https://medicaldevicecourses.com/members/psm34/activity/ Activity feed for psm34. Fri, 24 Apr 2026 18:41:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e144341fa04fea48549d9ce076211cd1 https://medicaldevicecourses.com/activity/p/15640/ Wed, 15 May 2019 19:12:24 -0400 There can be a lot of reasons to change a device and as long as it doesn’t effect he safety, efficacy or performance of the device, there shouldn’t be too much of a hassle to change it. Reasons to change…   Read more»

]]> 72590bcc13f93660b57b37545a64c555 https://medicaldevicecourses.com/activity/p/15639/ Wed, 15 May 2019 19:12:23 -0400 At work we were working on a project to develop a new diagnostic test. We hit a road bump about 2 weeks prior to turning over the project to manufacturing. This put the entire project behind by a week. Fortunately,…   Read more»

]]> 7f4219fd273b22ff6129e08480b4fd41 https://medicaldevicecourses.com/activity/p/15522/ Wed, 15 May 2019 19:07:15 -0400 I recently have found it interesting at my job how different the metrics can be based on what upper management deems a quality project or not. It’s pretty self explanatory but I’m working on two projects and one of them…   Read more»

]]> 47f460f7591bdedac055119d5a4d33d7 https://medicaldevicecourses.com/activity/p/15518/ Wed, 15 May 2019 19:07:13 -0400 To add on, this will let the team and upper management decide whether or not a project is worth following through on if it hits too many road bumps. If there are major set backs that were not planned for…   Read more»

]]> 2c09dc5fb4cd21ef609dde833ccaa686 https://medicaldevicecourses.com/activity/p/15517/ Wed, 15 May 2019 19:07:12 -0400 There was a project that I was on that we should have spent more time in the research phase. We were culturing cells for this project and there was one very old article that we found a few weeks after…   Read more»

]]> b43e505f47812618b869a51dd85c3c66 https://medicaldevicecourses.com/activity/p/15366/ Wed, 15 May 2019 19:05:36 -0400 I work at a very small company so they assume that they do not need to complete WBS at all. So this accounts for everyone taking on more responsibility than is needed and certain things falling through the cracks. We…   Read more»

]]> 47f585493acccdc04542d1c981b5c460 https://medicaldevicecourses.com/activity/p/15364/ Wed, 15 May 2019 19:05:35 -0400 One of the manufacturing projects that my team works on at my company, was delayed because of an issue in the biology department. The cell biology department had an incubator that was contaminated that killed all of the cells that…   Read more»

]]> fcc1e7ede7e90e627f3cff49b8c717bf https://medicaldevicecourses.com/activity/p/15363/ Wed, 15 May 2019 19:05:35 -0400 Catheter with antimicrobial coating is another example of a combination product. This allows the catheter to function as it is intended but prevents catheter-associated urinary tract infections (CAUTI). This allows the user to use a catheter with the same function…   Read more»

]]> ce092139b5af4ff9229194d7efbd1669 https://medicaldevicecourses.com/activity/p/14934/ Wed, 15 May 2019 19:01:30 -0400 I agree with everything said so far. This is more an example of where having an interpersonal “beef” with another employee caused a long delay in the production at the company I currently work for. There was an issue with…   Read more»

]]> 1c101ff2da7abea9f3ef3b3b4a2f6f1f https://medicaldevicecourses.com/activity/p/14921/ Wed, 15 May 2019 19:01:23 -0400 Currently, I work for Scimedx, a small diagnostic medical device company. Since the company is small (only about 30 people) its a little harder to describe how we operate but I think it is closely related to a matrix organization….   Read more»

]]> a6be82f85505b4bd160f215a7358d8e7 https://medicaldevicecourses.com/activity/p/14920/ Wed, 15 May 2019 19:01:22 -0400 To add on to what aij5 has said, there is also legal liabilities that companies should make sure that they have covered. If a product goes out to market with known risks and they have made sure that the public…   Read more»

]]> 175d207dee1f48421c40d0246c36a026 https://medicaldevicecourses.com/activity/p/14641/ Wed, 15 May 2019 18:58:47 -0400 This one might be a layup but a pretty common one would be a first aid kit. They have aspririn and antibiotic cream that would go through CDER which are probably class 2 with 510k. The bandages and gauze would…   Read more»

]]> d0139e46c0030a0b56053af7e9f4c626 https://medicaldevicecourses.com/activity/p/14581/ Wed, 15 May 2019 18:58:13 -0400 I think there is the assumption that engineers will be well equipped enough in their jobs that they can learn and evolve throughout the entire process. Interpersonal skills are something that are necessary in every job and for some people,…   Read more»

]]> 7c289b66196d4d62d1de6f778ceaa853 https://medicaldevicecourses.com/activity/p/7115/ Mon, 02 Apr 2018 00:00:57 -0400 There can be a lot of reasons to change a device and as long as it doesn’t effect he safety, efficacy or performance of the device, there shouldn’t be too much of a hassle to change it. Reasons to change a device can be a little as rotating the image of the logo on a device to make it more aesthetically pleasing or it could be an actual change to…[Read more]

]]> 0 51b948c1d6ddfd43c623282f2beafaa6 https://medicaldevicecourses.com/activity/p/7114/ Sun, 01 Apr 2018 23:53:11 -0400 At work we were working on a project to develop a new diagnostic test. We hit a road bump about 2 weeks prior to turning over the project to manufacturing. This put the entire project behind by a week. Fortunately, the engineers on the manufacturing and the development team worked overtime for 2 weeks to catch up and allow for the project to still…[Read more]

]]> 0 8ff93efd694aec10ede6870a80439bd2 https://medicaldevicecourses.com/activity/p/6973/ Sun, 25 Mar 2018 22:16:04 -0400 I recently have found it interesting at my job how different the metrics can be based on what upper management deems a quality project or not. It’s pretty self explanatory but I’m working on two projects and one of them has a way lower success rate so the planned value is much lower than the other project. However, the people on this task and much…[Read more]

]]> 0 fb422203977cb28853875c03f0d440eb https://medicaldevicecourses.com/activity/p/6969/ Sun, 25 Mar 2018 21:53:56 -0400 To add on, this will let the team and upper management decide whether or not a project is worth following through on if it hits too many road bumps. If there are major set backs that were not planned for in the planned value and the actual costs begin to skyrocket, its clear that the project will shut down prior to completion.

]]> 0 15b7e2b3bc1ca95a69fea1255e404908 https://medicaldevicecourses.com/activity/p/6968/ Sun, 25 Mar 2018 21:50:32 -0400 There was a project that I was on that we should have spent more time in the research phase. We were culturing cells for this project and there was one very old article that we found a few weeks after the project had finished that mentioned that we should try to culture the cells in spinner flasks and that would increase the growth rate of the…[Read more]

]]> 0 9af58a7c2ef4f851c80c73775bb05bbb https://medicaldevicecourses.com/activity/p/6781/ Thu, 08 Mar 2018 17:08:37 -0500 I work at a very small company so they assume that they do not need to complete WBS at all. So this accounts for everyone taking on more responsibility than is needed and certain things falling through the cracks. We manufacture diagnostic tests and every year we have certain tests that we make for only about 2 months out of the year (not a large…[Read more]

]]> 0 d85cbbfe6fde01bcc3c8e1f2e101fbc0 https://medicaldevicecourses.com/activity/p/6779/ Thu, 08 Mar 2018 17:01:40 -0500 One of the manufacturing projects that my team works on at my company, was delayed because of an issue in the biology department. The cell biology department had an incubator that was contaminated that killed all of the cells that were needed to manufacture the diagnostic tests that we make. This pushes us back about a month because of all the…[Read more]

]]> 0 fb0d241f6656d84c015a7c6df9fff36c https://medicaldevicecourses.com/activity/p/6778/ Thu, 08 Mar 2018 16:53:14 -0500 Catheter with antimicrobial coating is another example of a combination product. This allows the catheter to function as it is intended but prevents catheter-associated urinary tract infections (CAUTI). This allows the user to use a catheter with the same function as one with no coating on it, but with less risk of infection. This is submitted to…[Read more]

]]> 0 ddce9692afdee2d412159e3ec8ddf644 https://medicaldevicecourses.com/activity/p/6209/ Fri, 09 Feb 2018 16:43:49 -0500 I agree with everything said so far. This is more an example of where having an interpersonal “beef” with another employee caused a long delay in the production at the company I currently work for. There was an issue with production that most likely could have been solved in about 2 weeks if it was managed by the head of manufacturing, however the…[Read more]

]]> 0 1073b7ef2d10b59fb54a2bf3870806a4 https://medicaldevicecourses.com/activity/p/6196/ Thu, 08 Feb 2018 16:57:18 -0500 Currently, I work for Scimedx, a small diagnostic medical device company. Since the company is small (only about 30 people) its a little harder to describe how we operate but I think it is closely related to a matrix organization. If there is a large product, the people in the microbiology department (my department) will help out whatever other…[Read more]

]]> 0 05548789df3824de677a8d5fc80e1df7 https://medicaldevicecourses.com/activity/p/6195/ Thu, 08 Feb 2018 16:48:55 -0500 To add on to what aij5 has said, there is also legal liabilities that companies should make sure that they have covered. If a product goes out to market with known risks and they have made sure that the public knows about them and have warning labels and such on the product, they are less liable for legal action against them. If a drug goes to…[Read more]

]]> 0 c0b6dae29b238d8a9045e495d994dec5 https://medicaldevicecourses.com/activity/p/5858/ Thu, 25 Jan 2018 00:34:29 -0500 This one might be a layup but a pretty common one would be a first aid kit. They have aspririn and antibiotic cream that would go through CDER which are probably class 2 with 510k. The bandages and gauze would go through the CDHR and be a class 1 device.

]]> 0 81df0affdf224d52c923dbfdb048b86d https://medicaldevicecourses.com/activity/p/5714/ Mon, 22 Jan 2018 01:01:10 -0500 I think there is the assumption that engineers will be well equipped enough in their jobs that they can learn and evolve throughout the entire process. Interpersonal skills are something that are necessary in every job and for some people, these skills are harder to develop than technical skills or knowledge. So if you come out of college with a…[Read more]

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