https://medicaldevicecourses.com/members/dyc6/activity/ Activity feed for dyc6. Sat, 25 Apr 2026 02:56:45 -0400 https://buddypress.org/?v= en-US 30 hourly 2 c68b561f43a5592040a27cc4eada3b12 https://medicaldevicecourses.com/activity/p/21039/ Fri, 27 Nov 2020 21:52:52 -0500 I agree that written agreements are preferred over verbal agreements, especially when it comes to legal disputes in court. However, possible advantages to verbal agreements include ease, convenience, and flexibility. For small agreements without much risk, verbal agreements may be…   Read more»

]]> 3dc9691ac3af9ece9f825bee7207aa49 https://medicaldevicecourses.com/activity/p/21038/ Fri, 27 Nov 2020 21:12:19 -0500 An example of a recent kickback is in October 2020, when Medtronic agreed to pay neurosurgeon Dr. Wilson Asfora for social events at a restaurant which he owned. Dr. Asfora would also have social gatherings at his restaurant in which…   Read more»

]]> 82e81b97d369fe01ca005617a9cb0a5c https://medicaldevicecourses.com/activity/p/21037/ Fri, 27 Nov 2020 20:50:32 -0500 I really liked the practicality of the information taught in this class. For those wanting to work in the medical device industry (or already do), this course teaches each step of medical device development very clearly and gives practical advice…   Read more»

]]> 726fdc1446b5f7b53b86fc432ff43633 https://medicaldevicecourses.com/activity/p/20990/ Sun, 22 Nov 2020 18:33:15 -0500 Upper management and middle management also differ in their vision, with the former being more long-term focused and the latter being more short-term focused. Both share effective leadership qualities, but have different tasks. Upper management sets the goals for the…   Read more»

]]> c964f6a5eb4aee9e0ead78e8b288060c https://medicaldevicecourses.com/activity/p/20989/ Sun, 22 Nov 2020 18:21:30 -0500 I don’t think there is one best and most effective organizational structure for a company, but there is a particular organizational structure that works best for an employee at the company. Some may argue that a matrix organization is the…   Read more»

]]> de2660c5a6c78d13c878ef05a570b13d https://medicaldevicecourses.com/activity/p/20987/ Sun, 22 Nov 2020 17:41:21 -0500 I would like to work in a matrix type organization, because it seems to be highly efficient, i.e. there are no departmental silos nor are there redundant resources, and knowledge transfers well from project to project and between departments. Although…   Read more»

]]> c2dae5859fc75d669ec69f9f32e3c2a0 https://medicaldevicecourses.com/activity/p/20900/ Sat, 14 Nov 2020 23:05:03 -0500 Another factor contributing to risk values is the percentage of false-positives or false negatives, particularly for diagnostic devices. For example, if a patient is scanned (with X-ray, MRI, ultrasound, etc.) and the result is actually a false positive, then the…   Read more»

]]> e459000bb55a68a0d88ae65f847de7fb https://medicaldevicecourses.com/activity/p/20899/ Sat, 14 Nov 2020 22:26:03 -0500 A Risk Matrix can also be used to assess risk and see whether or not the risk should be accepted. For a medical device with high severity of risk, it may be acceptable if the occurrence is occasional, since that…   Read more»

]]> 66c59b8528010f7ae535e6caaaec7ced https://medicaldevicecourses.com/activity/p/20898/ Sat, 14 Nov 2020 22:08:51 -0500 Another risk management method is Root Cause Analysis (RCA), which gets to the main reason for risk. It identifies the fundamental risks involved in a project, usually after the problem has come up. RCA asks questions such as: “what happened?…   Read more»

]]> 2507b26608c233d7b5796aa2e36bd4a6 https://medicaldevicecourses.com/activity/p/20829/ Sat, 07 Nov 2020 23:04:32 -0500 This might sound a bit silly, but I think one factor to consider is whether one needs a Gantt Chart in the first place. For my capstone project, we used a simple project timeline along with weekly to-do lists, which…   Read more»

]]> 3037a0d4dee72380e151ff496a08cdef https://medicaldevicecourses.com/activity/p/20828/ Sat, 07 Nov 2020 22:34:04 -0500 In a research lab setting, we commonly look at previous studies that would be similar to our proposed study and calculate the effect size for that study (which is sometimes directly stated in the research paper). First, it is important…   Read more»

]]> cc73f98a6c7e1e1ca75331531583e1c9 https://medicaldevicecourses.com/activity/p/20827/ Sat, 07 Nov 2020 18:26:27 -0500 Meeting minutes are especially important for those working on multiple projects, since each project has its own set of tasks and someone may easily confuse or forget those tasks. It also helps the team stay organized, which is important for…   Read more»

]]> 642ec747bdf87ad1cc1d0d0ca1c82778 https://medicaldevicecourses.com/activity/p/20768/ Sun, 01 Nov 2020 14:46:02 -0500 It is difficult to exactly pinpoint the issues that arise from insufficient design controls, since the process of design controls has 9 parts within it: planning, input, output, review, verification, validation, transfer, design changes, and design history file. If a…   Read more»

]]> ce1cb2cda9d89858a96d37898c43297c https://medicaldevicecourses.com/activity/p/20767/ Sun, 01 Nov 2020 14:27:15 -0500 A risk vs. benefit analysis can also be done to decide whether one should outsource or perform in-house production. With in-house production, one may face risks with money, especially for smaller companies which may not have the best equipment to…   Read more»

]]> 4a9354d366380c872494ba5a67a624be https://medicaldevicecourses.com/activity/p/20766/ Sun, 01 Nov 2020 13:42:19 -0500 Another way to choose which test to perform is to look at previous studies’ design specifications and question how they obtained those specifications. For my senior capstone project, we did a lot of research into the design specifications listed for…   Read more»

]]> a643e26d2fd306a77f63731d8a7b3e4c https://medicaldevicecourses.com/activity/p/20712/ Sun, 25 Oct 2020 16:44:15 -0400 I believe placebo-controlled trials are necessary and can be done ethically, since previous studies have shown the placebo-effect to be apparent in a wide range of fields. The mechanism behind the placebo-effect is still not quite fully understood, but multiple…   Read more»

]]> 0b0b4e78f6474f7be41f856325fbd45d https://medicaldevicecourses.com/activity/p/20711/ Sun, 25 Oct 2020 14:08:00 -0400 I think having a clinical background is not necessary, since people can learn while interacting with the patients on the spot, however, there are many benefits to having a clinical background. Since having a clinical background is a plus, it…   Read more»

]]> 54f73f1aa7aef74dd1e603bea24d442c https://medicaldevicecourses.com/activity/p/20710/ Sun, 25 Oct 2020 13:44:53 -0400 I believe it is acceptable to expose a few human subjects to risk of harm for the benefit of future patients, since those few human subjects are told of all the risks and benefits of the clinical trial and make…   Read more»

]]> 5dd75e2b65bd5352535c6b8c2261801c https://medicaldevicecourses.com/activity/p/20655/ Sun, 18 Oct 2020 21:14:28 -0400 I think the best advertisements really know how to speak to their audience. I remember watching tv ads featuring McDonald’s Happy Meals as a kid, where they would show the different toys available in the meal, and would really grab…   Read more»

]]> 317794207b0d771a3d0e3ddb6b612061 https://medicaldevicecourses.com/activity/p/20654/ Sun, 18 Oct 2020 21:02:27 -0400 Although color in branding is very important in catching one’s eye, there may be individual differences in interpreting the colors as well. For example, some people have a preference for one color over the other. Different cultural backgrounds can also…   Read more»

]]> 67a0a858e06ec88f69d580aa3801295a https://medicaldevicecourses.com/activity/p/20651/ Sun, 18 Oct 2020 19:06:11 -0400 I believe EI is not only important in marketing, but in every facet of life where you need to interact with others. Humans are strongly influenced by their relationships with others, so practicing EI will inevitably benefit the individual and…   Read more»

]]> 1d273234ce67801f13765f92a5d5ec94 https://medicaldevicecourses.com/activity/p/20591/ Sun, 11 Oct 2020 16:42:58 -0400 I agree that choosing the type of corporation is only one step in running a successful business. However, it is an important stage nonetheless, especially since you will likely be considering who you may or may not want to work…   Read more»

]]> 1f0979ecf2f6e5e4f3e5af28223c4359 https://medicaldevicecourses.com/activity/p/20590/ Sun, 11 Oct 2020 16:23:22 -0400 I would not consider taking part in a partnership business, especially if the partnership is with a friend/partner/family member, since the stresses of starting and maintaining a business could possibly erode the relationship. That is a risk that is not…   Read more»

]]> 0179510145320352a93d79c5d0abbbe5 https://medicaldevicecourses.com/activity/p/20589/ Sun, 11 Oct 2020 15:44:16 -0400 I did some research on Siemens Healthineers AG, a medical technology company which develops medical imaging devices, diagnostic tests, and much more, headquartered in Germany. The following financial ratios were found: Price per earnings (P/E): 25.32. This is above the…   Read more»

]]> 0ac00cc464c7966bf8a6d421d983f05d https://medicaldevicecourses.com/activity/p/20530/ Sun, 04 Oct 2020 17:00:47 -0400 Keeping up with new technology such as IoT, AI, and ML not only requires literature reviews and reading more on the emerging fields, but it may also help to hire scientists/engineers familiar in those areas. Many engineers in computational research…   Read more»

]]> 6006bc8d9c834d5f265d6ad3f7ff891e https://medicaldevicecourses.com/activity/p/20529/ Sun, 04 Oct 2020 14:30:37 -0400 I believe the “vicious game” talked about here cannot be stopped for as long as the American culture relies more on curative medicine rather than preventative medicine. If the patient is healthy, then the doctor wouldn’t prescribe drugs, however, if…   Read more»

]]> 57ae567492f08a96faa90e08bc00711d https://medicaldevicecourses.com/activity/p/20527/ Sun, 04 Oct 2020 04:42:53 -0400 A major difference between QA and QC is that QA is more process oriented, whereas QC is more product oriented. Another distinction between the two is that QA usually requires the whole team to participate (such as following SOPs), while…   Read more»

]]> bde2900760abd26e8674d8e77c8be74a https://medicaldevicecourses.com/activity/p/20451/ Sun, 27 Sep 2020 03:43:40 -0400 Drug review times at the FDA have been shown to be significantly shorter than that of the European Medicines Agency (EMA), with the median times of initial review being 303 days, compared to 366 days at the EMA. Although the…   Read more»

]]> acd5f96a961b344b10a659b28f700bf9 https://medicaldevicecourses.com/activity/p/20444/ Sat, 26 Sep 2020 13:47:37 -0400 An example of a combination product currently on the market is an antibiotic-loaded bone cement. Antibiotic-loaded bone cements are used in orthopedic surgery for implant fixation, holding the implant against the bone, while reducing the chances of infection. The antibiotics…   Read more»

]]> 41f7c72eec186ed19f2180866f4ac532 https://medicaldevicecourses.com/activity/p/20443/ Sat, 26 Sep 2020 12:44:30 -0400 Although the physician may face many challenges, the physician is in a very good position to know which medical devices are in need in the medical device industry and which medical devices need to be improved. This is a great…   Read more»

]]> aaf58ac0221b7990ab0c78a05fcfe9de https://medicaldevicecourses.com/activity/p/20360/ Sat, 19 Sep 2020 20:24:48 -0400 Generally, the closer to humans the animals are, the more restrictions and checks there are to perform the animal study. For example, in the case of using zebrafish, fewer people are against it, since they are not only widely abundant,…   Read more»

]]> c543075483119c701eda72fe59930a8e https://medicaldevicecourses.com/activity/p/20359/ Sat, 19 Sep 2020 18:34:56 -0400 Although research in academia may be flexible in terms of time due to not having a rigid 9-5 schedule, over-working can also be an issue. In industry, you may be paid more for working over-time, but that is not the…   Read more»

]]> 61ebddb0268ce4320b5c1679e7aa6ac8 https://medicaldevicecourses.com/activity/p/20357/ Sat, 19 Sep 2020 17:15:25 -0400 From a project management standpoint, one factor I would look for in a biomaterial is how outdated the material is. Although previous posts have mentioned that using new biomaterials may be risky, I think the opposite side of the spectrum…   Read more»

]]> 3871448457d26fd3f030d6730a015619 https://medicaldevicecourses.com/activity/p/20272/ Sat, 12 Sep 2020 14:05:44 -0400 In addition to the soft skills mentioned, I believe a good project manager should be up to date with technology and equipping the team with relevant software or recent technology. A big set-back to completing a project may be lack…   Read more»

]]> c9fa57753e82738e1a01da0abc52c661 https://medicaldevicecourses.com/activity/p/20271/ Sat, 12 Sep 2020 13:31:23 -0400 During my senior design project, which involved building a low-cost scanning acoustic microscope, one obstacle we encountered was the fact that no one had experience in LabView programming. This was a major hurdle for the team, since the professor (the…   Read more»

]]> 238f57c928d0145ad415d20ab92a61f9 https://medicaldevicecourses.com/activity/p/20268/ Sat, 12 Sep 2020 04:34:15 -0400 I believe a great challenge in being a project manager in medical devices as opposed to being a project manager in building a skyscraper is the fact that the medical device industry is very susceptible to pandemics and new diseases….   Read more»

]]> 5b4f2f5304219a1506cf6e9387e99fa1 https://medicaldevicecourses.com/activity/p/20184/ Thu, 03 Sep 2020 17:41:57 -0400 I think an under-looked factor in those graduating with BME degrees is their communication skills. Since we have been exposed to such a range of topics, we are better equipped to communicate effectively with people from different fields, which is…   Read more»

]]> b6e3df5ab74f26c265e63eb296ac7d41 https://medicaldevicecourses.com/activity/p/20183/ Thu, 03 Sep 2020 16:52:29 -0400 I can see the appeal in going to work and doing the same thing everyday, i.e. working on a manufacturing floor as Dr. Simon mentioned, since it may be less stressful than creating novel ideas or constantly working on a…   Read more»

]]> a37dafb549aa462bf3f2a2da62eab98b https://medicaldevicecourses.com/activity/p/20181/ Thu, 03 Sep 2020 15:02:01 -0400 Due to covid19, many companies in the medical devices industry have had to shift supply chains from international to domestic. There have been difficulties on importing international medical devices due to health concerns as well as political friction. On a…   Read more»

]]> d03d19e1b189ec54502e63f527856461 https://medicaldevicecourses.com/activity/p/20023/ Sun, 03 May 2020 18:41:06 -0400 I think Americans are putting more hours in, because of a variety of factors, including motivation, peer pressure, and a heavy workload. The combination of all those factors inevitably leads to more hours worked per day. I would like to…   Read more»

]]> 8f96966ec04021c9d863e09b821c7c2e https://medicaldevicecourses.com/activity/p/20021/ Sun, 03 May 2020 17:58:18 -0400 If I were a project manager in a medical industry, I would motivate the team members by using various methods, since I believe everyone is motivated differently. However, I think the project manager should first be motivated, since setting a…   Read more»

]]> ae91da54cacf1861395874f86e323bbb https://medicaldevicecourses.com/activity/p/20020/ Sun, 03 May 2020 17:44:08 -0400 This class was very helpful in allowing me to understand the various aspects and steps needed to successfully manage a project, from the necessary documents needed for each PM process, to the soft skills required in a project team. I…   Read more»

]]> 2233c37db4619280dcc3bd4cb26b3a6a https://medicaldevicecourses.com/activity/p/19947/ Sat, 25 Apr 2020 17:26:44 -0400 I agree with the previous posts that someone planning to go into management should have experience in the more entry-level jobs and go up the ladder, step by step. This way, the manager can relate to those under management and…   Read more»

]]> bf9e66b6234d1cc245eafcd9439bcd65 https://medicaldevicecourses.com/activity/p/19946/ Sat, 25 Apr 2020 16:56:33 -0400 I am also not surprised by these results, since exciting and challenging work seems to hold the most importance for most people in general when asked about work. Also, in a previous forum, when asked what their motivation was, many…   Read more»

]]> 5198bec6f38b736cfddb8c0f5fe4be79 https://medicaldevicecourses.com/activity/p/19945/ Sat, 25 Apr 2020 14:43:57 -0400 What motivates me is collaboration coupled with learning. Whether it be a group assignment in a class, or working together with co-workers, or reaching a goal with another individual, the simple case of working with others to achieve something greatly…   Read more»

]]> b6b0584f119999263718b10906071ab3 https://medicaldevicecourses.com/activity/p/19909/ Mon, 20 Apr 2020 02:51:25 -0400 I also agree that reactive management is not necessarily bad, but preventative management is preferred. It is best to leave reactive management to circumstances which need immediate and sudden action, as the name implies. If people only relied on reactive…   Read more»

]]> fe9995840480319e2741d849ec8b3465 https://medicaldevicecourses.com/activity/p/19903/ Mon, 20 Apr 2020 00:34:42 -0400 The project manager should not be the sole communicator, but should instead effectively encourage the communication of groups and bring together those who should be communicating together. I agree with the posts above which mention everyone on a project should…   Read more»

]]> 720afedd9a728d052b9299c0fe91e150 https://medicaldevicecourses.com/activity/p/19900/ Sun, 19 Apr 2020 23:51:52 -0400 Project team members usually do give at least two weeks notice before changing positions to a different job, however, in the case that an emergency occurs or the team member suddenly quits, which does happen, other actions must be taken….   Read more»

]]> a213dc2061a35021a5348cbfbbbcf74f https://medicaldevicecourses.com/activity/p/19828/ Fri, 10 Apr 2020 21:54:07 -0400 Everyone has emphasized the importance of communication in this situation, which I agree should be of focus. I would like to add that in the case a substitute is found for the person on vacation or emergency situation, the substitute…   Read more»

]]> 3e8a33e3d52825f0ce01c7e0fe98b73b https://medicaldevicecourses.com/activity/p/19821/ Fri, 10 Apr 2020 18:48:33 -0400 I agree with the previous posts on the importance of metrics in the success of a project and would like to add that it not only gives upper management or project managers a better idea of how the project is…   Read more»

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