https://medicaldevicecourses.com/members/dsk35/activity/ Activity feed for dsk35. Fri, 24 Apr 2026 20:02:28 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ea25d19950ba2d3f4f2349c3acb59a6d https://medicaldevicecourses.com/activity/p/17295/ Wed, 15 May 2019 21:38:19 -0400 I would prefer middle management because you are more directly involved in the projects that happen. You have a better idea of what needs to be done and how to achieve them. Although it may be a lot of work,…   Read more»

]]> 35f01c39561f3c6ec1ec3b82def05e87 https://medicaldevicecourses.com/activity/p/17293/ Wed, 15 May 2019 21:38:18 -0400 Matrix organizational structures are more flexible in that you might have more flexibility with how you spend your time. With this structure, resources could be limited and there could be conflict if another project comes along and you have to…   Read more»

]]> 81eca99b17904a34c4a180589c4b266f https://medicaldevicecourses.com/activity/p/17292/ Wed, 15 May 2019 21:38:17 -0400 It always works out well when you really get along with the people in your groups. However, there does need to be some ground rules set before you begin working with someone you already know. Part of working in a…   Read more»

]]> 1d7f8bd2a358290042d9139cb87d8272 https://medicaldevicecourses.com/activity/p/17185/ Wed, 15 May 2019 21:37:22 -0400 Once the meeting is set up and the purpose and function of the device is fully understood, it would be a good idea to have a group discussion about the potential risks associated with that product. Once the basic ones…   Read more»

]]> 7781dd5416fb1e37f9465ec0b2a87c1d https://medicaldevicecourses.com/activity/p/17183/ Wed, 15 May 2019 21:37:21 -0400 I think one reason why companies get risk analysis wrong is because they know it requires a lot of work. What I mean by this is that once risks are identified and a plan is put out to deal with…   Read more»

]]> 87e6a1c6f99d27eccec822630cbfb974 https://medicaldevicecourses.com/activity/p/17182/ Wed, 15 May 2019 21:37:20 -0400 One technique for risk analysis that I came across is a bottom-up approach called HAZOP (Hazard and operability). This is usually used for more complex devices that has a very involved process. In this instance, multiple control factors are identified…   Read more»

]]> c439afa83dd8186fbe6d8188623a5d03 https://medicaldevicecourses.com/activity/p/17052/ Wed, 15 May 2019 21:36:16 -0400 Design inputs include customer needs as well as customer requirements. These are the aspects of the product that are expected to happen. For example, if you state that your product has a sensor that should flash red when interacting with…   Read more»

]]> 6c0b6ba99ef43d2ce9abbbae5bd45da4 https://medicaldevicecourses.com/activity/p/17040/ Wed, 15 May 2019 21:36:10 -0400 It hasn’t happened to me personally, but recording the minutes of each meeting allows everyone involved to be on the same page about what was discussed. Many times some things may be stated or decided that are later disagreed upon….   Read more»

]]> 70201a8daa6a26cad8beda81d42f98b2 https://medicaldevicecourses.com/activity/p/17038/ Wed, 15 May 2019 21:36:09 -0400 The purpose of Design Controls is to prove to the FDA that the product has all of the necessary requirements for being released to the market. The FDA needs a way of mapping out exactly how your product was made…   Read more»

]]> f56f69f80ed23bd0b0105790e5d46eae https://medicaldevicecourses.com/activity/p/17025/ Wed, 15 May 2019 21:36:03 -0400 Each document serves a different purpose. The DID gives a broader view of the product, outlining certain indicators and/or how it will function in a general sense. This document is mainly targeted towards people who are just trying to understand…   Read more»

]]> 65b4ffb9060b191043bb9069cb37fbdc https://medicaldevicecourses.com/activity/p/17024/ Wed, 15 May 2019 21:36:03 -0400 If there is no way of mapping out how the device was made, the effects can be very detrimental. If something were to go wrong, there needs to be way of tracing back and figuring how/what went wrong and if…   Read more»

]]> aa32622d7d2c56effd8d73ffb81f0d42 https://medicaldevicecourses.com/activity/p/17023/ Wed, 15 May 2019 21:35:59 -0400 Design controls are a way to prove that you have done everything according to the procedures outlined by the FDA. It ensures that everything is accounted for in terms of risk management and that it performs the way it is…   Read more»

]]> ac6fedb8abdb53a3ecaa61c5b0d790f0 https://medicaldevicecourses.com/activity/p/16842/ Wed, 15 May 2019 21:34:25 -0400 I think the point of a double blind study is that it eliminates any biases. The researchers and doctors might expect or wish for a certain outcome and might influence the distribution of the drug/therapy, making it biased. In order…   Read more»

]]> e972492d1894da51d48e59790781d624 https://medicaldevicecourses.com/activity/p/16841/ Wed, 15 May 2019 21:34:24 -0400 Placebos used in studies are useful because they act as a sort of control. As stated previously, the brain is very powerful and can allow you think something is happening, when it actually may not be. As long as the…   Read more»

]]> b77d4a4fdef02a91ab81dc6dad2308d5 https://medicaldevicecourses.com/activity/p/16840/ Wed, 15 May 2019 21:34:24 -0400 Clinical trials are necessary in order to further advance the final product. As Professor Simon stated in his lecture, you can’t assume that because something works in a mouse or rabbit, it will work the same way in a human….   Read more»

]]> eeaab5246f8ba366888292403e3e55db https://medicaldevicecourses.com/activity/p/16751/ Wed, 15 May 2019 19:42:14 -0400 EI, or emotional intelligence, is the ability to understand one’s own emotions as well as the those of other people. EI is used a lot in marketing because it allows companies to focus on things that will grab peoples’ attention…   Read more»

]]> 66492b4e7c9cf17fa31b8486feb2e1a6 https://medicaldevicecourses.com/activity/p/16748/ Wed, 15 May 2019 19:42:13 -0400 I don’t know if I would use the word “manipulating,” but rather influential persuasion. People who work in marketing need to be able to persuade people enough to influence them to buy the product you’re trying to sell. A huge…   Read more»

]]> ac6720b1a052adff8ea2e4e2c85d6743 https://medicaldevicecourses.com/activity/p/16742/ Wed, 15 May 2019 19:42:10 -0400 To me, marketing is knowing your customers and targeting your sales pitch to get them to want to buy your product. This includes things like getting advertisements sent by mail or online, commercials/infomercials, or phone calls. Marketing in the medical…   Read more»

]]> a95a0b34ed38eb1c2e23133201434ac7 https://medicaldevicecourses.com/activity/p/16640/ Wed, 15 May 2019 19:41:11 -0400 If a company of that size existed as an Inc corporation, it would allow more people to invest in the company’s shares. This also gives the option of eventually going public, which would create a lot of revenue for the…   Read more»

]]> 185440ac556f807867f5f18e9ad6dd0f https://medicaldevicecourses.com/activity/p/16639/ Wed, 15 May 2019 19:41:10 -0400 I think depending on your skill set, you need to decide whether the company’s success is big factor in accepting that position. If you’re fresh out of school, I wouldn’t think that this statistic would matter too much, unless however,…   Read more»

]]> b0f4775682e794679d10decd9312270c https://medicaldevicecourses.com/activity/p/16638/ Wed, 15 May 2019 19:41:10 -0400 Private companies are not able to trade shares with the public, whereas public companies can. The benefit of staying private is that you don’t have to alter you business model to fit Wall Street’s expectations. You are also in control…   Read more»

]]> 3da30b0bec89a72e3320f019a2fe7af6 https://medicaldevicecourses.com/activity/p/16524/ Wed, 15 May 2019 19:40:00 -0400 There always seems to be a lack of communication between QA and other departments. In my department, whenever the QA department is testing for certain results, it may take a long time, Often times, moving forward with the process relies…   Read more»

]]> 3b77fdecee487f240142bac5d7fbff84 https://medicaldevicecourses.com/activity/p/16521/ Wed, 15 May 2019 19:39:59 -0400 As people have stated before, I think a good way of improving QC/QA is to have better communication among different departments. I think in most cases, the quality department only reviews the product at the very end, right before a…   Read more»

]]> e798fae35541f898ab05e9fa0e72c2dc https://medicaldevicecourses.com/activity/p/16520/ Wed, 15 May 2019 19:39:58 -0400 I think most companies view the QA/QC departments as being a burden because of the amount of questions that need to be addressed before the release of a certain product. People may be on a time crunch to release certain…   Read more»

]]> 9fe964bda482dfed510fb9b244e48988 https://medicaldevicecourses.com/activity/p/16404/ Wed, 15 May 2019 19:38:55 -0400 I think the reason the FDA is so harsh when it comes to rules, regulations, and the process to approve a device/treatment is because of liability issues. If a patient/customer is not satisfied with the device or shows any adverse…   Read more»

]]> afb00959675452ab89ad69448e8317bb https://medicaldevicecourses.com/activity/p/16403/ Wed, 15 May 2019 19:38:54 -0400 In terms of medical devices, accuracy measures how closely certain data fall into the acceptable ranges of operation. If this does not hold true for the device, the device may not perform as intended. Precision requires the device to perform…   Read more»

]]> 7dbc14a28013e60428f51a20f0c51b7b https://medicaldevicecourses.com/activity/p/16402/ Wed, 15 May 2019 19:38:54 -0400 Recalls usually occur due to the product no longer adhering to the FDA laws. For instances where certain devices are recalled after 5-8 years, I would say it is usually because of long term adverse effects that are not detectable…   Read more»

]]> 2eb75b5b6f993f3167934a411cbd292e https://medicaldevicecourses.com/activity/p/16287/ Wed, 15 May 2019 19:37:46 -0400 While very unfortunate, animal testing is critical in developing medical devices for humans. If someone in a medical device-related field is completely against animal testing, they might be in the wrong business. The alternative would be to not have animal…   Read more»

]]> f4f5a19ed49d09752b0a4667387afd36 https://medicaldevicecourses.com/activity/p/16286/ Wed, 15 May 2019 19:37:45 -0400 If a company were to develop a new biomaterial, there would need to be a significant amount of tests done to ensure that the device has a strong biological performance. Toxicity tests (from the toxicity chart attached with this week’s…   Read more»

]]> c39b1c7ed433d03b20735966f541d610 https://medicaldevicecourses.com/activity/p/16285/ Wed, 15 May 2019 19:37:45 -0400 Outsourcing, in general, gives you less control over the final results. You have no way of directly observing how the study is being conducted. Also, if the university really is 1000 miles away, it would be too far to monitor…   Read more»

]]> 6d007396070e44fa855d973389760254 https://medicaldevicecourses.com/activity/p/16220/ Wed, 15 May 2019 19:18:27 -0400 Some other questions that would definitely need to be asked in the initiation phase of the project are: 1. Do I have the necessary resources to do this? If not, how feasible is it to obtain those resources. While there…   Read more»

]]> 9ebca9e3cb580f04fdffe10695141720 https://medicaldevicecourses.com/activity/p/16219/ Wed, 15 May 2019 19:18:27 -0400 Missing critical milestones such as deadlines can push back the deadlines of other critical milestones and delay the completion of the project. However, there can be ways to override this problem. Sometimes, you’re able to figure out a way to…   Read more»

]]> 69a90a5507a14859ff8d693378913bc9 https://medicaldevicecourses.com/activity/p/16176/ Wed, 15 May 2019 19:17:59 -0400 The biggest difference, in my opinion, between a project manager for a medical device versus a that of a construction project is the customer, which in most cases, is a patient seeking medical aid. Along with making sure the device…   Read more»

]]> a5cec7f71848c0db510be53b48ffc839 https://medicaldevicecourses.com/activity/p/16082/ Wed, 15 May 2019 19:16:51 -0400 Not necessarily! If we’re talking about an undergraduate student, they may or may not know what they want to focus on. However for a Master’s student, I would think that at point in their academic career, they have a better…   Read more»

]]> 6e2190d1ee709413b25101aea8904f2f https://medicaldevicecourses.com/activity/p/16079/ Wed, 15 May 2019 19:16:50 -0400 I definitely this MS program lacks in the amount of practical courses offered. As other people stated previously, working in the industry is a lot more involved and requires a lot of “hands-on” experience, paid or not. In my opinion,…   Read more»

]]> 053be52622a080444ffe9a156504b027 https://medicaldevicecourses.com/activity/p/16078/ Wed, 15 May 2019 19:16:49 -0400 While I agree that academia has more flexibility in terms of work hours/balanced work life you’re able to focus on the areas that you’re truly passionate about, I really think working in the industry gives you more opportunity to branch…   Read more»

]]> 676c0922c254ad2bb1fef8ad70c6ad4c https://medicaldevicecourses.com/activity/p/16077/ Wed, 15 May 2019 19:16:49 -0400 I do definitely agree that BME is really broad degree that overlaps into a lot of different fields. In my opinion, when starting out, it’s definitely good to some a variety of skill sets, rather than just one. Companies want…   Read more»

]]> 113e429ff4d6202a7fee020b1e5f53fe https://medicaldevicecourses.com/activity/p/16076/ Wed, 15 May 2019 19:16:48 -0400 I would definitely agree that networking is huge part of landing that first job. It also helps if you’ve had previous internships/co-ops while completing your undergraduate degree. However, sometimes this can be difficult because a lot of companies want to…   Read more»

]]> c4ffea1e741009a185f13450c19a56fc https://medicaldevicecourses.com/activity/p/9124/ Mon, 26 Nov 2018 02:52:37 -0500 I would prefer middle management because you are more directly involved in the projects that happen. You have a better idea of what needs to be done and how to achieve them. Although it may be a lot of work, a middle manager effectively communicates with the team and escalates and major issues to the “higher-ups” if need be. Sometimes upper…[Read more]

]]> 0 961dc05149d3e1f5d0b60c12984a1ff2 https://medicaldevicecourses.com/activity/p/9122/ Mon, 26 Nov 2018 02:44:08 -0500 Matrix organizational structures are more flexible in that you might have more flexibility with how you spend your time. With this structure, resources could be limited and there could be conflict if another project comes along and you have to decide if the current project or the new project gets priority, especially when the bosses are not on the…[Read more]

]]> 0 ab15a3a5eefc21e9fa6278761bd01c9a https://medicaldevicecourses.com/activity/p/9121/ Mon, 26 Nov 2018 02:36:25 -0500 It always works out well when you really get along with the people in your groups. However, there does need to be some ground rules set before you begin working with someone you already know. Part of working in a group means sometimes you might not agree on everything, but keeping things professional and being flexible are a good way to alleviate…[Read more]

]]> 0 68f32b036a7f347e8b1c53e596225176 https://medicaldevicecourses.com/activity/p/9004/ Mon, 19 Nov 2018 01:31:08 -0500 Once the meeting is set up and the purpose and function of the device is fully understood, it would be a good idea to have a group discussion about the potential risks associated with that product. Once the basic ones are identified, have everyone in the group fill out a risk analysis questionnaire that further uncovers any and all risks that…[Read more]

]]> 0 6ee0ad82ff3bd093aab2c17ed0ff4dbe https://medicaldevicecourses.com/activity/p/9002/ Mon, 19 Nov 2018 01:21:45 -0500 I think one reason why companies get risk analysis wrong is because they know it requires a lot of work. What I mean by this is that once risks are identified and a plan is put out to deal with those risks, part of doing the risk analysis is to follow up with those tasks. If a new risk is identified along the way that maybe wasn’t thought of…[Read more]

]]> 0 f766ac5eea08df236ad428fc509c0d7f https://medicaldevicecourses.com/activity/p/9001/ Mon, 19 Nov 2018 01:11:04 -0500 One technique for risk analysis that I came across is a bottom-up approach called HAZOP (Hazard and operability). This is usually used for more complex devices that has a very involved process. In this instance, multiple control factors are identified and evaluated using a risk matrix. Another approach is FTA (fault tree analysis), which is a…[Read more]

]]> 0 2940042ab8caa07bab9759dabdb82ca4 https://medicaldevicecourses.com/activity/p/8865/ Fri, 09 Nov 2018 15:15:15 -0500 Design inputs include customer needs as well as customer requirements. These are the aspects of the product that are expected to happen. For example, if you state that your product has a sensor that should flash red when interacting with a certain indicator, it should not flash green. These are the broader inputs that are addressed in the DID. The…[Read more]

]]> 0 6d8c9142fb21920e50a014704d53cc23 https://medicaldevicecourses.com/activity/p/8853/ Thu, 08 Nov 2018 15:14:45 -0500 It hasn’t happened to me personally, but recording the minutes of each meeting allows everyone involved to be on the same page about what was discussed. Many times some things may be stated or decided that are later disagreed upon. If the meeting minutes are logged correctly, this can be easily resolved by referencing that. It also allows you to…[Read more]

]]> 0 00d5743c351b91ba0931b1725dc132bd https://medicaldevicecourses.com/activity/p/8851/ Thu, 08 Nov 2018 14:17:56 -0500 The purpose of Design Controls is to prove to the FDA that the product has all of the necessary requirements for being released to the market. The FDA needs a way of mapping out exactly how your product was made and the steps you took to make it. It is also a way to back track if something goes wrong and to see if there are aspects of the product…[Read more]

]]> 0 24adab38539be37d9bd7ab6cd96a8dee https://medicaldevicecourses.com/activity/p/8837/ Tue, 06 Nov 2018 23:19:09 -0500 Each document serves a different purpose. The DID gives a broader view of the product, outlining certain indicators and/or how it will function in a general sense. This document is mainly targeted towards people who are just trying to understand what your product is. However, the DSD gives the specifications of each part of the product. This…[Read more]

]]> 0 5da7dde607733aa32634188270a2943b https://medicaldevicecourses.com/activity/p/8836/ Tue, 06 Nov 2018 23:10:29 -0500 If there is no way of mapping out how the device was made, the effects can be very detrimental. If something were to go wrong, there needs to be way of tracing back and figuring how/what went wrong and if there’s anyway to rectify this mistake. The FDA wants to make sure that the manufacturers are held accountable for everything regarding their…[Read more]

]]> 0 be32545317652f252795c928a11ea232 https://medicaldevicecourses.com/activity/p/8835/ Tue, 06 Nov 2018 22:50:16 -0500 Design controls are a way to prove that you have done everything according to the procedures outlined by the FDA. It ensures that everything is accounted for in terms of risk management and that it performs the way it is designed to. Not only does this help the manufacturer for any liability issues but it also allows for future modifications. The…[Read more]

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