https://medicaldevicecourses.com/members/wms7/activity/ Activity feed for wms7. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 471371620b511dc362a011c0b151e91a https://medicaldevicecourses.com/activity/p/15974/ Wed, 15 May 2019 19:15:47 -0400 I fully believe that a project manager’s level of motivation affects the team’s productivity and motivation level. If the project manager is very passionate about the project then it will rub onto the team and make them work harder. If…   Read more»

]]> b4502592018fb5da1c2cb226d73f4c08 https://medicaldevicecourses.com/activity/p/15973/ Wed, 15 May 2019 19:15:46 -0400 Project management techniques differ from company to company because it is due to availability of resources and past experiences. Larger companies will more resources to work with, and I’m sure they have gone through many projects and have learned from…   Read more»

]]> aa7d5f268e0219e1695377877b60b1a4 https://medicaldevicecourses.com/activity/p/15972/ Wed, 15 May 2019 19:15:46 -0400 I would prefer to be an engineer and then transition into a manager role once I’m more experienced and have more knowledge of how the industry I am working for works. I first want to be an engineer working in…   Read more»

]]> 305e8dff44684bb6a64773a9ec35aa3e https://medicaldevicecourses.com/activity/p/15840/ Wed, 15 May 2019 19:14:28 -0400 I’m not too surprised by these results, but I thought fair pay would be higher than just 32%. Some people of talked to wanted as much pay as possible, but I guess it varies from person to person. For me,…   Read more»

]]> f784254fbeeb85e7be83fa0e896ca6c8 https://medicaldevicecourses.com/activity/p/15839/ Wed, 15 May 2019 19:14:27 -0400 I think Americans are putting in more time for a variety of reasons. Some could be because they are motivated to work on the project and are “workaholics”, others because deadlines are coming up and they need all the time…   Read more»

]]> 7cc722372b8f748556c728c461123a55 https://medicaldevicecourses.com/activity/p/15838/ Wed, 15 May 2019 19:14:27 -0400 I guess for me the challenge and the reward is what motivates me to complete a project. The challenge aspect is important to me because it brings fun and excitement to the project. It engages me to research, brainstorm, ask…   Read more»

]]> cb78cf34e7970ee0cc720f05cd737667 https://medicaldevicecourses.com/activity/p/15714/ Wed, 15 May 2019 19:13:09 -0400 For a class project in my undergraduate studies, I had to research plastics for use in the product we were designing. Plastics we researched included polypropylene, mylar, polyethylene, etc. I learned a great deal about different kinds of plastic and…   Read more»

]]> e2085c262fd08c32a32e54a62e8920a2 https://medicaldevicecourses.com/activity/p/15713/ Wed, 15 May 2019 19:13:08 -0400 In my opinion using the same supplier for two different products doesn’t fully satisfy the dual source requirement. While yes it does provide an alternative product in case the primary one isn’t available for whatever reason, but the problem for…   Read more»

]]> 056aadcaaf241ba36a9f2c631740440c https://medicaldevicecourses.com/activity/p/15712/ Wed, 15 May 2019 19:13:07 -0400 One of the project I worked required us to use specific captive bolts. The shoulder length, tread size, knob type, etc. all had to be a specific value. I researched companies for a while until I found one. That produced…   Read more»

]]> 099b76442b2a2f773d19712d735d62a3 https://medicaldevicecourses.com/activity/p/15580/ Wed, 15 May 2019 19:07:54 -0400 From my experience working at my current company, during the closing phase we have a few tasks that need to be done. Close up any loose ends with our vendors, typically ensure that they have the most up to date…   Read more»

]]> 882b4f474ce50e6b439496be61afe097 https://medicaldevicecourses.com/activity/p/15578/ Wed, 15 May 2019 19:07:52 -0400 I’m with ks629 on this one. EV is only one part of the project and represents only one aspect of it. Any EV estimate whether under budget or over budget will need to be accompanied by something to back it…   Read more»

]]> fba6989ae9eeb1bf84593653c4c326e5 https://medicaldevicecourses.com/activity/p/15460/ Wed, 15 May 2019 19:06:36 -0400 Increasing project risk should be avoided as much as possible. In the mini-sim example, decreasing the animal experiment time would be very bad. From these studies we will see how well the product performs and observe any negative reactions that…   Read more»

]]> 2be89308c8b6fced6a8ca2bde5ad7074 https://medicaldevicecourses.com/activity/p/15453/ Wed, 15 May 2019 19:06:32 -0400 I agree with srg36 and hc255 view that they are important parts of a project but may not necessarily be the absolute most important. They are only one part of a large process when developing a project. Still, the items…   Read more»

]]> 5a3df075570563980e54239238b2e769 https://medicaldevicecourses.com/activity/p/15365/ Wed, 15 May 2019 19:05:36 -0400 During one project I was on at my company, the WBS wasn’t executed well. One particular mechanical engineering team was overloaded with many tasks, the other teams had a more reasonable workload. The reason for the overload of tasks was…   Read more»

]]> 9d201e6845b973ed2267c99cdd33c3ed https://medicaldevicecourses.com/activity/p/15362/ Wed, 15 May 2019 19:05:34 -0400 One of the project I worked on at my company, we had to include anchoring brackets with a new server rack that we built up to show to our customer for their opinion and approval. We got a shipment from…   Read more»

]]> 46746921a5332a4e1dce62ed3c214605 https://medicaldevicecourses.com/activity/p/15361/ Wed, 15 May 2019 19:05:34 -0400 As a PA with an uncooperative member of the team, I would try to get some one on one time with them to figure out the situation. As others have mentioned there could be an underlining reason why they are…   Read more»

]]> f4771874de10479e83a69ba27572b112 https://medicaldevicecourses.com/activity/p/15281/ Wed, 15 May 2019 19:04:48 -0400 I agree with all the points that everyone in this thread has mentioned so far. The planning phase will down the foundation of how you will tackle the project. A poorly executed planning phase may cause the project to fail,…   Read more»

]]> 6ed2e66364dfaaac9af5ee56f189d50d https://medicaldevicecourses.com/activity/p/15262/ Wed, 15 May 2019 19:04:32 -0400 On one of the project that I was a part of, there came about an issue with air dams not being compatible with our new server racks. Air dams are used to restrict air flow from underneath the rack and…   Read more»

]]> 17776f0ef35ad5ef01d7442aae706aea https://medicaldevicecourses.com/activity/p/15261/ Wed, 15 May 2019 19:04:32 -0400 I had experienced a change in PM once in my career, and the resulting events were similar to what jlw23 had mentioned. We had a get up to speed meeting with the new PM, which I attended with my team…   Read more»

]]> 0dec434bfbe5b12866b83915e3faad2c https://medicaldevicecourses.com/activity/p/15148/ Wed, 15 May 2019 19:03:27 -0400 At my current company, the design review meetings are overall pretty calm as we work together on establishing any potential changes based on feedback or simulation data. Sometimes the meetings involve having a conference call with the potential vendor to…   Read more»

]]> fe00fa518f8c967fef07b64b5ad88b33 https://medicaldevicecourses.com/activity/p/15147/ Wed, 15 May 2019 19:03:26 -0400 There are many different things that could happen that will cause pitfalls. As you mentioned team members taking time off is one such circumstance that could occur that may cause a pitfall. In Dr. Simon’s lecture, he also mentioned not…   Read more»

]]> 8a767326e63f24d85c1203c0956c9fe9 https://medicaldevicecourses.com/activity/p/15141/ Wed, 15 May 2019 19:03:24 -0400 The planning phase is very important because it will set the foundation of how you’re going to tackle this project. If poorly planned out then the project could face delays, cancellation, or might not be profitable in the end for…   Read more»

]]> 141425d784beb2e6629a22321e670afc https://medicaldevicecourses.com/activity/p/15033/ Wed, 15 May 2019 19:02:27 -0400 During the development process, identified potential risks can come from a variety of sources. In my experience, most of the risks identified were from our engineering teams working on the project and from previous experiences on past projects. Some risks…   Read more»

]]> c52bf9d4c6847099fffdf66dc611da5c https://medicaldevicecourses.com/activity/p/15024/ Wed, 15 May 2019 19:02:17 -0400 For my company, to initiate a design change request, the CAD model and drawings must be updated with any changes that are being proposed. It is then reviewed and hopefully approved. If approved, our PM team creates a change request…   Read more»

]]> 7ae9b413c453b8cc068b106dec9159a1 https://medicaldevicecourses.com/activity/p/15023/ Wed, 15 May 2019 19:02:16 -0400 Similarly like srg36, if I was a PM running risk management meetings, I would schedule major and minor checkpoint meetings throughout the entire development process. Major meetings for when we complete a step in the development cycle, such switching from…   Read more»

]]> a177ec9247d257201b473b63f4dcc73f https://medicaldevicecourses.com/activity/p/14914/ Wed, 15 May 2019 19:01:19 -0400 Initiating a project idea is the hardest part of project development because it can have a lot of consequences on what happens to the company if the project was worth pursuing or not. Marketing research plays a massive role because…   Read more»

]]> 70f2c3282d3200b271ddc74b548218f1 https://medicaldevicecourses.com/activity/p/14900/ Wed, 15 May 2019 19:01:12 -0400 Picking the right members of a project team is very important in many ways. Obviously you want people with the proper technical knowledge depending on their department (engineering, marketing, etc.) but also people that are compatible with each other and…   Read more»

]]> 2dcb830537a7d134bf02b4e48a348886 https://medicaldevicecourses.com/activity/p/14899/ Wed, 15 May 2019 19:01:11 -0400 Not for medical devices, but I’ve been involved with testing shipping containers that would be used to ship out my company’s products. Tests were done with accordance to ASTM D4196-16 specs. These tests involved rotational flat drops of around 3…   Read more»

]]> 623b402a70743a26f65d34ef0caa262b https://medicaldevicecourses.com/activity/p/14775/ Wed, 15 May 2019 18:59:57 -0400 I think these 9 design controls are necessary as a good checklist to ensure the project proceeds smoothly. While I don’t work in a medical device company, we follow a similar structure where I work. I’m part of the design…   Read more»

]]> b11b172be6a996554a2a7dbf1c821966 https://medicaldevicecourses.com/activity/p/14772/ Wed, 15 May 2019 18:59:55 -0400 Personally I prefer the Project-Based organization. Being able to be transparent with other departments working on the project would be greatly beneficial. Information would flow more easily between each department versus everyone being on their own and you having to…   Read more»

]]> 20343fbd7def58961d025f5f14784358 https://medicaldevicecourses.com/activity/p/14650/ Wed, 15 May 2019 18:58:52 -0400 The FDA’s Office of Combination Products would develop regulations and guidance for any combination products that are presented by a company. The Office of Combination Products would review and assign responsibility for combination products to one of the branches of…   Read more»

]]> 35f69faa7f2a1755f9e98068a1294d35 https://medicaldevicecourses.com/activity/p/14639/ Wed, 15 May 2019 18:58:46 -0400 A combination product’s primary mode of action establishes its regulatory and product development framework as well as how it is viewed in the eyes of a regulator depending on which agency it’s assigned to within the FDA, as we learned…   Read more»

]]> d47dd6ebeb1ad500709facf5655ba2c4 https://medicaldevicecourses.com/activity/p/14523/ Wed, 15 May 2019 18:57:39 -0400 I would say the squeezable stress reliever ball can be considered a general wellness product. There are different kinds of them but in general they round soft objects with some kind liquid inside. We squeeze them to help alleviate stress…   Read more»

]]> 25be55db914b2c39bb50316c49c1563a https://medicaldevicecourses.com/activity/p/14521/ Wed, 15 May 2019 18:57:38 -0400 At my current job, I would say that my company is still growing in terms of project management awareness at least in my department. At my company we do have Project Managers or PJMs as we call them that oversee…   Read more»

]]> c8b3fda5f60bc8295cb14a3f8855d272 https://medicaldevicecourses.com/activity/p/14520/ Wed, 15 May 2019 18:57:37 -0400 I believe the skills necessary for an ideal properly functioning project team are: communication, good leadership, and knowledge of the problem. Everyone in this thread has already gone into great details about these skills, so I want to talk about…   Read more»

]]> cd953985435432ff1e4d2a891a0fe108 https://medicaldevicecourses.com/activity/p/10689/ Wed, 15 May 2019 16:35:37 -0400 In this week’s lecture we learned about different kinds of changes for a project. They were non-essential design change (NDC), design change number (DCN), and engineering change order (ECO). So my question is, if any of you have experienced firsthand…   Read more»

]]> dd56bb5751cddae004b5145ddbaa5f95 https://medicaldevicecourses.com/activity/p/10632/ Wed, 15 May 2019 16:35:07 -0400 From this week’s lecture we learned about three types of project organizations. Which were functional, project-based, and matrix organizations. Talk about your first hand experiences with any of these three organizational types that you’ve been a part of from a…   Read more»

]]> af1ebc3b7743481f68434282d21e12e3 https://medicaldevicecourses.com/activity/p/10621/ Wed, 15 May 2019 16:35:02 -0400 This week’s lecture introduced us to the different branches of the FDA that new products in development get assigned. The branches in question are the Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and…   Read more»

]]> e776baa586d18801c7850f7606f7c0da https://medicaldevicecourses.com/activity/p/7533/ Thu, 26 Apr 2018 21:49:29 -0400 I fully believe that a project manager’s level of motivation affects the team’s productivity and motivation level. If the project manager is very passionate about the project then it will rub onto the team and make them work harder. If the PM is disconnected from the project then the team will do the minimum to get on by because they see that wha…[Read more]

]]> 0 3f26f4f3a4f075619e2d4491eaacc1bf https://medicaldevicecourses.com/activity/p/7532/ Thu, 26 Apr 2018 21:34:41 -0400 Project management techniques differ from company to company because it is due to availability of resources and past experiences. Larger companies will more resources to work with, and I’m sure they have gone through many projects and have learned from them all and have optimized their techniques fully. Smaller companies need to pick and choose w…[Read more]

]]> 0 b8cec563de634ee7186c27a730c94164 https://medicaldevicecourses.com/activity/p/7531/ Thu, 26 Apr 2018 21:16:33 -0400 I would prefer to be an engineer and then transition into a manager role once I’m more experienced and have more knowledge of how the industry I am working for works. I first want to be an engineer working in the industry because that will give me a more technical background because of working directly on the products. Once I’m more com…[Read more]

]]> 0 6924bf78eb50a15d549b4383983dba6e https://medicaldevicecourses.com/activity/p/7367/ Wed, 18 Apr 2018 15:37:36 -0400 I’m not too surprised by these results, but I thought fair pay would be higher than just 32%. Some people of talked to wanted as much pay as possible, but I guess it varies from person to person. For me, what I want the most is exciting and challenging work and being recognized/valued & respected. Exciting work will motivate me to actually want t…[Read more]

]]> 0 30ab61db6d4c7defb43a90ff5b8760c9 https://medicaldevicecourses.com/activity/p/7366/ Wed, 18 Apr 2018 14:40:45 -0400 I think Americans are putting in more time for a variety of reasons. Some could be because they are motivated to work on the project and are “workaholics”, others because deadlines are coming up and they need all the time they can get, some because they need the overtime money. There are plenty of others reasons but I think these capture the maj…[Read more]

]]> 0 207b172cd0f27613b02e5dc4b0427476 https://medicaldevicecourses.com/activity/p/7365/ Wed, 18 Apr 2018 14:20:18 -0400 I guess for me the challenge and the reward is what motivates me to complete a project. The challenge aspect is important to me because it brings fun and excitement to the project. It engages me to research, brainstorm, ask questions, and gets me going because I’m learning new things. If there was no challenge I would probably just ease my way t…[Read more]

]]> 0 1fcbf791b87107691c52ecf5e503231a https://medicaldevicecourses.com/activity/p/7224/ Thu, 12 Apr 2018 17:59:15 -0400 For a class project in my undergraduate studies, I had to research plastics for use in the product we were designing. Plastics we researched included polypropylene, mylar, polyethylene, etc. I learned a great deal about different kinds of plastic and their specific properties, such as modulus of elasticity, tensile strength, melting point, and…[Read more]

]]> 0 6dc831086886ca8c6471a9e2942f5512 https://medicaldevicecourses.com/activity/p/7223/ Thu, 12 Apr 2018 16:23:19 -0400 In my opinion using the same supplier for two different products doesn’t fully satisfy the dual source requirement. While yes it does provide an alternative product in case the primary one isn’t available for whatever reason, but the problem for me is that it isn’t from a different supplier. There could be situations where the supplier is closed o…[Read more]

]]> 0 8a277459bc32d9f36f9a7c944b9d4581 https://medicaldevicecourses.com/activity/p/7222/ Thu, 12 Apr 2018 13:49:18 -0400 One of the project I worked required us to use specific captive bolts. The shoulder length, tread size, knob type, etc. all had to be a specific value. I researched companies for a while until I found one. That produced exactly the screw I wanted. Along with the procurement team we contacted them and were able to get a few samples, which were used…[Read more]

]]> 0 f02dad18c21fda4a5aa323a9fc2dc947 https://medicaldevicecourses.com/activity/p/7039/ Thu, 29 Mar 2018 17:51:28 -0400 From my experience working at my current company, during the closing phase we have a few tasks that need to be done. Close up any loose ends with our vendors, typically ensure that they have the most up to date designs of the product. Make sure logistics are reviewed and are good to go. Our documentation team will complete various reports like…[Read more]

]]> 0 eb2cd941920196e99501e37af58f0585 https://medicaldevicecourses.com/activity/p/7036/ Thu, 29 Mar 2018 16:25:52 -0400 I’m with ks629 on this one. EV is only one part of the project and represents only one aspect of it. Any EV estimate whether under budget or over budget will need to be accompanied by something to back it up and see where the estimates are coming from. By understanding where the origins of the estimate are coming from then you as a project m…[Read more]

]]> 0 ed4d9f574efc2fafdb2101a5c0829a27 https://medicaldevicecourses.com/activity/p/6901/ Wed, 21 Mar 2018 20:44:42 -0400 Increasing project risk should be avoided as much as possible. In the mini-sim example, decreasing the animal experiment time would be very bad. From these studies we will see how well the product performs and observe any negative reactions that the product can potentially cause. If we decrease the time we may miss something important that could…[Read more]

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