Medical Device Courses | rachelpatel1796 | Activity https://medicaldevicecourses.com/members/rachelpatel1796/activity/ Activity feed for rachelpatel1796. Fri, 24 Apr 2026 20:47:02 -0400 https://buddypress.org/?v= en-US 30 hourly 2 d318e2310f3d5e2b359183d3c1d37e97 rachelpatel1796 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/14437/ Wed, 15 May 2019 18:56:57 -0400 Dr. Simon, I did go into this class thinking it would be like the rest, but I do believe your consistency is putting up lectures and keeping them interesting was why your course was different and little bit more to…   Read more»

]]> 10fcfb165fb09ca67505f63b59594e59 rachelpatel1796 replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/14436/ Wed, 15 May 2019 18:56:56 -0400 I do believe that this is too restricted, to go as not paying for the physician’s wife to a dinner. I believe that these companies should have some type of budget that they know they are willing to spend regardless…   Read more»

]]> dc2453ffc369a2c3c6e9d2d0e5c4525f rachelpatel1796 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/14430/ Wed, 15 May 2019 18:56:53 -0400 Verbal agreements can be enforced, and are constantly used in the medical field. When a patient cannot make their own decision and their life is in an emergency life-threatening situation that requires certain medical procedures, the guardian of the patient…   Read more»

]]> 0460e14a9c932622074774522dd841ed rachelpatel1796 replied to the topic "Upper vs Middle Management." - https://medicaldevicecourses.com/activity/p/14283/ Wed, 15 May 2019 18:54:44 -0400 I also believe that I could do both. I believe that I have the leadership qualities to set a vision and to make sure that it gets done to completion. However, I would be more comfortable in middle management. Setting…   Read more»

]]> 40464be7ebdba06e31a6a092f856f23d rachelpatel1796 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/14281/ Wed, 15 May 2019 18:54:43 -0400 I think a little bit of both would be the best in terms of creating a team. If you know who you want to work with, you already have an idea of that person’s skill set and their capabilities of…   Read more»

]]> a207d432178a491e17d4e8c3f36e153b rachelpatel1796 replied to the topic "Collaboration projects" - https://medicaldevicecourses.com/activity/p/14275/ Wed, 15 May 2019 18:54:40 -0400 I believe when two companies team up, there needs to be some type of organization that occurs so that effective communication occurs and that the product is being developed well enough to be put on to the market. As said…   Read more»

]]> b72594fd56e96d1c6380354fc6032192 rachelpatel1796 replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/14173/ Wed, 15 May 2019 18:52:43 -0400 As the professor says, plainly putting something on the label does not help manage risk for the user. He describes that the instructions on the packages of equipment never get read, which is true for the most part. A lot…   Read more»

]]> e417e9ebe70049be18d118af20d59246 rachelpatel1796 replied to the topic "Usability Risk Analysis" - https://medicaldevicecourses.com/activity/p/14152/ Wed, 15 May 2019 18:52:32 -0400 I believe that the Task Analysis and the Use Error analysis is a good way to asses product design risks. Older models tend to neglect the psychological aspects of the individual user. Also, traditional human factors methods only detect errors…   Read more»

]]> 9ad4d8054f756fc69b6a094c9a54a0d0 rachelpatel1796 replied to the topic "Factors Contributing to Risk Values" - https://medicaldevicecourses.com/activity/p/14136/ Wed, 15 May 2019 18:52:21 -0400 Other factors should also contribute to the risk value. The EDP audit staffs usually look for both threat and vulnerability in the corporate information systems. Usually, this can take some time to evaluate. Other factors to consider would be the…   Read more»

]]> 2474dd42f6c332a265fb82d0d3731604 rachelpatel1796 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/13995/ Wed, 15 May 2019 17:10:16 -0400 Each manufacturer is responsible for establishing and maintained a procedure to ensure that design requirements relating to device are appropriate and address the intended use of the device. The design input requirements should be documented and approved by a designated…   Read more»

]]> a1ed7658fa0b7fd340cb40d55dbfabec rachelpatel1796 replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/13992/ Wed, 15 May 2019 17:10:14 -0400 Although I have no been involved in any industry jobs, I had the pleasure of having design meetings with my capstone group in order to create a product for an outside company. I plan to continue to work with this…   Read more»

]]> 1671451c0f975d0139b81b8a3c14681c rachelpatel1796 replied to the topic "What FDA Looks For In A Design Control System ?" - https://medicaldevicecourses.com/activity/p/13990/ Wed, 15 May 2019 17:10:13 -0400 The FDA has very strict guidelines that have to be followed in order to have a device reach the market. These protocols are just standard for FDA. The device may also need to be classified in terms of a Class…   Read more»

]]> 932917122200cee6dc83fca7836be3dd rachelpatel1796 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/13988/ Wed, 15 May 2019 17:10:12 -0400 I have yet to work in industry, but I do have experience in creating gantt charts in my capstone class in high school and during my undergraduate years in BME. I feel that sometimes the timelines are always off or…   Read more»

]]> f1c2f067902679601fd085b4a14a82d4 rachelpatel1796 replied to the topic "Customer Needs, Business Requirements, Test Plan" - https://medicaldevicecourses.com/activity/p/13981/ Wed, 15 May 2019 17:10:07 -0400 I also am taking capstone, where the requirements are the same. I am working with another orthopedics company in hopes of finding a way to create a product that fits their requirements and works well with the body. Along with…   Read more»

]]> 0537ce08ac93a85eb02cdb147e4e9529 rachelpatel1796 replied to the topic "Customer Needs, Business Requirements, Test Plan" - https://medicaldevicecourses.com/activity/p/13839/ Wed, 15 May 2019 17:08:41 -0400 I am currently also in the BME Capstone class, as I am in my senior year. I also had to make an extensive list for the design requirements and customer needs. We met with our customer and they told us…   Read more»

]]> f5bec643dd89cfbe83123992476dd905 rachelpatel1796 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/13838/ Wed, 15 May 2019 17:08:41 -0400 I have also yet to work in industry, but I do have experience in creating a gantt chart in high school, for my capstone class, and again at NJIT in my current capstone class. Both times, I believe the easiest…   Read more»

]]> 6e323e631f3b25b88c933ec345161873 rachelpatel1796 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/13835/ Wed, 15 May 2019 17:08:39 -0400 There have been countless amount of times where minutes served its actual purpose of re-capping what was said at the meeting and what new deadlines were established that needed to get done. Even for people that were not at the…   Read more»

]]> fa5170d6869d7d075aa1da56969c9b2b rachelpatel1796 replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" - https://medicaldevicecourses.com/activity/p/13754/ Wed, 15 May 2019 17:07:55 -0400 In terms of the Henrietta Lacks case, I do believe that it was immoral for what they did, and even gave their family no compensation when they asked. However, since the rise of informed consent, I do believe that people…   Read more»

]]> 56e1dac276fed0847dccce919642cfbd rachelpatel1796 replied to the topic "Clinical Studies" - https://medicaldevicecourses.com/activity/p/13751/ Wed, 15 May 2019 17:07:54 -0400 I believe that clinical studies are necessary in order to determine the best possible treatment for a disease or other pathology. There are some advantages to the participant as well, being monetary compensation and follow up check-ups for a potential…   Read more»

]]> da032ac1cd69686702b0df58ea79a087 rachelpatel1796 replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" - https://medicaldevicecourses.com/activity/p/13724/ Wed, 15 May 2019 17:07:34 -0400 Placebo-controlled trials have been around in clinical testing for a long time. Placebos mainly act as a control procedure that needs to be done in order to keep all the variables the same, except for the actual drug. It can…   Read more»

]]> da530d6b6a418c221796b6b23644bbd6 rachelpatel1796 replied to the topic "Fuzz before launch of product." - https://medicaldevicecourses.com/activity/p/13626/ Wed, 15 May 2019 17:06:41 -0400 Many newly medical device companies usually showcase their new medical devices by attending conferences and expos. They also advertise through email and websites, detailing their products and why it is a good fit for many customers. The marketing strategy for…   Read more»

]]> 21045d558ad021d84876f43ebd962679 rachelpatel1796 replied to the topic "Manipulation or no?" - https://medicaldevicecourses.com/activity/p/13618/ Wed, 15 May 2019 17:06:34 -0400 Manipulation and persuasion both describe the same thing but have different methods of achieving the same result. Manipulation deliberately markets certains aspects of a device or feature to a target audience, leaving out crucial details of the product. On the…   Read more»

]]> b4acd805e7162bfae6ab9fe7b22c1998 rachelpatel1796 replied to the topic "Medical Device SWOT Analysis" - https://medicaldevicecourses.com/activity/p/13615/ Wed, 15 May 2019 17:06:31 -0400 Siemens Healthcare is a global medical device company which undertakes the design, development, manufacture, and distribution of medical devices and technologies for diagnostic markets. Siemens offers various imaging equipment, healthcare information systems, management consulting and support services. It is a…   Read more»

]]> 16a75193f9550068a029e354c81e8103 rachelpatel1796 replied to the topic "Discussion Topic: Inc. vs. LLC in the US" - https://medicaldevicecourses.com/activity/p/13427/ Wed, 15 May 2019 17:04:48 -0400 A medical device company that has 50 people and $10 million in revenue, there has to be a comparison between an Inc corporation and an LLC corporation in order to maximize all the benefits. An advantages of an LLC is…   Read more»

]]> a6158ddacec5acf878c62f9a3b2647df rachelpatel1796 replied to the topic "Public vs. Private Companies" - https://medicaldevicecourses.com/activity/p/13426/ Wed, 15 May 2019 17:04:47 -0400 The main difference between a public and a private corporation is that the public corporation have shares that can be traded and enlisted in the stock market. There are also differences in the management between the two. Public corporations are…   Read more»

]]> 72f509191b8c0cf49996de455a0c56b9 rachelpatel1796 replied to the topic "Corporate Veil" - https://medicaldevicecourses.com/activity/p/13421/ Wed, 15 May 2019 17:04:45 -0400 There are several reasons that a court can use in order to pierce the corporate veil. As thuytienlecao listed above, more than one reason can exist in order for a court to hold off on being liable and hold a…   Read more»

]]> 0b558d3ce93d040e88c5e5ac2b95856c rachelpatel1796 replied to the topic "Your Ideas about Improving Quality Control" - https://medicaldevicecourses.com/activity/p/13352/ Wed, 15 May 2019 17:04:13 -0400 I agree with a lot of akshayakirthy’s points when it comes to involving the employees in quality control. It is highly important to have written guidelines and rules in order for all the employees to follow. When it comes to…   Read more»

]]> 8911eb6f587ed89b3c0ffec31d993adf rachelpatel1796 replied to the topic "Quality Control and Quality Assurance + Ethics" - https://medicaldevicecourses.com/activity/p/13331/ Wed, 15 May 2019 17:03:57 -0400 Although I have not been exposed to a major ethical issue regarding quality control, I still know that it occurs, especially when it deals with hospital equipment. When I was shadowing a phlebotomist (a person who draws blood from patients)…   Read more»

]]> ed389c8e044f648a928c4ed50bf3d061 rachelpatel1796 replied to the topic "Good Quality Control or Quality Assurance Department" - https://medicaldevicecourses.com/activity/p/13318/ Wed, 15 May 2019 17:03:51 -0400 Working in a laboratory in a hospital, there are many quality control departments that come to inspect the area. The specific company is known as CAPS (College of American Pathologists) which accredits the entire spectrum of laboratory test disciplines using…   Read more»

]]> 727f538cf9bc5b43e8177b251218ca88 rachelpatel1796 replied to the topic "FDA rules too strict?" - https://medicaldevicecourses.com/activity/p/13186/ Wed, 15 May 2019 17:02:43 -0400 I believe that the FDA’s strict rules are necessary to protect the public and what they consume on a daily basis. Although there is a long process that needs to be taken in order to get a drug on the…   Read more»

]]> 7d67000d63ddd97c671a3bdf76dfaadb rachelpatel1796 replied to the topic "Combination Product" - https://medicaldevicecourses.com/activity/p/13160/ Wed, 15 May 2019 17:02:30 -0400 A collagen coated vascular prosthesis is considered a combination product. The product is used as a vascular graft and considered non-porous by coating it with a layer of collagen, taken from young calf skin. These grafts were implemented in the…   Read more»

]]> a13bfe2552ac5286bca2f1ca41192ee3 rachelpatel1796 replied to the topic "FDA rules too strict?" - https://medicaldevicecourses.com/activity/p/13153/ Wed, 15 May 2019 17:02:26 -0400 I believe that the FDA’s strict rules are necessary to protect the public and what they consume on a daily basis. Although there is a long process that needs to be taken in order to get a drug on the…   Read more»

]]> 28234d55f72dc5e2584ff29c3fd49fb8 rachelpatel1796 replied to the topic "FDA on Recalled Items" - https://medicaldevicecourses.com/activity/p/13151/ Wed, 15 May 2019 17:02:25 -0400 One product that was on recall by the FDA was the Insulin Corporation Omnipod Insulin Management System. This product is basically a small pod that you fill with insulin, attach to any part of the body that will receive the…   Read more»

]]> 83a08a0dc9e8543c42cb1176a9718610 rachelpatel1796 replied to the topic "Discussion Topic: e-cigarettes" - https://medicaldevicecourses.com/activity/p/13140/ Wed, 15 May 2019 17:02:20 -0400 E-cigarettes are currently regulated by the FDA, as said by their website. Since e-cigarettes use electronic nicotine delivery systems, it is regulated by the FDA. Although not all e-cigarettes contain nicotine, they are still regulated by the FDA because they…   Read more»

]]> 37e1e5efbca0ceb631b295ceb657e9ad rachelpatel1796 replied to the topic "Research for the Fututre or Now?" - https://medicaldevicecourses.com/activity/p/13004/ Wed, 15 May 2019 17:01:10 -0400 Although both types of research are important, I do believe that research for the future is more important than research for now. Companies make research important for the current generation in order to remain relevant to the public and in…   Read more»

]]> 252354fa12448acdb3c3d3504ea62f13 rachelpatel1796 replied to the topic "Failure's of Pre-Clinical / Clinical Research" - https://medicaldevicecourses.com/activity/p/12999/ Wed, 15 May 2019 17:01:07 -0400 I have assisted in many pre-clinical and clinical research opportunities to know a lot of the ways that it can go wrong. I specifically worked with rats and performing surgery to remove their brain and basically freeze them in a…   Read more»

]]> 97f871b16363248a7341bf807355d07c rachelpatel1796 replied to the topic "Approaches to Research" - https://medicaldevicecourses.com/activity/p/12997/ Wed, 15 May 2019 17:01:06 -0400 Research in academia and industry both has its advantages and disadvantages. I have only been exposed to the academia portion of research as a student at NJIT. However, as mentioned in the lecture, there is little pay. However, there is…   Read more»

]]> 0f8a39748e8b2480c9fc802562570c85 rachelpatel1796 replied to the topic "Discussion Topic: Project Management in a medical device setting" - https://medicaldevicecourses.com/activity/p/12761/ Wed, 15 May 2019 16:58:56 -0400 Project management for medical devices and building a school or skyscraper are very different projects which require different planning and execution phases. Medical devices should be planned in a way to ensure that the device will work and not cause…   Read more»

]]> 6874305ad013db611f2868ccd0fcc8e1 rachelpatel1796 replied to the topic "Project Life Cycle" - https://medicaldevicecourses.com/activity/p/12760/ Wed, 15 May 2019 16:58:55 -0400 I do believe that there are two important phases in the project cycle. The controlling process and the planning process are absolutely crucial in running the project to completion. Although all of the phases are very important, I do believe…   Read more»

]]> 1b19d61dab17d315fa833ca8b9577952 rachelpatel1796 replied to the topic "Obstacles while working on a project" - https://medicaldevicecourses.com/activity/p/12758/ Wed, 15 May 2019 16:58:54 -0400 There were multiple times where a problem had caused me to have detrimental effects on a project. Most of the time, the problem arises from poor planning, which is a crucial step in the project life cycle. A capstone project…   Read more»

]]> 7c2c9c2771debb216bd6e171d3cec8f7 rachelpatel1796 replied to the topic "Advice for Biomedical Engineering Students" - https://medicaldevicecourses.com/activity/p/12700/ Wed, 15 May 2019 16:58:21 -0400 Just like akashranpura, I am also still in my senior year of undergrad. A lot of the posters above say to do an internship, and I do believe this will be valuable if the person is working as a BME….   Read more»

]]> 49b4f822bbdfb101e8afe9d0b229b1f7 rachelpatel1796 replied to the topic "Discussion Topic: Academia vs. Industry" - https://medicaldevicecourses.com/activity/p/12691/ Wed, 15 May 2019 16:58:16 -0400 There are many differences one has to consider when deciding what career path to choose. I am not too exposed to the aspects of the industry field, but I have been exposed to research for about 3 years. An academic…   Read more»

]]> 7fc57d136c114370b989bd5240ab07b4 rachelpatel1796 replied to the topic "Discussion Topic: Practical vs. Informational courses" - https://medicaldevicecourses.com/activity/p/12683/ Wed, 15 May 2019 16:58:11 -0400 Personally, I do believe practical knowledge is essential in order to learn the various tasks required in the job market as a BME, but informational classes are just as necessary. Informational classes detail the information that needs to be learned,…   Read more»

]]> 6000cda710df8b15b7f8797bdc582ecf rachelpatel1796 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5487/ Sun, 03 Dec 2017 22:37:43 -0500 Dr. Simon,

I did go into this class thinking it would be like the rest, but I do believe your consistency is putting up lectures and keeping them interesting was why your course was different and little bit more to my taste. As a pre-med student, hoping to enter medical school next year, I believe this course has given me a bit more…[Read more]

]]> 0 3e8f2b3eeb31d7b7f3de6794422cfd5d rachelpatel1796 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5486/ Sun, 03 Dec 2017 22:22:57 -0500 I do believe that this is too restricted, to go as not paying for the physician’s wife to a dinner. I believe that these companies should have some type of budget that they know they are willing to spend regardless of who is involved, even if that person was not part of the actual project. Companies can also make it clear that they should not…[Read more]

]]> 0 12cad0a36d143cdcc41e5923e6171ed8 rachelpatel1796 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5480/ Sun, 03 Dec 2017 21:41:10 -0500 Verbal agreements can be enforced, and are constantly used in the medical field. When a patient cannot make their own decision and their life is in an emergency life-threatening situation that requires certain medical procedures, the guardian of the patient can make a quick verbal agreement in order to save the patient’s life as long as the…[Read more]

]]> 0 e59526243460cf067576b85d845887d0 rachelpatel1796 replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5323/ Sun, 26 Nov 2017 22:05:46 -0500 I also believe that I could do both. I believe that I have the leadership qualities to set a vision and to make sure that it gets done to completion. However, I would be more comfortable in middle management. Setting daily tasks and being organized are my strengths and I feel that each day another goal needs to be accomplished in order to get…[Read more]

]]> 0 70b35f68f858cdc1aa4c618326e7a9e6 rachelpatel1796 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5321/ Sun, 26 Nov 2017 21:47:20 -0500 I think a little bit of both would be the best in terms of creating a team. If you know who you want to work with, you already have an idea of that person’s skill set and their capabilities of getting things done when prompted to do so. However, sometimes there may be another individual that you may not know well, but who is more knowledgeable in…[Read more]

]]> 0 bef9ed3d9c0197018c56125c50ac288e rachelpatel1796 replied to the topic Collaboration projects in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5315/ Sun, 26 Nov 2017 21:28:53 -0500 I believe when two companies team up, there needs to be some type of organization that occurs so that effective communication occurs and that the product is being developed well enough to be put on to the market. As said previously, I believe that the matrix organization is the best way to keep that good management and keep a good communication…[Read more]

]]> 0 2aeb96464423707bb05cc30431596bc0 rachelpatel1796 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5207/ Mon, 20 Nov 2017 02:08:06 -0500 As the professor says, plainly putting something on the label does not help manage risk for the user. He describes that the instructions on the packages of equipment never get read, which is true for the most part. A lot of companies can help by maybe holding seminars about the equipment and teach surgeons and technicians how to use the equipment…[Read more]

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