Medical Device Courses | tilak | Activity https://medicaldevicecourses.com/members/tilak/activity/ Activity feed for tilak. Fri, 24 Apr 2026 22:30:17 -0400 https://buddypress.org/?v= en-US 30 hourly 2 9c92912cb5e56d91f340204e0bee158d tilak replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/14398/ Wed, 15 May 2019 18:55:46 -0400 This course really opened my eyes to how the world of medical devices really operates. As a biomedical engineering student, most of my education was focused on theoretical design and processes of medical devices and instruments. However, this course taught…   Read more»

]]> 56876558333cbc99e6b164a40f88f0a5 tilak replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/14395/ Wed, 15 May 2019 18:55:44 -0400 In its simplest form, an NDA (Non Disclosure Agreement) is a legally binding contract that creates a confidential relationship between persons holding an idea or invention and persons to whom this information will be revealed. NDAs help to protect sensitive…   Read more»

]]> ee92493a5a40ea4ad31cee52e60dc6a4 tilak replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/14394/ Wed, 15 May 2019 18:55:44 -0400 Although it is possible to begin a project based on a verbal agreements, it is still a very informal method of commitment and is not effectively reinforced. Written agreements are physical evidence of a contract between two or more parties…   Read more»

]]> 4615b1fccafb55c9c15f5c19c854ed14 tilak replied to the topic "Collaboration projects" - https://medicaldevicecourses.com/activity/p/14290/ Wed, 15 May 2019 18:54:49 -0400 The main goal in this type of situation is to find an organizational structure that both parties can agree on for the duration of the collaboration. Communication is the most important factor for such a task to be successful. The…   Read more»

]]> 13abfa524b181cc0c6f3a06a21e0a467 tilak replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/14282/ Wed, 15 May 2019 18:54:44 -0400 My workplace consists of a matrix organization in which resources are split based on project priorities. Project managers are able to share the skills of employees across projects and departments. Project managers in the research and development team lead projects…   Read more»

]]> 50eb0576699d707597897beece9bd180 tilak replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/14262/ Wed, 15 May 2019 18:54:32 -0400 In a company setting, it is easy to work with people that we have cordial relationships with since everyones goals are aligned. After that, its a matter of selecting people that can provide a versatile set of skills and abilities….   Read more»

]]> 68fcd6fe08ec545d320cfc5687d4898c tilak replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/14186/ Wed, 15 May 2019 18:52:51 -0400 I don’t agree with this reason. For an effective product design, I believe risk management and design controls should occur in parallel to one another. That way risks can be identified in each step of a design and fixed immediately….   Read more»

]]> b107639a7ecf50242da2ffa05a1d8119 tilak replied to the topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/14181/ Wed, 15 May 2019 18:52:48 -0400 Strict regulations allow for enforcement agencies such as the FDA to filter out companies that are dedicated in meeting regulatory standards along with creating an effective product. Purchasing these standards shows how committed companies are in advancing their agenda. It…   Read more»

]]> f9e74b83a25bd9bb3e0aabf21501ca74 tilak replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/14178/ Wed, 15 May 2019 18:52:46 -0400 Depending on the situation or the environment in which a medical device or drug is used, its cautionary labels may not always work effectively. As Dr. Simon mentioned, in highly dynamic environments, such as an operation theatre or in an…   Read more»

]]> ede837a7b99810c14b82e769f79c91cc tilak replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/14055/ Wed, 15 May 2019 18:51:29 -0400 The largest source of design input is market research. Understanding the market gap for your product can help to understand what services need to be fulfilled by your product. From this market research, an outline of customer needs can be…   Read more»

]]> 052e22d6de36396952ec8e0753db8218 tilak replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/14054/ Wed, 15 May 2019 18:51:29 -0400 DDPs as a whole are very crucial in the timeline of the project. The gantt chart helps to outline each segment as it is approached. The project manager must effectively build a DDP to outline all the different departments of…   Read more»

]]> 9d52291bff425de7d431a1bc542a04c2 tilak replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/14051/ Wed, 15 May 2019 18:51:27 -0400 Although I’ve never attended a design review meeting, I think it’s safe to say these meetings are crucial to get every member of the team and even sponsors and consumers on the same page. It would be the perfect platform…   Read more»

]]> 8d2923ace7c0f00b91f60464bb1da73b tilak replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" - https://medicaldevicecourses.com/activity/p/13747/ Wed, 15 May 2019 17:07:52 -0400 Placebo controlled trials are a great way of helping scientists understand why a new medical treatment is more useful and effective than no treatment at all. Due to the “Placebo effect”, some patients may progress and get better without receiving…   Read more»

]]> 24bd6fa7a86beb7256d00f2e01c3d8b0 tilak replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/13730/ Wed, 15 May 2019 17:07:37 -0400 In most cases, double blind studies are an effective way of performing a research study and learning new information about a drug or new treatments. Double blind studies are also a way of removing bias from the testing of these…   Read more»

]]> ba9f96af1540182074a42726a5fc1b10 tilak replied to the topic "Discussion Topic: Having a "clinical background"" - https://medicaldevicecourses.com/activity/p/13727/ Wed, 15 May 2019 17:07:35 -0400 A background in clinical studies should be required depending on the profession and work environment. For example, a Principal Investigator (PI) is the “primary individual responsible for the preparation, conduct, and administration of a research grant or other sponsored project…   Read more»

]]> 31bbac3c250f051c4f0f46380ca4a2a3 tilak replied to the topic "Discussion Topic: Mission and Vision statements" - https://medicaldevicecourses.com/activity/p/13572/ Wed, 15 May 2019 17:06:10 -0400 Currently I work as a clinical research intern at Colgate-Palmolive Co. Their mission statement is as follows: “As a Company that strives to be the best truly global consumer products company, we are committed to doing business with integrity and…   Read more»

]]> e91570a1adcaf0276fc93dbe674ac7b1 tilak replied to the topic "Discussion Topic: The Fifth "P" of Marketing" - https://medicaldevicecourses.com/activity/p/13570/ Wed, 15 May 2019 17:06:09 -0400 In today’s fast paced, media centric, society most technology giants spend most of their money only on the initial marketing of a product. This means that once it is given the initial push, they rely on the consumers to spread…   Read more»

]]> 69ce3df260d1ae335aad50027fdce6e6 tilak replied to the topic "Family Businesses" - https://medicaldevicecourses.com/activity/p/13500/ Wed, 15 May 2019 17:05:26 -0400 As can be predicted by its name, a sole proprietorship has one owner who is fully responsible for the operation of the company. The owner makes decision that will affect the overall growth of the business. Its not possible for…   Read more»

]]> c78f8d67f224156bfd2a5bb60761a13a tilak replied to the topic "Discussion Topic: Inc. vs. LLC in the US" - https://medicaldevicecourses.com/activity/p/13484/ Wed, 15 May 2019 17:05:17 -0400 First its important to identify the difference between an incorporation and a limited liability company. An LLC is the United States’ version of a private limited company. An LLC’s business structure combines the taxation of a partnernship with the limited…   Read more»

]]> a078bdd935d88d616e3d60939fda9697 tilak replied to the topic "Relation of Quality with other department." - https://medicaldevicecourses.com/activity/p/13338/ Wed, 15 May 2019 17:04:06 -0400 When we observe the hierarchy of the government it is clear that a system of checks and balances keeps the three branches running in agreement. However, this is not always the case in an industrial setting where various departments influence…   Read more»

]]> bc612389d47d69958fcc1d2696997722 tilak replied to the topic "FDA rules too strict?" - https://medicaldevicecourses.com/activity/p/13195/ Wed, 15 May 2019 17:02:48 -0400 The processes laid down by the FDA maybe lengthy and tedious but they are not too strict. Without the FDA, there aren’t many other government organizations or groups that can be as effective in delivering rulings, and regulations over the…   Read more»

]]> 961bc98a2c83f8dfe13183f49f937c27 tilak replied to the topic "Precision and Accuracy" - https://medicaldevicecourses.com/activity/p/13194/ Wed, 15 May 2019 17:02:47 -0400 Precision and accuracy are two valuable pillars of judgement that are often overlooked by consumers. How well these two conditions are met can significantly impact the ruling presented by the FDA on any medical device, substance or product. If precision…   Read more»

]]> bd930bcf2265d75c75261a1dcf449ef9 tilak replied to the topic "Discussion Topic: e-cigarettes" - https://medicaldevicecourses.com/activity/p/13179/ Wed, 15 May 2019 17:02:39 -0400 Vaporizers, E-Cigs, hookah pens, etc. are all terms used to describe what the FDA calls Electronic Nicotine Delivery Systems (ENDS). The organic compounds along with the vaporized water contain nicotine and other compositions of flavors. In 2016, the FDA extended…   Read more»

]]> 3d1a3cf98f041b0bd6353876012bd0ca tilak replied to the topic "Discussion Topic: Brand new biomaterial" - https://medicaldevicecourses.com/activity/p/12994/ Wed, 15 May 2019 17:01:04 -0400 The reason a biocompatibility test is performed is to determine the effectiveness and durability of a biomaterial, medical device or drug for human use and to analyze any potentially harmful or physiological side effects. To prevent insufficiently tested materials and…   Read more»

]]> 1a9173751a51b70f47dc65f2ef147cf9 tilak replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5448/ Sat, 02 Dec 2017 20:02:52 -0500 This course really opened my eyes to how the world of medical devices really operates. As a biomedical engineering student, most of my education was focused on theoretical design and processes of medical devices and instruments. However, this course taught me a lot about how these devices are put out into society and what it takes for a product to…[Read more]

]]> 0 268261b4f5441434c3fb2c37cd626acc tilak replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5445/ Sat, 02 Dec 2017 18:52:48 -0500 In its simplest form, an NDA (Non Disclosure Agreement) is a legally binding contract that creates a confidential relationship between persons holding an idea or invention and persons to whom this information will be revealed. NDAs help to protect sensitive information. More specifically, NDAs also outline what information is considered private…[Read more]

]]> 0 695d3445d32d4b500eb42d6d15741536 tilak replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5444/ Sat, 02 Dec 2017 18:41:05 -0500 Although it is possible to begin a project based on a verbal agreements, it is still a very informal method of commitment and is not effectively reinforced. Written agreements are physical evidence of a contract between two or more parties that can efficiently motivate the successful completion of the project. In most cases, there are no…[Read more]

]]> 0 9ef6fc613d21c6f4ba1057584b383a8a tilak replied to the topic Collaboration projects in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5330/ Sun, 26 Nov 2017 23:25:48 -0500 The main goal in this type of situation is to find an organizational structure that both parties can agree on for the duration of the collaboration. Communication is the most important factor for such a task to be successful. The type of structure that best fits this scenario is a matrix organization.
Matrix organization allows for multiple…[Read more]

]]> 0 ff5ccbd2b55bf758a8190dfe5177545f tilak replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5322/ Sun, 26 Nov 2017 21:50:26 -0500 My workplace consists of a matrix organization in which resources are split based on project priorities. Project managers are able to share the skills of employees across projects and departments. Project managers in the research and development team lead projects within specialized departments with the help of junior scientists and researchers. I…[Read more]

]]> 0 a183f96a71b7da5adf3d7810c6475725 tilak replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5301/ Sun, 26 Nov 2017 18:35:39 -0500 In a company setting, it is easy to work with people that we have cordial relationships with since everyones goals are aligned. After that, its a matter of selecting people that can provide a versatile set of skills and abilities. It is essential for each member to have comprehensive knowledge of their department. The most common problem in…[Read more]

]]> 0 2420debce2cfc35919f630d681cb68e0 tilak replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5220/ Mon, 20 Nov 2017 03:18:08 -0500 I don’t agree with this reason. For an effective product design, I believe risk management and design controls should occur in parallel to one another. That way risks can be identified in each step of a design and fixed immediately. The second reason is true. The reason most companies fail to effectively assess risk is because it is approached a…[Read more]

]]> 0 b01c18d196841a068f451bdc55a7c3aa tilak replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5215/ Mon, 20 Nov 2017 02:46:53 -0500 Strict regulations allow for enforcement agencies such as the FDA to filter out companies that are dedicated in meeting regulatory standards along with creating an effective product. Purchasing these standards shows how committed companies are in advancing their agenda. It also helps companies to maintain their safety standards throughout all…[Read more]

]]> 0 1c8c43911e3cad2cb1b0b4ec90b6b24d tilak replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5212/ Mon, 20 Nov 2017 02:25:09 -0500 Depending on the situation or the environment in which a medical device or drug is used, its cautionary labels may not always work effectively. As Dr. Simon mentioned, in highly dynamic environments, such as an operation theatre or in an ambulance, its highly unlikely that the user will stop and read the instructions or labels. After putting it…[Read more]

]]> 0 3237e583860dd650005bdf053ef6c4a3 tilak replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5078/ Mon, 13 Nov 2017 04:21:08 -0500 The largest source of design input is market research. Understanding the market gap for your product can help to understand what services need to be fulfilled by your product. From this market research, an outline of customer needs can be developed. The way to meet each of these needs will require detailed technical research that will outline the…[Read more]

]]> 0 40f1bdffd15832d1e1680f3bb54aca8e tilak replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5077/ Mon, 13 Nov 2017 04:14:11 -0500 DDPs as a whole are very crucial in the timeline of the project. The gantt chart helps to outline each segment as it is approached. The project manager must effectively build a DDP to outline all the different departments of the project. With this in mind, the communication management plan can thus be argued as one of the most important parts in…[Read more]

]]> 0 efd5bda37ca498c7a94bd79b378a4ad4 tilak replied to the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5074/ Mon, 13 Nov 2017 04:06:02 -0500 Although I’ve never attended a design review meeting, I think it’s safe to say these meetings are crucial to get every member of the team and even sponsors and consumers on the same page. It would be the perfect platform for outlining the details of the design and receiving constructive criticism and approval on the various design phases. These…[Read more]

]]> 0 65c3f7e214eac8f4db291dd9dfcc59fe tilak replied to the topic Placebo-controlled trials: Are they ethical? Are they necessary ? in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/4611/ Sun, 29 Oct 2017 21:35:20 -0400 Placebo controlled trials are a great way of helping scientists understand why a new medical treatment is more useful and effective than no treatment at all. Due to the “Placebo effect”, some patients may progress and get better without receiving any treatment at all, therefore lowering the accuracy of these trials. Nevertheless, because of this…[Read more]

]]> 0 c2389913ad33f713a4f5a348cbc5fdc6 tilak replied to the topic Double Blind Vs Single blind Study in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/4590/ Sun, 29 Oct 2017 19:05:11 -0400 In most cases, double blind studies are an effective way of performing a research study and learning new information about a drug or new treatments. Double blind studies are also a way of removing bias from the testing of these drugs. Any previous knowledge that an investigator may have can affect on the outcome of how the new drug is analyzed. In…[Read more]

]]> 0 579ed76ca98aa3db5b25805fe45f9ac5 tilak replied to the topic Discussion Topic: Having a "clinical background" in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/4587/ Sun, 29 Oct 2017 18:44:19 -0400 A background in clinical studies should be required depending on the profession and work environment. For example, a Principal Investigator (PI) is the “primary individual responsible for the preparation, conduct, and administration of a research grant or other sponsored project in compliance with applicable laws and regulations” and for this…[Read more]

]]> 0 08c5dd5e30be035666c7f95157fe02cd tilak replied to the topic Discussion Topic: Mission and Vision statements in the forum Marketing and Sales https://medicaldevicecourses.com/activity/p/4290/ Sun, 22 Oct 2017 17:00:31 -0400 Currently I work as a clinical research intern at Colgate-Palmolive Co. Their mission statement is as follows:

“As a Company that strives to be the best truly global consumer products company, we are committed to doing business with integrity and respect for all people and for the world around us. and Continuous Improvement will continue to drive…[Read more]

]]> 0 686466afeede8cde31d970c1d929c284 tilak replied to the topic Discussion Topic: The Fifth "P" of Marketing in the forum Marketing and Sales https://medicaldevicecourses.com/activity/p/4288/ Sun, 22 Oct 2017 16:41:48 -0400 In today’s fast paced, media centric, society most technology giants spend most of their money only on the initial marketing of a product. This means that once it is given the initial push, they rely on the consumers to spread the word further. This naturally occurring participation takes marketing to a whole new level. Technology giants such as…[Read more]

]]> 0 793f62418379f6b3179918fcf8c96713 tilak replied to the topic Family Businesses in the forum Business 101 https://medicaldevicecourses.com/activity/p/4182/ Mon, 16 Oct 2017 03:29:52 -0400 As can be predicted by its name, a sole proprietorship has one owner who is fully responsible for the operation of the company. The owner makes decision that will affect the overall growth of the business. Its not possible for the owner to pass it on to his two sons because a sole proprietorship can only have one owner. However, the first step…[Read more]

]]> 0 3f598f4fd34207816acbb1c8b76f9b03 tilak replied to the topic Discussion Topic: Inc. vs. LLC in the US in the forum Business 101 https://medicaldevicecourses.com/activity/p/4166/ Mon, 16 Oct 2017 02:17:54 -0400 First its important to identify the difference between an incorporation and a limited liability company. An LLC is the United States’ version of a private limited company. An LLC’s business structure combines the taxation of a partnernship with the limited liability of a corporation. On the contrast, an incorporated company is legally separate…[Read more]

]]> 0 4f9486a18e63615db7fa62e80aabd145 tilak replied to the topic Relation of Quality with other department. in the forum Quality Control and Quality Assurance https://medicaldevicecourses.com/activity/p/3962/ Mon, 09 Oct 2017 00:46:06 -0400 When we observe the hierarchy of the government it is clear that a system of checks and balances keeps the three branches running in agreement. However, this is not always the case in an industrial setting where various departments influence the outcome of a company’s product. Quality departments seemed to have established a sort of tyranny over…[Read more]

]]> 0 99131f3be87d09993724ae4648e4dba4 tilak replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices https://medicaldevicecourses.com/activity/p/3794/ Mon, 02 Oct 2017 00:16:54 -0400 The processes laid down by the FDA maybe lengthy and tedious but they are not too strict. Without the FDA, there aren’t many other government organizations or groups that can be as effective in delivering rulings, and regulations over the vast amounts of medical devices, drugs and other consumer products that are released into the market every…[Read more]

]]> 0 4710efc0666310140ab92a4cba9d2536 tilak replied to the topic Precision and Accuracy in the forum Regulatory Basics for Medical Devices https://medicaldevicecourses.com/activity/p/3793/ Sun, 01 Oct 2017 23:57:09 -0400 Precision and accuracy are two valuable pillars of judgement that are often overlooked by consumers. How well these two conditions are met can significantly impact the ruling presented by the FDA on any medical device, substance or product. If precision and accuracy are not met properly by a commonly used medical device, it can often lead to a…[Read more]

]]> 0 5c52a576dce7cba91d4d71db6d303ece tilak replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices https://medicaldevicecourses.com/activity/p/3775/ Sun, 01 Oct 2017 20:48:11 -0400 Vaporizers, E-Cigs, hookah pens, etc. are all terms used to describe what the FDA calls Electronic Nicotine Delivery Systems (ENDS). The organic compounds along with the vaporized water contain nicotine and other compositions of flavors. In 2016, the FDA extended their ruling and passed regulation to cover all tobacco products and ENDS devices…[Read more]

]]> 0 ba3fcd70bf54728d4f16ea5ccaf3daa6 tilak replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development https://medicaldevicecourses.com/activity/p/3462/ Sun, 24 Sep 2017 17:49:50 -0400 The reason a biocompatibility test is performed is to determine the effectiveness and durability of a biomaterial, medical device or drug for human use and to analyze any potentially harmful or physiological side effects. To prevent insufficiently tested materials and devices from entering the market, governments around the world have established…[Read more]

]]> 0 966aef9f0d06f25bc5aa806ddcf8ef67 tilak became a registered member https://medicaldevicecourses.com/activity/p/3455/ Sun, 24 Sep 2017 16:07:52 -0400 0