https://medicaldevicecourses.com/members/rv347/activity/ Activity feed for rv347. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 9e5d63833aba515db683e0b5c0cac1fc https://medicaldevicecourses.com/activity/p/17391/ Wed, 15 May 2019 21:39:05 -0400 A critical thing to note about a verbal agreement is that it often comes with a paper trail and can have many forms of evidence to back it up, despite it being “verbal” in nature. Verbal here simply means that…   Read more»

]]> c124632e87adcc7158a1f33765e26e97 https://medicaldevicecourses.com/activity/p/17389/ Wed, 15 May 2019 21:39:04 -0400 Stark law restricts the physician from referring patient to a designated place where he or his family members has a financial relationship unless an exception is met. It is intended to eliminate financial motivation for a physicians to refer a…   Read more»

]]> f182c35db5dca928ced4015770b5dda7 https://medicaldevicecourses.com/activity/p/17385/ Wed, 15 May 2019 21:39:02 -0400 NDA only gives you protection from the individual in the contract, in which they promise to keep the idea confidential. A patent grants you proof of ownership and full protection for your idea. The main difference can be shown by…   Read more»

]]> 76985fe11d9841993afff671ee8fb4f8 https://medicaldevicecourses.com/activity/p/17227/ Wed, 15 May 2019 21:37:45 -0400 Being a project manager for a matrix organization can be a lot more challenging and requires more communication and organizational skills, but ultimately it can be more rewarding. There is another project manager who the employees have to report to,…   Read more»

]]> b9d063b75b689f9e65fff2fa109149c5 https://medicaldevicecourses.com/activity/p/17226/ Wed, 15 May 2019 21:37:44 -0400 I think that even in a project based organization, they can still make efforts to collaborate between departments. For example, there can be monthly presentations given by a member of one team to all the different teams and this way…   Read more»

]]> 568f89338545761d7169de1d30d22b13 https://medicaldevicecourses.com/activity/p/17225/ Wed, 15 May 2019 21:37:44 -0400 My ideal type of company to work for would be a matrix organization. I think it is beneficial to the company’s productivity that departments communicate with each other and can transfer knowledge about the project with other departments. This would…   Read more»

]]> 9328bfd430516ad9b1822f45b0fb816c https://medicaldevicecourses.com/activity/p/17115/ Wed, 15 May 2019 21:36:46 -0400 A Gantt chart is essential for staying on track and getting the project done in a timely manner. I can tell you from experience that working with companies that don’t set out a timeline or set clear goals, work is…   Read more»

]]> 6e668bac098ecdcf983325467b1c7f0b https://medicaldevicecourses.com/activity/p/17114/ Wed, 15 May 2019 21:36:46 -0400 When design controls are not set up properly, it results in a failed medical device as stated by those examples above. In the case of recalled medical devices, it would be interesting to study and review their design controls and…   Read more»

]]> 300823824e926f1c6e6701843ed3477b https://medicaldevicecourses.com/activity/p/16930/ Wed, 15 May 2019 21:35:12 -0400 From my experience in clinical research, one such document required by the FDA is an IRB, Institutional Review Board. This document is necessary to protect the welfare and rights of human subjects by ensuring that your experiment will not harm…   Read more»

]]> dfa400ffa106ab67b9e84e41844a49ff https://medicaldevicecourses.com/activity/p/16929/ Wed, 15 May 2019 21:35:11 -0400 Design transfer involves transitioning the design from planning stages to production. This is a critical trade-off that requires a few things in order to go smoothly. One is communication between departments, which is essential. Another is a multitude of technical…   Read more»

]]> a9da8ad16483f539ed19e94825dd65ac https://medicaldevicecourses.com/activity/p/16928/ Wed, 15 May 2019 21:35:11 -0400 Yes I agree that design control is an integral process and its failure can have a wide effect. If not done properly, the company will have to make recalls on the product which results in a large loss of money…   Read more»

]]> 7e52ef27260d65a8454f80ee0fc3024f https://medicaldevicecourses.com/activity/p/16813/ Wed, 15 May 2019 19:42:53 -0400 I think it is very complicated to get IRB approval for a clinical trial where the outcome is unknown. The IRB wants to make sure that a device will offer no potential harm to any subjects, and this is a…   Read more»

]]> d38c4fc1d4a32bda8713808eadeec083 https://medicaldevicecourses.com/activity/p/16812/ Wed, 15 May 2019 19:42:53 -0400 I think it depends on the study matter and double blind is not always necessary. Yet there are certain cases where double blind would be preferable. It is used to prevent research outcomes from being influenced by the placebo effect…   Read more»

]]> c5d6ccecd1be9f50aad5b97653d097f6 https://medicaldevicecourses.com/activity/p/16811/ Wed, 15 May 2019 19:42:52 -0400 I would like the role of CQA – clinical quality assurance. CQA inspects the documents and processes clinical trial data and ensures that testing follows proper guidelines as stated by good clinical practice (GCP). CQA can give exposure to all…   Read more»

]]> fcf8d0dbfcb7971d72de24578b5a1afb https://medicaldevicecourses.com/activity/p/16810/ Wed, 15 May 2019 19:42:52 -0400 EI, or emotional intelligence, is the ability to recognize and modulate one’s own emotions, and to recognize the emotions of those around them. This is an important quality for a businessman or anyone in a company who interacts with anyone…   Read more»

]]> f64e0a11605102f24733780d1f60a708 https://medicaldevicecourses.com/activity/p/16809/ Wed, 15 May 2019 19:42:51 -0400 A company that comes to mind when I think of good marketing is Starbucks. What type of grand strategy do they use? They have achieved global market status, there are Starbucks everywhere and in almost every country. The stores themselves…   Read more»

]]> 79031f9a9a4c558c3646eb2a0dd9996f https://medicaldevicecourses.com/activity/p/16808/ Wed, 15 May 2019 19:42:50 -0400 Color plays an important role in branding and advertising as it is immediately noticeable and affects a persons mood or perception. One color that no one mentioned so far is white. I think it is extremely important how a company…   Read more»

]]> 8937e5f9f3094092b39dbbf92a9b77c2 https://medicaldevicecourses.com/activity/p/16631/ Wed, 15 May 2019 19:41:05 -0400 What would make a company choose LLC vs Inc? LLC is a way to combine the benefit of limited liability and pass-through taxation. However an LLC can’t have investors. On the other hand, C corporation is owned by the shareholders….   Read more»

]]> 96fd97387d1824a7ab023002ce05e1ae https://medicaldevicecourses.com/activity/p/16630/ Wed, 15 May 2019 19:41:05 -0400 This is an interesting question. I think it depends. Corporations have their advantages while start-ups have their own advantages. It depends on what you are looking to learn and gain from a job. Also, as a soon-to-be-grad I am looking…   Read more»

]]> e363aa5f26346aa9494caebffe534986 https://medicaldevicecourses.com/activity/p/16628/ Wed, 15 May 2019 19:41:04 -0400 I looked up Microsoft to see how they compare financially, these were my findings: ROI (return on investment)= 10.69.%. This value is calculated by dividing net sales by investments. Its not great, should be above 20%. ROA (return on Assets)…   Read more»

]]> 8d9dabf865f24b5a36ac5f3525ccbd0e https://medicaldevicecourses.com/activity/p/16563/ Wed, 15 May 2019 19:40:22 -0400 I also think our economic market has unintentionally discouraged quality. There are constantly new phone upgrades and newer editions of products. It is somehow expected that the first edition will not be the best, but its okay as long as…   Read more»

]]> 8955117b43cf7fc4d318c0bc854f0ae5 https://medicaldevicecourses.com/activity/p/16562/ Wed, 15 May 2019 19:40:21 -0400 @Zbw2 made an interesting point about market competition as a motivating factor for quality. A company wants to make sure their product is better than all the competitors, so they will be concerned with quality. While I think this is…   Read more»

]]> defee525b8a53baf7ae269263f74bb49 https://medicaldevicecourses.com/activity/p/16560/ Wed, 15 May 2019 19:40:20 -0400 I think this has especially become a problem in American culture where people are constantly looking for a lawsuit. Hoping to win the big bucks, they will take a company down at any cost. Companies are filled with anxiety over…   Read more»

]]> 5fa14cafcdd97e4a6cd1e74b441d16a3 https://medicaldevicecourses.com/activity/p/16399/ Wed, 15 May 2019 19:38:52 -0400 The main reason the stem cells therapy is not FDA approved is for political reasons surrounding stem cells and pro-life movement. Also, even if the stem cells are drawn from the patients own body the FDA considers it a drug…   Read more»

]]> 73cbc2cbd794ded173f94494f33cd97a https://medicaldevicecourses.com/activity/p/16398/ Wed, 15 May 2019 19:38:51 -0400 This is a good point. It is good that the FDA is so careful and protects us, but sometimes it may be overdone. For example, stem cell treatments. They are non FDA approved, but are legal in other countries such…   Read more»

]]> f36ff43289607b45ba1d37e067ec9d26 https://medicaldevicecourses.com/activity/p/16397/ Wed, 15 May 2019 19:38:50 -0400 Recalls occur when there is a defect in the medical device. This is usually not a theoretical risk, as that would be more obvious and caught in the development stages. It is usually an unexpected health risks or danger that…   Read more»

]]> 77d467069ed060077ec6b674ac3566e7 https://medicaldevicecourses.com/activity/p/16301/ Wed, 15 May 2019 19:37:54 -0400 I believe that animal testing for medical purposes is ethical. This is partially based on the utilitarian argument in ethics. Utilitarianism states that the most ethical choice is one that will produce the greatest good for the greatest number. Yet…   Read more»

]]> 97c25345934650d835bf8b238e7234e7 https://medicaldevicecourses.com/activity/p/16300/ Wed, 15 May 2019 19:37:53 -0400 As stated, this is regulated by ISO 10993 and the toxicity table. This depends on the application and intended use of the new biomaterial and its placement on the body. Whether it is a surface device, external communicating device, or…   Read more»

]]> fa4d3f94fb9a8f0439fe19f533c1e7d0 https://medicaldevicecourses.com/activity/p/16218/ Wed, 15 May 2019 19:18:26 -0400 This depends on how critical that milestone is. Some milestone will have a larger impact on the overall project and some not as much. In general missing a milestone is definitely a failure, but in life it is important to…   Read more»

]]> 1686e2601c694e12a193d0a8f31662ce https://medicaldevicecourses.com/activity/p/16199/ Wed, 15 May 2019 19:18:14 -0400 Work breakdown structure (WBS) is critical for planning and accomplishing a project successfully. It is basically a family tree listing all the “parent” tasks and then breaking them down into smaller tasks. This helps the team understand what needs to…   Read more»

]]> 56480c67079b9cc862269018d55e6371 https://medicaldevicecourses.com/activity/p/16198/ Wed, 15 May 2019 19:18:13 -0400 This is a good point. Before one invests time and money into a project, they need to make sure there is a need for their idea/project and it will bring in money. As much as bme is about helping people…   Read more»

]]> b9a4c7ab221e97605a1b88511891f40c https://medicaldevicecourses.com/activity/p/16075/ Wed, 15 May 2019 19:16:48 -0400 I think the above posts mentioned many good tips, and personally my best advice would be to find a mentor and job internship. These will really help you get far and teach you more skills than you could have possibly…   Read more»

]]> 8e60ec713b0cf2b436415a8de49d026b https://medicaldevicecourses.com/activity/p/16068/ Wed, 15 May 2019 19:16:44 -0400 I think there should be options, and thus an equal amount of courses offered in both the academic and practical realm. Depending on if a student is interested in research or academia they can choose the relevant coursework. One student…   Read more»

]]> d0f04a9260b2c0848404beba08d93d8d https://medicaldevicecourses.com/activity/p/15894/ Wed, 15 May 2019 19:15:02 -0400 As I was scrolling through this page, I was truly fascinated by the different forces that motivate people and how diverse the responses are. I personally am motivated by feeling challenged and feeling that my work is meaningful. As Dr….   Read more»

]]> 2fc2a68709b9f39a3c124e53678f20f8 https://medicaldevicecourses.com/activity/p/15760/ Wed, 15 May 2019 19:13:37 -0400 I agree with the above posts. It is critical when selecting a supplier that you create a clear contract stating that they will notify your company of any changes to the product. Otherwise a lot of trouble can be caused…   Read more»

]]> 45662006d9530d27e1fccf16503f6393 https://medicaldevicecourses.com/activity/p/15540/ Wed, 15 May 2019 19:07:26 -0400 The various budget techniques are crucial to the monitoring and controlling phase. I would go so far as to say they are the most important factor for control of the project’s schedule and budget. To figure out if the project…   Read more»

]]> 4382e3617c060d0de9426f393cb9ded9 https://medicaldevicecourses.com/activity/p/15537/ Wed, 15 May 2019 19:07:24 -0400 This raises a good point. I agree with the above comments that it ultimately depends on the company. A small company can’t afford to go over budget, so in that case a positive cost variance and negative schedule variance would…   Read more»

]]> bfd823e2b75ce5d230451cfb335ffd2b https://medicaldevicecourses.com/activity/p/15429/ Wed, 15 May 2019 19:06:18 -0400 I think the greatest concerns to the PM are quality of the product, time constraints, and cost budgeting. The PM must determine if this particular part can be produced in-house and if so what would the quality be, how much…   Read more»

]]> 501b2dbde7c91e90b76a0e14f5ecd357 https://medicaldevicecourses.com/activity/p/15240/ Wed, 15 May 2019 19:04:20 -0400 To add to the above posts, the uniqueness of the Gantt (in comparison to network diagrams) is that it shows task relationships. This includes FS, SF, FF, SS deadlines. Portraying this information, of whether projects must start on the same…   Read more»

]]> 6a01151b1a441fc9cb725e4369805368 https://medicaldevicecourses.com/activity/p/15062/ Wed, 15 May 2019 19:02:42 -0400 I think this raises an interesting point. As many people mentioned, risk is an essential part of the planning process and deciding if its worthwhile to pursue the project. Yet how exactly is the risk/benefit ratio determined? Is seems partly…   Read more»

]]> d037dd73ada9686721a942b1df383f60 https://medicaldevicecourses.com/activity/p/15061/ Wed, 15 May 2019 19:02:42 -0400 Risk is the primary barometer for deciding if its worthwhile to pursue a project and how to avoid potential pitfalls. This is logical because at its core the project is a financial endeavor, and thus must be accompanied with a…   Read more»

]]> 3f8ef7ec16bf6f252484b12c82be485f https://medicaldevicecourses.com/activity/p/14735/ Wed, 15 May 2019 18:59:37 -0400 Ap962, interesting discovery. No one previously commented that fitbit should be Class II, yet this is the case. One participant compared it to a device that monitors fertility, which I found a good comparison, yet she concluded that fitbit would…   Read more»

]]> 033f97c7fdb8b18486cc4a7750d8de30 https://medicaldevicecourses.com/activity/p/14721/ Wed, 15 May 2019 18:59:29 -0400 This is an interesting question. One participant (“bb254”) compared it to an existing device, the 670G system by Medtronic, a sort of artificial pancreas. I agree that a lab grown organ would be Class III, however I would argue that…   Read more»

]]> 7998ddafe681a91fc77e32a7a2a59337 https://medicaldevicecourses.com/activity/p/10762/ Wed, 15 May 2019 16:36:19 -0400 In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, “red knob”), whereas the DSD is design specification and gives a very specific description(ex, “red knob 3cm…   Read more»

]]> 4fd12ed5ec2bf04f741aa1452845e3d6 https://medicaldevicecourses.com/activity/p/10734/ Wed, 15 May 2019 16:36:04 -0400 Hi – In this week’s lecture Dr. Simon mentioned how BME is a diverse degree, in which you learn a little bit of everything. While it can be an advantage to have a variety of skill sets, you are not…   Read more»

]]> 21414974a1fef1563f40f25974e12fe1 https://medicaldevicecourses.com/activity/p/10684/ Wed, 15 May 2019 16:35:34 -0400 As we saw in the miniSIm, a project is often accompanied by time complications that must be dealt with in order for the project to proceed. Hopefully, a calm and productive discussion can give way to a solution. What about…   Read more»

]]> 5125b4a503c0ab906b0860ce4970eee6 https://medicaldevicecourses.com/activity/p/9227/ Mon, 03 Dec 2018 00:15:26 -0500 A critical thing to note about a verbal agreement is that it often comes with a paper trail and can have many forms of evidence to back it up, despite it being “verbal” in nature. Verbal here simply means that there was no formal contract written for the agreement.
For example, there can be a verbal agreement to sell a house for a certain amount…[Read more]

]]> 0 2550ddff2c07f4b902f141a97382635a https://medicaldevicecourses.com/activity/p/9225/ Mon, 03 Dec 2018 00:03:00 -0500 Stark law restricts the physician from referring patient to a designated place where he or his family members has a financial relationship unless an exception is met. It is intended to eliminate financial motivation for a physicians to refer a patient to a lab or hospitals for unnecessary tests or treatment in order just to get money.The…[Read more]

]]> 0 8422f6c3fec4a1d3c059b91ed1df99b3 https://medicaldevicecourses.com/activity/p/9221/ Sun, 02 Dec 2018 22:31:18 -0500 NDA only gives you protection from the individual in the contract, in which they promise to keep the idea confidential. A patent grants you proof of ownership and full protection for your idea. The main difference can be shown by an example – let’s say you have an idea to develop something and you share that idea with person A and sign an NDA with…[Read more]

]]> 0 834e9530e28749eb714dd4a369e5521c https://medicaldevicecourses.com/activity/p/9048/ Tue, 20 Nov 2018 15:21:33 -0500 Being a project manager for a matrix organization can be a lot more challenging and requires more communication and organizational skills, but ultimately it can be more rewarding. There is another project manager who the employees have to report to, and who the project manager has to coordinate with. It is kind of like checks and balances in the…[Read more]

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