwards from the project’s estimated completion date. This ensures that all tasks and deadlines are done before the project is expected to be concluded and gives…   Read more»

]]> 881f5a6dcc5002d8cec2d7f775760148 https://medicaldevicecourses.com/activity/p/23902/ Mon, 01 Nov 2021 01:44:39 -0400 I definitely agree on the importance of taking minutes in a meeting. It proves beneficial when your team or department has several ongoing projects or multiple deadlines coming up and meetings have to cover all these tasks and responsibilities. You…   Read more»

]]> eb141c23ea6262d5899a713695d3c798 https://medicaldevicecourses.com/activity/p/23901/ Mon, 01 Nov 2021 01:44:01 -0400 I agree that although there isn’t a document that explicitly states a design output, it doesn’t mean that the design doesn’t have an output. The design input provides a general overview of what your product will look like and how…   Read more»

]]> 77ea519a899c290b512ee9845fb2057c https://medicaldevicecourses.com/activity/p/23900/ Mon, 01 Nov 2021 01:43:23 -0400 A validation process we are currently executing is to determine if a new testing equipment will provide the same result as the previous equipment. The equipment is used to test our raw material and final product. Essentially, the process requires…   Read more»

]]> 4b11be300c79bb76525c2d6be32f95a3 https://medicaldevicecourses.com/activity/p/23819/ Sun, 24 Oct 2021 13:06:08 -0400 Drugs do not have to claim to cure a disease or illness but drugs have been created to help alleviate symptoms of an illness or prevent flare-ups of a disease.  Regardless of the drug’s indication, clinical trials are there to…   Read more»

]]> 0a7d90d6afafa1a9931c0d93b1338cf0 https://medicaldevicecourses.com/activity/p/23818/ Sun, 24 Oct 2021 12:53:01 -0400 Although I have not had the experience in working in either a small CRO or big pharma, as someone who is new to the industry, I think I would opt for working in a small CRO. I work for a…   Read more»

]]> 4243dc4a66d3cb0aa609feeb411294d1 https://medicaldevicecourses.com/activity/p/23817/ Sun, 24 Oct 2021 12:47:19 -0400 While there are risks to participating in a clinical study for new drugs, treatments, or medical devices, they are necessary to ensure that products being released to market are safe and effective for human use. It is important to note…   Read more»

]]> 112662685f829cbb4435ca009ef30fba https://medicaldevicecourses.com/activity/p/23740/ Sat, 16 Oct 2021 13:19:33 -0400 The internet has definitely had an impact in the way companies can advertise and sell their products. With the growth of social media and online platforms and an increasing number of people with a digital presence, it is easier for…   Read more»

]]> c79d1b0066f45a8eb1caf16f9dcec387 https://medicaldevicecourses.com/activity/p/23739/ Sat, 16 Oct 2021 13:07:58 -0400 I can understand why someone from engineering might decide to go into marketing or sales. After spending time developing a product, an engineer might find the idea of promoting the product they helped develop to the people who would actually…   Read more»

]]> bebe0ccd8181defc20878169cb9adf6d https://medicaldevicecourses.com/activity/p/23738/ Sat, 16 Oct 2021 13:01:38 -0400 As many have mentioned before me, the best way companies can market their products nowadays is through social media. With more and more social media platforms being created and gaining popularity, establishing a social media presence is a great way…   Read more»

]]> 697542a07153d25280fc0cd6db491141 https://medicaldevicecourses.com/activity/p/23676/ Sun, 10 Oct 2021 23:07:42 -0400 As the posts before me have stated, I don’t think that engineers have to actively worry about the shareholder’s opinions. From personal experience, that is definitely not something I have really concerned myself with in my projects. By the time…   Read more»

]]> 4ab13a75b5cd1bad9ba6ae54ab9bbc35 https://medicaldevicecourses.com/activity/p/23673/ Sun, 10 Oct 2021 22:48:24 -0400 Since graduating undergrad, I have only worked for a small start-up biotech company so I cannot speak on what it is like to work for a big, established company. From personal experience however, a start up certainly allows me to…   Read more»

]]> e1b8b2136a3867c1abab43da98f54029 https://medicaldevicecourses.com/activity/p/23577/ Sun, 03 Oct 2021 11:27:57 -0400 I currently work in R&D and have not worked in QA or QC role. In R&D, because we are focused on improving or creating new formulations and not making the product that gets released, we do not always have to…   Read more»

]]> eb9febf3091ad368d8e2a39f20d8358d https://medicaldevicecourses.com/activity/p/23576/ Sun, 03 Oct 2021 11:21:19 -0400 I have not worked in a quality role; however, I agree that organizational skills and communication are very important to the job. QC is part of every step of getting the product to market, from raw materials to release testing,…   Read more»

]]> 6f5829f1d640aaa1819a485dc31640bf https://medicaldevicecourses.com/activity/p/23575/ Sun, 03 Oct 2021 10:55:27 -0400 The roles in the quality team vary between companies. Because I work in a very small company, the quality assurance and quality control team consist of the QA engineer/associate, a documents specialist, the QC associates and then the managers of…   Read more»

]]> 6dec513ae6aafc846db202d1eba50b95 https://medicaldevicecourses.com/activity/p/23484/ Sun, 26 Sep 2021 16:59:07 -0400 I can see some of the value of the 510(k). It could make the process more efficient. If a company can prove some similarity to a pre-existing, successful device, then they can use the existing research or data to back…   Read more»

]]> 27d39b2b8dd8c4660db539c999e20d6a https://medicaldevicecourses.com/activity/p/23483/ Sun, 26 Sep 2021 16:38:54 -0400 As my work is currently in the process of getting a medical device FDA approved, I understand where the frustration comes from with how strict and lengthy the FDA process is. However, I do not think that the FDA rules…   Read more»

]]> 3a2f0a637aa7ef20168b9f24a6bf65a0 https://medicaldevicecourses.com/activity/p/23482/ Sun, 26 Sep 2021 16:23:31 -0400 While I certainly agree with those who say that the FDA process could be made more efficient with an increase in workforce, I don’t believe that the FDA process can really be accelerated. The phases in the FDA process that…   Read more»

]]> 41999f6cc5cb5c7bec6b0077bdba84f8 https://medicaldevicecourses.com/activity/p/23294/ Sun, 12 Sep 2021 15:30:45 -0400 As many have stated before, I do agree that missing a milestone is going to be typically looked at as a failure. Regardless of the reason for missing the milestone, it reflects poor planning or poor execution and can often…   Read more»

]]> 8f5ad790d927b83126fdc53d33a5b780 https://medicaldevicecourses.com/activity/p/23293/ Sun, 12 Sep 2021 15:20:17 -0400 Recently, I encountered an obstacle at work that certainly could have been avoided if my team and I spent more time planning out the project. Our product requires to be sent out for sterilization as we do not do any…   Read more»

]]> 928ddc1c228156fe31dd3421686fbb3c https://medicaldevicecourses.com/activity/p/23290/ Sun, 12 Sep 2021 14:56:02 -0400 I do believe that virtual communications have helped improve project life cycles to some degree. As a result of the COVID-19 pandemic, virtual communication has certainly improved as we now have plenty of platforms to accommodate WFH work arrangements. Many…   Read more»

]]> dfc5cfe0cc61fc4e771730d3901f1740 https://medicaldevicecourses.com/activity/p/23176/ Sun, 05 Sep 2021 13:27:44 -0400 As many of the previous posts have stated, a 30/70 practical to academic ratio is not the best. I, like many, learn better from hands-on experience. Courses aimed at teaching you the practical applications of concepts you learn in class…   Read more»

]]> 4f3316ff8969a76a6883c86b97f9d0c7 https://medicaldevicecourses.com/activity/p/23175/ Sun, 05 Sep 2021 13:15:44 -0400 I certainly agree with many of the advantages and disadvantages made in the previous posts. Initially, when deciding to pursue a BME degree, I was drawn to the idea of being exposed to different areas of knowledge. I believe that…   Read more»

]]> 8917b1e10aadc67ce37c5b6c7e67d795 https://medicaldevicecourses.com/activity/p/23174/ Sun, 05 Sep 2021 12:50:30 -0400 I began my R&D role in the company I currently work for in the midst of the COVID-19 pandemic. Unlike many people who began working or worked through the pandemic, I was always required to be onsite regardless of the…   Read more»

]]> eaf4b641386cdb2cb248d4d103dd8df7 https://medicaldevicecourses.com/activity/p/22158/ Sun, 18 Apr 2021 22:13:02 -0400 Because projects can last for years, it is not surprising that in that time team members may leave/quit or members change positions. Usually, if the employee is making the decision to leave, they should give notice to their managers. This…   Read more»

]]> c3460d3979ff9e2b73a4b2b10155308a https://medicaldevicecourses.com/activity/p/22157/ Sun, 18 Apr 2021 22:02:16 -0400 It is important that the product you produce is within the specifications that you set. These specifications are set to ensure that your product is not only able to do what its intended to do but can also carry out…   Read more»

]]> 4b575bce745e40ecdf0db6ee41bdc691 https://medicaldevicecourses.com/activity/p/22156/ Sun, 18 Apr 2021 21:49:16 -0400 To answer the first question, effective communication is achieved by every member of a project, regardless of size or role. It is important that project team members maintain constant communication with one another to reduce risk of delays or setbacks….   Read more»

]]> e388d45d604311878dee0b8cefc2fba5 https://medicaldevicecourses.com/activity/p/22036/ Sun, 11 Apr 2021 15:12:46 -0400 I agree that project cost can never be accurately established at the beginning of the project. There are factors that may come up that may not have been planned for in the beginning of the project. Increase in project cost…   Read more»

]]> d3a0c1a979b0cb650ccbe7faa495e700 https://medicaldevicecourses.com/activity/p/22035/ Sun, 11 Apr 2021 14:26:03 -0400 I agree that those 5 factors are important for the success of any project, especially effective communication. In a project where there may be several departments and a lot of people working in collaboration to achieve the same goals, it…   Read more»

]]> 602daa528ad5436c6d4dc4fad66970d8 https://medicaldevicecourses.com/activity/p/22034/ Sun, 11 Apr 2021 14:15:47 -0400 The completion of any project relies on the full cooperation of everyone on the team. With that being said, when planning for the project and selecting members of the project team, it is important that each member disclose any other…   Read more»

]]> 62f5eae1238698d03134feb789521530 https://medicaldevicecourses.com/activity/p/21726/ Sun, 14 Mar 2021 15:41:03 -0400 First, it’s important to sit down with the team to understand what the problem is and brainstorm its possible causes. Our team first tackled the issue of the formulation clumping and leaking from the syringe. From this, we decided that…   Read more»

]]> 5647db4107c0e70555178333b909d548 https://medicaldevicecourses.com/activity/p/21725/ Sun, 14 Mar 2021 15:24:19 -0400 When creating a device, the team comes up with the product specifications and requirements which essentially tell you how the device does what it’s supposed to do. These are your design inputs. Design verification entails tests or analyses that show…   Read more»

]]> ca08941fb05545ccaa10b4b6d316302a https://medicaldevicecourses.com/activity/p/21724/ Sun, 14 Mar 2021 15:11:37 -0400 As a few have mentioned before, one aspect of a project that can cause failure is poor planning and communication. Of course plans can change and the team can adjust or adapt to setbacks but if the project is poorly…   Read more»

]]> 8640e383f28b2d3e0d4e2af2b8c6517a https://medicaldevicecourses.com/activity/p/21716/ Sat, 13 Mar 2021 23:45:46 -0500 If your app does in fact retrain auditory cues, then I believe the capstone project would be classified as a medical mobile app. The number of FDA-cleared or approved mobile medical apps has definitely grown and has been created for…   Read more»

]]> 4d35098d24ac006e55a5eadd26e0d4d1 https://medicaldevicecourses.com/activity/p/21707/ Sat, 13 Mar 2021 23:45:32 -0500 I agree with the responses before me that products should be subjected to FDA recall if there are label errors associated with the product. The product’s label is one of the first things that the customer will see before purchasing/using…   Read more»

]]> 8f64d1001b084859fa51fe84ec751f42 https://medicaldevicecourses.com/activity/p/21551/ Sun, 07 Mar 2021 23:02:41 -0500 There are risks to every project so it is important that risks are assessed in the beginning of the project. More often than not risks affect a project negatively which is why project teams have to come with backup plans…   Read more»

]]> 7b5628844d7423ec049b1d18274679e6 https://medicaldevicecourses.com/activity/p/21548/ Sun, 07 Mar 2021 22:49:05 -0500 If milestones are missed, the first step is to get the team together to investigate why deadlines weren’t met. During this process, as with any process, communication is essential. In this case, the project’s Gantt chart could prove extremely beneficial in…   Read more»

]]> b3848d32154cb4a155217b509edd4ef0 https://medicaldevicecourses.com/activity/p/21546/ Sun, 07 Mar 2021 22:43:25 -0500 First, I think it is important that you plan for any possible failures that could occur with your project in the very beginning. For example, in this week’s sim, calcium sulfate hardens when exposed to water so the team should…   Read more»

]]> f2c640ee394471bc7d0725e50149dac8 https://medicaldevicecourses.com/activity/p/21451/ Sun, 28 Feb 2021 16:46:40 -0500 The Gantt chart helps to visualize the tasks in a project. Through the chart you are able to see how long tasks will take and which tasks are needed to be completed first before starting another task. It is important…   Read more»

]]> 27ce6b01ebd7ad073bac86cc7873d52f https://medicaldevicecourses.com/activity/p/21450/ Sun, 28 Feb 2021 16:32:13 -0500 Like many of the previous posts have stated, this course has definitely proven to be valuable. In my undergraduate classes, you don’t always see assignments or projects try to simulate a real world or industry experience. In these classes, you…   Read more»

]]> efba78209222e072f7a8d524f9d4bf6e https://medicaldevicecourses.com/activity/p/21449/ Sun, 28 Feb 2021 16:30:01 -0500 I have worked on projects before where the work breakdown was not clear. The members of the group were all assigned tasks but there was no clear timeline on when each task should be completed to ensure that the whole…   Read more»

]]> 35acd6e57bf24b23b1dee2f7674dd450 https://medicaldevicecourses.com/activity/p/21385/ Sun, 21 Feb 2021 17:01:13 -0500 As many have mentioned, overestimating a project’s completion time is a good way to lessen the chances of the team underestimated task duration. When planning the project, the team must always consider all the things that could go wrong in…   Read more»

]]> 5840fe32ebf4f0cf71b4579fff7f8b7f https://medicaldevicecourses.com/activity/p/21384/ Sun, 21 Feb 2021 16:45:01 -0500 When assembling the project team and delegating tasks, the PM should be sure to outline the responsibilities for each team member. Furthermore, if an individual is part of other teams and has other obligations, it is important that they disclose…   Read more»

]]> 7223a64265c296f862712e0135f09146 https://medicaldevicecourses.com/activity/p/21383/ Sun, 21 Feb 2021 16:25:49 -0500 First, as mentioned in the lecture, it is important for the PM to obtain the best methods of communication from each of the team members. Especially in a time when many in-person meetings are limited and projects may have to…   Read more»

]]> 1e584a40dfbfd999c80e30d6e2cb77b5 https://medicaldevicecourses.com/activity/p/21304/ Mon, 08 Feb 2021 02:47:18 -0500 I believe there are several factors that go into deciding what organization type will work best for a company. For example, a functional organization might work well for a big company with multiple projects and plenty of resources. These companies…   Read more»

]]> f3e93602e9f70f1d71f1b75606038f40 https://medicaldevicecourses.com/activity/p/21300/ Mon, 08 Feb 2021 02:30:30 -0500 I work in a small medical device company that uses a matrix organization. Although I have not been with the company for a long time, I can see the cons to a matrix organization. Because the company is small, individuals…   Read more»

]]> e01574b47f24809c0d8554ce9b269346 https://medicaldevicecourses.com/activity/p/21227/ Sun, 31 Jan 2021 19:40:46 -0500 I think there are definitely skills that a project manager may possess that are transferable and equally important in any project you are assigned regardless of the field. Skills like organization, good communication, adaptability and a host of other interpersonal…   Read more»

]]> 9aaac83f7fd4baebe5e8f3b4ec99a424 https://medicaldevicecourses.com/activity/p/21226/ Sun, 31 Jan 2021 19:15:53 -0500 Like many of the responses before, I believe that communication is essential in the success of project managers. I have worked in a project in the past where the designated project manager delegated the roles of the project in the…   Read more»

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