Medical Device Courses | nitinhebbar | Activity https://medicaldevicecourses.com/members/nitinhebbar/activity/ Activity feed for nitinhebbar. Sat, 16 May 2026 09:37:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b001df2224b853d94d5aef3ffecdb911 nitinhebbar replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/14476/ Wed, 15 May 2019 18:57:17 -0400 Rules are to be properly formed. It is good that they don’t need to give a gift that would be out of education. But there is no necessity in keeping the limits. When it comes to education it must a…   Read more»

]]> cd0232b2eb67c399da857360d1b4396a nitinhebbar replied to the topic "Non Compete Agreement" - https://medicaldevicecourses.com/activity/p/14471/ Wed, 15 May 2019 18:57:15 -0400 Depending upon the states even the law enforcement differs. Each and every state has its own policies with Non Compete enforcement. The court expects a valid reason for this. If the entire business or part of it is getting some…   Read more»

]]> 3953cff24e9060976d6318d076cf0776 nitinhebbar replied to the topic "Matrix Organization- Conflict" - https://medicaldevicecourses.com/activity/p/14312/ Wed, 15 May 2019 18:55:01 -0400 I worked on a collaborative project between a biometrics firm and a computer vision laboratory. Most of the R&D work was done by the lab. My project manager had a tough time working with the lab as they were very…   Read more»

]]> 1495ac7334c219d752a9d889bbe1f5a6 nitinhebbar replied to the topic "Collaboration projects" - https://medicaldevicecourses.com/activity/p/14302/ Wed, 15 May 2019 18:54:56 -0400 In total agreeance with Adrian and amandaally1029. I also believe that the process of collaboration and working environment matters a lot than the organizational structure of the company. However, it is a priority for any company to choose an organizational…   Read more»

]]> 269718ab6879e3212e130bd32378079b nitinhebbar replied to the topic "Organization Type vs. Effectiveness" - https://medicaldevicecourses.com/activity/p/14298/ Wed, 15 May 2019 18:54:54 -0400 I believe that the strategy is to manage resources based on needs and good planning as well. However, I agree with sa596’s answer. If the project manager has good communication with other department and functional manager understands needs, then the…   Read more»

]]> 0ea0d0fc5b53058cf9a546de1128998b nitinhebbar replied to the topic "Manage Risk" - https://medicaldevicecourses.com/activity/p/14206/ Wed, 15 May 2019 18:53:01 -0400 Acceptance can be done for low severity risks because since the risks are low accepting and taking chances to get the benefits would be good. Avoidance and mitigation is good for high severity risks because since risks are too high…   Read more»

]]> 57068f6cbc1439780d1190d5260372d4 nitinhebbar replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/14205/ Wed, 15 May 2019 18:53:01 -0400 Instructions, labelling a medical device try to tell the users how to use or operate the product. So it is important that users read them carefully. To make sure that users follow the instructions, companies can do some training sessions…   Read more»

]]> d37d3e0797a31ba0317e72df6b19e8d7 nitinhebbar replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/14204/ Wed, 15 May 2019 18:53:00 -0400 Risk analysis, risk identification should be done at all points in the product develepoment. It should not be considered as separate task that should be done at the end stage of the product development. And also risk analysis should continue…   Read more»

]]> 9a5e75a3364a89d55d3aa365bd832cc3 nitinhebbar replied to the topic "Design Verification & Validation vs Clinical & Pre-Clinical Trials" - https://medicaldevicecourses.com/activity/p/14058/ Wed, 15 May 2019 18:51:31 -0400 Device like thermometer, gauze piece, micropores are used outside the body. Only verification and validation is sufficient for these devices and clinical/preclinical trials are not needed. These devices are low risk devices which does not harm patients.

]]> 34f56db7d813d4cf145252f9346ef231 nitinhebbar replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/14057/ Wed, 15 May 2019 18:51:30 -0400 Gantt chart is very important which defines the rough time of project execution and also documents the outlines involved in the process. It is a schedule that helps to plan, record/document and track specific tasks in a project. It should…   Read more»

]]> 8b7cdcfe4d6e689570d51e71f0931e60 nitinhebbar replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/14056/ Wed, 15 May 2019 18:51:30 -0400 I feel all the steps in DDP is equally important.It is difficult to say which one them has more weightage than the rest. Communication management plan helps us communicate with people involved in the project. Quality management plan helps us…   Read more»

]]> 1f65871285f8f87abc88eba9bd0e8c32 nitinhebbar replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" - https://medicaldevicecourses.com/activity/p/13761/ Wed, 15 May 2019 17:07:59 -0400 I agree with rd389 and Ibraheem shaikh with regards to respecting a person’s consent. Nowadays, IBR makes it a must for potential participants to be briefed with full information of the outcome and benefits form the test. In the case…   Read more»

]]> 23de4d432bec82fa68c999a18d1e8acf nitinhebbar replied to the topic "Who should own clinical trial Inventions?" - https://medicaldevicecourses.com/activity/p/13758/ Wed, 15 May 2019 17:07:57 -0400 I agree with dipanpatel regarding the ownership of IP. I also believe in having a good lawyer to have a look at the agreement before they go onboard the with the study. Some firms have a strict policy of IP…   Read more»

]]> a22d6ad170898427abd85f3c316432d7 nitinhebbar replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/13756/ Wed, 15 May 2019 17:07:56 -0400 In your case, Let us say that there is a new pill developed to treat Alzheimer’s. In the clinical trials, generally with an existing medicine or placebo, the new pill is tested and is it will be a randomized control…   Read more»

]]> f449360adab7e1bd3aca0627c14f443c nitinhebbar replied to the topic "Fuzz before launch of product." - https://medicaldevicecourses.com/activity/p/13645/ Wed, 15 May 2019 17:06:51 -0400 Unlike many consumer products, MedTech companies cannot employ same strategies to promote their products. One serious way that can attract many physicians and healthcare professionals is by creating compelling case studies. Case studies share insight on positive patient outcomes, reduce…   Read more»

]]> fcd31d86db67973ff004230bcdbf9dcd nitinhebbar replied to the topic "Manipulation or no?" - https://medicaldevicecourses.com/activity/p/13636/ Wed, 15 May 2019 17:06:47 -0400 The only way to increase the market share of your company is by showcasing that your product is much more superior or sometimes cheaper than the others. To a certain extent, I would say the companies try to influence your…   Read more»

]]> 8c2286e4f4aaf1f2b9843ac7f3fbc278 nitinhebbar replied to the topic "Grand Strategies" - https://medicaldevicecourses.com/activity/p/13619/ Wed, 15 May 2019 17:06:35 -0400 I want to introduce a cellular network firm (JIO networs) that recently disrupted the market and already has more than 100 million subscribers within one year of its launch in India. The strategy that it employed was a freemium strategy…   Read more»

]]> d474dfdc3d161ae66e3a233e42545ff6 nitinhebbar replied to the topic "Corporate Veil" - https://medicaldevicecourses.com/activity/p/13510/ Wed, 15 May 2019 17:05:31 -0400 The main three reasons for the Courts to pierce the corporate veil and impose personal liability on officers, directors, shareholders, or members when 1) There is no real separation between the company and its owners: For instance, if the owner…   Read more»

]]> 300f39b2da1806efebc184e355063bef nitinhebbar replied to the topic "Family Businesses" - https://medicaldevicecourses.com/activity/p/13503/ Wed, 15 May 2019 17:05:28 -0400 father can execute sale deed for transfer of assets and liabilities of sole proprietary concern by father in name of 2 sons. There are other ways such as simthshah said is by converting it into LLP. Another way is by…   Read more»

]]> 23bb86799ecea6360f4b9ec768850f14 nitinhebbar replied to the topic "Partnership characteristics" - https://medicaldevicecourses.com/activity/p/13496/ Wed, 15 May 2019 17:05:24 -0400 I prefer to getting into a partnership with someone who understands the objective and gives valuable insights into how to grow the business big. A partnership is a major commitment and risk associated would have a dent on your personal…   Read more»

]]> 67791f1b628034313bee26593ad350cf nitinhebbar replied to the topic "R&D vs Quality" - https://medicaldevicecourses.com/activity/p/13362/ Wed, 15 May 2019 17:04:17 -0400 I have no experience in this matter but, from product development cycle, I can pull out few points. R&D and QA may have major conflicts are during revisions of features while prototyping a deceive. R&D’s duty is to innovate and…   Read more»

]]> a2b5a4a6cc6f440357e4b600ab2855ef nitinhebbar replied to the topic "Discussion Topic: The cost of Quality" - https://medicaldevicecourses.com/activity/p/13361/ Wed, 15 May 2019 17:04:17 -0400 I believe that medical devices act as a tool for treating or diagnosing a patient and hence, it may play a bigger role than doctors themselves in some instances. While doctors, nurses and other medical staff are held to a…   Read more»

]]> f44afed294bdc7230f8871956fe21aac nitinhebbar replied to the topic "Regulations with quality" - https://medicaldevicecourses.com/activity/p/13360/ Wed, 15 May 2019 17:04:17 -0400 I believe that while FDA certifies devices and products for safety, the Quality of the device needs to just above the minimum requirement. Most competitive companies try to achieve much better quality to get the edge over others. No doubt…   Read more»

]]> 0546f74e0cf9b91215657388639f9216 nitinhebbar replied to the topic "FDA on Recalled Items" - https://medicaldevicecourses.com/activity/p/13198/ Wed, 15 May 2019 17:02:49 -0400 Even Though it’s FDA’s responsibility to test and certify a product safe for clinical use, they are not held responsible for the mistake. The manufacturer are responsible to produce a safe and a reliable product. However, with every recalls, the…   Read more»

]]> a7834648198516e00e77f48760b2d67c nitinhebbar replied to the topic "FDA rules too strict?" - https://medicaldevicecourses.com/activity/p/13197/ Wed, 15 May 2019 17:02:49 -0400 I Feel FDA rules are more like a filter to bad products from entering into market. With lot of competition in the market, some companies tries to cut corners and save time or even money. Since, any company’s main motto…   Read more»

]]> c4909a0721aeaa00c52e7f8faf8c8098 nitinhebbar replied to the topic "Changes in FDA under Trump's Administration" - https://medicaldevicecourses.com/activity/p/13196/ Wed, 15 May 2019 17:02:48 -0400 I agree with Ibraheem Shaikh. Many affordable medicine or medical devices are developed by new firms that are also smaller in terms of financial resources. When every aspect of innovation and translation to a product is a big hurdle, this…   Read more»

]]> 1d51b9e516733c158455205e9ed5a460 nitinhebbar replied to the topic "Research for the Fututre or Now?" - https://medicaldevicecourses.com/activity/p/13056/ Wed, 15 May 2019 17:01:35 -0400 I personally prefer to work in an industrial environment where the lifespan of the research is short. My motivation and driving force are the results from the research that I do. Since, research in industries have immediate results and have…   Read more»

]]> add1778fabf332f05930e208b91d5eaf nitinhebbar replied to the topic "Academia vs. Industry Research" - https://medicaldevicecourses.com/activity/p/13030/ Wed, 15 May 2019 17:01:23 -0400 I agreeance total with dag56,i would like to add few points. In an Industry, the deadlines are generally based on a necessity and the resources are allocated accordingly where money is not a constraint. When a new project is started…   Read more»

]]> 209f0f2001c545e69a42dbf9faaa19fe nitinhebbar replied to the topic "Ethics of Animal Testing" - https://medicaldevicecourses.com/activity/p/13020/ Wed, 15 May 2019 17:01:17 -0400 I totally understand where this question arises from. Until we find another alternative, the only two options left are humans and animals. The objective of pre-clinical study is to find a solution i.e, a drug or a new device for…   Read more»

]]> 7eafc61847cc5b16e7d16f317342e97d nitinhebbar replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5529/ Mon, 04 Dec 2017 02:55:11 -0500 Rules are to be properly formed. It is good that they don’t need to give a gift that would be out of education. But there is no necessity in keeping the limits. When it comes to education it must a worthy enough constructive one. Or high limits must be set for the amount. Also there is nothing wrong in spending for a meal. I feel that the rules…[Read more]

]]> 0 ba3048c63c6679ef051368dc9135e59e nitinhebbar replied to the topic Non Compete Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5524/ Mon, 04 Dec 2017 02:36:55 -0500 Depending upon the states even the law enforcement differs. Each and every state has its own policies with Non Compete enforcement. The court expects a valid reason for this. If the entire business or part of it is getting some issues then they can consider the situation. I don’t think there will be a major issues with respect to changing a job…[Read more]

]]> 0 bc8a67af7886d5445ecc472cc03d4e89 nitinhebbar replied to the topic Matrix Organization- Conflict in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5353/ Mon, 27 Nov 2017 02:28:50 -0500 I worked on a collaborative project between a biometrics firm and a computer vision laboratory. Most of the R&D work was done by the lab. My project manager had a tough time working with the lab as they were very slow in their process and we had to change our timelines several times. The reason behind it was that the Ph.D. students were…[Read more]

]]> 0 2b8034473b78abbf6cca750a61cf0da0 nitinhebbar replied to the topic Collaboration projects in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5343/ Mon, 27 Nov 2017 01:15:17 -0500 In total agreeance with Adrian and amandaally1029. I also believe that the process of collaboration and working environment matters a lot than the organizational structure of the company. However, it is a priority for any company to choose an organizational structure for the project to run efficiently. Certainly, the matrix structure is an…[Read more]

]]> 0 e27e8c3ea3de0cd81df5cd50f766aebe nitinhebbar replied to the topic Organization Type vs. Effectiveness in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5338/ Mon, 27 Nov 2017 00:56:22 -0500 I believe that the strategy is to manage resources based on needs and good planning as well. However, I agree with sa596’s answer. If the project manager has good communication with other department and functional manager understands needs, then the matrix organizational structure is the best-suited structure for many companies. Even though…[Read more]

]]> 0 799a337b9bf0a13e16856c55691d07ed nitinhebbar replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5240/ Mon, 20 Nov 2017 04:51:43 -0500 Acceptance can be done for low severity risks because since the risks are low accepting and taking chances to get the benefits would be good. Avoidance and mitigation is good for high severity risks because since risks are too high and can cause potential harm to patients its better to avoid them or to eliminate them. Transferance can be done for…[Read more]

]]> 0 db957410b3fd1943cc622fd136c9dc90 nitinhebbar replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5239/ Mon, 20 Nov 2017 04:50:26 -0500 Instructions, labelling a medical device try to tell the users how to use or operate the product. So it is important that users read them carefully. To make sure that users follow the instructions, companies can do some training sessions where in they tell about how to use the product and also explain the risks associated with them when not used…[Read more]

]]> 0 8bb517a29690bf7a307500792bd4226c nitinhebbar replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5238/ Mon, 20 Nov 2017 04:49:55 -0500 Risk analysis, risk identification should be done at all points in the product develepoment. It should not be considered as separate task that should be done at the end stage of the product development. And also risk analysis should continue even afer the product is released in the market. This gives better feedback about the product to the company.

]]> 0 6897cba784a44b4f780ec0fc1c930846 nitinhebbar replied to the topic Design Verification & Validation vs Clinical & Pre-Clinical Trials in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5081/ Mon, 13 Nov 2017 04:31:04 -0500 Device like thermometer, gauze piece, micropores are used outside the body. Only verification and validation is sufficient for these devices and clinical/preclinical trials are not needed. These devices are low risk devices which does not harm patients.

]]> 0 c13926e022b628df44384626910ee5b6 nitinhebbar replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5080/ Mon, 13 Nov 2017 04:30:01 -0500 Gantt chart is very important which defines the rough time of project execution and also documents the outlines involved in the process. It is a schedule that helps to plan, record/document and track specific tasks in a project. It should invovle the individual steps like planning, designing, developing, manufacturing, quality control, budget…[Read more]

]]> 0 a7615cea757760585187495045b764d2 nitinhebbar replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/5079/ Mon, 13 Nov 2017 04:27:41 -0500 I feel all the steps in DDP is equally important.It is difficult to say which one them has more weightage than the rest. Communication management plan helps us communicate with people involved in the project. Quality management plan helps us meet quality standards of the product set by FDA. Both are equally important to have a successfful medical device.

]]> 0 f8367180585626a3a84e1082f951f554 nitinhebbar replied to the topic Informed consent: What if Henrietta Lacks checked No for research use? in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/4625/ Sun, 29 Oct 2017 23:47:21 -0400 I agree with rd389 and Ibraheem shaikh with regards to respecting a person’s consent. Nowadays, IBR makes it a must for potential participants to be briefed with full information of the outcome and benefits form the test. In the case of compensation, it is generally nominal but certainly, there is a room for improvement. I believe that we should…[Read more]

]]> 0 b5a36a8835dcf61368633f42ba479d32 nitinhebbar replied to the topic Who should own clinical trial Inventions? in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/4622/ Sun, 29 Oct 2017 23:26:56 -0400 I agree with dipanpatel regarding the ownership of IP. I also believe in having a good lawyer to have a look at the agreement before they go onboard the with the study. Some firms have a strict policy of IP ownership and some are flexible with IP claims. Also, if the lab is not investing but assisting with the study, more or less, the innovation…[Read more]

]]> 0 3474747dea09788e7128d7d1196761ff nitinhebbar replied to the topic Double Blind Vs Single blind Study in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/4620/ Sun, 29 Oct 2017 23:08:54 -0400 In your case, Let us say that there is a new pill developed to treat Alzheimer’s. In the clinical trials, generally with an existing medicine or placebo, the new pill is tested and is it will be a randomized control test. If the doctors do not know which participant gets what, the results concluded by them are based on the findings from the test…[Read more]

]]> 0 b7f779633145bc63db200dffcb60672b nitinhebbar replied to the topic Fuzz before launch of product. in the forum Marketing and Sales https://medicaldevicecourses.com/activity/p/4365/ Mon, 23 Oct 2017 03:37:16 -0400 Unlike many consumer products, MedTech companies cannot employ same strategies to promote their products. One serious way that can attract many physicians and healthcare professionals is by creating compelling case studies. Case studies share insight on positive patient outcomes, reduce operational costs, increase productivity, lower readmission…[Read more]

]]> 0 4b708841b883b623e4a0f66711640d25 nitinhebbar replied to the topic Manipulation or no? in the forum Marketing and Sales https://medicaldevicecourses.com/activity/p/4356/ Mon, 23 Oct 2017 03:18:02 -0400 The only way to increase the market share of your company is by showcasing that your product is much more superior or sometimes cheaper than the others. To a certain extent, I would say the companies try to influence your decision rather than manipulation. If marketers employ covert tactics to manipulate customers, then they run the risk of being…[Read more]

]]> 0 00f09cb1f7eb1f06298d1b04a041e437 nitinhebbar replied to the topic Grand Strategies in the forum Marketing and Sales https://medicaldevicecourses.com/activity/p/4341/ Mon, 23 Oct 2017 02:37:56 -0400 I want to introduce a cellular network firm (JIO networs) that recently disrupted the market and already has more than 100 million subscribers within one year of its launch in India. The strategy that it employed was a freemium strategy when you lure in potential customers giving everything for free but charge a premium for additional features. By…[Read more]

]]> 0 5518d513659f3dee2f94abed040ed5bb nitinhebbar replied to the topic Corporate Veil in the forum Business 101 https://medicaldevicecourses.com/activity/p/4193/ Mon, 16 Oct 2017 03:56:38 -0400 The main three reasons for the Courts to pierce the corporate veil and impose personal liability on officers, directors, shareholders, or members when

1) There is no real separation between the company and its owners:
For instance, if the owner pays personal bills from the business checking account or ignores the legal
formalities that a…[Read more]

]]> 0 4dbb9b15bbd03677abe4ca74d0e114b4 nitinhebbar replied to the topic Family Businesses in the forum Business 101 https://medicaldevicecourses.com/activity/p/4185/ Mon, 16 Oct 2017 03:36:00 -0400 father can execute sale deed for transfer of assets and liabilities of sole proprietary concern by father in name of 2 sons. There are other ways such as simthshah said is by converting it into LLP. Another way is by executing the gift deed and transfer all the capital to his two sons as a gift but the only catch is, the gift deeds are very hard…[Read more]

]]> 0 0a8f3aeab2f02360d3de245a7c06bcca nitinhebbar replied to the topic Partnership characteristics in the forum Business 101 https://medicaldevicecourses.com/activity/p/4178/ Mon, 16 Oct 2017 03:20:27 -0400 I prefer to getting into a partnership with someone who understands the objective and gives valuable insights into how to grow the business big. A partnership is a major commitment and risk associated would have a dent on your personal savings. If a person is fully committed to the views and objectives of what the other person shares, then its a…[Read more]

]]> 0 1160f437ee0866cc4d85ead6cc5de8af nitinhebbar replied to the topic R&D vs Quality in the forum Quality Control and Quality Assurance https://medicaldevicecourses.com/activity/p/3986/ Mon, 09 Oct 2017 03:32:40 -0400 I have no experience in this matter but, from product development cycle, I can pull out few points. R&D and QA may have major conflicts are during revisions of features while prototyping a deceive. R&D’s duty is to innovate and bring about a competitive edge to the company and keep the company in business. However, while in the stage of…[Read more]

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