Medical Device Courses | Bhargav | Activity https://medicaldevicecourses.com/members/bv87/activity/ Activity feed for Bhargav. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ceb131482f3181b6203619c7c265689f Bhargav replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/14479/ Wed, 15 May 2019 18:57:18 -0400 NDA would not substitute for the patent. NDA is helpful for your legal case when the person who signed the NDA uses company’s idea as his own. However, NDA is not useful when the person who signed the NDA reveal…   Read more»

]]> e5cd7fb615eed6531e4b07c428ad8ed7 Bhargav replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/14427/ Wed, 15 May 2019 18:56:01 -0400 I think that oral agreement are often looked upon warily because they are not easily enforceable. Contract that are written are can be easily presented for a legal defense than the oral testimony. It is also difficult to remove contract…   Read more»

]]> 5dcb39f27cbcb268dce1102ada47d484 Bhargav replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/14261/ Wed, 15 May 2019 18:54:32 -0400 I work at the company which manufactures dental prosthetics. I consider this organization as a functional based one since this organization structure is a hierarchical organization structure wherein people are grouped as per their area of specialization. Each department have…   Read more»

]]> bc19e90b2cc2f86dead3e5e08a5d3248 Bhargav replied to the topic "Risk management methods" - https://medicaldevicecourses.com/activity/p/14118/ Wed, 15 May 2019 18:52:07 -0400 One of the method to use from the design perspective is R & M or reliability and maintainability. As a Design engineer, I want to make sure that the product will be reliable after further use. The product should also…   Read more»

]]> 3e53188eff55065a8796d5774e649b5c Bhargav replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/14117/ Wed, 15 May 2019 18:52:06 -0400 There were a lot of mistakes can be made while implementing the FMEA. The mistakes cause the FMECA not meeting the objectives of it. Conceptually, Poka Yoke is able to fit into the Process FMEA. Failure Mode and Effect Analysis…   Read more»

]]> 17322967abca2372c1ee3b23121c1922 Bhargav replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/13850/ Wed, 15 May 2019 17:08:48 -0400 I believe that design controls should be part of the process used to determine the commercial viability of a product in development. Design input requirements can help customers and stakeholders identify and satisfy product requirements. Another vital part of the…   Read more»

]]> a8c9036d4727d1a59be79c4407f1d3fb Bhargav replied to the topic "Discussion Topic: Mission and Vision statements" - https://medicaldevicecourses.com/activity/p/13606/ Wed, 15 May 2019 17:06:27 -0400 A mission statement communicates the organization’s reason for being, and how it aims to serve its key stakeholders. Customers, employees, and investors are the stakeholders most often emphasized, but other stakeholders like government or communities can also be discussed. A…   Read more»

]]> 3904872abe81ea722fd720fa9eaa8953 Bhargav replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" - https://medicaldevicecourses.com/activity/p/13603/ Wed, 15 May 2019 17:06:25 -0400 The four branch model as the construct of emotional intelligence: (1) the ability to accurately perceive, appraise and express emotion; (2) the ability to use emotion to facilitate thinking; (3)the ability to understand the temporal course and probable outcome of…   Read more»

]]> 0aa115c7aa938e7e7e13630c5ecde8a5 Bhargav replied to the topic "How Quality Departments React to Audits" - https://medicaldevicecourses.com/activity/p/13356/ Wed, 15 May 2019 17:04:15 -0400 I have not been a part of the audit during the the FDA or BSI visits. However, I have been called during the visit regarding the documents that I have written. Their main objective was to clear out the inconsistencies…   Read more»

]]> 08741f68434c55b2f254067d4b7f16d9 Bhargav replied to the topic "Discussion Topic: e-cigarettes" - https://medicaldevicecourses.com/activity/p/13103/ Wed, 15 May 2019 17:01:58 -0400 In 2016, the FDA issued a final deeming regulation that will regulate e-cigarettes as tobacco products, but the regulation, while addressing some key policy issues, still leaves significant regulatory gaps. In addition, the regulation will be phased in over the…   Read more»

]]> 80d2e426c967202cd4fba0bad8affc20 Bhargav replied to the topic "Academia vs. Industry Research" - https://medicaldevicecourses.com/activity/p/12938/ Wed, 15 May 2019 17:00:32 -0400 There are many differences between doing research in academic and industry. I have had experienced both during my career. Amount of time given to the research in industry may not be as comparable to academics. However, proper structure in industry…   Read more»

]]> 3c4b1db815b8070a9659b535a2fb146e Bhargav replied to the topic "Discussion Topic: Brand new biomaterial" - https://medicaldevicecourses.com/activity/p/12926/ Wed, 15 May 2019 17:00:20 -0400 The tests to assess the biocompability of the material should follow ISO 10993. The following tests should be done on the biomaterial for verification and validation of the product: Evaluation and testing within a risk management process, tests for genotoxicity,…   Read more»

]]> 7a829597ff1efaeb6ebad892ecf584d9 Bhargav replied to the topic "Obstacles while working on a project" - https://medicaldevicecourses.com/activity/p/12791/ Wed, 15 May 2019 16:59:11 -0400 While working on a project, we hit a roadblock during the verification phase. Before this obstacle, we have already spent most of our time and budget on the project. Before submitting 510k for our product, we had to complete a…   Read more»

]]> d071edc6ece9f3d0c5ef20689badaa5d Bhargav replied to the topic "Discussion Topic: Project Management in a medical device setting" - https://medicaldevicecourses.com/activity/p/12789/ Wed, 15 May 2019 16:59:10 -0400 I think the challenges are different for other industries as opposed to medical device. These differences are in the regulations involved on a project of respective industries such as building a school. For instance, projects in the medical device industries…   Read more»

]]> b6da11f81d0823ca3e734c48cddbe496 Bhargav replied to the topic "Project Life Cycle" - https://medicaldevicecourses.com/activity/p/12788/ Wed, 15 May 2019 16:59:09 -0400 I think initiation and planing phase is most important because in this phase you define your baseline. During these phases we gather the requirements and specifications for the project. Scope is defined in these phases which gives better picture of…   Read more»

]]> 997ca85a6464e25b96dfc5fc57141226 Bhargav replied to the topic "Discussion Topic: Academia vs. Industry" - https://medicaldevicecourses.com/activity/p/12648/ Wed, 15 May 2019 16:57:53 -0400 Since working in both academia and industry, I have experienced both pros and cons. Working in academia allows you to take in-charge of your project and choose your own direction. You can freely choose your own objectives and goals regarding…   Read more»

]]> 413fbf2eed688d5cf020d5c7c45e3282 Bhargav replied to the topic "Discussion Topic: Practical vs. Informational courses" - https://medicaldevicecourses.com/activity/p/12647/ Wed, 15 May 2019 16:57:53 -0400 I think this is not an appropriate ratio because students need more exposure to the practical tools to succeed in the industry. Practical knowledge allows you to gain the specific techniques that become the tools of your trade. Practical knowledge…   Read more»

]]> 163f10821434b5965ba6ec2835f241e8 Bhargav replied to the topic "Engineer vs. Manager" - https://medicaldevicecourses.com/activity/p/12608/ Wed, 15 May 2019 16:57:32 -0400 I want to keep working as an Engineer because I will be directly involved in the project. Engineer also have an important part to perform in the project. If an engineer’s job is done so poorly as to make the…   Read more»

]]> 6c2b11340bcf66e654745a41368ad948 Bhargav replied to the topic "Procurement Management" - https://medicaldevicecourses.com/activity/p/12458/ Wed, 15 May 2019 16:56:14 -0400 I would take the opportunity to review the financial stability of the vendor as problems often mean an unprofitable company.I would also look at the performance of the vendor coupled with their direct and indirect benefits is compared to the…   Read more»

]]> f7288271e22428f43b94dee635f91aaa Bhargav replied to the topic "Organizational structure" - https://medicaldevicecourses.com/activity/p/12456/ Wed, 15 May 2019 16:56:13 -0400 There was an instant when one of our lead Engineer was removed from our team. This really pushed our timeline of our project back several week since we had to evaluate and assign his tasks to another member. The project…   Read more»

]]> 4b3db7d96c3296d5d63dd9ad501e7d62 Bhargav replied to the topic "General Wellness Product" - https://medicaldevicecourses.com/activity/p/11764/ Wed, 15 May 2019 16:49:31 -0400 Health apps could be considered a general wellness product. These apps allow users to count their daily calories and facilitate their exercise routines. Therefore these apps help to maintain healthy lifestyle and prevent the chronic diseases. I consider this product…   Read more»

]]> f5c9150c5e5f95d181827ca4ba5b3be7 Bhargav replied to the topic "Tests for validation and verification phase" - https://medicaldevicecourses.com/activity/p/11694/ Wed, 15 May 2019 16:48:47 -0400 Most of the verification and validation tests are carried out by international standards such as ISO or ASTM. These standards specify the testing for strength, biological and chemical properties of the material used in product. For example, ISO 6872 specifies…   Read more»

]]> cb40c95fbb56e58f9c19c09e7cbd76a8 Bhargav replied to the topic "Experience with Design Control" - https://medicaldevicecourses.com/activity/p/11690/ Wed, 15 May 2019 16:48:46 -0400 Working at the dental implant company, I have been exposed to the design control that have been mentioned in the lecture. During the beginning of the project, the general purpose of the medical device or its function is established. This…   Read more»

]]> 2b595dc3348f19bc8eccf8d46d9691de Bhargav replied to the topic "Best timing for validation and verification" - https://medicaldevicecourses.com/activity/p/11688/ Wed, 15 May 2019 16:48:45 -0400 I disagree with the posts above. The verification and validation covers all phases of the product development cycle. Its really critical to start the verification and validation at the beginning to establish the user needs and product specification. During the…   Read more»

]]> 4499221bd3f498af361fb4a4ae9a1ba5 Bhargav replied to the topic "Mobile Medical Applications" - https://medicaldevicecourses.com/activity/p/11636/ Wed, 15 May 2019 16:48:18 -0400 Applications whose functionality poses a risk to a patient’s safety if the mobile app were to not function as intended are considered mobile medical applications. Therefore app to retain the auditory cues is considered the mobile medical application. Furthermore, FDA…   Read more»

]]> 552408c716ccd72072137df28db545f6 Bhargav replied to the topic "Significant or non-significant risk" - https://medicaldevicecourses.com/activity/p/11597/ Wed, 15 May 2019 16:47:58 -0400 We can have better understanding of the “significant risk” by reviewing the FDA’s requirement to review all the adverse events. The medical device reporting regulation states that a serious injury is one that is life threatening, results in permanent impairment…   Read more»

]]> e8496a83f1d4577472bb9c280c829765 Bhargav replied to the topic "Discussion Topic: Share your project management experience" - https://medicaldevicecourses.com/activity/p/11561/ Wed, 15 May 2019 16:47:40 -0400 The project management at my company is advanced and uses visual project management system to manage projects. Each project begins with the master schedule set up by the member of each department such as quality, product development, material research, process…   Read more»

]]> 748156ef8be04c4b1636f48f2e65982b Bhargav replied to the topic "Discussion Topic: Projects of all types" - https://medicaldevicecourses.com/activity/p/11516/ Wed, 15 May 2019 16:45:36 -0400 I think project management skills are transferable to the different industries to a certain extent. Project managers possess the skills such as leadership, communication and punctuality that can be applied to any type of project in different industries. Good project…   Read more»

]]> 94a16410d6f717bae53511d393fb64a4 Bhargav replied to the topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/11499/ Wed, 15 May 2019 16:45:28 -0400 I work at Nobel Biocare which manufactures dental prosthetics. I consider this organization as a functional based one since this organization structure is a hierarchical organization structure wherein people are grouped as per their area of specialization. Each department have…   Read more»

]]> 2079d92d8feb0b7e5cc82d927be6b87b Bhargav replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5532/ Mon, 04 Dec 2017 03:34:29 -0500 NDA would not substitute for the patent. NDA is helpful for your legal case when the person who signed the NDA uses company’s idea as his own. However, NDA is not useful when the person who signed the NDA reveal the idea to the third party.
On the other hand,patents protect the idea from the people who innocently and coincidentally come out with…[Read more]

]]> 0 906ac09c2373a49f59c1bf636481827e Bhargav replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5477/ Sun, 03 Dec 2017 20:59:27 -0500 I think that oral agreement are often looked upon warily because they are not easily enforceable. Contract that are written are can be easily presented for a legal defense than the oral testimony. It is also difficult to remove contract defects when they are not in writing.

]]> 0 3f31492f98613fa42fd5b5570102d5a1 Bhargav replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5300/ Sun, 26 Nov 2017 18:27:30 -0500 I work at the company which manufactures dental prosthetics. I consider this organization as a functional based one since this organization structure is a hierarchical organization structure wherein people are grouped as per their area of specialization. Each department have its own manager who will be responsible for the performance of his team…[Read more]

]]> 0 4918716950f4b7a7e0de3c44774a47b7 Bhargav replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5152/ Sun, 19 Nov 2017 04:26:41 -0500 One of the method to use from the design perspective is R & M or reliability and maintainability. As a Design engineer, I want to make sure that the product will be reliable after further use. The product should also have low cost and easy maintainance going forward. The causes for maintenance and operating costs need to be studied in the initial…[Read more]

]]> 0 f9b749208be76716890f281af5d68563 Bhargav replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5151/ Sun, 19 Nov 2017 04:04:35 -0500 There were a lot of mistakes can be made while implementing the FMEA. The mistakes cause the FMECA not meeting the objectives of it. Conceptually, Poka Yoke is able to fit into the Process FMEA. Failure Mode and Effect Analysis (FMEA) helps predict and prevent problems through proper control or detection methods. Mistake proofing emphasizes…[Read more]

]]> 0 406a462628bf30afc203f64e8fa3437e Bhargav replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/4856/ Sun, 05 Nov 2017 00:28:05 -0400 I believe that design controls should be part of the process used to determine the commercial viability of a product in development. Design input requirements can help customers and stakeholders identify and satisfy product requirements. Another vital part of the product development process is design output. A medical device cannot exist without…[Read more]

]]> 0 ac2439362bff26aa0299740c4bd7e4b7 Bhargav replied to the topic Discussion Topic: Mission and Vision statements in the forum Marketing and Sales https://medicaldevicecourses.com/activity/p/4327/ Sun, 22 Oct 2017 22:28:03 -0400 A mission statement communicates the organization’s reason for being, and how it aims to serve its key stakeholders. Customers, employees, and investors are the stakeholders most often emphasized, but other stakeholders like government or communities can also be discussed.

A vision statement, in contrast, is a future-oriented declaration of t…[Read more]

]]> 0 7c72d6fea63fba7b24f86d2c86b1d048 Bhargav replied to the topic Discussion Topic: Emotional Intelligence and its affect on sales in the forum Marketing and Sales https://medicaldevicecourses.com/activity/p/4324/ Sun, 22 Oct 2017 22:01:02 -0400 The four branch model as the construct of emotional intelligence: (1) the ability to accurately perceive, appraise and express emotion; (2) the ability to use emotion to facilitate thinking; (3)the ability to understand the temporal course and probable outcome of emotions; and (4) the ability to regulate emotions effectively.

Today’s m…[Read more]

]]> 0 a1622b303c4a91beae90e7761063f6c3 Bhargav replied to the topic How Quality Departments React to Audits in the forum Quality Control and Quality Assurance https://medicaldevicecourses.com/activity/p/3980/ Mon, 09 Oct 2017 02:01:57 -0400 I have not been a part of the audit during the the FDA or BSI visits. However, I have been called during the visit regarding the documents that I have written. Their main objective was to clear out the inconsistencies in the reports. The documentation meets the defined quality objective of the organizations The activities performed are in…[Read more]

]]> 0 f4779a1045116dece81eb395bbe83a86 Bhargav replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices https://medicaldevicecourses.com/activity/p/3612/ Fri, 29 Sep 2017 20:12:55 -0400 In 2016, the FDA issued a final deeming regulation that will regulate e-cigarettes as tobacco products, but the regulation, while addressing some key policy issues, still leaves significant regulatory gaps. In addition, the regulation will be phased in over the next few years, so even if it is not delayed as a result of litigation or other…[Read more]

]]> 0 7ef407ca3760cf0bc316420dc3aec195 Bhargav replied to the topic Academia vs. Industry Research in the forum Pre-clinical Device Development https://medicaldevicecourses.com/activity/p/3393/ Thu, 21 Sep 2017 13:05:17 -0400 There are many differences between doing research in academic and industry. I have had experienced both during my career. Amount of time given to the research in industry may not be as comparable to academics. However, proper structure in industry drives efficiency with the amount of time provided.

There were many factors that insured that I was…[Read more]

]]> 0 3177ac37b2b4da0ed044fa394229d734 Bhargav replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development https://medicaldevicecourses.com/activity/p/3377/ Tue, 19 Sep 2017 20:54:07 -0400 The tests to assess the biocompability of the material should follow ISO 10993. The following tests should be done on the biomaterial for verification and validation of the product: Evaluation and testing within a risk management process, tests for genotoxicity, carcinogenicity and reproductive toxicity, tests for in vitro cytotoxicity, tests for…[Read more]

]]> 0 580a1e108fed9cc8416efb883b87249e Bhargav replied to the topic Obstacles while working on a project in the forum Intro to Project Management https://medicaldevicecourses.com/activity/p/3236/ Sat, 16 Sep 2017 16:41:12 -0400 While working on a project, we hit a roadblock during the verification phase. Before this obstacle, we have already spent most of our time and budget on the project. Before submitting 510k for our product, we had to complete a strength testing of our material. The material and the product design failed to pass the specification and thus we had to…[Read more]

]]> 0 d8398666cc1e8c097801f9a4811ac162 Bhargav replied to the topic Discussion Topic: Project Management in a medical device setting in the forum Intro to Project Management https://medicaldevicecourses.com/activity/p/3234/ Sat, 16 Sep 2017 14:36:19 -0400 I think the challenges are different for other industries as opposed to medical device. These differences are in the regulations involved on a project of respective industries such as building a school. For instance, projects in the medical device industries need to take into consideration the FDA regulations, such as 510(K) clearance. While…[Read more]

]]> 0 9cc9180661c7a0383194f782dd34d99a Bhargav replied to the topic Project Life Cycle in the forum Intro to Project Management https://medicaldevicecourses.com/activity/p/3233/ Sat, 16 Sep 2017 14:23:06 -0400 I think initiation and planing phase is most important because in this phase you define your baseline. During these phases we gather the requirements and specifications for the project. Scope is defined in these phases which gives better picture of the project. Project objective are also constructed in this phase which helps in accuracy of project…[Read more]

]]> 0 25f364ab552ef6a5449fbf4e7d877d1e Bhargav replied to the topic Discussion Topic: Academia vs. Industry in the forum Introduction to Medical Device Development https://medicaldevicecourses.com/activity/p/3038/ Sat, 09 Sep 2017 20:11:34 -0400 Since working in both academia and industry, I have experienced both pros and cons. Working in academia allows you to take in-charge of your project and choose your own direction. You can freely choose your own objectives and goals regarding the projects. Meanwhile in the industry, the deadlines and project objectives are dictated by your…[Read more]

]]> 0 7bd1828a432c4c4c139a5d92afd07129 Bhargav replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development https://medicaldevicecourses.com/activity/p/3037/ Sat, 09 Sep 2017 18:59:34 -0400 I think this is not an appropriate ratio because students need more exposure to the practical tools to succeed in the industry. Practical knowledge allows you to gain the specific techniques that become the tools of your trade. Practical knowledge leads to a deeper understanding of a concept through the act of doing and by gaining personal…[Read more]

]]> 0 af23a4c41aa82e148dbf248b0cc97a49 Bhargav replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2553/ Sun, 30 Apr 2017 23:39:38 -0400 I want to keep working as an Engineer because I will be directly involved in the project. Engineer also have an important part to perform in the project. If an engineer’s job is done so poorly as to make the product non-marketable, the product will fail and won’t be used. When the quality along all dimensions passes the adoption threshold, every…[Read more]

]]> 0 6fc9a24f94c40f6629feb69bc56d844c Bhargav replied to the topic Procurement Management in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2342/ Thu, 20 Apr 2017 22:32:39 -0400 I would take the opportunity to review the financial stability of the vendor as problems often mean an unprofitable company.I would also look at the performance of the vendor coupled with their direct and indirect benefits is compared to the physical cost of doing business with them. These costs would include such matters as: overpricing, early…[Read more]

]]> 0 b32b3ba458c9cb1b09290200e6cafc38 Bhargav replied to the topic Organizational structure in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2340/ Thu, 20 Apr 2017 22:24:42 -0400 There was an instant when one of our lead Engineer was removed from our team. This really pushed our timeline of our project back several week since we had to evaluate and assign his tasks to another member. The project also missed his expertise on certain topics. At the end, he was asked to work on both project simultaneously.

]]> 0 d79f3931307de4d89714a518e47ed8d3 Bhargav replied to the topic General Wellness Product in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/1450/ Fri, 10 Feb 2017 04:00:08 -0500 Health apps could be considered a general wellness product. These apps allow users to count their daily calories and facilitate their exercise routines. Therefore these apps help to maintain healthy lifestyle and prevent the chronic diseases. I consider this product as a second category since it makes a direct reference to the diseases such as…[Read more]

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