Medical Device Courses | ak977 | Activity https://medicaldevicecourses.com/members/ak977/activity/ Activity feed for ak977. Fri, 24 Apr 2026 14:09:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 20e58ce2ffff7c0e7ba272c11eb0eaa1 ak977 replied to the topic "Different PM techniques based on size" - https://medicaldevicecourses.com/activity/p/15983/ Wed, 15 May 2019 19:15:52 -0400 The thing with project management techniques is that they MUST differ from not only company to company, but also project to project. Depending on the size, culture, and type of company, most places usually have a baseline of rules and…   Read more»

]]> 3633b2bccdb0ebf5a346f514ef2ec077 ak977 replied to the topic "Discussion Topic: Outsource vs. Insource the clinical trial" - https://medicaldevicecourses.com/activity/p/15982/ Wed, 15 May 2019 19:15:52 -0400 As stated above, CROs should be used when necessary. If a company has the time and money for it, then a reputable CRO would not be an issue if it was utilised. In addition, some small companies could possibly benefit…   Read more»

]]> e74f4966ababa84ea93f7bbbc9e4358e ak977 replied to the topic "Are you an X or Y?" - https://medicaldevicecourses.com/activity/p/15981/ Wed, 15 May 2019 19:15:51 -0400 I would prefer to have an employee who is a Y personality simply because motivation is more important than prior knowledge most of the time. If I want an employee who only does the bare minimum, I might take far…   Read more»

]]> 1ac07c7d4b714530e459644aa258a161 ak977 replied to the topic "Why do people leave work?" - https://medicaldevicecourses.com/activity/p/15842/ Wed, 15 May 2019 19:14:29 -0400 There’s a few reasons I have left jobs in the past but the main has always been a better opportunity. However, there are jobs that I have regretted leaving and others I have not. The ones I have not regretted…   Read more»

]]> 7d4192f0bfbdcf929b09596adeb168eb ak977 replied to the topic "Overworked Americans vs. Motivation" - https://medicaldevicecourses.com/activity/p/15841/ Wed, 15 May 2019 19:14:28 -0400 I agree with srg36 — I believe that its primarily due to peer pressure. Americans are vastly overworked. According for the Center for Progress, Americans are overworked in several ways: 1. We have no maximum work hour limit. Although this…   Read more»

]]> 2e1f22dba5653c03a4f6fa3f8aa2289b ak977 replied to the topic "Designing effective Communication management Plan" - https://medicaldevicecourses.com/activity/p/15777/ Wed, 15 May 2019 19:13:47 -0400 As ala26 stated, it would be good to have some groundwork that is created as an SOP for the entire company and then allow the project manager to tailor it as needed. For example, some people communicate better in person,…   Read more»

]]> 099b19604e9836de3f30fa47e2bf9e45 ak977 replied to the topic "Importance of Human Resource Management" - https://medicaldevicecourses.com/activity/p/15776/ Wed, 15 May 2019 19:13:46 -0400 As we’ve previously discussed in this class, communication is key in any project, especially for a manager. HR is meant to help employees improve their engagement and this is also the case in engaging with on another, even across departments….   Read more»

]]> d9607190c67f236d1b138e154d88227b ak977 replied to the topic "Analogous vs Bottom Up Cost Estimating" - https://medicaldevicecourses.com/activity/p/15774/ Wed, 15 May 2019 19:13:45 -0400 As you both discussed, you prefer Bottom Up Estimation. I am inclined to agree with you on most projects. However, there might be instances, such as small, fast projects, that might require Analogous Cost Estimating because they simply don’t cost…   Read more»

]]> 3a64159c65905967df28b27bd38b91c3 ak977 replied to the topic "Things help to understand project status other than project matrix" - https://medicaldevicecourses.com/activity/p/15630/ Wed, 15 May 2019 19:12:18 -0400 I also think that there should be an emphasis on the performance of the work, as previously stated. Project managers must ensure that their team is doing more than the bare minimum just to meet standards. A reasonably higher level…   Read more»

]]> 0e8951e260a6fc3ac86f06017e83e3ee ak977 replied to the topic "kinds of changes in PM" - https://medicaldevicecourses.com/activity/p/15629/ Wed, 15 May 2019 19:12:18 -0400 There are several types of changes within the Monitoring and Controlling Phase of a project: 1. Non-Essential Design Change (NDC): Change to a design control document while product is still in design control 2. Design Change Number (DNC): Major change…   Read more»

]]> 80be933f88c168eb1e1223eacf2fbb69 ak977 replied to the topic "Sucess Factors" - https://medicaldevicecourses.com/activity/p/15625/ Wed, 15 May 2019 19:08:21 -0400 I do believe that communication is key to the success of any project. However, one thing that I really liked, which you highlighted, was Number 3: Develop clearly defined plans with assigned responsibilities. I think that goes absolutely hand-in-hand with…   Read more»

]]> 7c9ff3a6e629313e7cbd8eb4dc632ce6 ak977 replied to the topic "Which of the following project would you say is better and why" - https://medicaldevicecourses.com/activity/p/15524/ Wed, 15 May 2019 19:07:16 -0400 As the above posters have said, I agree with them. There can be instances where one or the other being positive can workout for the benefit of the company. However, making that choice without knowing company culture, project projection, the…   Read more»

]]> ef632ee6aec9ee98d82920c550a9dc8a ak977 replied to the topic "planned value vs actual costs" - https://medicaldevicecourses.com/activity/p/15520/ Wed, 15 May 2019 19:07:14 -0400 As we’ve learned, the planned value (PV) of a project is the estimated cost of the project’s activities which have been planned as of the reporting date. On the other hand, the actual value (AV) of the project is how…   Read more»

]]> 7700a7dcbde8ffd9e9adffc8bbd5f1bc ak977 replied to the topic "Importance of Metrics" - https://medicaldevicecourses.com/activity/p/15515/ Wed, 15 May 2019 19:07:11 -0400 As the professor discussed, every metric that we utilise must be measurable, actionable, and visually understandable. The last is especially important because we can use dashboards to keep track of them. Keeping track of the metrics that were discussed is…   Read more»

]]> 9a74ce63cc398e226ae483ef9819c895 ak977 replied to the topic "PM: Timeline, Risk, Social Approaches" - https://medicaldevicecourses.com/activity/p/15387/ Wed, 15 May 2019 19:05:48 -0400 In this simulation, there were a few paths you could take to complete the mini simulation. The first one I took, which seemed the simplest, was to have Patty and Dr. M sit together and figure out the issue. I…   Read more»

]]> 371cdc4b864832405d86f029d326aada ak977 replied to the topic "Design validation" - https://medicaldevicecourses.com/activity/p/15386/ Wed, 15 May 2019 19:05:48 -0400 Design Verification entails that the product you put out is what was actually requested and what the FDA has said is acceptable. Let’s say that the customer wants a product that addresses issues A, B, C, and D. In addition,…   Read more»

]]> 6319a1c4976a2346c1d7460ff74bbbf7 ak977 replied to the topic "Scope Creep" - https://medicaldevicecourses.com/activity/p/15385/ Wed, 15 May 2019 19:05:48 -0400 Scope creep mainly occurs when the interference comes from upper management. They see that a product is capable of A and B and then they ask if C is possible and push for it. I think that a better way…   Read more»

]]> 5c6c496a5ad9c4c9f4561df813982849 ak977 replied to the topic "Work Breakdown Structure" - https://medicaldevicecourses.com/activity/p/15299/ Wed, 15 May 2019 19:05:00 -0400 Although I have no medical device industry experience, I have worked on team projects in other fields. As a supervising teacher, I have had lead on several projects that have been implemented with varying degrees of success. I believe that…   Read more»

]]> ca78f19ad39ec97b776a53850abea3a2 ak977 replied to the topic "Risk Management" - https://medicaldevicecourses.com/activity/p/15298/ Wed, 15 May 2019 19:04:59 -0400 Following up on what bnb6 said, I think that we should also discuss metal-on-metal (MoM) hip replacements and the special risks they carry. In terms of risk management, they are far less likely to be used now because the risks…   Read more»

]]> 06185ad281e1d07a19b0cfcac44edecb ak977 replied to the topic "Verification Testing Deviations and Failures" - https://medicaldevicecourses.com/activity/p/15296/ Wed, 15 May 2019 19:04:58 -0400 Hey, I also think that information that is discovered once the verification is over should also be discussed. This could lead to additional or updated reports that would be necessary, especially if discrepancies are discovered. Sometimes, the verification process might…   Read more»

]]> b72b3f3e982dc9a19a7cd1c6a75275b7 ak977 replied to the topic "Planning Phase" - https://medicaldevicecourses.com/activity/p/15177/ Wed, 15 May 2019 19:03:43 -0400 Going back to Devarshi’s original point, I think it is actually good that sometimes a user’s needs are a bit vague. This allows the engineer to be a bit more creative catering to the needs of the user. For example,…   Read more»

]]> e5a3a3313b945af5df979105341a6390 ak977 replied to the topic "Mapping- Gantt Chart" - https://medicaldevicecourses.com/activity/p/15176/ Wed, 15 May 2019 19:03:43 -0400 The Gantt Chart is actually really great for any sort of project management but especially helpful for the medical device field because it allows for projects to be seen visually by all members of the team. Since in the medical…   Read more»

]]> d1cca18ba493e4802ae8e0915caba85b ak977 replied to the topic "Dangerous Syndromes for risk management" - https://medicaldevicecourses.com/activity/p/15113/ Wed, 15 May 2019 19:03:09 -0400 Everything is about risk — as everyone above me has stated, its all about whether the good will outweigh what might possibly go wrong. Therefore, a good PM must be able to analyse and handle the risk in the most…   Read more»

]]> 9f7b7d15b9cdc02be242ed518d6dd331 ak977 replied to the topic "Process Groups vs. Project Lifecycle Phases" - https://medicaldevicecourses.com/activity/p/15111/ Wed, 15 May 2019 19:03:08 -0400 According to the PMBOK, standard process groups can be created and applied (and edited as needed) for companies. Most companies have a dynamic way of doing their projects and if they are able to pin down the exact way they…   Read more»

]]> 599f9ba1f10176298b7396d5e63982e1 ak977 replied to the topic "Project Scope: When the timeline you have doesn't work" - https://medicaldevicecourses.com/activity/p/15108/ Wed, 15 May 2019 19:03:06 -0400 Ethically speaking, one cannot skip over any regulations, regardless of what the situation might be, monetarily. The main aspect of the situation must be that the device follows all regulations and protocols as written. In actuality, it might, at first,…   Read more»

]]> 710cf56406a64cc6f1e9fe645b52c1dd ak977 replied to the topic "Funding in Medical Devices Industry" - https://medicaldevicecourses.com/activity/p/14974/ Wed, 15 May 2019 19:01:51 -0400 What I find to be actually pretty interesting now is that we’re in the age of Kickstarter. Scientists and engineer who have innovative ideas are actually able to bypass much of the needed fundraising by simply setting up pages, displaying…   Read more»

]]> f216c5ecc84968b1109b6886231c76ce ak977 replied to the topic "Categorization of Medical Devices" - https://medicaldevicecourses.com/activity/p/14973/ Wed, 15 May 2019 19:01:51 -0400 According to the FDA, the medical devices are characterized into three categories based on a few factors. According to them, “The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their…   Read more»

]]> d6a21fc78987639797abcee6d703e3a6 ak977 replied to the topic "Your Ideas about How to prepare/write a Successful Project Proposal" - https://medicaldevicecourses.com/activity/p/14847/ Wed, 15 May 2019 19:00:44 -0400 As you guys have mentioned, the project proposal is the heart of the initial project. It is meant to be a short, insightful look into what the device will be about, its cost, and why it should be created. Its…   Read more»

]]> 6ae8b4d72832f73f3e16399c6aa122be ak977 replied to the topic "Validation and Verification" - https://medicaldevicecourses.com/activity/p/14843/ Wed, 15 May 2019 19:00:42 -0400 I think that the process of V&V, with the many years of re-evaluating, has become a lot more streamlined than it was previously. Although it can be cumbersome and add on time if issues come up, it is still in…   Read more»

]]> 407291de8078325c9b005b6c3498d6ff ak977 replied to the topic "Validation and Verification" - https://medicaldevicecourses.com/activity/p/14842/ Wed, 15 May 2019 19:00:41 -0400 I think that the process of V& V, with the many years of re-evaluating, has become a lot more streamlined than it was previously. Although it can be cumbersome and add on time if issues come up, it is still…   Read more»

]]> dffd860b577f49a3379c03fdc27fe0a3 ak977 replied to the topic "''Quality Plan'' meaning ?" - https://medicaldevicecourses.com/activity/p/14839/ Wed, 15 May 2019 19:00:40 -0400 I agree with krp67 — the question of why is very important when it comes to any sort of development. Why is something being created? Why must it go through quality? Why did other companies fail at certain points? That…   Read more»

]]> f2938539e6ec41bb851e9ca0eca56586 ak977 replied to the topic "Stakeholders in Medical Device development" - https://medicaldevicecourses.com/activity/p/14835/ Wed, 15 May 2019 19:00:37 -0400 It makes sense that the customers for medical device companies would be hospitals/doctors and not actual patients. Companies need to sell their products in bulk and that isn’t really a possibility when it comes to single patients (just how many…   Read more»

]]> 9ab6799f15a602fa47a2d5861d4a336c ak977 replied to the topic "Challenges in the Global Regulatory Environment" - https://medicaldevicecourses.com/activity/p/14754/ Wed, 15 May 2019 18:59:46 -0400 Reply to: ap962 Its interesting that the FDA is so much more stringent with medical devices in comparison with other countries. However, there are aspects to these fields in which other countries were more stringent. For instance, no cosmetic brands…   Read more»

]]> c8724f6a29d56f9002ca92a7e3ef0d48 ak977 replied to the topic "FDA Approves First Digital Pill in USA" - https://medicaldevicecourses.com/activity/p/14651/ Wed, 15 May 2019 18:58:52 -0400 I agree with wms7 — the pill’s primary function is to cause changes in the body biologically and therefore, it would be assigned to the CDER. The sensor does not make actual changes to the body and therefore, is a…   Read more»

]]> 0e5d9aff49d7d80cd030753a4b028d20 ak977 replied to the topic "Discussion Topic: Projects of all types" - https://medicaldevicecourses.com/activity/p/14636/ Wed, 15 May 2019 18:58:44 -0400 The ideal version of a project manager would allow the person to be able to work across the board of industries, regardless of their technical knowledge. PMI is the sort of organization that helps to create these types of PMs….   Read more»

]]> 482f4ba50312ef58191fbb0839c4d7b8 ak977 replied to the topic "Discussion Topic: Share your project management experience" - https://medicaldevicecourses.com/activity/p/14592/ Wed, 15 May 2019 18:58:19 -0400 At my previous jobs, which were not in the medical device industry, the lines of communication were relatively open but not always utilised to the fullest. * What sorts of project management software or systems does your company have? We…   Read more»

]]> b82a2ad9faa8e13d7d2e1feb80c2fb3b ak977 replied to the topic "Decision Making: To do or Not to Do?" - https://medicaldevicecourses.com/activity/p/14588/ Wed, 15 May 2019 18:58:17 -0400 If there were more coatings then there might be more options to what the clear choice may have been. Perhaps coating C could have garnered quicker results, such as coating A, but without the stress deaths, such as coating B….   Read more»

]]> 800c617f003c2f5ba827aa7a8a1f5cce ak977 replied to the topic "Interpersonal skills vs technical knowledge" - https://medicaldevicecourses.com/activity/p/14586/ Wed, 15 May 2019 18:58:16 -0400 I agree with smk45 — technical skills, for a student, are a bit more important than they are for the average professional. As a student, its hard to get your foot in the door because you need to show that…   Read more»

]]> ce25ba1bf57586e6c8a9be96262348f3 ak977 posted a new topic "Clinical Project Team Roles" - https://medicaldevicecourses.com/activity/p/10719/ Wed, 15 May 2019 16:35:53 -0400 As Dr. S listed for us, the roles of a clinical project team are as follows: Clinical Project Manager, Clinical Research Associates (CRA’s), Monitors, Regulatory, Statisticians, Investigators, Site Coordinators, SROs, CROs, Centers, Labs, IRB’s, and Recruitment Organizations. If you had…   Read more»

]]> 87a68456eeffe29903af51440d568406 ak977 posted a new topic "Preplanning for Risk" - https://medicaldevicecourses.com/activity/p/10663/ Wed, 15 May 2019 16:35:24 -0400 We’ve previously discussed what risk management. The concept is to ensure that all risks are minimized and only those that are necessary for the project are taken. The point is to be as cost effective as possible, while still remaining…   Read more»

]]> 956c4d72f09382b8838f340b80cd64e3 ak977 posted a new topic "Inadequate Testing" - https://medicaldevicecourses.com/activity/p/10646/ Wed, 15 May 2019 16:35:14 -0400 So far this semester, we have gone over the requirements of testing and have seen the side of quality testing from the POV of the medical device companies. However, we are aware that issues have come up in the past…   Read more»

]]> 0fb11903b773d030547b44c487cacaab ak977 replied to the topic Different PM techniques based on size in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7544/ Sat, 28 Apr 2018 02:38:38 -0400 The thing with project management techniques is that they MUST differ from not only company to company, but also project to project. Depending on the size, culture, and type of company, most places usually have a baseline of rules and regulations they follow in terms of their management style. However, depending on what the project is, things can…[Read more]

]]> 0 1a6820a82c7edfb7ead70c7079fa0ae5 ak977 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/7543/ Sat, 28 Apr 2018 01:44:37 -0400 As stated above, CROs should be used when necessary. If a company has the time and money for it, then a reputable CRO would not be an issue if it was utilised. In addition, some small companies could possibly benefit from the use of a CRO, especially if they’re new in the game and do not have the resources to run clinical trials…[Read more]

]]> 0 1a9f99146680d93bdab5ad3809dad36e ak977 replied to the topic Are you an X or Y? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7542/ Sat, 28 Apr 2018 01:30:47 -0400 I would prefer to have an employee who is a Y personality simply because motivation is more important than prior knowledge most of the time. If I want an employee who only does the bare minimum, I might take far longer to complete any sort of work or make any progress. Innovation comes from doing the maximum, not the minimum.

However, someone…[Read more]

]]> 0 4724efe41c869e7510e501a3fd19e601 ak977 started the topic Clinical Project Team Roles in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7370/ Wed, 18 Apr 2018 20:46:06 -0400 As Dr. S listed for us, the roles of a clinical project team are as follows: Clinical Project Manager, Clinical Research Associates (CRA’s), Monitors, Regulatory, Statisticians, Investigators, Site Coordinators, SROs, CROs, Centers, Labs, IRB’s, and Recruitment Organizations.

If you had to pick one of these roles to follow (except for Project…[Read more]

]]> 0 fd977dfbe1bebaae1c54cbe4303018e0 ak977 replied to the topic Why do people leave work? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7369/ Wed, 18 Apr 2018 20:40:23 -0400 There’s a few reasons I have left jobs in the past but the main has always been a better opportunity. However, there are jobs that I have regretted leaving and others I have not. The ones I have not regretted were ones with either hostile environments or ones which were simply, as the professor had said, unfulfilling in terms of praise and…[Read more]

]]> 0 bb4b4aa5e540c978330e4cbb0d71675e ak977 replied to the topic Overworked Americans vs. Motivation in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7368/ Wed, 18 Apr 2018 20:16:58 -0400 I agree with srg36 — I believe that its primarily due to peer pressure. Americans are vastly overworked. According for the Center for Progress, Americans are overworked in several ways:
1. We have no maximum work hour limit. Although this might be beneficial to a point, it also does not punish companies that overwork their employees.
2. In the…[Read more]

]]> 0 f5ba518cce90fc63ccf578c8df04eabd ak977 replied to the topic Designing effective Communication management Plan in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7299/ Mon, 16 Apr 2018 00:34:51 -0400 As ala26 stated, it would be good to have some groundwork that is created as an SOP for the entire company and then allow the project manager to tailor it as needed. For example, some people communicate better in person, some respond through text, and others are strictly email senders. Therefore, in order to create proper documentation and track…[Read more]

]]> 0 95ba602212065ff830146c22712a3290 ak977 replied to the topic Importance of Human Resource Management in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7298/ Mon, 16 Apr 2018 00:29:54 -0400 As we’ve previously discussed in this class, communication is key in any project, especially for a manager. HR is meant to help employees improve their engagement and this is also the case in engaging with on another, even across departments. We’ve also discussed how, when communication is stressed, companies are able to save money, time, and…[Read more]

]]> 0 58012d1b3f4617401f73028d8cfb1a80 ak977 replied to the topic Analogous vs Bottom Up Cost Estimating in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7296/ Mon, 16 Apr 2018 00:26:27 -0400 As you both discussed, you prefer Bottom Up Estimation. I am inclined to agree with you on most projects. However, there might be instances, such as small, fast projects, that might require Analogous Cost Estimating because they simply don’t cost enough to put in the effort to create an entire Bottom Up Estimation.

For example, if my boss were to…[Read more]

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