Medical Device Courses | Shachi | Activity https://medicaldevicecourses.com/members/sy335/activity/ Activity feed for Shachi. Sat, 25 Apr 2026 02:21:41 -0400 https://buddypress.org/?v= en-US 30 hourly 2 26438a7770e0fc2e221bb21911b81f9c Shachi replied to the topic "Disconnect in rewarding motivation" - https://medicaldevicecourses.com/activity/p/12581/ Wed, 15 May 2019 16:57:19 -0400 In my opinion, this issue can be addressed by facilitating better communications. Usually, in many organizations the communication is carried out by the medium of pay stub, but this leaves the majority of workers without any access to this effective…   Read more»

]]> 696bce8eb99d477a90df4b11e8575820 Shachi replied to the topic "Engineer vs. Manager" - https://medicaldevicecourses.com/activity/p/12579/ Wed, 15 May 2019 16:57:18 -0400 In my opinion, both engineers and managers make great supervisors. And engineers especially have those qualities which a managerial position demands as they are analytical, good at managing risk, innovative and very good with figures. So after working in the…   Read more»

]]> 03741316df84ae367e7711fc6b67f03f Shachi replied to the topic "Six Sigma Green Belt Certificate" - https://medicaldevicecourses.com/activity/p/12577/ Wed, 15 May 2019 16:57:17 -0400 A Six Sigma affirmation is an accreditation course that is very well known these days and many people are going for it. It seems that it has lot of weightage in anyone’s resume as it demonstrates one’s capacity and readiness…   Read more»

]]> c6ceb5aa06ff8ee66e25a577416af250 Shachi replied to the topic "Let's Be Motivated!!!" - https://medicaldevicecourses.com/activity/p/12484/ Wed, 15 May 2019 16:56:26 -0400 A PM should avoid nagging his team mates for meaningless questions about project mechanics at all the cost because that leads to loss of faith in the PM. He/She should focus on building a healthy relation within the team and…   Read more»

]]> 601cdcf3f9ee969104eda19b782759d0 Shachi replied to the topic "Change Requests During Clinical Trials" - https://medicaldevicecourses.com/activity/p/12483/ Wed, 15 May 2019 16:56:26 -0400 Any Change or modification to the clinical protocol may be reported in a 5-day notice and they can be implemented if they do not affect: a)validity of data or information resulting from the protocol b)scientific soundness of the investigation plan…   Read more»

]]> 87b328f0ee179a5812cfbd0df897f889 Shachi replied to the topic "Discussion Topic: Outsource vs. Insource the clinical trial" - https://medicaldevicecourses.com/activity/p/12479/ Wed, 15 May 2019 16:56:24 -0400 Many times the clinical trials conducted by the CRO are done with the intention of gaining maximum profit out of the business without any concern for the safety and efficacy of the patients. In my opinion, the outsourcing policy only…   Read more»

]]> 6f8a27c11511687fed6ef700425a52ab Shachi replied to the topic "Discussion Topic: Costs and managing your investment" - https://medicaldevicecourses.com/activity/p/12407/ Wed, 15 May 2019 16:55:43 -0400 It is difficult to exactly pinpoint the required rate of return due to the various estimates and preferences that differ from one decision maker to another.The various factors that determine the rate of return are the risk return preferences, inflation…   Read more»

]]> 57b8dba9e73436f94c08189741c3c097 Shachi replied to the topic "Discussion Topic: Risk Analysis methods" - https://medicaldevicecourses.com/activity/p/12404/ Wed, 15 May 2019 16:55:41 -0400 Fault Tree Analysis(FTA); which is used to give a graphical representation of the reliability of a system in order to predict the performance of its elements and identify any key poor performers that need further designing.And maintains the overall life…   Read more»

]]> 1a3615ddddece1d9180071c38ddf72bd Shachi replied to the topic "Procurement Management" - https://medicaldevicecourses.com/activity/p/12400/ Wed, 15 May 2019 16:55:39 -0400 In my opinion, if it is a small organization looking for outsourcing, then it should go for smaller vendors to cut down on the cost and to maintain flexibility rather than going for larger players as they may not provide…   Read more»

]]> e606ee1e7dc15463aa5250dfe0203cd3 Shachi replied to the topic "Combination Product" - https://medicaldevicecourses.com/activity/p/12342/ Wed, 15 May 2019 16:55:08 -0400 Photodynamic therapy with PHOTOFRIN is an example of combination device that comprises of two stages. In the first stage, an intravenous injection of PHOTOFRIN is given to the patient. It gets cleared from most of the tissues over 40-72 hours,…   Read more»

]]> e4b6f748779d9c4e22115530fb9952c4 Shachi replied to the topic "Design Review Meeting Culture" - https://medicaldevicecourses.com/activity/p/12284/ Wed, 15 May 2019 16:54:30 -0400 In my opinion, the project review meetings are vital for delivering the status of the project to executive management and other stakeholders, it provides them with the updates and the major milestones of the project, while addressing any emerging issue…   Read more»

]]> 1545fe16440e978127134650546332a7 Shachi replied to the topic "Ideal PM Processes vs. Real life" - https://medicaldevicecourses.com/activity/p/12283/ Wed, 15 May 2019 16:54:29 -0400 In my opinion, completing the product life cycle is not that easy in real life.A bunch of people who are experts in their fields and are working together to complete a project, will have to overcome many minor issues with…   Read more»

]]> ea6858c36a79e61fa404364cbdabe0cc Shachi replied to the topic "Engineering change order" - https://medicaldevicecourses.com/activity/p/12226/ Wed, 15 May 2019 16:53:59 -0400 Once the problem is identified by someone and it requires a change.The scope of the issue and its possible impact are estimated before generating an engineering change request (ECR) to examine the feasibility of the change that might include identification…   Read more»

]]> 1ca54c9b7c009d73f15f65e0d49800c0 Shachi replied to the topic "Work Logs and FDA Audits" - https://medicaldevicecourses.com/activity/p/12207/ Wed, 15 May 2019 16:53:48 -0400 I do not have any personal experience with FDA audits. But i feel its always wise to adhere to the Good Clinical Practices(GCP) to stay on the safer side. Sticking to the proper Standard Operating Procedures(SOP) to maintain the consistency,…   Read more»

]]> 2a2f517de02baa62422a5ccb146db212 Shachi replied to the topic "Monitoring & Controlling Techniques" - https://medicaldevicecourses.com/activity/p/12205/ Wed, 15 May 2019 16:53:47 -0400 Every project requires the Monitoring and Controlling Process to review the progress and make changes in it to eliminate chances of future setbacks and to increase the workflow. And it comprises of set of skills and knowledge to implement the…   Read more»

]]> 40b0ee1caa2d51d76d7e38d99544f8f7 Shachi replied to the topic "Source Selection in Executing Process" - https://medicaldevicecourses.com/activity/p/12127/ Wed, 15 May 2019 16:53:00 -0400 I agree with Robert, that the suppliers must be contacted in the Project Planning Phase as this is the phase where the PM has to make an educated guess of the staff, resources and equipment needed to complete the project….   Read more»

]]> ea3b7fac824cdad50be1604cf555ca2c Shachi replied to the topic "PM: Quality Assurance Process" - https://medicaldevicecourses.com/activity/p/12125/ Wed, 15 May 2019 16:53:00 -0400 I would like to add to the above discussion that in any quality assurance, the corrective plan is vital to address any type of gaps in the quality controls or procedures. And in order to do that, the person responsible…   Read more»

]]> 973f27ae9e1125f4c6996ccaa94a992d Shachi replied to the topic "Benefits of this course" - https://medicaldevicecourses.com/activity/p/12087/ Wed, 15 May 2019 16:52:41 -0400 I would say this course is a must for anyone and everyone looking for career advancement in any field. It really helped me by giving an insight into the life of a PM and helped me understand better the roles…   Read more»

]]> d375a425a0303a4d60c4fa4a4047ee26 Shachi replied to the topic "PM Internationally" - https://medicaldevicecourses.com/activity/p/12044/ Wed, 15 May 2019 16:52:19 -0400 Any company seeking global presence, has to consider several key factors to handle an international project successfully such as: 1. Legal Systems 2. Quality Standards 4. Language Barriers 5. Time Zone Changes 6. Economic Conditions 7. Cultural differences. If these…   Read more»

]]> b9da56f137597941b8b70b31796abb1a Shachi replied to the topic "Are Missed Milestones really Bad?" - https://medicaldevicecourses.com/activity/p/12023/ Wed, 15 May 2019 16:52:04 -0400 In any project, the milestones are the important landmarks to assess the project.The project manager uses milestones to gauge if the project is on the right track, whether it is ending the project phase or completing the deliverables. In order…   Read more»

]]> 6cea6643f8f7227c2076eacde5fc087a Shachi replied to the topic "In the Shoes of a Project Manager" - https://medicaldevicecourses.com/activity/p/12022/ Wed, 15 May 2019 16:52:03 -0400 If i were the project manager for this week’s simulation, first and foremost 1. I would have come up with a game plan for the simulations by defining the timelines that can be achieved realistically. 2. Afterwards, I would have…   Read more»

]]> 69cd914fc906c1376dd1caa9fb676e18 Shachi replied to the topic "Risk Management" - https://medicaldevicecourses.com/activity/p/11948/ Wed, 15 May 2019 16:51:22 -0400 I came across an article on implant dentistry, where the dental claims related to implants often have a high degree of severity. And there were several reasons illustrated for these high claim severity. One, implant dentistry is reallu expensive and…   Read more»

]]> 31f965931dbf26d739e3246adcd3ac05 Shachi replied to the topic "Work Breakdown Structure" - https://medicaldevicecourses.com/activity/p/11947/ Wed, 15 May 2019 16:51:22 -0400 I agree with everyone regarding working in the team and using the Work Breakdown Structure(WBS) for assigning the work to the team members. There are few more points i would like to add to the discussion: 1.To successfully use a…   Read more»

]]> 6b3881301a63447472e17748a3dab178 Shachi replied to the topic "Discussion Topic: Integrating Six Sigma into Project Planning" - https://medicaldevicecourses.com/activity/p/11896/ Wed, 15 May 2019 16:50:49 -0400 The DMAIC process of Six Sigma involves defining and quantifying a problem, collecting the data and clarifying the problem, tools are used to resolve the problem from the root, and finally, the improved operations are used as control to prevent…   Read more»

]]> c9ba4fd7826d22ae510d23120f8e3928 Shachi replied to the topic "Discussion Topic: Design and Process Verification" - https://medicaldevicecourses.com/activity/p/11879/ Wed, 15 May 2019 16:50:40 -0400 The Execution Phase of any project plan is to make sure all the activities of the project that were planned are carried out in an effective and efficient way.The verification test designed for the execution phase depends heavily on the…   Read more»

]]> 59d3d9d214bd5af17c17d294d13baced Shachi replied to the topic "Discussion Topic: Realities of Planned Value" - https://medicaldevicecourses.com/activity/p/11873/ Wed, 15 May 2019 16:50:35 -0400 In every company the project is planned based on the resources available. If the budget is bigger, more people can be roped in to finish the project more quickly and deliver more. Therefore, no project planning is complete until you…   Read more»

]]> 9c566ca4bdc8d489b22e03775fb2caa1 Shachi replied to the topic "Simulations" - https://medicaldevicecourses.com/activity/p/11805/ Wed, 15 May 2019 16:49:54 -0400 One major difference between a virtual team over real industry team is that the team members can pitch in at their own comfortable timings. So usually its the two or three members at a time who will be discussing the…   Read more»

]]> 65daeea97e47d78a8757538f3a77b817 Shachi replied to the topic "Ideal project team" - https://medicaldevicecourses.com/activity/p/11755/ Wed, 15 May 2019 16:49:25 -0400 I totally agree with Robert and jvv6 regarding the ideal project team. Apart from that all the team members should be open to new ideas. Its always better to have people from different fields in a team which brings about…   Read more»

]]> ba5dcc2b6f6abbb1d15e3a8b57f4b25d Shachi replied to the topic "LifeVest Wearable Cardioverter Defibrillator" - https://medicaldevicecourses.com/activity/p/11744/ Wed, 15 May 2019 16:49:18 -0400 I agree with bb252 that it is definitely a Class III device as it poses high risk to the patients. But this device is generally used under the condition where the patient has a weak heart and implanting ICD is…   Read more»

]]> 570981939fd08c405828ac190ae22b52 Shachi replied to the topic "How to initiate project successfully" - https://medicaldevicecourses.com/activity/p/11731/ Wed, 15 May 2019 16:49:07 -0400 For any project to be launched successfully and get a sponsorship, it should follow the following six steps: Step 1: Create a detailed business case for everyone to know what the exact the business requirements are. It will be the…   Read more»

]]> d36a3cb7bd914ec66afb895ee491967f Shachi replied to the topic "Toxic Medicine" - https://medicaldevicecourses.com/activity/p/11724/ Wed, 15 May 2019 16:49:04 -0400 The homeopathic medicine has been practiced for more than 200 years and is based on the principle where pharmacologically-active agents are administered to treat the symptoms of a disease. Homeopathic products come under the category of over-the-counter (OTC) or prescription…   Read more»

]]> 4ba6cc74729947c8e776623dbb971fb6 Shachi replied to the topic "Potential FDA Changes under Trump" - https://medicaldevicecourses.com/activity/p/11719/ Wed, 15 May 2019 16:49:01 -0400 It’s indeed a very interesting topic to debate upon. According to the latest data on time taken by FDA on the product approval varies from 6 to 10 months. Relaxing the regulation a bit would definitely expedite the whole process….   Read more»

]]> f479ff0bfebdbe9ee3107c42106eecd2 Shachi replied to the topic "Human Factors study in combination products" - https://medicaldevicecourses.com/activity/p/11598/ Wed, 15 May 2019 16:47:59 -0400 Human factors is the study of the interaction of people and technology to ensure that a good compatability exists between the human beings and the device,manufactured to address a disorder or a condition. In addition to that, it provides safety…   Read more»

]]> 014a815fdd76da591d28b5c8858ce652 Shachi replied to the topic "Difference" - https://medicaldevicecourses.com/activity/p/11571/ Wed, 15 May 2019 16:47:45 -0400 A project manager is a person who is responsible for the successful planning, design, execution, monitoring, controlling and closure of a project. Their main role is to come up with solutions or approaches that facilitate the commercialization of that particular…   Read more»

]]> d2857b86f39feee3305d670e8433b4d8 Shachi replied to the topic "Discussion Topic: To trial or not to trial" - https://medicaldevicecourses.com/activity/p/11570/ Wed, 15 May 2019 16:47:45 -0400 Any Design Validation procedure comprises of the tests required to demonstrate the functions of the medical device as expected and it should meet the needs of the user. It incorporates inspection and analyses as part of validation in addition to…   Read more»

]]> 23f1d5fb41c821dea6a0906f661c5733 Shachi posted a new topic "Project Scope Management" - https://medicaldevicecourses.com/activity/p/10482/ Wed, 15 May 2019 16:33:54 -0400 Hey guys, So far we all have read about the Scope of the project that comprises of documenting and determining the list of deliverables, goals, deadlines etc pertaining to any project. But my question is what do you understand by…   Read more»

]]> fb6378143cdeddaa8361e25e4713e320 Shachi replied to the topic Disconnect in rewarding motivation in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2515/ Sun, 30 Apr 2017 02:19:02 -0400 In my opinion, this issue can be addressed by facilitating better communications. Usually, in many organizations the communication is carried out by the medium of pay stub, but this leaves the majority of workers without any access to this effective method of staff communication. The companies need to understand their people and their diversity to…[Read more]

]]> 0 3cea6b4ab98ef22adbc901d0ea3c125d Shachi replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2513/ Sun, 30 Apr 2017 02:02:02 -0400 In my opinion, both engineers and managers make great supervisors. And engineers especially have those qualities which a managerial position demands as they are analytical, good at managing risk, innovative and very good with figures. So after working in the industry for a few years, i would definitely like to become a manager one day. Obviously,…[Read more]

]]> 0 fd5a2bdaa591d604646ce88e728a87a4 Shachi replied to the topic Six Sigma Green Belt Certificate in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2511/ Sun, 30 Apr 2017 01:47:53 -0400 A Six Sigma affirmation is an accreditation course that is very well known these days and many people are going for it. It seems that it has lot of weightage in anyone’s resume as it demonstrates one’s capacity and readiness to improve. It is considered very helpful in enhancing one’s abilities and business discernment. It is not important to know…[Read more]

]]> 0 d59f17cc012b8061dadf3ff2d0e309e3 Shachi replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2378/ Sun, 23 Apr 2017 03:59:13 -0400 A PM should avoid nagging his team mates for meaningless questions about project mechanics at all the cost because that leads to loss of faith in the PM. He/She should focus on building a healthy relation within the team and engage with team mates on a more meaningful level. And set up a RACI (Responsible, Accountable, Consulted, Informed) Matrix…[Read more]

]]> 0 a4fc001be6c9e9a34b9766238d3ddaa1 Shachi replied to the topic Change Requests During Clinical Trials in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2377/ Sun, 23 Apr 2017 03:38:54 -0400 Any Change or modification to the clinical protocol may be reported in a 5-day notice and they can be implemented if they do not affect:
a)validity of data or information resulting from the protocol
b)scientific soundness of the investigation plan
c)The rights,safety or welfare of the human subjects

And the changes that do not require any FDA…[Read more]

]]> 0 0641c81ad0b363a22731b07f2845060a Shachi replied to the topic Discussion Topic: Outsource vs. Insource the clinical trial in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2373/ Sat, 22 Apr 2017 23:46:58 -0400 Many times the clinical trials conducted by the CRO are done with the intention of gaining maximum profit out of the business without any concern for the safety and efficacy of the patients. In my opinion, the outsourcing policy only benefits the organization by extracting the poor, illiterate and needed population by giving them lucrative offers.…[Read more]

]]> 0 13e4c9fbeb0f72359012076a3953663e Shachi replied to the topic Discussion Topic: Costs and managing your investment in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2275/ Sun, 16 Apr 2017 18:09:24 -0400 It is difficult to exactly pinpoint the required rate of return due to the various estimates and preferences that differ from one decision maker to another.The various factors that determine the rate of return are the risk return preferences, inflation and the capital structure of the firm. Each of these factors greatly affect the intrinsic value…[Read more]

]]> 0 28ba75cf55bf49a97b4313728505633b Shachi replied to the topic Discussion Topic: Risk Analysis methods in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2272/ Sun, 16 Apr 2017 17:43:50 -0400 Fault Tree Analysis(FTA); which is used to give a graphical representation of the reliability of a system in order to predict the performance of its elements and identify any key poor performers that need further designing.And maintains the overall life cycle cost of keeping a system available.

Pros:
1. Allows a clear representation of the…[Read more]

]]> 0 9b6c26411c805716e13e4e040bc18a72 Shachi replied to the topic Procurement Management in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2268/ Sun, 16 Apr 2017 15:54:56 -0400 In my opinion, if it is a small organization looking for outsourcing, then it should go for smaller vendors to cut down on the cost and to maintain flexibility rather than going for larger players as they may not provide that much attention to a smaller client. Secondly, if the requirement of the company is niche that can be met only by an…[Read more]

]]> 0 26ace2d5ca00649147f37402d1626e82 Shachi replied to the topic Combination Product in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2193/ Mon, 10 Apr 2017 02:08:12 -0400 Photodynamic therapy with PHOTOFRIN is an example of combination device that comprises of two stages. In the first stage, an intravenous injection of PHOTOFRIN is given to the patient. It gets cleared from most of the tissues over 40-72 hours, but tumors, skin, and organs of the reticuloendothelial system that includes
liver and spleen retain…[Read more]

]]> 0 fbdc18f312c59c9b5d00724ec684fbfb Shachi replied to the topic Design Review Meeting Culture in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2127/ Fri, 07 Apr 2017 22:22:09 -0400 In my opinion, the project review meetings are vital for delivering the status of the project to executive management and other stakeholders, it provides them with the updates and the major milestones of the project, while addressing any emerging issue within the project. But one problem with these monthly meetings is that no matter how…[Read more]

]]> 0 1070f5a5775527bbc6427e41862691a1 Shachi replied to the topic Ideal PM Processes vs. Real life in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2126/ Fri, 07 Apr 2017 21:58:13 -0400 In my opinion, completing the product life cycle is not that easy in real life.A bunch of people who are
experts in their fields and are working together to complete a project, will have to overcome many minor
issues with in the team to achieve the target. For instance, the PM might not be on the same page with the
the designer of the product and…[Read more]

]]> 0 5a09cfb0f77f1bcfdb75ef7062040510 Shachi replied to the topic Engineering change order in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2035/ Mon, 27 Mar 2017 02:45:16 -0400 Once the problem is identified by someone and it requires a change.The scope of the issue and its possible impact are estimated before generating an engineering change request (ECR) to examine the feasibility of the change that might include identification of parts, components,resources, estimation of the costs and change in documentation to…[Read more]

]]> 0 fba5e5a96373d59239bb711b136d768e Shachi replied to the topic Work Logs and FDA Audits in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2016/ Sun, 26 Mar 2017 22:49:32 -0400 I do not have any personal experience with FDA audits. But i feel its always wise to adhere to the Good Clinical Practices(GCP) to stay on the safer side. Sticking to the proper Standard Operating Procedures(SOP) to maintain the consistency, or proper documentation of the data, receipts, subject consent forms and records keeps one in compliance…[Read more]

]]> 0