https://medicaldevicecourses.com/members/andrew684/activity/ Activity feed for andrew684. Sat, 25 Apr 2026 01:24:17 -0400 https://buddypress.org/?v= en-US 30 hourly 2 03dd0f9d622bc4a5d32c1e11810a537a https://medicaldevicecourses.com/activity/p/28540/ Sun, 26 Nov 2023 21:46:32 -0500 There are multiple aspects that are considered in making a confidential agreement that make the agreement binding, enforceable, and agreeable by both parties. In the agreement, the definition of confidential information is clearly listed and defined for the individual, which…   Read more»

]]> c1cac10f004f9d344c8e22202f8b9444 https://medicaldevicecourses.com/activity/p/28539/ Sun, 26 Nov 2023 21:24:10 -0500 Non-compete agreements are pretty common in any industry. In the jobs I’ve worked, each one had a non-compete agreement that I was required to sign before working. This agreement basically protects the company from an individual taking all their knowledge…   Read more»

]]> 7400f48fc48f5c2ffcd4b8668acb53c0 https://medicaldevicecourses.com/activity/p/28537/ Sun, 26 Nov 2023 21:01:48 -0500 This gift-giving in the “older days” was abused by some big companies, which was over the line and unethical, namely in the case of perdue pharma. Perdue Pharma, a company in the healthcare field, was marketing opoids, which were painkillers…   Read more»

]]> c694944fae8f32ccfc057750a4197015 https://medicaldevicecourses.com/activity/p/28512/ Mon, 20 Nov 2023 21:09:46 -0500 The one organization setting that would be right for me would be a project-based organization because of the familiarity and single focus on the project. While working on this type of team, I am working with the same team members…   Read more»

]]> 335ae6f48f560812af3ec6d53aad78ac https://medicaldevicecourses.com/activity/p/28511/ Mon, 20 Nov 2023 20:37:27 -0500 This is a common scenario in corporate organizations because of the age difference that comes with their experience levels as well as their different styles of working. In this scenario, what usually helps is to hold a meeting between the…   Read more»

]]> 84130f5fcf6d3ae7ba59e117f9551b45 https://medicaldevicecourses.com/activity/p/28510/ Mon, 20 Nov 2023 20:15:05 -0500 Maslow’s hierarchy of needs tends to focus on the self-development of the person and can be likened to the organization one works at as a whole. Beginning with the psychological needs of a person in the organization, they would have…   Read more»

]]> e3b29251f8ad199a32334187ae69a13e https://medicaldevicecourses.com/activity/p/28435/ Sun, 12 Nov 2023 22:52:12 -0500 A minority of biotechnology companies would look at the rewards compared to the risks because the potential to reap the benefits of the reward is better than the associated risk. The majority of companies bear more risks than rewards because…   Read more»

]]> 80faabbf26ad680b3fa525ab1a74c1cd https://medicaldevicecourses.com/activity/p/28433/ Sun, 12 Nov 2023 22:27:52 -0500 I think the most important risk management stage of the project would be during the manufacturing stage because of the different risks that were not accounted for in the product design of the project. In the planning stage of the…   Read more»

]]> 9f3e1e4f6b4703b931854ac222db80e6 https://medicaldevicecourses.com/activity/p/28432/ Sun, 12 Nov 2023 22:07:16 -0500 In order for this device to get approval from the FDA, the risk management process would roughly look like the following: The device would undergo the usual process for FDA approval of a level 3 medical device. In terms of…   Read more»

]]> 5d1c644371d6c8b28ac6add87dd87740 https://medicaldevicecourses.com/activity/p/28388/ Tue, 07 Nov 2023 00:22:40 -0500 In the design review, multiple departments are included to cover all their bases in different aspects, including design, quality, and manufacturing, among others. Having multiple people with experience in these reviews gives the product the optimal rate of success, so…   Read more»

]]> c94da5158978c24bf4be807501e16aed https://medicaldevicecourses.com/activity/p/28387/ Mon, 06 Nov 2023 22:45:51 -0500 There are a couple different forms of validation that I have encountered in my work experience that are interesting in their own right. One of the types of validation is process validation, where in the environment of manufacturing, a process…   Read more»

]]> 08552c2dc42d0d2bfb6730f81dc8ff1c https://medicaldevicecourses.com/activity/p/28386/ Mon, 06 Nov 2023 22:24:06 -0500 On the medical device side of a company, strict standards are in place for good reason due to the inherent risk of potential harm and influence on human subjects. In the type of industry I was in, change was very…   Read more»

]]> 265928cf6287f943d9f3a8978a1c3028 https://medicaldevicecourses.com/activity/p/28329/ Sun, 29 Oct 2023 23:30:08 -0400 Designing verification tests is not something I have done from scratch, but I have some experience working in a lab and using these skills for tests. In a laboratory, many of the test methods are not made from scratch due…   Read more»

]]> 0a32e06655f71ea536c258f739a8b522 https://medicaldevicecourses.com/activity/p/28327/ Sun, 29 Oct 2023 23:17:22 -0400 Validation is very important no matter which field it is encountered in due to making sure that this piece of equipment, whether it be medical devices or something as simple as a blender, The process starts with installation qualification, which…   Read more»

]]> 7c8d291753a9dcf15b9a283623c11965 https://medicaldevicecourses.com/activity/p/28324/ Sun, 29 Oct 2023 22:54:35 -0400 Corporate responsibility is pretty important to companies due to the long-lasting effects that a company can have on people through their products. This type of responsibility tends to be very wide in terms of what a company does and their…   Read more»

]]> bb0fd7ed5d02ebbd3d721435fa834062 https://medicaldevicecourses.com/activity/p/28265/ Sun, 22 Oct 2023 22:30:48 -0400 One of the most important good clinical practices in the FDA documents I found was 21 CFR Part 50, which has to do with the protection of human subjects, namely informed consent. This is such an important concept to grasp…   Read more»

]]> af95995ccda22278ac6318098e45d088 https://medicaldevicecourses.com/activity/p/28263/ Sun, 22 Oct 2023 22:09:12 -0400 Intellectual property is a tricky subject because the term of ownership becomes less clear in the way multiple parties are involved, but in the case of clinical trials, it is very clear who owns inventions. Before a clinical trial takes…   Read more»

]]> 54306bf1301812c7e29dc82ebdd753e6 https://medicaldevicecourses.com/activity/p/28261/ Sun, 22 Oct 2023 21:52:12 -0400 Clinical trials are expensive as well as time-consuming, so reducing a device to a semester is a very tough task to do and is impossible. In the capstone class, students are working together to get primarily a grade in the…   Read more»

]]> 624b3137ea6d690d086a83e189f0aae0 https://medicaldevicecourses.com/activity/p/28214/ Sun, 15 Oct 2023 21:51:36 -0400 The qualifications of salespeople I’ve encountered are very different, which is mainly based on the chemical industry, where most of the people I knew to be salespeople had a technical degree and their main degree wasn’t in business. There were…   Read more»

]]> 239eddbca2d8a8b9b8465e4c99aec7dc https://medicaldevicecourses.com/activity/p/28213/ Sun, 15 Oct 2023 21:24:43 -0400 In the transition from engineering to sales, in my experience, I’ve seen people complete engineering degrees and then use that engineering degree in a sales position in a company. Most people have gained experience through positions such as retail at…   Read more»

]]> 9452d955cf437e1df0273617fbf6fad9 https://medicaldevicecourses.com/activity/p/28212/ Sun, 15 Oct 2023 20:41:40 -0400 As a sales rep for a company, following up on cold calls and inquiries by customers about the products of the customers becomes essential for the company to acquire a sale and make a profit. Creating this bond of trust…   Read more»

]]> 6236e1dbc58afa31ffb635a7b7e2bf07 https://medicaldevicecourses.com/activity/p/28173/ Mon, 09 Oct 2023 02:09:56 -0400 Financially, companies wouldn’t go about developing medical devices if they didn’t see profit in the near future, but there are ways companies develop these devices even though they aren’t profitable. There are devices similar to drugs, better known as orphan…   Read more»

]]> f20c41a51c34d213133b240a0df842ae https://medicaldevicecourses.com/activity/p/28160/ Sun, 08 Oct 2023 22:22:45 -0400 Going into business becomes a difficult process for one individual. The way I would do it is to get business partners on a product, like a start-up, and my partners would also invest in a common investment. The other side…   Read more»

]]> 1387be02d9b6cdc90b5e63d98e8d16f1 https://medicaldevicecourses.com/activity/p/28159/ Sun, 08 Oct 2023 22:09:33 -0400 In the company I worked for, they weren’t a very big company and were rather small, so I was boxed into one particular field while working there. My position had to do with different parts of manufacturing, such as planned…   Read more»

]]> 154c3fe10495797ccaa913bb0856b595 https://medicaldevicecourses.com/activity/p/28101/ Sun, 01 Oct 2023 23:03:05 -0400 The Form 483 reminds me of this one case study I learned about, which had to deal with Harvard and some medical tests they were doing. The case study was based on the fact that Harvard was conducting clinical trials…   Read more»

]]> 692b8bccfe2eaaf1ecd61672d1cafdc5 https://medicaldevicecourses.com/activity/p/28099/ Sun, 01 Oct 2023 22:47:40 -0400 Manufacturing safety becomes a second thought often during manufacturing because many companies are concerned with profit and how much they can make. Having the safety-approved equipment becomes less important because there isn’t a disaster or worst-case scenario where companies aren’t…   Read more»

]]> 4dd003eeb7f0304c420ef4b5d203d880 https://medicaldevicecourses.com/activity/p/28098/ Sun, 01 Oct 2023 22:23:58 -0400 Quality assurance and quality control serve different purposes within the medical device field, where each complements the other. My background is in quality control, not in medical devices, but in lab testing, which is the hands-on experience of testing the…   Read more»

]]> d35fdea4ecc23448fab93bc631038626 https://medicaldevicecourses.com/activity/p/28032/ Sun, 24 Sep 2023 23:48:21 -0400 Switching from the engineering role to a regulatory role has always interested me because of the perks of the job that other jobs do not have. More and more regulatory roles are becoming remote due to the nature of the…   Read more»

]]> e37c650f1e9ea9d900b0cd14ed9963a1 https://medicaldevicecourses.com/activity/p/28027/ Sun, 24 Sep 2023 23:13:58 -0400 Handling a pandemic is of course going to be messy, no matter which government agency handles it, and the way the FDA handled the vaccine rollout was probably the best that could’ve happened. The vaccine was developed rather quickly due…   Read more»

]]> a122b7d2b65654d0df5dd96081a70d23 https://medicaldevicecourses.com/activity/p/28023/ Sun, 24 Sep 2023 22:48:38 -0400 The main impact on the project is product development as opposed to post-market management because of the nature of the project. In any project, most of the work is done during product development, but because this is regulatory work, most…   Read more»

]]> 3d4464878aace89de0c59bdff6b0f138 https://medicaldevicecourses.com/activity/p/27978/ Tue, 19 Sep 2023 00:02:54 -0400 Considering the fact that a pre-clinical study and/or clinical study consist of several tasks, this would constitute a project, so a project manager would be necessary in this case. The project manager is tying all the personnel that are involved…   Read more»

]]> 88de8e4bd993b84bc528a2e5916d4b24 https://medicaldevicecourses.com/activity/p/27977/ Mon, 18 Sep 2023 23:40:24 -0400 The guideline I found most important to this would be “requirement of due care,” which encompasses the animals, the study, as well as those outside the study. The guidelines previously mentioned cover certain requirements for the FDA as well as…   Read more»

]]> b9664ac6b94dd4e6a076345a2a623dbd https://medicaldevicecourses.com/activity/p/27976/ Mon, 18 Sep 2023 23:20:35 -0400 Stability testing is done in order to maintain the function as well as to make sure the product is safe to use, such as the use of IV needles, which need to be sterilized. These types of products in the…   Read more»

]]> 09a78f7b3216e28522d6edbc25aa0664 https://medicaldevicecourses.com/activity/p/27922/ Mon, 11 Sep 2023 23:36:42 -0400 Putting academia and industry side by side in terms of project management I tend to find many similarities in what I have experienced in both fields. In terms of academic research, making a Gnatt chart becomes unclear in some instances…   Read more»

]]> e0bcd1de6b1c657bdd3c8c92892c2e7a https://medicaldevicecourses.com/activity/p/27921/ Mon, 11 Sep 2023 23:11:40 -0400 When managing a project, the first few questions before beginning a project are ultimately what the subject of the project is and what can be allocated to certain resources. In my experience, the project needed to be approved based on…   Read more»

]]> 2dbad4e6369309efaa4ec0bc8d41ca42 https://medicaldevicecourses.com/activity/p/27920/ Mon, 11 Sep 2023 22:29:06 -0400 Implementing AI into project management seems like a good idea and seems like a very different approach to project management. I think applying AI to project management can happen in today’s society because of the immense amount of data the…   Read more»

]]> 1bafbfcaf1304afdf1e69eacc20fb833 https://medicaldevicecourses.com/activity/p/27838/ Wed, 06 Sep 2023 22:17:15 -0400 Going into the industry with a bachelor’s degree shows the employer that you went to college and are capable of doing work at the entry level. There are other jobs that require only a high school education but pay significantly…   Read more»

]]> 21bfd776a68bb8426a7a3491b4f38c0d https://medicaldevicecourses.com/activity/p/27836/ Wed, 06 Sep 2023 21:36:38 -0400 Most industry jobs require a bachelor’s degree, and in some cases, a higher degree would open more doors. At the same time, when recruiters screen through the applicants, they consider the GPA to be one of the deciding factors in…   Read more»

]]> e9ee21d9bfc64a5f8a804db88bf623f2 https://medicaldevicecourses.com/activity/p/27835/ Wed, 06 Sep 2023 21:12:18 -0400 Working remotely from home as opposed to the office has been a topic that I have considered multiple times in my industry as well as academic life. With the transition during COVID during my academic BS of my undergrad, I…   Read more»

]]> 4b83147b7f991149007dc4bbf63f15c6 https://medicaldevicecourses.com/activity/p/27820/ Tue, 05 Sep 2023 20:04:10 -0400 0