https://medicaldevicecourses.com/members/sheila-sarathy/activity/ Activity feed for Sheila Sarathy. Sat, 25 Apr 2026 02:56:45 -0400 https://buddypress.org/?v= en-US 30 hourly 2 8e15067218d1528f8c09f8d129d7669f https://medicaldevicecourses.com/activity/p/24151/ Mon, 06 Dec 2021 15:39:17 -0500 That is true, it can be pretty expensive and not financially efficient for a clinical trial company to have to pay each participant subject for partaking in the study. Other than money, another qualifying incentive that could possibly attract potential…   Read more»

]]> 74cd0eb60f23b32870275c5ee555be8c https://medicaldevicecourses.com/activity/p/24150/ Mon, 06 Dec 2021 15:39:17 -0500 I believe that would depend on if the company is working on something with high demand and urgency. For instance, I work for a laboratory that has a pcr lab that processes covid19 samples. With the height of the pandemic…   Read more»

]]> 7cca9292a1b9f5516ab12ec87ce7d16a https://medicaldevicecourses.com/activity/p/24149/ Mon, 06 Dec 2021 15:39:16 -0500 With Design Control, I believe that Output is the most important part. The output is considered as any work that’s produced at the end of the design. That would include any drawings, manufacturing instruction, or material specifications. The output is…   Read more»

]]> abb3c28ea6e6f0d2b32db70bce547508 https://medicaldevicecourses.com/activity/p/24148/ Mon, 06 Dec 2021 15:39:16 -0500 @mattie718 I would have to agree with you in the sense that the Design Input Document (DID) and Design Specification Document (DSD) are similar documents. But I do think that the DID is most vital because the writer who composed…   Read more»

]]> 9fb575189d3eb1c3bf9a8f17c1a0e673 https://medicaldevicecourses.com/activity/p/24140/ Mon, 06 Dec 2021 15:38:36 -0500 @cem34 I’d have to disagree with you. I believe that validation is incredibly necessary for a medical device. I could say that I work in the industry because I work with instruments that are use to screen for drug enzymes….   Read more»

]]> 0845f85cb0051ca3c6a50cee39e6e9b5 https://medicaldevicecourses.com/activity/p/24139/ Mon, 06 Dec 2021 15:38:35 -0500 @anthonynjit This is true. Developing protocols based on tensile strength of a device after repeated use is a commonly overlooked factor. I would have to believe its because big corporations might sign a contract with the buyer and cover the…   Read more»

]]> b58f0fec91ea82e7b4117537e408df0a https://medicaldevicecourses.com/activity/p/24133/ Mon, 06 Dec 2021 15:37:04 -0500 An example of a risk that can be instance where it would it be okay to accept the risk in medical device development is a risk that there wont be enough of the device to sell on the market because…   Read more»

]]> 6f786788e38940d6a1248e6b7177d9c9 https://medicaldevicecourses.com/activity/p/24132/ Mon, 06 Dec 2021 15:37:03 -0500 An example of a risk that can be instance where it would it be okay to accept the risk in medical device development is a risk that there wont be enough of the device to sell on the market because…   Read more»

]]> c4ea5ea861cd3d8ca39d13d2a150e7ad https://medicaldevicecourses.com/activity/p/24131/ Mon, 06 Dec 2021 15:37:02 -0500 Patients usually don’t even realize that they accept the risks that are associated with the medical device. Although the risk management process can be tedious, it is very essential for making sure a device functions as per its intent to…   Read more»

]]> a61ae2458ceac23f1ce465269bee2418 https://medicaldevicecourses.com/activity/p/24130/ Mon, 06 Dec 2021 15:37:02 -0500 Apparently it changed from “as low as reasonably practicable” to “as far as possible” Basically the first one, ALARP; allows a manufacturer to include economic impacts into considerations as to what are acceptable and unacceptable risks. AFAP; does not allow…   Read more»

]]> 492914bb10b90c7d30435f6fbbad4d32 https://medicaldevicecourses.com/activity/p/24126/ Mon, 06 Dec 2021 15:37:00 -0500   I feel like its better to work with people who are more knowledgeable in their department role. Working on a project team with people who already have a pre-existing relationship with can get dicey. There would be interdepartmental struggles…   Read more»

]]> bbcf6f781da57a568ce16556991e0b84 https://medicaldevicecourses.com/activity/p/24125/ Mon, 06 Dec 2021 15:36:59 -0500 @cassiem I totally agree with you on the fact that the team would be most effective when made up with different types of people. When you involve different types of people on the team with different professional backgrounds and a…   Read more»

]]> a1174b8d4d7b6a0ee1e1c76fd61b7c51 https://medicaldevicecourses.com/activity/p/24124/ Mon, 06 Dec 2021 15:36:43 -0500 @cassiem I totally agree with you on the fact that the team would be most effective when made up with different types of people. When you involve different types of people on the team with different professional backgrounds and a…   Read more»

]]> 5ab06702a52b9b91bbc620aaa2e3b91f https://medicaldevicecourses.com/activity/p/24123/ Mon, 06 Dec 2021 15:36:43 -0500 I also believe I can excel in both areas; Upper management and middle management. I might prefer being in a position of upper management because I find myself to be quite strategic and pretty good at visualizing things in a…   Read more»

]]> 61dd48718db6a08a1412cec52d5a59ec https://medicaldevicecourses.com/activity/p/23887/ Sun, 31 Oct 2021 14:06:01 -0400 That is true, it can be pretty expensive and not financially efficient for a clinical trial company to have to pay each participant subject for partaking in the study. Other than money, another qualifying incentive that could possibly attract potential…   Read more»

]]> 938c57ce338798eda52173dcb25cb8a2 https://medicaldevicecourses.com/activity/p/23886/ Sun, 31 Oct 2021 14:06:00 -0400 I believe that the majority of the reason for why clinical testing/trials are done for pharmaceutical drugs is to document any potential or inherent side effects that may transpire when taking the drug. If there is documentation of a person…   Read more»

]]> 7ae21e7711aa234ed78cffb671325115 https://medicaldevicecourses.com/activity/p/23885/ Sun, 31 Oct 2021 14:06:00 -0400 Placebo controlled trials are ethical from a bigger picture sense. There is a greater good at hand when conducting them. It is for a good and moral purpose, so therefore, it should not be considered unethical. They are necessary for…   Read more»

]]> efb0282c6348071e492ca889d278c3cd https://medicaldevicecourses.com/activity/p/23784/ Mon, 18 Oct 2021 13:45:51 -0400 Yes it does seem like the cons overweigh the pros when referencing C-Corp vs. S-Corp. However there are many cases where C-Corp is the best option. For instance, C-Corp is better for international owners because C-Corp does not require the…   Read more»

]]> b6b80d248b335caed1c39e0e0872f0dd https://medicaldevicecourses.com/activity/p/23783/ Mon, 18 Oct 2021 13:45:50 -0400 Hi Cassie, you are right. Technically a sole proprietorship isn’t a corporation. First of all, a corporation is multiple people. Also, a whole corporation cannot go to jail per say, however, a sole proprietor surely can. I believe the reason…   Read more»

]]> d35dab44deccf45e472a35efb0d2a660 https://medicaldevicecourses.com/activity/p/23782/ Mon, 18 Oct 2021 13:45:50 -0400 Great question, Cruz. I think a lot of the business scheme in the engineering world is lost when working as a field tech or most entry level positions. I doubt they have to be concerned with the opinions of shareholders…   Read more»

]]> c7b3d25147f787c718578972fb1a0d78 https://medicaldevicecourses.com/activity/p/23778/ Mon, 18 Oct 2021 13:45:37 -0400 I agree with the majority here with the best form of participation in marketing being social media. I would have to admit that I also have purchased items that I find on Instagram ads all the time. Another good form…   Read more»

]]> 91e77b115e70355bee94f487ab9e1072 https://medicaldevicecourses.com/activity/p/23774/ Mon, 18 Oct 2021 13:45:35 -0400 The internet has greatly changed the world of marketing by many means. The best way it has revolutionized the field is by expanding the pool of potential clientele and long term users. It can be utilized as a tool to…   Read more»

]]> 2b8a3bd77913ec398ca47419a35f7a60 https://medicaldevicecourses.com/activity/p/23773/ Mon, 18 Oct 2021 13:45:34 -0400 I believe that the best way a medical device company can induce excitement on the release of their product is by trying to keep up with the latest trends in technology related culture today. For instance, a big thing with…   Read more»

]]> 912a24544089530f8dccc7dc41a5c51b https://medicaldevicecourses.com/activity/p/23624/ Wed, 06 Oct 2021 19:23:22 -0400 Any flaw that can be discovered in the manufacturing of a medical device, would be a substantial factor that influences quality assurance with regards to a medical device project. They (the QA team) usually preemptively end up catching the potential…   Read more»

]]> 36eef0574a9c7bc85caad757e57d9782 https://medicaldevicecourses.com/activity/p/23623/ Wed, 06 Oct 2021 19:23:21 -0400 The root cause analysis process is applied in my department at work all the time. I work for a occupational testing services, forensic toxicology laboratory. The department screens for drug substances in human specimens, as well as review the data,…   Read more»

]]> 2bc82c5129feb196af1417c07aa28719 https://medicaldevicecourses.com/activity/p/23622/ Wed, 06 Oct 2021 19:23:20 -0400 A substantial way that I believe can improve the way we keep up to date with the latest technologies and implementations is by employing more younger staff and personnel. Another way is by utilizing forums that are open to students…   Read more»

]]> f3dd8e7db7b99d995707051b510b30ec https://medicaldevicecourses.com/activity/p/23532/ Thu, 30 Sep 2021 13:04:02 -0400 @gaberuiz13 Great point here regarding the fact that precision requires devices to perform in a similar way consistently so that the same results are produced each time. Branching off of that, its especially crucial for validation or comprehensive checks where…   Read more»

]]> 698badbcbe55fe43122a97b7a7923e83 https://medicaldevicecourses.com/activity/p/23531/ Thu, 30 Sep 2021 13:04:01 -0400 As far as whether or not the FDA should be responsible for if a food is labeled “organic” that it should be 100% organic, I don’t believe that is the case, nor should it be the case. As per information…   Read more»

]]> caf2d33cc9791e31e587ea732a34c8bc https://medicaldevicecourses.com/activity/p/23530/ Thu, 30 Sep 2021 13:04:01 -0400 At first I would have had to agree with your sentiment in that its non sensical to compare a new medical device now to a medical device of 40 years ago for a pre market approval or 510(k). However, after…   Read more»

]]> 329453d04969f99f4d793decce2b5dc8 https://medicaldevicecourses.com/activity/p/23432/ Thu, 23 Sep 2021 12:56:24 -0400 There is that ethical debate on using animals for scientific research and how most people are against the act of that, but have no issue with killing animals for food. There are a few reasons for this, I believe. One…   Read more»

]]> 5e14bc480af2df2f770d5ea162e3d470 https://medicaldevicecourses.com/activity/p/23431/ Thu, 23 Sep 2021 12:56:24 -0400 There is that ethical debate on using animals for scientific research and how most people are against the act of that, but have no issue with killing animals for food. There are a few reasons for this, I believe. One…   Read more»

]]> b4fec9a5c1a1de542d2150eef2385e4d https://medicaldevicecourses.com/activity/p/23430/ Thu, 23 Sep 2021 12:56:23 -0400 The Nobel prize incentive of recognition and publishing should be considered as a decent excuse for an “upper management” figure for evaluating the performances of professors for their projects. A different form of this probably would not set the ball…   Read more»

]]> 0443166c1f39e508461e54ed83ded292 https://medicaldevicecourses.com/activity/p/23429/ Thu, 23 Sep 2021 12:56:22 -0400 @srp98 I would have to agree with you on what guideline I happen to think is the most important guideline for biomedical research on animals, “Responsibility for openness and sharing of data and material”. The biggest issue revolving around ethics…   Read more»

]]> 95bf8b2a348e363ea33ea22a91776e95 https://medicaldevicecourses.com/activity/p/23339/ Wed, 15 Sep 2021 21:55:41 -0400 I can imagine Scope Creep is quite frustrating to deal with and handle, not only for the team but also for the Project Manager. I think I’d like to express the whole ordeal in the analogy of a menu at…   Read more»

]]> a6025f4b75b5f474271def12e0c80c60 https://medicaldevicecourses.com/activity/p/23224/ Wed, 08 Sep 2021 12:07:15 -0400 I would much rather for my work to be from a fully remote position. Much like others, a hybrid (half remote/half onsite) type of setup is not too bad either. As mentioned earlier by others, flexibility is a huge factor…   Read more»

]]> 55ed182afdaa5dd855a95116a8e0588a https://medicaldevicecourses.com/activity/p/23220/ Wed, 08 Sep 2021 12:07:00 -0400 @jaf22 I would have to agree with you there with more classes needing to be offered that have a practical application in hardware/software integration, with that Biorobotics course especially. A basic C# coding class should be required, however all of…   Read more»

]]> 0845fde4a5e7323806acbdeace8edddd https://medicaldevicecourses.com/activity/p/23219/ Wed, 08 Sep 2021 12:07:00 -0400 An obstacle I’ve encountered while working on a project with a team is a delay in terms of a hardware piece not being able to be delivered to us in time for assembling our product. This particular product was on…   Read more»

]]> 23ae9c759e4107722dc161752e2e4dac https://medicaldevicecourses.com/activity/p/23218/ Wed, 08 Sep 2021 12:06:59 -0400 An obstacle I’ve encountered while working on a project with a team is a delay in terms of a hardware piece not being able to be delivered to us in time for assembling our product. This particular product was on…   Read more»

]]> 62cc473f71de2a410f33fd801541dfcb https://medicaldevicecourses.com/activity/p/23217/ Wed, 08 Sep 2021 12:06:58 -0400 Basing off a week 2 lecture in the BME 684 course, I believe a good project manager should excel at quick thinking on their feet. Project managers should pick up the slack where other members of the team are lacking…   Read more»

]]> 97b44ac4803d0846dc8c2f166191e8b7 https://medicaldevicecourses.com/activity/p/23183/ Tue, 07 Sep 2021 01:06:08 -0400 @sseal98 I would have to agree with you in that particular point you made about BME lacking focus because the applications of it are so vast. That is probably the main reason why we as Biomedical Engineering majors do not…   Read more»

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