https://medicaldevicecourses.com/members/dh239/activity/ Activity feed for dh239. Sat, 16 May 2026 03:45:18 -0400 https://buddypress.org/?v= en-US 30 hourly 2 a9a306672edec319a0aaa19f08c8aaae https://medicaldevicecourses.com/activity/p/14481/ Wed, 15 May 2019 18:57:19 -0400 I feel that the rules are necessary. While it is nice to thank a collaborator and talk business over a dinner or conclude a deal with a gift, it is influencing the other party in a way that has nothing…   Read more»

]]> bb1a410c9a411ec8a4f515d472be62e6 https://medicaldevicecourses.com/activity/p/14480/ Wed, 15 May 2019 18:57:19 -0400 Initially, I imagined this course would be about the considerations put into each medical device and the creation of devices and was not expecting a course on the industry itself. However, the course has been extremely helpful and I came…   Read more»

]]> 61b7d5d6c5fbe6c913fe34b4306f2d48 https://medicaldevicecourses.com/activity/p/14478/ Wed, 15 May 2019 18:57:18 -0400 An NDA seems to be a precursor to a patent where a developing idea can be reserved and kept secret while it is developed into an idea that is capable of being patented. NDAs cannot substitute a patent and are…   Read more»

]]> 79068b95b5b65fc9b4943d6c570c3207 https://medicaldevicecourses.com/activity/p/14337/ Wed, 15 May 2019 18:55:15 -0400 I agree with the previous post: matrix organizations are definitely better suited for collaboration projects. They are more efficient and would save resources and allow for a more seamless flow between departments in the project.

]]> a8a39d1c3be00a7bcbdb789f4adcda65 https://medicaldevicecourses.com/activity/p/14334/ Wed, 15 May 2019 18:55:13 -0400 I definitely think that there should be a balance between team relationship and expertise. It is possible to develop a good team dynamic from random individuals so long as there is proper leadership, so a strong leader with expertise in…   Read more»

]]> e6fd7184f4cf2542fbfa34b53d9ccb22 https://medicaldevicecourses.com/activity/p/14327/ Wed, 15 May 2019 18:55:10 -0400 I also see myself to be better suited for a middle management role. I have limited experience and would not be suited for an upper management position which would require expertise on a more global level. Middle management is in…   Read more»

]]> 99db32a2af2cbf851b90337b1ccf9743 https://medicaldevicecourses.com/activity/p/14171/ Wed, 15 May 2019 18:52:42 -0400 As others have mentioned, a thorough understanding and full participation from all members is crucial for a risk management meeting. In order to ensure unique thought and involvement, I feel that it would be best to have members analyze risks…   Read more»

]]> f31d597cdae70f78d50c4762115742c1 https://medicaldevicecourses.com/activity/p/14169/ Wed, 15 May 2019 18:52:41 -0400 I believe that thorough documentation of failures and tests with attention to a variety of components would be the best way to analyze risk. Often times, failures due to one cause can indicate weaknesses in different parts of the design….   Read more»

]]> b891578c719104721511f5f738711dfe https://medicaldevicecourses.com/activity/p/14166/ Wed, 15 May 2019 18:52:39 -0400 “As Far As Possible” (AFAP) sounds like a very general term that is open to interpretation and so it becomes the work of the company to meet industry standards for risk assessment and minimalization. This would include the use of…   Read more»

]]> 624dab5d070311091cf6ae5041876f64 https://medicaldevicecourses.com/activity/p/14035/ Wed, 15 May 2019 18:51:17 -0400 During a design review, at least within the bounds of our senior project, we would evaluate our project step by step with our customer and group members. Usually, during this time, problems were pointed out and points were clarified by…   Read more»

]]> cba99d1d439d76d10dc2bf3a923c17e1 https://medicaldevicecourses.com/activity/p/14033/ Wed, 15 May 2019 18:51:15 -0400 Early verification and a thorough verification are both necessary to ensure that no problems arise in the future. I agree that the cost to compensate for a mistake far exceeds that of taking preventative measures. By implementing multiple checkpoints throughout…   Read more»

]]> 7e7061ed5b8e70a4719bc70ffc0fd2d7 https://medicaldevicecourses.com/activity/p/14002/ Wed, 15 May 2019 17:10:19 -0400 While I agree that outsourcing can be a cost-effective and overall wise move for a company, there are also a few drawbacks to consider. Primarily, outsourcing adds another step to bringing the product to market. Transfer between the company and…   Read more»

]]> f57058f26ee2bbb0cbb0caea1cfd2421 https://medicaldevicecourses.com/activity/p/13915/ Wed, 15 May 2019 17:09:22 -0400 Validation is not necessary when there is an update to the design which has no bearing on the usability or function of the product. For example, changing the color of a device from blue to green, where color has no…   Read more»

]]> e1a116dfdbee5d1cd5c0f6e4063bf88f https://medicaldevicecourses.com/activity/p/13913/ Wed, 15 May 2019 17:09:21 -0400 Design verification deals with confirming the inputs of the project with its outputs. It is a way to see that the requirements have been met and that the device was created in its entirety. Validation confirms the function of the…   Read more»

]]> 09bc7562d35c0a8aa2519fd40926c5fb https://medicaldevicecourses.com/activity/p/13912/ Wed, 15 May 2019 17:09:20 -0400 In our student organizations, minutes were always a chore delegated to the lowest ranking member. However, last year it became an issue when our minutes were not posted on the website. We were finalizing a project and erroneously left out…   Read more»

]]> 8054ee04d63a43be2f4f95ed46df1fe9 https://medicaldevicecourses.com/activity/p/13741/ Wed, 15 May 2019 17:07:49 -0400 I feel that it is acceptable to take the risk of a clinical trial when the results of the trial are expected to either benefit or not affect those involved. This would be in the case of testing an intervention…   Read more»

]]> 9b194f412a1d8deaf7f25afd97ef98d7 https://medicaldevicecourses.com/activity/p/13739/ Wed, 15 May 2019 17:07:48 -0400 Placebo-controlled studies are a necessity when it comes to establishing the efficacy of a drug, however, their ethical foundation comes into question when a placebo is given instead of an established treatment. This would be like giving a diabetic a…   Read more»

]]> da5cecc3656811dcbbb65a3af9665997 https://medicaldevicecourses.com/activity/p/13737/ Wed, 15 May 2019 17:07:47 -0400 I feel that, while not necessary, it is very advantageous to have a clinical background in the role of a CRA and especially in the role of a principal investigator. The reason for this is that a clinician has been…   Read more»

]]> c06dc663d28641e9755c4c1671c9af7e https://medicaldevicecourses.com/activity/p/13594/ Wed, 15 May 2019 17:06:21 -0400 While the comparison between Apple and a medical device company is a bit of a stretch, they do use some similar techniques in terms of advertising. My father, who is a physician, always comes back from conferences with company-sponsored pamphlet…   Read more»

]]> a7300ae73e95f6d2e73d859b61c3151f https://medicaldevicecourses.com/activity/p/13593/ Wed, 15 May 2019 17:06:21 -0400 Participation is an important aspect of marketing because of how easy it is to block out all the noise. Companies need to make it so that their consumers seek out and engage with the company and the product rather than…   Read more»

]]> 6b2e0b29cd158b9cc99e386991c6cca2 https://medicaldevicecourses.com/activity/p/13590/ Wed, 15 May 2019 17:06:19 -0400 I feel that there is a strong negative connotation to the word “manipulation” and that its use in this field is not always appropriate. When the features of a product or the availability of a product convince a consumer that…   Read more»

]]> 2be71827993fae2d19b9bcafbcecfee4 https://medicaldevicecourses.com/activity/p/13425/ Wed, 15 May 2019 17:04:47 -0400 I think this question depends heavily on the business being started. In my case, I have an interest in medicine and would probably open a clinic as an LLC. As an LLC, my company would be separate from my personal…   Read more»

]]> 8462ff760c590587fe59ffb504dc844a https://medicaldevicecourses.com/activity/p/13422/ Wed, 15 May 2019 17:04:45 -0400 Using data published by the Wall Street Journal on Tesla Inc. (TSLA) I have found the following metrics to be very interesting. Earnings per share: -4.68 Gross Margin: +22.48 Operating Margin: -9.86 ROA: -4.39 ROE: -23.11 ROI: -8.7 Revenue: 2.79…   Read more»

]]> b74a8e14a683cb6cc934a1818d90f016 https://medicaldevicecourses.com/activity/p/13420/ Wed, 15 May 2019 17:04:44 -0400 A company of that size would need to weigh the benefits and drawbacks of both of the choices. An LLC is excellent for smaller operations at it offers protection in the form of reduced personal liability as well as reduced…   Read more»

]]> c7bb01a501a55acd326914c2bddd3a7a https://medicaldevicecourses.com/activity/p/13316/ Wed, 15 May 2019 17:03:51 -0400 Quality control is similar to an insurance policy for a company’s product. It is expensive, burdensome and, for younger companies, not obviously necessary. However, as the company grows, the need for quality control becomes increasingly important. Public trust, safety and,…   Read more»

]]> 9974ff34f6d026476fb28525910c3a9c https://medicaldevicecourses.com/activity/p/13315/ Wed, 15 May 2019 17:03:50 -0400 While I haven’t been witness to any exceptional quality practices, I remember reading about how the auto industry handles mechanical defects in some of their parts. Apparently, if a defect is discovered (usually through an injury or malfunction report) the…   Read more»

]]> 53bf5b867f3649bae99650107d5244a7 https://medicaldevicecourses.com/activity/p/13314/ Wed, 15 May 2019 17:03:50 -0400 In my opinion, the best quality departments can work with both the company’s and the customer’s needs and wants in mind. In order to mesh well with the vision of the company, and allow for a synergistic approach to getting…   Read more»

]]> a54a6c060b4ddd0354cb7b7c455ea3da https://medicaldevicecourses.com/activity/p/13152/ Wed, 15 May 2019 17:02:26 -0400 Although e-cigarettes are currently regulated by the FDA, they come with hazards that are overlooked because they are viewed as a “healthy” alternative to smoking. The combination device works by vaporizing water with organic compounds including nicotine and delivering it…   Read more»

]]> 178d048822aeb4a4e4383980293498d1 https://medicaldevicecourses.com/activity/p/13150/ Wed, 15 May 2019 17:02:25 -0400 The net effect of the increased user fees seems to be pointing to increased cost for small to mid-sized businesses in the medical device field and a greater burden on the end user of the device. Small companies that produce…   Read more»

]]> b7670ae431bb4d7951e14f8de75fd811 https://medicaldevicecourses.com/activity/p/13149/ Wed, 15 May 2019 17:02:24 -0400 I agree with the points you made; the regulations of the FDA do, indeed, protect us and the compromise is worth the lives being saved. However, I feel that there is still room for improvement in the system that is…   Read more»

]]> 45cc68fd826ff6ff34853cbc1d5afafe https://medicaldevicecourses.com/activity/p/12968/ Wed, 15 May 2019 17:00:50 -0400 In academia, research is approached with a sense of curiosity and passion for the field. The work is driven by grants and the hierarchy is structured in a way such that a professor or senior researcher leads a team of…   Read more»

]]> fe62ae75816481dfaf253f20cad7bb83 https://medicaldevicecourses.com/activity/p/12967/ Wed, 15 May 2019 17:00:49 -0400 Although I haven’t had any experience working in industry research, it seems that industry research is the most impactful work in terms of changes to our lives and ways of doing things. Companies like Du Pont have created countless products…   Read more»

]]> 4be3d61e67989fe781a56bcae00b6b07 https://medicaldevicecourses.com/activity/p/12966/ Wed, 15 May 2019 17:00:48 -0400 I am currently researching at the University on a project that is intended to have benefits years from now. I feel that while there is no immediate product to be released, there is still quite a bit of satisfaction building…   Read more»

]]> 9cdce2380b819014bad04cdbf6ae6039 https://medicaldevicecourses.com/activity/p/12886/ Wed, 15 May 2019 16:59:59 -0400 I agree with the notion that missing milestones are intrinsically considered failures. Being late, or unable to produce results, is never something that is desired. However, my own experiences missing milestones have been learning experiences, and usually, lead to structural…   Read more»

]]> 2cdfbff1880bcf882fb2858158073e03 https://medicaldevicecourses.com/activity/p/12885/ Wed, 15 May 2019 16:59:58 -0400 During my undergrad, I was tasked with leading a committee for a student government organization. Our task was to promote our organization’s initiatives through social media and other advertising, but we ran into a variety of issues due to regulations…   Read more»

]]> a3621bf53f17c3764bebb432b83599a6 https://medicaldevicecourses.com/activity/p/12883/ Wed, 15 May 2019 16:59:57 -0400 The regulations enforced by the FDA are definitely a large and unique consideration that sets medical device development apart from other projects. This, coupled with the demands of global regulatory bodies, makes medical device development particularly complicated. However, there are…   Read more»

]]> b834b04783f64db37b40998b0fb72545 https://medicaldevicecourses.com/activity/p/12696/ Wed, 15 May 2019 16:58:19 -0400 Practical courses do fall short to informational courses when research or academia is the goal of the student. For professionals and those looking to go into industry, practical courses are perhaps the most important. For that reason, a wide variety…   Read more»

]]> 719b6195493f2541878d492d555e5d1a https://medicaldevicecourses.com/activity/p/12695/ Wed, 15 May 2019 16:58:18 -0400 I feel that practical courses are far more important than informational courses at a higher, graduate level. Undergraduate courses should be informational as they lay down a foundation. Once the graduate level is reached, courses should be specific and targeted…   Read more»

]]> 6e7cb570e1142d48532f31834d53ff98 https://medicaldevicecourses.com/activity/p/12694/ Wed, 15 May 2019 16:58:17 -0400 Working in academia has quite a few benefits. First, there’s a certain satisfaction that comes with developing new research and technology and disseminating ideas in an academic setting. Also, there is greater time flexibility and access to a broader field…   Read more»

]]> f86838bac177c70ac09c6e980d57cefa https://medicaldevicecourses.com/activity/p/5534/ Mon, 04 Dec 2017 03:44:00 -0500 I feel that the rules are necessary. While it is nice to thank a collaborator and talk business over a dinner or conclude a deal with a gift, it is influencing the other party in a way that has nothing to do with the actual business. Gifts, dinners and other gestures distract from the main business and can lead to biased decision making that can,…[Read more]

]]> 0 fabc9c14ebc9f9f5c8652543234edefc https://medicaldevicecourses.com/activity/p/5533/ Mon, 04 Dec 2017 03:39:01 -0500 Initially, I imagined this course would be about the considerations put into each medical device and the creation of devices and was not expecting a course on the industry itself. However, the course has been extremely helpful and I came out learning a lot more about the industry than I had ever imagined I would while still in academia. This…[Read more]

]]> 0 380bb9139bcc7165a118bb414faacc2b https://medicaldevicecourses.com/activity/p/5531/ Mon, 04 Dec 2017 03:23:42 -0500 An NDA seems to be a precursor to a patent where a developing idea can be reserved and kept secret while it is developed into an idea that is capable of being patented. NDAs cannot substitute a patent and are most often used when an idea cannot be patented. An NDA has little bearing over cases that are outside of the direct agreement between the…[Read more]

]]> 0 b0873a8870702dcc3f485b0e9d2a8831 https://medicaldevicecourses.com/activity/p/5379/ Mon, 27 Nov 2017 04:56:40 -0500 I agree with the previous post: matrix organizations are definitely better suited for collaboration projects. They are more efficient and would save resources and allow for a more seamless flow between departments in the project.

]]> 0 89fdc51bd7580e0722cfb8dedac22a8b https://medicaldevicecourses.com/activity/p/5376/ Mon, 27 Nov 2017 04:46:40 -0500 I definitely think that there should be a balance between team relationship and expertise. It is possible to develop a good team dynamic from random individuals so long as there is proper leadership, so a strong leader with expertise in motivating a group is of utmost importance. Then, individuals who are sufficiently knowledgeable in their…[Read more]

]]> 0 5849623ef5c1d93bb68a7f673629767f https://medicaldevicecourses.com/activity/p/5369/ Mon, 27 Nov 2017 04:27:42 -0500 I also see myself to be better suited for a middle management role. I have limited experience and would not be suited for an upper management position which would require expertise on a more global level. Middle management is in charge of smaller groups of individuals and is an important link in the chain of command whereas upper management…[Read more]

]]> 0 cc528407712946b1611ea27dbd683f55 https://medicaldevicecourses.com/activity/p/5205/ Mon, 20 Nov 2017 01:59:33 -0500 As others have mentioned, a thorough understanding and full participation from all members is crucial for a risk management meeting. In order to ensure unique thought and involvement, I feel that it would be best to have members analyze risks independently, drawing from their own backgrounds and then compiling the list of risks together for…[Read more]

]]> 0 dba1e04865af9c405dc709a907a597e0 https://medicaldevicecourses.com/activity/p/5203/ Mon, 20 Nov 2017 01:56:40 -0500 I believe that thorough documentation of failures and tests with attention to a variety of components would be the best way to analyze risk. Often times, failures due to one cause can indicate weaknesses in different parts of the design. By monitoring the reason for failure along with other aspects of the design, it is possible o improve the…[Read more]

]]> 0 5b1f038397b36e753b73bf2749745b4b https://medicaldevicecourses.com/activity/p/5200/ Mon, 20 Nov 2017 01:52:47 -0500 “As Far As Possible” (AFAP) sounds like a very general term that is open to interpretation and so it becomes the work of the company to meet industry standards for risk assessment and minimalization. This would include the use of up-to-date methods of analyzing risk and constantly updating documentation and procedures to ensure that risk is…[Read more]

]]> 0 023590d0880329df024c7a2aafaf8682 https://medicaldevicecourses.com/activity/p/5058/ Mon, 13 Nov 2017 03:02:10 -0500 During a design review, at least within the bounds of our senior project, we would evaluate our project step by step with our customer and group members. Usually, during this time, problems were pointed out and points were clarified by the group members. This is a constructive meeting that allows the group to track progress and ensure that…[Read more]

]]> 0 9dcee0ae2ba2fbed0b0cff6e89d106a9 https://medicaldevicecourses.com/activity/p/5056/ Mon, 13 Nov 2017 02:58:01 -0500 Early verification and a thorough verification are both necessary to ensure that no problems arise in the future. I agree that the cost to compensate for a mistake far exceeds that of taking preventative measures. By implementing multiple checkpoints throughout the process, and doing testing on batches based on a statistically representative…[Read more]

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