https://medicaldevicecourses.com/members/akashranpura/activity/ Activity feed for akashranpura. Fri, 24 Apr 2026 20:47:02 -0400 https://buddypress.org/?v= en-US 30 hourly 2 deb38eef4f08a5966c0bb65e8d0d1ec8 https://medicaldevicecourses.com/activity/p/14424/ Wed, 15 May 2019 18:56:00 -0400 A NDA is a non-disclosure agreement. While a patent is something that is filed to protect a developing property. In a NDA, the people who have signed it must keep the information confidential and secret. The NDA is seen as…   Read more»

]]> 45c4e35d0d4be77eebd19bd08d7e287a https://medicaldevicecourses.com/activity/p/14423/ Wed, 15 May 2019 18:55:59 -0400 The risks of starting a new project on just a Verbal Agreement is that there is tremendous room for genuine misunderstandings. The other team may not fully understand the nuances of the contract and because it was orally made there…   Read more»

]]> 01c4850978e177386438add3581a7888 https://medicaldevicecourses.com/activity/p/14421/ Wed, 15 May 2019 18:55:58 -0400 Throughout my undergraduate experience, there has never been a class that helped relate what I learned in the classroom to real life. I did not have first hand knowledge of the various opportunities engineers have coming out of college. This…   Read more»

]]> fb2dbf60670f94af840daae745e00f39 https://medicaldevicecourses.com/activity/p/14234/ Wed, 15 May 2019 18:54:17 -0400 When building a team many people make the mistake of just picking people they know really well. While yes this brings some form of comfortability to the team, the end results might be poor. When working with friends, one tends…   Read more»

]]> 56189d169b695f0c76d4f1c5c910cfb5 https://medicaldevicecourses.com/activity/p/14233/ Wed, 15 May 2019 18:54:17 -0400 When dealing with a medical device company, the best way to form the company would be through the marriage of a matrix organization and a geographical organizational structure. Because this company is providing products throughout the world, there must be…   Read more»

]]> bafc2f457b48ff3b1a5306f86bb27efd https://medicaldevicecourses.com/activity/p/14232/ Wed, 15 May 2019 18:54:16 -0400 The organization I would like to work in should be Project based organization. Something I value is the ability to work as a team on a specific job. And being part of a project based organization, I would have the…   Read more»

]]> 13305fc7fbd4216cf6aa0417759d3a2f https://medicaldevicecourses.com/activity/p/14099/ Wed, 15 May 2019 18:51:54 -0400 When looking at risk-benefit analysis, one is basically answering the question “is the risk worth it?” To answer this question a thorough analysis needs to be done on the trade-offs of the product. Statistical measures need to be taken in…   Read more»

]]> 7d5c7370af5575acd6f15250caecbebb https://medicaldevicecourses.com/activity/p/14098/ Wed, 15 May 2019 18:51:53 -0400 When dealing with low severity risks it can be deemed worthy to accept the risk. By using the strategy of risk acceptance you can anticipate or adjust for greater profit margins and this should cover for the risks. Because the…   Read more»

]]> 469acf532c70eb6bcbb6962b1565652a https://medicaldevicecourses.com/activity/p/14097/ Wed, 15 May 2019 18:51:53 -0400 There are several ways of managing risk. Being part of a medical device company, it is integral to understand and predict certain risks and dangers the product might face. One form of risk management is risk mitigation. Risk Mitigation is…   Read more»

]]> 87283b1bdedd4cabd69c8f3a92fc64dc https://medicaldevicecourses.com/activity/p/13994/ Wed, 15 May 2019 17:10:15 -0400 Design inputs are critical to medical device development. The design requirements can be a document that can prove if the product will have issues or not. Usually, products that result in failure is due to faulty design inputs. The design…   Read more»

]]> a793232fc69ca0357a47f34e942eb0ae https://medicaldevicecourses.com/activity/p/13993/ Wed, 15 May 2019 17:10:14 -0400 Whenever production of a product needs to be exported, there are several production issues to look out for. When exporting the production design, it is integral to have strict, concise, and clear instructions for the other company. Also there needs…   Read more»

]]> a8047284e3891e2243498ba3243e3640 https://medicaldevicecourses.com/activity/p/13991/ Wed, 15 May 2019 17:10:13 -0400 The DHF is an integral part of the project design and development aspect. The DHF must be a set of documents that clearly states the intricacies of the product. The DHF must be continually updated in order to have the…   Read more»

]]> cb5ad181ec70085ab4b00a8fd11a7e04 https://medicaldevicecourses.com/activity/p/13845/ Wed, 15 May 2019 17:08:44 -0400 Design controls are parameters that are vital to the completion of a medical device. These controls are given out in conjunction with the customer needs. In fact, the design controls are put together in response to the customer needs and…   Read more»

]]> 5c8c58b327d6e7101afaf50ba9a17a00 https://medicaldevicecourses.com/activity/p/13843/ Wed, 15 May 2019 17:08:43 -0400 I have had to make a Gantt chart twice through my academic career. The first time I made a Gantt chart was in high school as a senior. We had a capstone project and in order to keep the team…   Read more»

]]> 519eb49354ce7175f0f4b47cd6904cdf https://medicaldevicecourses.com/activity/p/13842/ Wed, 15 May 2019 17:08:43 -0400 Being part of the BME capstone class this semester, many of the criteria and aspects detailed above are something I have encountered and worked on. For my particular project we are working with an outside company, not just a professor…   Read more»

]]> 9c2093172ae75fc0b32fe31938ec9c67 https://medicaldevicecourses.com/activity/p/13731/ Wed, 15 May 2019 17:07:38 -0400 When looking at the benefits of clinical studies, it is hard not to look at the potential risks of such studies. In clinical trials where the patient’s life is at risk there are always measures taken to warn the patient…   Read more»

]]> 54f5312b29a2d29e9afcaa149cfe9d90 https://medicaldevicecourses.com/activity/p/13720/ Wed, 15 May 2019 17:07:31 -0400 Placebo controlled trials are a staple of medical trials. Placebo trials allow for researchers to understand the efficacy of a novel drug or procedure. There is always concern for ethical issues when providing placebo therapy because certain patients will not…   Read more»

]]> b620b07e81c1f72f2f0464b4c67af9e6 https://medicaldevicecourses.com/activity/p/13718/ Wed, 15 May 2019 17:07:30 -0400 I can understand your hesitation on working with a double blind study. However, a double blind study at times is necessary to obtain clear unbiased results. There have been times where studies have been manipulated by doctors or principal investigators….   Read more»

]]> 07176c07c83252b804a1088ca3ed7681 https://medicaldevicecourses.com/activity/p/13629/ Wed, 15 May 2019 17:06:43 -0400 Creating fuss for a medical device is hard because many times a product is for a specific population, and this would usually be a small percentage of people. Therefore, it is difficult to get a large group of people excited….   Read more»

]]> e732338f3b00040c6fef3d50a3c259dd https://medicaldevicecourses.com/activity/p/13616/ Wed, 15 May 2019 17:06:32 -0400 Advertising manipulation versus persuasion is an interesting topic to look into in terms of product marketing. Advertisements surround us everywhere we go, ranging from social media to televisions. In fact, advertising has become geared towards becoming personal and intimate. Companies…   Read more»

]]> 2f31ec237aaec1628f642d16e3a71a26 https://medicaldevicecourses.com/activity/p/13614/ Wed, 15 May 2019 17:06:31 -0400 A SWOT Analysis of Biomet. Strengths: – Strenght of expertise in orthopedic implants – Strong reputation as a lot of surgeons prefer Biomet over other companies – Biomet has been a top company for years and has tremendous profits -…   Read more»

]]> efe336d9556506e603dab7ce9bc62d1a https://medicaldevicecourses.com/activity/p/13430/ Wed, 15 May 2019 17:04:49 -0400 When looking at choosing between an Inc or a LLC it is important to realize the necessity to pick what is best for the company. An LLC is good for protecting the business owners and will protect any personal assets….   Read more»

]]> b372cc790f9fa5b9ad3042c43a41da9f https://medicaldevicecourses.com/activity/p/13429/ Wed, 15 May 2019 17:04:49 -0400 There are several differences between public and private companies. One of the main differences is that public companies will have shares in the open tradable market. Private companies’ goals are not likely to focus on increasing value of the company….   Read more»

]]> 4170fd2a165dee1812d7a6ed9996214a https://medicaldevicecourses.com/activity/p/13428/ Wed, 15 May 2019 17:04:48 -0400 If I were to start my own corporation, I would start a Limited Liability Partnership. One of the main reasons I would choose this is because of the autonomy provided by this corporation structure. Also all profits will directly come…   Read more»

]]> 2cf887eac84e4261a1360ae0b8df81c2 https://medicaldevicecourses.com/activity/p/13328/ Wed, 15 May 2019 17:03:56 -0400 I can understand why documentation can be an annoyance as well unnecessary to a certain extent. However, it is an integral step in preventing certain mishaps and keeping everything in accord. The main reason companies document things is to make…   Read more»

]]> ad924e43da92d2cc80de1c5cf0ebf65c https://medicaldevicecourses.com/activity/p/13326/ Wed, 15 May 2019 17:03:55 -0400 In order to be successful as a company it is imperative to have a strong and healthy relationship between the quality control department and the rest of the company. The goal of each department is to come together and bring…   Read more»

]]> db2314aa3acc819c35f6ecc67f15cd1f https://medicaldevicecourses.com/activity/p/13323/ Wed, 15 May 2019 17:03:54 -0400 The problem many see with quality control is the amount of effort put into it. There are certain aspects of quality control that require tremendous amount of time and input. Companies tend to neglect the quality control part because they…   Read more»

]]> 062011ef4e955fdb3e9e2c0facea254f https://medicaldevicecourses.com/activity/p/13143/ Wed, 15 May 2019 17:02:21 -0400 I can see why many would think the FDA are being strict and potentially hampering the journey of medical devices. However, the FDA is a regulatory board and its main job is to be an overruling force. If the FDA…   Read more»

]]> b7535e41507e991c6697c7c909e86965 https://medicaldevicecourses.com/activity/p/13142/ Wed, 15 May 2019 17:02:21 -0400 A recalled item was Boston Scientific Corporation’s Chariot Guiding Sheath. Almost 6000 of these devices were recalled. The Guiding Sheath is used to help guide placement of interventional devices into peripheral vasculature. The reason for the recall was that fourteen…   Read more»

]]> be754dfa865d38585377319a41680015 https://medicaldevicecourses.com/activity/p/13141/ Wed, 15 May 2019 17:02:20 -0400 Trump’s new budget proposal of a 2-billion-dollar increase in the FDA User fees has its merits but can also be a drawback. One of the biggest merits of this change would be the increased benefits for the taxpayers. However, as…   Read more»

]]> 8708136d2c4430a32d54431f09955a73 https://medicaldevicecourses.com/activity/p/12978/ Wed, 15 May 2019 17:00:57 -0400 When outsourcing animal studies to other institutions there are several pitfalls that need to be addressed and looked into. One of the first ones is the distance between the university and the company. It is critical to ensure that if…   Read more»

]]> 0beca256a3ddbd59e1ad5d516a3575ef https://medicaldevicecourses.com/activity/p/12976/ Wed, 15 May 2019 17:00:56 -0400 The research I have done is working with the metabolic pathways of a fungus that is fatal for immunocompromised patients. While the work I am doing is crucial to understand the pathogenic tendencies of this fungus, the impact it has…   Read more»

]]> af6d2a00393114d32a0f55db6c4f1f6f https://medicaldevicecourses.com/activity/p/12975/ Wed, 15 May 2019 17:00:55 -0400 Looking into the divides between industry research and academic research, what stands out is the underlying motivation of each. Industrial research labs will tend to place most if not all their resources on monetizing their results. The end goal for…   Read more»

]]> 9ecbcc196bc49dffdb5027f4db9567d4 https://medicaldevicecourses.com/activity/p/12755/ Wed, 15 May 2019 16:58:53 -0400 Every phase of the project life cycle is vital to the success of the project. However, certain parts of the life cycle can be a lot more crucial to the success of the project. In my opinion the executing phase…   Read more»

]]> 0fab16ef8c5d4607c356694957df3d4c https://medicaldevicecourses.com/activity/p/12753/ Wed, 15 May 2019 16:58:52 -0400 In my freshman year of college, I had to participate in an engineering design project, where I would work with a team to create and code a robot to perform medically related tasks. One of the obstacles faced while working…   Read more»

]]> 68b8778f5c006dcbd2d2d1e4059a6ce4 https://medicaldevicecourses.com/activity/p/12752/ Wed, 15 May 2019 16:58:51 -0400 Project management for varying fields of work differ in the challenges they face and how they have to be tackled. When being a project manager for building a school or skyscraper, there are more mechanical regulations that need to be…   Read more»

]]> 0bbe076ab14e10ee88006da845c5b452 https://medicaldevicecourses.com/activity/p/12669/ Wed, 15 May 2019 16:58:04 -0400 Being a current undergraduate student at NJIT, I believe there should be more practical courses implemented not only at a graduate level but also at an undergraduate level. Most classes that I have taken have been heavy knowledge based. While…   Read more»

]]> ee2b320b76bd94a2a0cb4422df7b37fa https://medicaldevicecourses.com/activity/p/12667/ Wed, 15 May 2019 16:58:03 -0400 Looking at this from a current student’s perspective, I can state that all the advice given above is extremely valuable. I am currently a senior and throughout my past four years something that I have heard constantly is the importance…   Read more»

]]> 08d5dc581a77171c3369493d64378a9a https://medicaldevicecourses.com/activity/p/12650/ Wed, 15 May 2019 16:57:54 -0400 When looking into the debate of Academia vs. Industry it is important to first reflect upon how one would fit into either working atmosphere. Working in academia provides the opportunity to be around intellectual equals. In many senses this is…   Read more»

]]> 8dbb9cc4cc0e184869f646e3d86fa117 https://medicaldevicecourses.com/activity/p/5474/ Sun, 03 Dec 2017 20:24:57 -0500 A NDA is a non-disclosure agreement. While a patent is something that is filed to protect a developing property. In a NDA, the people who have signed it must keep the information confidential and secret. The NDA is seen as a contract and this separates it from the patent law. Contract laws are seen at a state level while patent laws take place on…[Read more]

]]> 0 ee4c4735a79c061595082c96fda1d659 https://medicaldevicecourses.com/activity/p/5473/ Sun, 03 Dec 2017 20:12:05 -0500 The risks of starting a new project on just a Verbal Agreement is that there is tremendous room for genuine misunderstandings. The other team may not fully understand the nuances of the contract and because it was orally made there is nothing to look back on to fully understand it. However, if the contract was a written contract it would be easier…[Read more]

]]> 0 ba5f6861211207fe0c2b2675150ab2d6 https://medicaldevicecourses.com/activity/p/5471/ Sun, 03 Dec 2017 19:52:08 -0500 Throughout my undergraduate experience, there has never been a class that helped relate what I learned in the classroom to real life. I did not have first hand knowledge of the various opportunities engineers have coming out of college. This was one of the main reasons why I took this course as I wanted to understand what happens after college. I…[Read more]

]]> 0 0eb3f63dcce502d0397d4cbcd055f07d https://medicaldevicecourses.com/activity/p/5270/ Fri, 24 Nov 2017 20:04:06 -0500 When building a team many people make the mistake of just picking people they know really well. While yes this brings some form of comfortability to the team, the end results might be poor. When working with friends, one tends to be complacent and it is hard to work cohesively, without getting distracted. Because you are working with your friends,…[Read more]

]]> 0 4f5c1f1d97f9bc940bc90488ae028eb9 https://medicaldevicecourses.com/activity/p/5269/ Fri, 24 Nov 2017 19:59:40 -0500 When dealing with a medical device company, the best way to form the company would be through the marriage of a matrix organization and a geographical organizational structure. Because this company is providing products throughout the world, there must be several divisional heads set up. Additionally, medical device companies have several branches…[Read more]

]]> 0 1717f262ebb21e92e2b96e8a0f43db13 https://medicaldevicecourses.com/activity/p/5268/ Fri, 24 Nov 2017 19:53:26 -0500 The organization I would like to work in should be Project based organization. Something I value is the ability to work as a team on a specific job. And being part of a project based organization, I would have the opportunity to work with a team and have a clear end goal in mind. This provides clarity as well as room for exploring and expanding…[Read more]

]]> 0 d06558289dbcb7f4d6fd7837274d5201 https://medicaldevicecourses.com/activity/p/5131/ Fri, 17 Nov 2017 20:06:29 -0500 When looking at risk-benefit analysis, one is basically answering the question “is the risk worth it?” To answer this question a thorough analysis needs to be done on the trade-offs of the product. Statistical measures need to be taken in order to fully understand and implement the risks versus reward of the product. When dealing with medical…[Read more]

]]> 0 963177965fc2d19beae2b63014c7dc90 https://medicaldevicecourses.com/activity/p/5130/ Fri, 17 Nov 2017 19:51:48 -0500 When dealing with low severity risks it can be deemed worthy to accept the risk. By using the strategy of risk acceptance you can anticipate or adjust for greater profit margins and this should cover for the risks. Because the risks taken in this case are minor, the adjustments needed will also be non-consequential. However, if the severity of the…[Read more]

]]> 0 387523b81e6b2e412f38d7163fcfff57 https://medicaldevicecourses.com/activity/p/5129/ Fri, 17 Nov 2017 19:46:14 -0500 There are several ways of managing risk. Being part of a medical device company, it is integral to understand and predict certain risks and dangers the product might face. One form of risk management is risk mitigation. Risk Mitigation is when the consequences of certain actions can be reduced or limited. This is used in cases where risk is…[Read more]

]]> 0 236e94b0fdc8dc505b7b63b0dcc420df https://medicaldevicecourses.com/activity/p/5014/ Sun, 12 Nov 2017 01:54:00 -0500 Design inputs are critical to medical device development. The design requirements can be a document that can prove if the product will have issues or not. Usually, products that result in failure is due to faulty design inputs. The design input acts as the foundation of the product. The manufacturer needs to establish design requirements that take…[Read more]

]]> 0 aee62679aac0b15ef7ae27e9bbd43d96 https://medicaldevicecourses.com/activity/p/5013/ Sun, 12 Nov 2017 01:43:31 -0500 Whenever production of a product needs to be exported, there are several production issues to look out for. When exporting the production design, it is integral to have strict, concise, and clear instructions for the other company. Also there needs to be a channel of clear communication between both companies for rapid communication in case of…[Read more]

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