https://medicaldevicecourses.com/members/dag56/activity/ Activity feed for dag56. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 0f1c0539c9aaf61dfb807cc225f167f0 https://medicaldevicecourses.com/activity/p/14422/ Wed, 15 May 2019 18:55:59 -0400 Personally, I believe that it is both necessary and in good business practice to separate family and business matters in today’s world with all the guidelines and laws in place. This remains true even during ‘business trips’ where a rep…   Read more»

]]> a818c75203d868f476e4373af2994626 https://medicaldevicecourses.com/activity/p/14420/ Wed, 15 May 2019 18:55:58 -0400 In my line of work, I had extensive experience in the manufacturing and testing of high throughput, immunoassay, analytical instruments that are used in many hospitals around the world. Having this experience and knowledge, if I were to apply to…   Read more»

]]> 35bf08ad90d1e6f29a9d14548bfcd0b5 https://medicaldevicecourses.com/activity/p/14419/ Wed, 15 May 2019 18:55:57 -0400 To add to the discussion about advice when signing an NDA, I would like to emphasize the point of fully understanding the magnitude of consequences that may be leveraged against you on the occasion that the agreement is broken. While…   Read more»

]]> 691f020cd84dd0d103bf2046248c02b0 https://medicaldevicecourses.com/activity/p/14279/ Wed, 15 May 2019 18:54:42 -0400 When looking inward at myself and asking if I would be a better suited in upper management or middle management, I would say that it is a tough decision. However, I would have to choose upper management because I believe…   Read more»

]]> 63e603160039b84fbbeb521dd9e705f5 https://medicaldevicecourses.com/activity/p/14273/ Wed, 15 May 2019 18:54:39 -0400 If I were charged with forming a project team, I would assemble a group of individuals with similar guidelines as aaq2 mentioned above valuing skills and abilities the most. However, it is important to note that I would also heavily…   Read more»

]]> f11815c5883344049d516a6f2fbba145 https://medicaldevicecourses.com/activity/p/14272/ Wed, 15 May 2019 18:54:39 -0400 In my current position, I believe it is mostly a functional-based organizational structure with minor aspects of matrix organizational structure. For the most part, there are supervisors (functional managers) of different departments. My direct supervisor has a lot of power…   Read more»

]]> 5cf4c6084d5501e08ba43d0051cd9738 https://medicaldevicecourses.com/activity/p/14084/ Wed, 15 May 2019 18:51:46 -0400 In general, I agree with the above comments that state that lower risks can mostly reasonably be managed by using the strategies acceptance and/ or mitigation. This makes sense because if it is relatively low risk, the consumer most likely…   Read more»

]]> 1f81ff9022ecf6dda25d4f7dd4f6214c https://medicaldevicecourses.com/activity/p/14082/ Wed, 15 May 2019 18:51:44 -0400 To add to what was said above by both Mark and amandaally1029 in the above comments, another factor to consider would be the “Availability of alternative treatments or diagnostics”. This is a critical factor to consider because it would not…   Read more»

]]> 4f0a52a2adf2687ff5187231aff534b5 https://medicaldevicecourses.com/activity/p/14081/ Wed, 15 May 2019 18:51:43 -0400 Adding to what was mentioned by amandaally1029 above after the risk analysis is completed in the FMECA technique; a critical decision must then be made by the heads of the company. That decision is: does this product’s risk outweigh the…   Read more»

]]> 9ef8072d790c52139b294a3f15072bf5 https://medicaldevicecourses.com/activity/p/13960/ Wed, 15 May 2019 17:09:54 -0400 In agreeance with Scott’s comment about the extent of the validation required, I have experience with similar guidelines in my position. Firstly, a standard is set for the immunoassay instrument to meet of the concentration of known analyte it is…   Read more»

]]> b6359e7308ea3ecc5b64ac187ac75562 https://medicaldevicecourses.com/activity/p/13955/ Wed, 15 May 2019 17:09:51 -0400 Siemens Atellica Solution Immunoassay Analyzer: The extensive verification process of the Immunoassay Analyzer’s generally consists of the instrument and laboratory diagnostic verification. In the instrument verification state, each subassembly must pass its designated test, confirming that it is working as…   Read more»

]]> bdac0931e2b905aae5a965cdc3844a19 https://medicaldevicecourses.com/activity/p/13940/ Wed, 15 May 2019 17:09:41 -0400 Adding to what myton said above, the process of verification also is generally an internal check to make sure the product follows its initial design specification. A good product will stay true to these original regulations, specifications, and regulations that…   Read more»

]]> 93441bf79a4ff77283b8cd08f52eb542 https://medicaldevicecourses.com/activity/p/13858/ Wed, 15 May 2019 17:08:52 -0400 In addition to the detailed outline of meeting minutes made by woolynn and others above, I would like to add that the minutes are not an exact transcription of what each individual had said in the meeting, rather a comprehensive…   Read more»

]]> 8a59a77d3417f9ac471f67bcb5b1e674 https://medicaldevicecourses.com/activity/p/13833/ Wed, 15 May 2019 17:08:38 -0400 As many have said above Gantt charts are one way of organizing the timetable of mini projects that comprise the overall product. My experience in industry pertaining to Gantt charts involves working with the manufacturing supervisors to come up with…   Read more»

]]> a1c8af0d8a9412f318a3bed36b6b4ce2 https://medicaldevicecourses.com/activity/p/13788/ Wed, 15 May 2019 17:08:12 -0400 After doing some research, I chose to pick an area where design controls were not in place. Within the African continent, only 7% of the 46 sub-Saharan countries had a regulatory policy, National Medicines Regulatory Authorities (NMRA), in place (2005)….   Read more»

]]> dc14e53b51d194b032857951bccc8960 https://medicaldevicecourses.com/activity/p/13677/ Wed, 15 May 2019 17:07:10 -0400 It is my personal opinion that when a person consents (signs) to having an operation/ procedure done which results in the removal of an organ/ bodily fluid, the patient waives any rights/ ownership they had over the now extracted substance….   Read more»

]]> 81c1fd81ff7c54e8051389d26b42b2e7 https://medicaldevicecourses.com/activity/p/13666/ Wed, 15 May 2019 17:07:04 -0400 In addition to the valid pros reshanm and ppp23 made, I would like to highlight that in a lot of cases, the patient volunteering to undergo clinical trials does not have to pay much (if any) out for their own…   Read more»

]]> dd7d5697cc0eca7bd8f392974aa8048d https://medicaldevicecourses.com/activity/p/13655/ Wed, 15 May 2019 17:06:57 -0400 It is my belief that placebo controlled studies are necessary and ethical, yet should not be the “proof” that a drug/ medical-device combination is effective. This is due to the many curiosities that still surround the idea of a placebo…   Read more»

]]> 015a7c9df26068a43ccfabe889e116f7 https://medicaldevicecourses.com/activity/p/13531/ Wed, 15 May 2019 17:05:42 -0400 Siemens Vision: A world of proven talent delivering breakthrough innovations giving our customers a unique competitive edge enabling societies to master their most vital challenges and creating sustainable value. Mission: Within the scope of Siemens’ core activities, to find the…   Read more»

]]> dfb206874c5c730888d158a770f20e5c https://medicaldevicecourses.com/activity/p/13526/ Wed, 15 May 2019 17:05:39 -0400 While some products hold firm to the traditional television commercials, there are a great deal that are utilizing different mediums of advertisement to market their product to their target audience. As mentioned by amandaally1209 above, some companies have already made…   Read more»

]]> c9ec024e84baf6cd9a1d68c2661a931e https://medicaldevicecourses.com/activity/p/13523/ Wed, 15 May 2019 17:05:38 -0400 Recently, some of the more clever and effective ways I have seen a device/ product marketed is to have paired with a celebrity/ athlete that can make a personal connection. As Dr. Simon mentioned above, ads can now be blocked…   Read more»

]]> fa7a0fc078ccc56715e5928f4ea8ce46 https://medicaldevicecourses.com/activity/p/13382/ Wed, 15 May 2019 17:04:27 -0400 Elaborating on what was mentioned above by both amandaally1029 and thuytienlecao in the above posts, I found the 3 most common occasions a court will rule to pierce the cooperate veil are: No real separation between the company and its…   Read more»

]]> 6f1220f8bd8ec97b3f24146aab9deb06 https://medicaldevicecourses.com/activity/p/13370/ Wed, 15 May 2019 17:04:21 -0400 If given the choice of being an owner of the above list of company structures, I would prefer filing my company under a Limited Liability Company (LLC) in the state of Delaware. Even though my business would be done primarily…   Read more»

]]> 07cc7bde71492de5b6f7afc24facecb7 https://medicaldevicecourses.com/activity/p/13364/ Wed, 15 May 2019 17:04:18 -0400 The company I am choosing to perform a brief valuation on is Bristol-Myers Squibb . ROI=20.87% The current return on investment that is given by marketwatch.com shows a healthy ROI percentage. This roughly translates to for every $5 invested in…   Read more»

]]> fc617508921d97d7de37ddd950e7d2b5 https://medicaldevicecourses.com/activity/p/13243/ Wed, 15 May 2019 17:03:12 -0400 My experience with the quality department at my company is very similar to reshamn’s as mentioned above in the previous posting. Some of the new processes that are currently trying to be put into place by R&D engineers are being…   Read more»

]]> 5b973b7773429a6731ba143e0578cf12 https://medicaldevicecourses.com/activity/p/13238/ Wed, 15 May 2019 17:03:10 -0400 I believe that the quality department, at the most successful and consistent companies, runs deep within the structure of the organization. By this I mean that although there is a designated quality department, there has to be a great emphasis…   Read more»

]]> e89f428f5fff1aa914caf0a0670feb11 https://medicaldevicecourses.com/activity/p/13229/ Wed, 15 May 2019 17:03:05 -0400 The idea that spending ‘excess’ funds on quality engineers is a burden and that they only bring bad news has been the general consensus of the previous companies for which I have worked. Currently at my job, upper management, engineers,…   Read more»

]]> de2823f1bb73dfc7a253036d15340820 https://medicaldevicecourses.com/activity/p/13089/ Wed, 15 May 2019 17:01:51 -0400 The incident I would like to briefly talk about is the abnormal corrosion-wear of β-Ti alloy TMZF (Ti-12Mo-6Zr-2Fe) in one model of Stryker’s early hip implants that was recalled in 2011. In this case, Stryker used an innovative TMZF alloy…   Read more»

]]> a043a6c238eaf9c12b14ecbc209361f7 https://medicaldevicecourses.com/activity/p/13088/ Wed, 15 May 2019 17:01:51 -0400 Combination product of investigation: Epinephrine auto-injector (injection pen) This device is intended to inject epinephrine directly into the patient’s body during an allergic reaction for most rapid response time. Epinephrine causes the body to delay/ stop anaphylaxis caused by the…   Read more»

]]> 156abc7acafc9cffceae4d98720a32a0 https://medicaldevicecourses.com/activity/p/13075/ Wed, 15 May 2019 17:01:44 -0400 As thuytienlecao mentioned above, the FDA currently regulates the electronic cigarette due to it containing tobacco products (nicotine) which is a controlled substance. This electronic device is also very different when compared to normal cigarettes due to its lack of…   Read more»

]]> 714656b75aa49d272a1c70e8d24f1787 https://medicaldevicecourses.com/activity/p/12920/ Wed, 15 May 2019 17:00:17 -0400 Research in academia is approached though the pure goal of knowing the unknown or in the sense to ascertain a solution to a particular personal problem regardless of the monetary reward. The research may have a deeper personal connection to…   Read more»

]]> a1026b9201c9aa2b1af7b321d47c1457 https://medicaldevicecourses.com/activity/p/12919/ Wed, 15 May 2019 17:00:16 -0400 In my experience of working in both academic and industrial laboratories, I believe there is a definite difference in the amount of resources available to each lab which then directly affects the scope, timeframe, and people involved within the project….   Read more»

]]> 0031e747f55574558e2aa9e2a56304ce https://medicaldevicecourses.com/activity/p/12910/ Wed, 15 May 2019 17:00:11 -0400 Research in academia is approached though the pure goal of knowing the unknown or in the sense to ascertain a solution to a particular personal problem regardless of the monetary reward. The research may have a deeper personal connection to…   Read more»

]]> 0ddda79cd1fbcd4c76e5c6678066ea90 https://medicaldevicecourses.com/activity/p/12908/ Wed, 15 May 2019 17:00:10 -0400 As mentioned above in the week 3 lectures as well as from bb254, biocompatibility testing should be completed in strict accordance to ISO 10993. The table dictates, in relation to its intended application and criticality to the body (ex. tooth…   Read more»

]]> 9286d149d03004fc3ab02a83fa9519bc https://medicaldevicecourses.com/activity/p/12769/ Wed, 15 May 2019 16:59:00 -0400 In agreeance most of what rachelpatel1796 said above, I believe that the project execution phase (especially the controlling aspect) is the most important stage of the project cycle. The need for strict compliance to key performance indicators as well as…   Read more»

]]> 4f4685a5c52c3adf05b78e5b16c75b74 https://medicaldevicecourses.com/activity/p/12767/ Wed, 15 May 2019 16:58:59 -0400 One example of an obstacle I encountered during the excitation of a project in my undergraduate pharmaceutical research laboratory would be that the inventory of essential chemicals was not up to date with the computer log. Often times, while preforming…   Read more»

]]> 73347e7ef0b99eb020c8b8b1200def39 https://medicaldevicecourses.com/activity/p/12766/ Wed, 15 May 2019 16:58:58 -0400 As briefly mentioned above, another project management style is Agile. This unique project management style is centered around being a fast, flexible approach to a project that relies on collaboration and adaptability to get a project done. This style works…   Read more»

]]> 2cd21c01f13685884daf61f756fb9c2d https://medicaldevicecourses.com/activity/p/12686/ Wed, 15 May 2019 16:58:13 -0400 In the debate of academia vs industry, I have been fortunate enough to say that I have had experience in both. Personally, my experience in academia lasted a total of just over two years and I really enjoyed the relaxed…   Read more»

]]> ec8e097c6b9aad017fe6e08c1d8c8f53 https://medicaldevicecourses.com/activity/p/12676/ Wed, 15 May 2019 16:58:08 -0400 In agreeance with puneet and hc225, I personally believe that there is not enough practical courses available at NJIT for both undergraduates/ graduates alike to pursue. Currently, as Dr. Simon states, there are only his 3 online courses that really…   Read more»

]]> 95b068345de496e69c006faa0497a1b5 https://medicaldevicecourses.com/activity/p/12673/ Wed, 15 May 2019 16:58:06 -0400 In agreeance with akashranpura along with multiple others who posted above, I would definitely stress the value of a Co-op and/or internship. These real world experiences are immensely valuable because they give you insight to the nuances of industry and…   Read more»

]]> bcdcee85f8fd4e576854fc54b5ae2ebd https://medicaldevicecourses.com/activity/p/12609/ Wed, 15 May 2019 16:57:33 -0400 Given the options of a management vs an engineer/scientist/tech’s role in a company, I would prefer to eventually end up as a manager much like many of my classmates before me have answered. However, my desired path to achieve this…   Read more»

]]> 5a9d747d07bb618bd311c1024b241dc3 https://medicaldevicecourses.com/activity/p/12607/ Wed, 15 May 2019 16:57:32 -0400 In my experience, I tend to feel that there is a definite moderate correlation between workplace recognition and challenging/exciting work. As many have said before me, bb254, jvv6, tn58, ect., expectations if you as an employee tend to change over…   Read more»

]]> 8a2821714e3144ccb3cabda44f261580 https://medicaldevicecourses.com/activity/p/12587/ Wed, 15 May 2019 16:57:22 -0400 Having recently earned my Six Sigma green belt from IISE (Institute of Industrial and Systems Engineers), I can say that my initial impression is that it is a very useful skill to have in industry. Six Sigma centers around DMAIIC…   Read more»

]]> 22118d6b5bf0bf693996d0926c97d44a https://medicaldevicecourses.com/activity/p/12517/ Wed, 15 May 2019 16:56:42 -0400 If I was a project manager, some of the ways I would motivate my team would be through monetary incentives, public recognition, and a simple small reward system. In regard to the monetary incentives, I would definitely employ overtime hours…   Read more»

]]> 546c02c08768fc4526aecd8019abe8b1 https://medicaldevicecourses.com/activity/p/12515/ Wed, 15 May 2019 16:56:41 -0400 I harbor that innate desire to make products for those less fortunate and to know I’ve made a positive difference in somebody’s quality of life. The main source of my motivation stems from my childhood. I grew up around my…   Read more»

]]> dd6f65d5f5e88f8df08be49a732d9e3d https://medicaldevicecourses.com/activity/p/12488/ Wed, 15 May 2019 16:56:28 -0400 In general, I am not surprised by the results gathered in this study. This is mainly due to working in industry for a number of years and getting to personally know a wide range of individuals holding a variety of…   Read more»

]]> b82a2e889c2296221a7ca1f9e7067969 https://medicaldevicecourses.com/activity/p/12433/ Wed, 15 May 2019 16:55:57 -0400 I experience scope creep firsthand almost every day at work when quality testing premarket immunoassay instruments. After a particular instrument is built by hand in an assembly line like fashion, my team is tasked to test verify and validate that…   Read more»

]]> 4ef3485471e211197759ed98944ad88a https://medicaldevicecourses.com/activity/p/12402/ Wed, 15 May 2019 16:55:40 -0400 At my current job, I have experienced a situation where a vital team member was temporality taken from my quality group to work in another project within the company. The individual chosen happen to be the most senior member of…   Read more»

]]> f87234b8ee73915ae5c4abe52392d25c https://medicaldevicecourses.com/activity/p/12401/ Wed, 15 May 2019 16:55:39 -0400 In my undergraduate drug discovery research laboratory, I often experienced situations where integration of two (or more) projects was required. When synthesizing relatively large, pharmaceutically active compounds, they would be occasionally be made in pieces. Each segment of the final…   Read more»

]]> ef2ac6d851a1c648f2173b9944937a5a https://medicaldevicecourses.com/activity/p/12294/ Wed, 15 May 2019 16:54:37 -0400 In one of my projects at NJIT, my group member and I were tasked to come up with an innovative medical device as a final project. What we had decided on was a wearable device that had the ability to…   Read more»

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