Medical Device Courses | Ibraheem Shaikh | Activity https://medicaldevicecourses.com/members/ibraheem-shaikh/activity/ Activity feed for Ibraheem Shaikh. Fri, 24 Apr 2026 21:58:15 -0400 https://buddypress.org/?v= en-US 30 hourly 2 25375ef4f3829674c738b880ec648740 Ibraheem Shaikh replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/14405/ Wed, 15 May 2019 18:55:49 -0400 The biggest disadvantage of NDA’s, I believe, is jurisdiction. While multilateral patent agreements exist across many first-world countries, such is not the case for NDA’s. This allows NDA signers with particularly valuable intellectual property to move to a different country…   Read more»

]]> 6711a76b9e0090c3964d31ea8d13ebe1 Ibraheem Shaikh replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/14404/ Wed, 15 May 2019 18:55:49 -0400 A small reimbursement of $100, I believe, is a good reimbursement for a doctor’s time that compensates the doctor without creating a meaningful conflict of interest. While the exact amount can be debated, a compensation that is insignificant in comparison…   Read more»

]]> bbf8fd08c7b63318bf5da2259333715d Ibraheem Shaikh replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/14403/ Wed, 15 May 2019 18:55:48 -0400 Like many of the students have stated previously, I expected this course to include a thorough technical look at different industry roles associated with Biomedical Engineering, as well as the general process of medical device development. 3 months later, I…   Read more»

]]> 4092bd914dc4c92c670f87bbfd998a67 Ibraheem Shaikh replied to the topic "Recent Examples of Kickback Allegations" - https://medicaldevicecourses.com/activity/p/14402/ Wed, 15 May 2019 18:55:48 -0400 While not directly related to the kind of kickbacks we are interested in (and wary of) as medical device developers, it is interesting to take note of the trial of Senator Robert Menendez (D-NJ). He was accused of taking advantage…   Read more»

]]> 78b58a295d384ecfbb08ab934f601851 Ibraheem Shaikh replied to the topic "Organization Type vs. Effectiveness" - https://medicaldevicecourses.com/activity/p/14278/ Wed, 15 May 2019 18:54:42 -0400 Choosing an appropriate organizational type brings with its tradeoffs. Every type has advantages and disadvantages, and these can vary depending on the size and culture of an organization. In very small companies, a flat hierarchical structure where “everyone does everything”…   Read more»

]]> 0c988e7124667cdc473247073eb65dc2 Ibraheem Shaikh replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/14276/ Wed, 15 May 2019 18:54:41 -0400 A large number of companies nowadays use matrix-style organizational structures. Organizational structure has a huge impact on the performance of a company, so choosing this style is not a matter of convenience, but rather the fact that matrix organizations have…   Read more»

]]> a9f8910737c1eccd70151c396c4ee8a5 Ibraheem Shaikh replied to the topic "Project Management Preferences" - https://medicaldevicecourses.com/activity/p/14274/ Wed, 15 May 2019 18:54:39 -0400 A project manager ideally wants to work in a functional, project-based organization where he or she has complete control over the team. Although matrix organizations are highly popular nowadays, the multiple-boss structure is, of course, something that most bosses would…   Read more»

]]> 69be0c152317f8971e717d6b099239af Ibraheem Shaikh replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/14168/ Wed, 15 May 2019 18:52:41 -0400 Often times, it is best to determine what the worst case scenario is when making a decision. When making a decision for the safety margins in a medical device, one way to think of what ought to be considered “as…   Read more»

]]> 7bb58acc836a18aa23d369c3cd2bb5d9 Ibraheem Shaikh replied to the topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/14162/ Wed, 15 May 2019 18:52:37 -0400 On one hand, it is easy to see how the burdensome costs of regulatory controls may deter businesses from pursuing medical device development. But there are reasons to believe that this is not as large a downside as it initially…   Read more»

]]> 8dc8a495330f4841e3bb4b079a5c0840 Ibraheem Shaikh replied to the topic "Risk Management - Identification" - https://medicaldevicecourses.com/activity/p/14160/ Wed, 15 May 2019 18:52:36 -0400 While it is essential for the entire team to identify risks during development, it falls primarily to the Quality Assurance team to ensure that risks are properly identified and accounted for. For this reason, an introductory job quite a few…   Read more»

]]> d82ee5a2739766c8c1ff82a0d85e76b4 Ibraheem Shaikh replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/14001/ Wed, 15 May 2019 17:10:18 -0400 During my capstone project, I engaged in regular project design review meetings. These were incredibly essential to making sure that our project was a) turning out to meet customer needs and b) was feasible and developing well. Every week, we…   Read more»

]]> aa756f208196f9f1a4aa10b892d2bc42 Ibraheem Shaikh replied to the topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/14000/ Wed, 15 May 2019 17:10:18 -0400 There a number of general financial reasons why a company may choose to outsource a portion of a business. Generally, these tend to depend on cash flow and the growth avenues a company chooses to focus on. When facing a…   Read more»

]]> 3ccf205a2412a5515f63c7fb4892a636 Ibraheem Shaikh replied to the topic "Design Controls in the other countries" - https://medicaldevicecourses.com/activity/p/13999/ Wed, 15 May 2019 17:10:17 -0400 Much like India, Pakistan has only recently implemented a detailed regulatory environment. Until 2015, the Medical Device landscape was an almost fully rule-free environment, just as seen in India. In 2012, legislation was passed that called for quality assessments, conformity…   Read more»

]]> fb5cd752df69b1e81e97678021cc1e37 Ibraheem Shaikh replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/13832/ Wed, 15 May 2019 17:08:38 -0400 As students learning about the various good practices and regulations of the Medical Device Industry, we encounter the importance of proper documentation again and again. Strong documentation is not only incredibly important, but is a cornerstone of this industry. Minutes,…   Read more»

]]> 0ab5fc1ef1ac0f9c6e0d4c28b2d951c6 Ibraheem Shaikh replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/13831/ Wed, 15 May 2019 17:08:37 -0400 Gantt charts provide a number of useful characteristics – they save time, allow for a manager to always be aware of where a team is compared to their proposed schedule, and provide a roadmap for a project. However, as mentioned…   Read more»

]]> d2f2b8bfc073ff89cf57065bb3de00e3 Ibraheem Shaikh replied to the topic "Design Controls in the other countries" - https://medicaldevicecourses.com/activity/p/13830/ Wed, 15 May 2019 17:08:37 -0400 As Rashed mentioned, no medical device regulations whatsoever existed in India before 2005. It’s pretty stunning to consider that such a large market (over 1.3 billion) could have such lax regulatory affairs in such a critical field. However, it’s less…   Read more»

]]> 952f56dfe85dbaae7c393ab895fb7720 Ibraheem Shaikh replied to the topic "Ethical Issues with Clinical Trials" - https://medicaldevicecourses.com/activity/p/13745/ Wed, 15 May 2019 17:07:51 -0400 As Dave mentioned above, one essential aspect of allowing risky clinical trials is letting patients who are using them as a last resort go through with them. A patient should be free to engage in a trial where a research…   Read more»

]]> 25dd4201e6f38cfc5801cb60fba3ee5e Ibraheem Shaikh replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" - https://medicaldevicecourses.com/activity/p/13744/ Wed, 15 May 2019 17:07:51 -0400 We all agree that consent is incredibly important. However, when it comes to being paid for research, I think it is essential to consider the money involved in it. To clarify, I believe that a university publishing research using government…   Read more»

]]> 911b91af0eb107f6f415be666621d9bb Ibraheem Shaikh replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/13742/ Wed, 15 May 2019 17:07:49 -0400 The biggest determining factor in performing a single or double-blind study is the feasibility of doing so. While a single-blind study is almost always possible to perform, there are a number of reasons why it may not be feasible to…   Read more»

]]> 5b281fd536e6f8323a355665099f9e49 Ibraheem Shaikh replied to the topic "The Expert" - https://medicaldevicecourses.com/activity/p/13602/ Wed, 15 May 2019 17:06:25 -0400 This comedy sketch illustrates a couple fundamental problems faced by many businesses, including those in the medical device development industry. First is that customers often sometimes need to be “taught” what to buy, as they may come in with distorted…   Read more»

]]> cae18375acbefd614c949a33991f4d7d Ibraheem Shaikh replied to the topic "Manipulation or no?" - https://medicaldevicecourses.com/activity/p/13599/ Wed, 15 May 2019 17:06:24 -0400 There’s no fundamental difference between persuasion and manipulation, in my opinion, except for perhaps maliciousness. Under this way of looking at it, companies that offer value propositions to customers and convince them to buy a better product are engaging in…   Read more»

]]> 57e419829a2f73c2fd3271d7db88cb8f Ibraheem Shaikh replied to the topic "Fuzz before launch of product." - https://medicaldevicecourses.com/activity/p/13592/ Wed, 15 May 2019 17:06:20 -0400 I want to second Ronak in that it is unfair to compare a generic medical device company to a giant like Apple that makes products aimed at the general market. Apple benefits from the massive media coverage and public interest…   Read more»

]]> 2cdb2b967b1f07926a4f6735e7735943 Ibraheem Shaikh replied to the topic "Accepting job based on company." - https://medicaldevicecourses.com/activity/p/13442/ Wed, 15 May 2019 17:04:55 -0400 As Gabriel said, choosing a job can be difficult for newcomers. As such, a decision to join a company based on its specific characteristics is often a luxury that only experienced employees can have. Barring any massive red flags, such…   Read more»

]]> b2deef232a00818f3a2f9408b7aa690f Ibraheem Shaikh replied to the topic "Discussion Topic: Exercise your research skills" - https://medicaldevicecourses.com/activity/p/13436/ Wed, 15 May 2019 17:04:52 -0400 Intel, the well-known chipset manufacturer, has published the following metrics (all of which are TTM, or the “trailing twelve months” data). Intel has had a revenue of $61.7 billion, with a gross margin of 62.1%. The gross margin is a…   Read more»

]]> 7b4e29ba49a5f504a8f7a551ecd9d8ac Ibraheem Shaikh replied to the topic "S-Corp vs C-Corp" - https://medicaldevicecourses.com/activity/p/13423/ Wed, 15 May 2019 17:04:46 -0400 People generally don’t think of corporations as “subchapter s” or “c-corps” primarily because most large corporations people see are C-Corporations. A C-Corporation has significantly higher potential to grow than a c-corp because of its ability to have >100 shareholders and…   Read more»

]]> 21c71f3461cf2befb69c94df26a24750 Ibraheem Shaikh replied to the topic "What are some ways Document Control can improve?" - https://medicaldevicecourses.com/activity/p/13306/ Wed, 15 May 2019 17:03:46 -0400 Document control is also essential to prevent information loss. It’s not unheard of for a particularly knowledgeable employee’s loss (due to any reason, from resignation to death) to cripple an R&D/manufacturing project, a QA program, or a related process. Document…   Read more»

]]> 0656a07ca91e230c633f105b10886ca9 Ibraheem Shaikh replied to the topic "Discussion Topic: The cost of Quality" - https://medicaldevicecourses.com/activity/p/13305/ Wed, 15 May 2019 17:03:46 -0400 One common bias found in the business world is “Discounting the Future.” This bias prevents people from seeing the value in future investments and causes them to chase after things that save money and provide immediate benefit, even at a…   Read more»

]]> b2b76b0b7fa784c22a560877c451eade Ibraheem Shaikh replied to the topic "Your Ideas about Improving Quality Control" - https://medicaldevicecourses.com/activity/p/13303/ Wed, 15 May 2019 17:03:44 -0400 I believe Scott’s first point – that everyone must buy into a “culture” of quality – is extremely essential. A number of workplaces will have a “not my problem” attitude when it comes to quality. Quality is also sacrificed when…   Read more»

]]> 7ffa9b38523d28735b77e443323a0fe9 Ibraheem Shaikh replied to the topic "Precision and Accuracy" - https://medicaldevicecourses.com/activity/p/13148/ Wed, 15 May 2019 17:02:24 -0400 The FDA is responsible for ensuring the safety of biomedical devices that are available in the United States. Precision and accuracy are both factors that affect how doctors and patients will react to results from a medical instrument, and so…   Read more»

]]> eb252c18b23d405b23a335286d44949b Ibraheem Shaikh replied to the topic "Changes in FDA under Trump's Administration" - https://medicaldevicecourses.com/activity/p/13147/ Wed, 15 May 2019 17:02:23 -0400 Cheaper medical device registrant fees are effectively subsidies to the medical device industry. The utility of such subsidies seems significantly higher than a federal budget cut of 0.06%. The nature of this cost increase, as the article points out, is…   Read more»

]]> dda3208f674af58408be52520a3824dd Ibraheem Shaikh replied to the topic "FDA rules too strict?" - https://medicaldevicecourses.com/activity/p/13145/ Wed, 15 May 2019 17:02:22 -0400 The standard example generally given to justify the FDA’s rules is Thalidomide, which resulted in thousands of babies being born with deformed limbs because their mothers used it during pregnancy. Hailed as a wonder drug that treated insomnia, mild depression,…   Read more»

]]> e42345fcae60805c0f8aba2cefe40ab7 Ibraheem Shaikh replied to the topic "Failure's of Pre-Clinical / Clinical Research" - https://medicaldevicecourses.com/activity/p/13006/ Wed, 15 May 2019 17:01:11 -0400 While I have never encountered a catastrophic failure for the clinical research we do in our lab, we have encountered a number of setbacks. The most common reason for these is rushing and failing to follow directions perfectly to maximize…   Read more»

]]> 315a2d3a07cd98eaace45c2685afd102 Ibraheem Shaikh replied to the topic "Research for the Fututre or Now?" - https://medicaldevicecourses.com/activity/p/13000/ Wed, 15 May 2019 17:01:08 -0400 As far as a company producing products is concerned, research for the future is even more important than research for the “now.” This is true for almost any company that isn’t monopolizing a particular market (in which case, research isn’t…   Read more»

]]> 9ad56de689dfaaaadeb67e88f42b0b16 Ibraheem Shaikh replied to the topic "Discussion Topic: Beyond experimental design issues" - https://medicaldevicecourses.com/activity/p/12998/ Wed, 15 May 2019 17:01:07 -0400 Very generally speaking, the distance of the institute conducting the research is not a huge concern in the face of modern communication technology and shipping availability. The most important factor in this particular decision is whether the university chosen was…   Read more»

]]> debdd0fe360328f5a3f9b313e0c595dc Ibraheem Shaikh replied to the topic "Manager Vs Engineering" - https://medicaldevicecourses.com/activity/p/12850/ Wed, 15 May 2019 16:59:39 -0400 Krp76 is absolutely right about a manager needing experience to avoid mistakes and issues during a project. A technical background helps a manager avoid make small but potentially catastrophic mistakes. Further, a manager with an experienced background will have realistic…   Read more»

]]> 6617f33e62db69d472291dccec8566fb Ibraheem Shaikh replied to the topic "Project Management Softwares" - https://medicaldevicecourses.com/activity/p/12827/ Wed, 15 May 2019 16:59:28 -0400 I will confirm that Microsoft Project is a great tool, with a variety of options. Another popular project management tool that may have also been used by some of my classmates is Asana, which is a web and mobile application….   Read more»

]]> 395ed4efe1c98ef822957160e612207e Ibraheem Shaikh replied to the topic "Multiple Project Managers for one project" - https://medicaldevicecourses.com/activity/p/12826/ Wed, 15 May 2019 16:59:27 -0400 Although I do not have industry experience, my (limited) experience in working with hierarchical groups leads me to believe that having multiple managers can sometimes be a recipe for disaster. Being a manager promotes a sense of responsibility. A project…   Read more»

]]> ae5a002a35a3d1e076460761f6afdf72 Ibraheem Shaikh replied to the topic "Professions in Academia and the Industry" - https://medicaldevicecourses.com/activity/p/12699/ Wed, 15 May 2019 16:58:21 -0400 As a hopeful medical student, I took this course because working on medical products is something I would love to do as a doctor. As a doctor, I would be in a position to provide valuable consulting expertise, but I…   Read more»

]]> f8437d86d118cb88428a0aa2cb1cf59e Ibraheem Shaikh replied to the topic "Discussion Topic: Practical vs. Informational courses" - https://medicaldevicecourses.com/activity/p/12698/ Wed, 15 May 2019 16:58:20 -0400 While a lot of us feel that NJIT does not provide enough practical courses (and probably rightfully so), it is important to note that NJIT, as far as I know, does not notably lag behind other universities in this regard….   Read more»

]]> e77dcde3c9429d305003516a990d0642 Ibraheem Shaikh replied to the topic "Discussion Topic: Academia vs. Industry" - https://medicaldevicecourses.com/activity/p/12697/ Wed, 15 May 2019 16:58:19 -0400 I definitely agree that time flexibility is a significant advantage of Academia. Industry, of course, pays better, but it is important to note that pay and advancements depend on your work being noticed, and your efforts may not be acknowledged…   Read more»

]]> 200a85fc5b84e22600de92a6d6249137 Ibraheem Shaikh replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5455/ Sat, 02 Dec 2017 23:05:37 -0500 The biggest disadvantage of NDA’s, I believe, is jurisdiction. While multilateral patent agreements exist across many first-world countries, such is not the case for NDA’s. This allows NDA signers with particularly valuable intellectual property to move to a different country and sell their stolen ideas.

NDA’s, as mentioned above, are of course…[Read more]

]]> 0 d6d95b92099fc85a43bd01bb46a8a6a3 Ibraheem Shaikh replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5454/ Sat, 02 Dec 2017 22:58:11 -0500 A small reimbursement of $100, I believe, is a good reimbursement for a doctor’s time that compensates the doctor without creating a meaningful conflict of interest. While the exact amount can be debated, a compensation that is insignificant in comparison to the doctor’s salary is a good way to minimize any risk of bribery, or even the appearance…[Read more]

]]> 0 adbb58b75dce846284135335cb93c834 Ibraheem Shaikh replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5453/ Sat, 02 Dec 2017 22:44:29 -0500 Like many of the students have stated previously, I expected this course to include a thorough technical look at different industry roles associated with Biomedical Engineering, as well as the general process of medical device development. 3 months later, I am glad it didn’t. Those aspects are things that are covered by almost every other course…[Read more]

]]> 0 3e883cc7f1a83ddd30ccf8573d7274ca Ibraheem Shaikh replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5452/ Sat, 02 Dec 2017 22:26:37 -0500 While not directly related to the kind of kickbacks we are interested in (and wary of) as medical device developers, it is interesting to take note of the trial of Senator Robert Menendez (D-NJ). He was accused of taking advantage of private trips offered by a doctor in Florida, in exchange for help in tax and Medicare fraud disputes.

A more…[Read more]

]]> 0 4eb5b3dbe982d561c5307fb52aeca4bb Ibraheem Shaikh replied to the topic Organization Type vs. Effectiveness in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5318/ Sun, 26 Nov 2017 21:35:15 -0500 Choosing an appropriate organizational type brings with its tradeoffs. Every type has advantages and disadvantages, and these can vary depending on the size and culture of an organization. In very small companies, a flat hierarchical structure where “everyone does everything” is very common, and may the most effective way for that company to…[Read more]

]]> 0 c8d1105d307d6ef01b0cbccfb55e482e Ibraheem Shaikh replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5316/ Sun, 26 Nov 2017 21:29:28 -0500 A large number of companies nowadays use matrix-style organizational structures. Organizational structure has a huge impact on the performance of a company, so choosing this style is not a matter of convenience, but rather the fact that matrix organizations have been shown many times to be effective. Although I have not ever been a corporate…[Read more]

]]> 0 d8a74c988a77ebcb34dcdcf903d63f60 Ibraheem Shaikh replied to the topic Project Management Preferences in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5314/ Sun, 26 Nov 2017 21:24:50 -0500 A project manager ideally wants to work in a functional, project-based organization where he or she has complete control over the team. Although matrix organizations are highly popular nowadays, the multiple-boss structure is, of course, something that most bosses would prefer to avoid because it cuts down on their authority and forces them to…[Read more]

]]> 0 5123e5dce3d62a379f8161259760b2d4 Ibraheem Shaikh replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5202/ Mon, 20 Nov 2017 01:55:20 -0500 Often times, it is best to determine what the worst case scenario is when making a decision. When making a decision for the safety margins in a medical device, one way to think of what ought to be considered “as far as possible” is to determine what a reasonable investigator (or jury!) would consider being as such when determining whether a…[Read more]

]]> 0 02707f329b09a4fb3b27955bbafbabe3 Ibraheem Shaikh replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5196/ Mon, 20 Nov 2017 01:47:46 -0500 On one hand, it is easy to see how the burdensome costs of regulatory controls may deter businesses from pursuing medical device development. But there are reasons to believe that this is not as large a downside as it initially seems. First, it must be noted that these regulations are essential for patient safety and product success. Further,…[Read more]

]]> 0 2dd1d6bd51880a00509df6ec4be69d69 Ibraheem Shaikh replied to the topic Risk Management - Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5194/ Mon, 20 Nov 2017 01:20:43 -0500 While it is essential for the entire team to identify risks during development, it falls primarily to the Quality Assurance team to ensure that risks are properly identified and accounted for. For this reason, an introductory job quite a few biomedical engineers enter into upon graduation is the QA department, where employees predict how customers…[Read more]

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