Medical Device Courses | ks629 | Activity https://medicaldevicecourses.com/members/ks629/activity/ Activity feed for ks629. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 a24a35a62eb7a93969cd56d83d063126 ks629 replied to the topic "Why do people work?" - https://medicaldevicecourses.com/activity/p/15996/ Wed, 15 May 2019 19:16:00 -0400 I agree in general with the results of the survey, it makes sense. I think the more interesting question to ask is why do people leave the job they are in? I am in a company right now where a…   Read more»

]]> bfcf582f9eba077d8d18e5cf18cb07c3 ks629 replied to the topic "How to make good relation with vendors" - https://medicaldevicecourses.com/activity/p/15995/ Wed, 15 May 2019 19:15:59 -0400 Having a good relationship with supplier is extremely important. I have worked in Supplier Quality for the last 7 years. I think what @ap962 posted is a great start but one of the most important things is making sure that…   Read more»

]]> cafed037e6942c01a7932936b40ca212 ks629 replied to the topic "What it an NCMR" - https://medicaldevicecourses.com/activity/p/15994/ Wed, 15 May 2019 19:15:59 -0400 I always like to give my suppliers the benefit of the doubt, I wouldn’t assume it’s an ethics issue. An NCMR is a Non-Conforming Material Report and it would be opened for anytime a material related non-conformance is found. This…   Read more»

]]> e72e7732a29a99daa9f2f47ed723fce7 ks629 replied to the topic "Overworked Americans vs. Motivation" - https://medicaldevicecourses.com/activity/p/15844/ Wed, 15 May 2019 19:14:30 -0400 I agree that Americans tend to be overworked. It really does come down to company culture though. I have worked in a bunch of companies and some of them its strictly 8-5 and others the schedule is more flexible but…   Read more»

]]> 0a0e4ae5e2a7064ac156f9b069696519 ks629 replied to the topic "Clinical Project Team Roles" - https://medicaldevicecourses.com/activity/p/15843/ Wed, 15 May 2019 19:14:30 -0400 I would choose to be in the Regulatory group because it is an exciting and ever changing environment. Due to constant changes in the world wide regulations the group that is making sure the trials adhere to current regulations has…   Read more»

]]> 93e1f971ea5468fd66fc2720f3979e57 ks629 replied to the topic "Six Sigma Green Belt Certificate" - https://medicaldevicecourses.com/activity/p/15816/ Wed, 15 May 2019 19:14:09 -0400 I have a Six Sigma Green Belt from my former employer. I also have a Certified Quality Auditor and Certified Quality Engineer. I work as a quality engineer and those are the most requested certifications in my field (At my…   Read more»

]]> 7e3cd88ffe95077b7eb7fcf1d32ef34d ks629 replied to the topic "Importance of Human Resource Management" - https://medicaldevicecourses.com/activity/p/15718/ Wed, 15 May 2019 19:13:13 -0400 I work in a company that has recently experienced high turnover and I can tell you from experience that losing talent and knowledge is a huge problem in the medical device field. As a quality engineer one of the most…   Read more»

]]> fcbe060d4838a156e267d5fa53e8f29e ks629 replied to the topic "Single Source/Dual Source" - https://medicaldevicecourses.com/activity/p/15705/ Wed, 15 May 2019 19:13:02 -0400 I guess my question to you all is how would selecting a different coating from the same supplier reduce sourcing risk? What is the major sourcing risk that is being reduced? Would it be acceptable if (in this case) Conmedics…   Read more»

]]> 75ca005bed13455820e5ea29529ffdc3 ks629 replied to the topic "Be wary of EV and statistics calculated with it" - https://medicaldevicecourses.com/activity/p/15577/ Wed, 15 May 2019 19:07:51 -0400 I disagree with this a bit. It’s true earned value could be skewed, but it should also not be used by itself. It should be presented along with other values to get a complete picture of the health of a…   Read more»

]]> 64c444d02cbc7aa90fefb0a6dd13636c ks629 replied to the topic "Which of the following project would you say is better and why" - https://medicaldevicecourses.com/activity/p/15576/ Wed, 15 May 2019 19:07:50 -0400 In project management there is a concept known as the triple constraint. The three constraints are cost, time, and scope. The idea being if you want to for example broaden the scope of the project, you would also need to…   Read more»

]]> 111c86b6ddb747fb047b14ecffb58f7b ks629 replied to the topic "Monitoring & Controlling Techniques" - https://medicaldevicecourses.com/activity/p/15456/ Wed, 15 May 2019 19:06:34 -0400 As a quality engineer, I have always been a huge fan of Metrics. I believe metrics can be a great way to identify problem areas and where you may need to reallocate resources. It is important to note that red…   Read more»

]]> 8b94e79143749481961f7b3f3d7d3f2f ks629 replied to the topic "Factors affect schedule variance (SV)" - https://medicaldevicecourses.com/activity/p/15454/ Wed, 15 May 2019 19:06:33 -0400 Today has me considering how much weather can negatively affect schedule. This month we have had 5 snow days. Last fall our site in Miami was closed for a week due to a hurricane. Forces of nature are hard to…   Read more»

]]> 0400a84700682f405c09d6a411f675b6 ks629 replied to the topic "PM: Timeline, Risk, Social Approaches" - https://medicaldevicecourses.com/activity/p/15371/ Wed, 15 May 2019 19:05:39 -0400 In this project simulation, Patty wasn’t the project manager but she was a significant stakeholder and team member. The project manager’s job is to mediate between these two personalities. It is possible however to have a difficult project manager who…   Read more»

]]> 23b127829e4277b51dba39ee89a166bd ks629 replied to the topic "Communication and Responsiveness" - https://medicaldevicecourses.com/activity/p/15370/ Wed, 15 May 2019 19:05:39 -0400 In a previous Project Management course we were asked to identfy the personality styles of our team members, analyze how those styles might conflict and to come up with a set of ground rules for the project team to address…   Read more»

]]> 0839562a69f2d58f3b0168e398f87887 ks629 replied to the topic "Work Breakdown Structure" - https://medicaldevicecourses.com/activity/p/15288/ Wed, 15 May 2019 19:04:52 -0400 In my company, the Work Breakdown structure more closely resembles option 2. I have seen various degrees of success with this. I think one of the problems I see occur is that the people providing input into the work breakdown…   Read more»

]]> 7b2a3b2e4cd2df94ea4607de970a8a05 ks629 replied to the topic "Missing a Milestone Experience" - https://medicaldevicecourses.com/activity/p/15287/ Wed, 15 May 2019 19:04:51 -0400 About 6 years ago the company I work for was developing a next gen drug coated coronarystent. Due to competition, sales were falling from the companies first drug coated stent. The first stent used to be a major money maker…   Read more»

]]> 7ee353be3a3a2ec5174d7d8bb3fac5a3 ks629 replied to the topic "Project Scope: When the timeline you have doesn't work" - https://medicaldevicecourses.com/activity/p/15154/ Wed, 15 May 2019 19:03:31 -0400 So first of all, regulations are rarely released by surprise. When a government entity releases a new version of a regulation they generally give a company plenty of advance notice and time to comply. What this means for the project…   Read more»

]]> 1525c4bfcd97042058f7258aaffa23dd ks629 replied to the topic "Overlapping activities" - https://medicaldevicecourses.com/activity/p/15144/ Wed, 15 May 2019 19:03:25 -0400 Project planning is very important and critical to the success of a project. Project plans are absolutely living documents that will be updated throughout the course of the project. One way to mitigate the issues you bring up is to…   Read more»

]]> 81abce6ff70024389dfedc4f248b7466 ks629 replied to the topic "Inputs for Design Input Document" - https://medicaldevicecourses.com/activity/p/15133/ Wed, 15 May 2019 19:03:19 -0400 I think we have to look at where Design Inputs come from. In medical devices Design Inputs come from the following. Industry standards Regulations Previous projects / products Competitor products End-users Prototypes So marketing will certainly have a role in…   Read more»

]]> 9c92b3e12c2e937f5b2843472982e203 ks629 replied to the topic "Design Change Request" - https://medicaldevicecourses.com/activity/p/15036/ Wed, 15 May 2019 19:02:29 -0400 In my company I support contract manufacturing. So while we also have very similar processes to those mentioned above for internal design changes, I will go into the process when we have a design change at a contract manufacturer. Generally…   Read more»

]]> 98a6bdfd823341bf47da2a57a7a1efd0 ks629 replied to the topic "Mange Project Risks" - https://medicaldevicecourses.com/activity/p/15035/ Wed, 15 May 2019 19:02:28 -0400 In addition to doing a strong stakeholder analysis and getting input from those stakeholders into the risk planning process, it is important to make sure that risk management is done throughout the project cycle. The project manager. In terms of…   Read more»

]]> f89cee3992e38c1783f158f57d00fc46 ks629 replied to the topic "Package Development Testing & Documentation" - https://medicaldevicecourses.com/activity/p/14940/ Wed, 15 May 2019 19:01:34 -0400 When developing packaging for medical devices there are two primary concerns. The first is maintaing product integrity throughout the shipping and storage process. This means we want to make sure the device does not get damanged between the time it…   Read more»

]]> 19deb7ef8775423093e91303133d10f2 ks629 replied to the topic "What is Risk Management Plan?" - https://medicaldevicecourses.com/activity/p/14939/ Wed, 15 May 2019 19:01:34 -0400 Hi, so here we are talking about two different kinds of Risk Managment Plans. In project management the Risk management plan is how we identify risk throughout the project. At the start of the project the project team will identify…   Read more»

]]> 287edf9a6cac69faea6b70d9f2531b40 ks629 replied to the topic "Challenges in the Global Regulatory Environment" - https://medicaldevicecourses.com/activity/p/14932/ Wed, 15 May 2019 19:01:29 -0400 I have recently come across another example of a challenge in the global regulatory involvement and that involves continuous improvement. When a product is launched, often times the manufacturing process or product quality or cost are not as efficient and…   Read more»

]]> ee116d9e99ccb4f10b89fe418f16cc4c ks629 replied to the topic "Experience with Design Control" - https://medicaldevicecourses.com/activity/p/14786/ Wed, 15 May 2019 19:00:02 -0400 I have been in the medical device industry for 14 years and have worked on many aspects of design controls. Most of our recent projects have been where instead of developing a device from the beginning internally, we purchase a…   Read more»

]]> c2a4d35092babf3cc93cafb54a3b225c ks629 replied to the topic "Your Ideas about How to prepare/write a Successful Project Proposal" - https://medicaldevicecourses.com/activity/p/14785/ Wed, 15 May 2019 19:00:02 -0400 The project proposal or project charter is the document approved by Management for a project to get underway. It actually will not usually include a Gantt Chart but instead a rough estimate of the timeline including major project milestones and…   Read more»

]]> 61ef68c1daf0aa7c57053266b78df77c ks629 replied to the topic "Potential FDA Changes under Trump" - https://medicaldevicecourses.com/activity/p/14643/ Wed, 15 May 2019 18:58:48 -0400 Now that we are 1 year in to this administration and the announcement to overhaul the FDA regulations, I thought this might be a interesting topic to revive. How do you think President Trump’s promise to simplify FDA regulations has…   Read more»

]]> 66964addce2dcb73d866a5079fe883b3 ks629 replied to the topic "Product PMOA Classification with FDA Branches" - https://medicaldevicecourses.com/activity/p/14640/ Wed, 15 May 2019 18:58:46 -0400 I have had the opportunity over the last 10 years to work with Drug-Eluting Coronary stents. These stents are delivered by a catheter, used to prop open the coronary artery and are coated with a drug that is absorbed into…   Read more»

]]> 0c534c2b939f3595d75af06c881644dc ks629 replied to the topic "Discussion Topic: GMP's" - https://medicaldevicecourses.com/activity/p/14559/ Wed, 15 May 2019 18:58:00 -0400 Early on in the initiation and planning phases it is important to understand GMP requirements and how they relate to the project. For example, if your company is now developing a combination device and they have not before, they will…   Read more»

]]> 1e12264e0cc935173011bb259f072429 ks629 replied to the topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/14555/ Wed, 15 May 2019 18:57:58 -0400 I work for Cordis, part of Cardinal Health and the organization is highly matrixed. I report to my supervisor within supplier quality and also serve on project teams for various internal projects. I have life cycle management responsibilities related exisiting…   Read more»

]]> 6ebe77bf54ae99f9b792598afd88db33 ks629 replied to the topic "Discussion Topic: Share your project management experience" - https://medicaldevicecourses.com/activity/p/14551/ Wed, 15 May 2019 18:57:56 -0400 I have worked in the medical device industry for the last 14 years. The last 10 years have been at Cordis which recently became part of Cardinal Health (previously part of Johnson and Johnson). I have always used Microsoft project…   Read more»

]]> ecc6f872959d5e12ec6b4b6584a28929 ks629 posted a new topic "Single Source/Dual Source" - https://medicaldevicecourses.com/activity/p/10706/ Wed, 15 May 2019 16:35:46 -0400 In the Mini-Sim, there is a requirement that a second source be selected for product coating due to it being a critical component. The second source selected is AquaWoah which comes from the same supplier as the current coating. Does…   Read more»

]]> 9e3f4e3f88354c717d08234a5007422e ks629 posted a new topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/10690/ Wed, 15 May 2019 16:35:37 -0400 Design Transfer is the process of handing off the new product from the design team to the manufacturing/base business team. In my company the design team (along with the manufacturing team) will continue to support a product after launch until…   Read more»

]]> 82cf238e8edf6612d06c59053c2a8cec ks629 posted a new topic "Scope Creep" - https://medicaldevicecourses.com/activity/p/10676/ Wed, 15 May 2019 16:35:30 -0400 In the lecture, Professor Simon mentions scope creep. Scope creep is when there is project work being done or considered that is outside the original agreed upon scope of the project. An example might be that the original scope was…   Read more»

]]> c9689809912cae031ddb518c200df0db ks629 posted a new topic "Verification Testing Deviations and Failures" - https://medicaldevicecourses.com/activity/p/10669/ Wed, 15 May 2019 16:35:26 -0400 In Lecture 6 we were given examples of verification protocols and reports. One section I see missing from the report is deviations. I don’t know that I have ever been part of a verification process where we did not have…   Read more»

]]> dea37efccc3b62fa9755ed0f51e4d465 ks629 posted a new topic "Process Groups vs. Project Lifecycle Phases" - https://medicaldevicecourses.com/activity/p/10655/ Wed, 15 May 2019 16:35:19 -0400 Chapter 3 of the PMBOK states that process groups are not the same as project lifecycle phases. It states that all process groups could be conducted within any phase. For example clinical trials may be part of the execute phase…   Read more»

]]> 4a9f0ed5c9480ab5489189d32dae3233 ks629 posted a new topic "Stakeholders in Medical Device development" - https://medicaldevicecourses.com/activity/p/10635/ Wed, 15 May 2019 16:35:09 -0400 Chapter 2 of the PMBOK discusses stakeholders. Identifying stakeholders is a process that occurs throughout the entire project lifecycle and the project manager is expected to manage these stakeholders. In Medical Device Development what are some stakeholders and unique challenges…   Read more»

]]> 9afd5b1656a51629039e07523ecb5e8a ks629 posted a new topic "Challenges in the Global Regulatory Environment" - https://medicaldevicecourses.com/activity/p/10620/ Wed, 15 May 2019 16:35:01 -0400 Medical Device Regulatory affairs in the global economy is highly complex and challenging. To grow, medical devices companies must expand to new markets. Increasingly, each country’s regulations are becoming more complex, stringent and ever changing. In my current position, I…   Read more»

]]> 9cc59961b959e7f0bebc0a9f3b7ac80d ks629 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7563/ Sun, 29 Apr 2018 02:18:26 -0400 I agree in general with the results of the survey, it makes sense. I think the more interesting question to ask is why do people leave the job they are in? I am in a company right now where a lot of people are leaving. Why? One of the reasons is that as people leave they are not replacing them. This means more work gets put on the people who…[Read more]

]]> 0 3f0b472ccd9120d575501bfbeb46966f ks629 replied to the topic How to make good relation with vendors in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7562/ Sun, 29 Apr 2018 02:08:01 -0400 Having a good relationship with supplier is extremely important. I have worked in Supplier Quality for the last 7 years. I think what @ap962 posted is a great start but one of the most important things is making sure that you select a supplier carefully who can meet expectations and also making sure that goals are aligned between the your company…[Read more]

]]> 0 b979d0b8e8cb5695243bf77813dd146c ks629 replied to the topic What it an NCMR in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7561/ Sun, 29 Apr 2018 01:58:50 -0400 I always like to give my suppliers the benefit of the doubt, I wouldn’t assume it’s an ethics issue.

An NCMR is a Non-Conforming Material Report and it would be opened for anytime a material related non-conformance is found. This could be in receiving inspections of the raw materials and components, on the manufacturing line, during in-process…[Read more]

]]> 0 e0c03df5e97f5497ac1dad79a0e89fe9 ks629 replied to the topic Overworked Americans vs. Motivation in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7375/ Thu, 19 Apr 2018 17:18:40 -0400 I agree that Americans tend to be overworked. It really does come down to company culture though. I have worked in a bunch of companies and some of them its strictly 8-5 and others the schedule is more flexible but you may end up working more. It is a really interesting dynamic, while so many people are overworked and trying to do more with less…[Read more]

]]> 0 e4b88510982eb06a9d524642c295ddfb ks629 replied to the topic Clinical Project Team Roles in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7374/ Thu, 19 Apr 2018 17:14:35 -0400 I would choose to be in the Regulatory group because it is an exciting and ever changing environment. Due to constant changes in the world wide regulations the group that is making sure the trials adhere to current regulations has a very important role. This position has a of job security because it is an ongoing process. I have been spending…[Read more]

]]> 0 48ec58dfbd5858e8a17659f4e7c5cb06 ks629 replied to the topic Six Sigma Green Belt Certificate in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7342/ Mon, 16 Apr 2018 17:01:32 -0400 I have a Six Sigma Green Belt from my former employer. I also have a Certified Quality Auditor and Certified Quality Engineer. I work as a quality engineer and those are the most requested certifications in my field (At my curret level a SS Black Belt is often requested). I currently work in a role supporting external and contract manufacturing…[Read more]

]]> 0 cade41fb5b24e065690dfd1bf1bedd4b ks629 replied to the topic Importance of Human Resource Management in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7229/ Thu, 12 Apr 2018 20:18:00 -0400 I work in a company that has recently experienced high turnover and I can tell you from experience that losing talent and knowledge is a huge problem in the medical device field. As a quality engineer one of the most valuable things when facing a product issue is to consult with someone with historic knowledge of the product. Unfortunately it…[Read more]

]]> 0 e5099b1cd9b80a63712b89cba1739cbe ks629 replied to the topic Single Source/Dual Source in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7209/ Wed, 11 Apr 2018 18:16:56 -0400 I guess my question to you all is how would selecting a different coating from the same supplier reduce sourcing risk? What is the major sourcing risk that is being reduced? Would it be acceptable if (in this case) Conmedics had a second qualified manufacturing site for HydroSurf? I see how it is easier than choosing a different supplier, but…[Read more]

]]> 0 75f1ac74f7d13fc2e75c1c3536ac07b5 ks629 started the topic Single Source/Dual Source in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7206/ Tue, 10 Apr 2018 20:00:15 -0400 In the Mini-Sim, there is a requirement that a second source be selected for product coating due to it being a critical component. The second source selected is AquaWoah which comes from the same supplier as the current coating. Does this actual meet the requirements for a second source? I would argue that it may not meet the requirement. We…[Read more]

]]> 0 af3d8b438f7067d02fa37d38d30d7b2d ks629 replied to the topic Be wary of EV and statistics calculated with it in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/7035/ Thu, 29 Mar 2018 14:14:56 -0400 I disagree with this a bit. It’s true earned value could be skewed, but it should also not be used by itself. It should be presented along with other values to get a complete picture of the health of a project. EAC, ETC, BAC, PV, AC should also be presented. Additionally any value that is significantly below or above expected should have an…[Read more]

]]> 0 997cf55c37fe3c659bf78452a66897e2 ks629 replied to the topic Which of the following project would you say is better and why in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/7034/ Thu, 29 Mar 2018 13:47:36 -0400 In project management there is a concept known as the triple constraint. The three constraints are cost, time, and scope. The idea being if you want to for example broaden the scope of the project, you would also need to increase cost or time so as not to sacrifice quality. If you wanted to shorten the timline of a project you would need to…[Read more]

]]> 0 0d9d07f23587530f0cec3c80d65403f6 ks629 started the topic Design Transfer in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6897/ Wed, 21 Mar 2018 20:18:11 -0400 Design Transfer is the process of handing off the new product from the design team to the manufacturing/base business team. In my company the design team (along with the manufacturing team) will continue to support a product after launch until the product meets certain criteria for stability. This way if there are issues with the product the…[Read more]

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