Medical Device Courses | bnb6 | Activity https://medicaldevicecourses.com/members/bnb6/activity/ Activity feed for bnb6. Wed, 13 May 2026 15:28:01 -0400 https://buddypress.org/?v= en-US 30 hourly 2 5cd92a1fa119f4abc08b6fb5d7f20b92 bnb6 replied to the topic "Specifications: A double edged sword?" - https://medicaldevicecourses.com/activity/p/15804/ Wed, 15 May 2019 19:14:03 -0400 The specifications should always have bounds, and if there is a bound for the coefficient of friction, then it is because that is what is desirable for the specific function. For example, sometimes you wouldn’t want there to be that…   Read more»

]]> 522d6a42676dc7a77f4245c2f78f5b82 bnb6 replied to the topic "Discussion Topic: Scope creep....when your project changes" - https://medicaldevicecourses.com/activity/p/15799/ Wed, 15 May 2019 19:14:00 -0400 This year my capstone project suffered from scope creep because we did not have a defined end product. We essentially would complete the main project task, and if we had time then we would start discussing other tasks that could…   Read more»

]]> a2855adbeb55feb53ec8575677633740 bnb6 replied to the topic "WBS Pitfalls" - https://medicaldevicecourses.com/activity/p/15797/ Wed, 15 May 2019 19:13:59 -0400 As stated above, a poorly structured WBS can have multiple undesirable consequences. Such an example would be many delays because sometimes you do not expect a problem to occur until you are actually doing the task and run into the…   Read more»

]]> 00f06eb104c5db57cd791a2c63616cde bnb6 replied to the topic "Missing a Milestone Experience" - https://medicaldevicecourses.com/activity/p/15601/ Wed, 15 May 2019 19:08:07 -0400 Our capstone team also created a gant chart, and in the beginning it was a lot of guessing on how much time we thought each task would take. We tried to be as accurate as possible by asking the person…   Read more»

]]> 97896675f9dbd38f053eef5388da48b7 bnb6 replied to the topic "Device Class Confusion" - https://medicaldevicecourses.com/activity/p/15600/ Wed, 15 May 2019 19:08:06 -0400 This year my senior capstone project focuses on the attachment between a polyethylene component and tibial implant used in total ankle replacements. There is currently two piece total ankle replacements on the market, so our device would be classified as…   Read more»

]]> 9737bf3c6ca3838dc12cc51e51c07716 bnb6 replied to the topic "Importance of Metrics" - https://medicaldevicecourses.com/activity/p/15510/ Wed, 15 May 2019 19:07:08 -0400 As Dr. Simon said in his lecture, “Metrics are calculations that let you measure things,” during the monitoring and controlling phase. Metrics are needed in order to show variances (difference between the baseline and what you have) in order to…   Read more»

]]> ed55057a579b59a00d7c541f4b59ecd3 bnb6 replied to the topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/15506/ Wed, 15 May 2019 19:07:05 -0400 I agree with krp67 that communication and status meetings are a great start to design transfers. I also believe that organization of all files if very important, making it as easy as possible for the new team to find individual…   Read more»

]]> 3bda1e98aa8997c49aae433e25cbaea5 bnb6 replied to the topic "Post-project lessons learned" - https://medicaldevicecourses.com/activity/p/15505/ Wed, 15 May 2019 19:07:05 -0400 This semester during my capstone project we had not anticipated a few delays, and learned a couple lessons. As a team we added additional tests to validate our design, but did not sit down and discuss all possible risks. During…   Read more»

]]> 6dfab097b1d4ad25ff59f51b4b488ee5 bnb6 replied to the topic "Overlapping activities" - https://medicaldevicecourses.com/activity/p/15291/ Wed, 15 May 2019 19:04:54 -0400 Sometimes the planning phase consists of a lot of guessing, as stated above. I have experienced this at my internship over the summer and one of the engineers had overlapping tasks and projects within the main project. This was a…   Read more»

]]> a5b73264d74191e6ef4fddc1358a82b6 bnb6 replied to the topic "Design Review Meeting Culture" - https://medicaldevicecourses.com/activity/p/15290/ Wed, 15 May 2019 19:04:53 -0400 In my company the design reviews were pretty standard as discussed numerous times above. However the only point I would like to add that hasn’t been discussed is that I believe typing all of the changes during these meetings is…   Read more»

]]> 3cb382d7290b55bb814c7a76c89c064d bnb6 replied to the topic "Risk Management" - https://medicaldevicecourses.com/activity/p/15289/ Wed, 15 May 2019 19:04:53 -0400 One medical device of my particular interest would be total knee replacements. One specific risk of knee replacements is loosening due to wear and tear over the years. Worst case scenario the implant would have to be removed, and a…   Read more»

]]> 7c3d2b7e48d702eeaa91ad72d87f2c61 bnb6 replied to the topic "Discussion Topic: The critical path" - https://medicaldevicecourses.com/activity/p/15209/ Wed, 15 May 2019 19:03:59 -0400 In industry there are many times where an extraneous task suddenly turns into the critical path for a project. I had experienced this while working at Stryker on surgical cut guides that were 3D printed out of grade 5 Titanium….   Read more»

]]> 74ab059eda543f18c739ca4dfdcf3b38 bnb6 replied to the topic "Preplanning for Risk" - https://medicaldevicecourses.com/activity/p/15183/ Wed, 15 May 2019 19:03:46 -0400 Preventative maintenance is very important in projects, which is why there is a huge emphasis on risk analysis. I see your point that task scheduling can create risk as well since each task can ultimately severely delay the project. Some…   Read more»

]]> e5fd9952fe8665ea461ea22fbb8c6416 bnb6 replied to the topic "Mapping- Gantt Chart" - https://medicaldevicecourses.com/activity/p/15179/ Wed, 15 May 2019 19:03:44 -0400 I agree with the two posts above about Gant Charts, as they are very useful in the Medical Device Industry. However there are some downfalls included, such as the time estimates being inaccurate due to the guessing nature of the…   Read more»

]]> d7326257a316693264dba2d90fd91097 bnb6 replied to the topic "Validation vs. Verification" - https://medicaldevicecourses.com/activity/p/14831/ Wed, 15 May 2019 19:00:35 -0400 I agree and like all of the above examples of verification and validation for different projects. Over the summer I worked on patient specific cut guides used for total ankle replacements. Just by the name, you can tell that verification…   Read more»

]]> dcd37051abc872bf0cbf8cb2fc34cbe2 bnb6 replied to the topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/14825/ Wed, 15 May 2019 19:00:26 -0400 I worked for Stryker last summer as an R&D intern on the Foot & Ankle team, and it is a matrix organization. My team consisted of two engineers leading the design of the project, and we worked closely with many…   Read more»

]]> 9bd6fe90b61319c79158551b44599c16 bnb6 replied to the topic "Validation and Verification" - https://medicaldevicecourses.com/activity/p/14823/ Wed, 15 May 2019 19:00:25 -0400 The verification and validation process can be very lengthy, especially because of all of the detail that is required. I wouldn’t necessarily say that there are risks within the V&V process itself, but potentially because of the amount of time…   Read more»

]]> aaa458cd721688787b0d7541ef0d4691 bnb6 replied to the topic "Challenges to Overcome" - https://medicaldevicecourses.com/activity/p/14675/ Wed, 15 May 2019 18:59:05 -0400 I agree that this is a major problem that is prevalent within the medical device industry. I had similarly posted in this forum (see “Clinical Trials” post) about how patients and engineers are effected because of the time/cost of the…   Read more»

]]> b77594663d3b6f4b7a906254b7299df2 bnb6 replied to the topic "How to initiate project successfully" - https://medicaldevicecourses.com/activity/p/14671/ Wed, 15 May 2019 18:59:03 -0400 I would first like to say I agree with all of the previous posts regarding the steps of the project initiation phase and I would like to add some of my feedback based off my internship experience. I believe the…   Read more»

]]> ee4b105a11aee322f6b111c41e90f9fc bnb6 replied to the topic "Interpersonal Skills" - https://medicaldevicecourses.com/activity/p/14553/ Wed, 15 May 2019 18:57:57 -0400 Addressing the last question asked: “What do you believe is the most important trait an individual can possess that relates to interpersonal skills?” I believe that the ability to make someone feel important when you talk to them is very…   Read more»

]]> e7a5c1f4362170a7568cf9abc2df094e bnb6 replied to the topic "Tests for validation and verification phase" - https://medicaldevicecourses.com/activity/p/14552/ Wed, 15 May 2019 18:57:57 -0400 I agree with all of the posts above, however I would like to elaborate on the high level understanding of verification and validation testing, based off my experience at Stryker. I was able to see many of these “tests” done…   Read more»

]]> 3e0ef5a4f09f200482d99dc8a0c327d1 bnb6 posted a new topic "Clinical Trials Discussion" - https://medicaldevicecourses.com/activity/p/10627/ Wed, 15 May 2019 16:35:05 -0400 Clinical trials are very expensive, take several years to complete, and are essentially a large risky investment. This can deter many companies from pursuing new innovative solutions, and will instead make sure the device is close enough to something already…   Read more»

]]> aaa8180fdab119b982af43ad74eac348 bnb6 posted a new topic "Determining project priority" - https://medicaldevicecourses.com/activity/p/10614/ Wed, 15 May 2019 16:34:58 -0400 Dr. Simon said in his lecture, “Projects have a beginning and an end that are very well defined.” During my experience at Stryker, I have seen projects put on hold due to lower priority, and projects being canceled. These projects…   Read more»

]]> 350d18127d7d1a868f455ef8e7d01cce bnb6 replied to the topic Specifications: A double edged sword? in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7330/ Mon, 16 Apr 2018 03:26:07 -0400 The specifications should always have bounds, and if there is a bound for the coefficient of friction, then it is because that is what is desirable for the specific function. For example, sometimes you wouldn’t want there to be that little amount of friction in a product. However some bounds you can theoretically say would just make the product…[Read more]

]]> 0 940fd7a966118149940dec7781dbf441 bnb6 replied to the topic Discussion Topic: Scope creep....when your project changes in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7325/ Mon, 16 Apr 2018 03:13:18 -0400 This year my capstone project suffered from scope creep because we did not have a defined end product. We essentially would complete the main project task, and if we had time then we would start discussing other tasks that could be done. However since our expectations were mainly for the one project, we did not plan in any time to attempt the…[Read more]

]]> 0 a1b4a7b65f7808b7a6cc115627a3d792 bnb6 replied to the topic WBS Pitfalls in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7323/ Mon, 16 Apr 2018 03:06:52 -0400 As stated above, a poorly structured WBS can have multiple undesirable consequences. Such an example would be many delays because sometimes you do not expect a problem to occur until you are actually doing the task and run into the problem itself. Then each problem must be resolved, and some times this simple issue may need many meetings and…[Read more]

]]> 0 5f6bb45370c02ba19c5f8b76096d50e7 bnb6 replied to the topic Missing a Milestone Experience in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/7069/ Sat, 31 Mar 2018 20:16:05 -0400 Our capstone team also created a gant chart, and in the beginning it was a lot of guessing on how much time we thought each task would take. We tried to be as accurate as possible by asking the person who would complete the task how much time they thought it would take them. However since the gant chart does not take vacations, spring break, and…[Read more]

]]> 0 073d007106dbb202e66212339298372e bnb6 replied to the topic Device Class Confusion in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/7068/ Sat, 31 Mar 2018 20:06:52 -0400 This year my senior capstone project focuses on the attachment between a polyethylene component and tibial implant used in total ankle replacements. There is currently two piece total ankle replacements on the market, so our device would be classified as class 2. However this is still a lot of testing for our team to complete in capstone to show…[Read more]

]]> 0 40699e475a053c8205302e2d8f5a77ab bnb6 replied to the topic Importance of Metrics in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6961/ Sun, 25 Mar 2018 19:45:00 -0400 As Dr. Simon said in his lecture, “Metrics are calculations that let you measure things,” during the monitoring and controlling phase. Metrics are needed in order to show variances (difference between the baseline and what you have) in order to keep the project under control, measure success, and evaluate the project.

]]> 0 4b7b38d5ca1dde4df0971863245c53a0 bnb6 replied to the topic Design Transfer in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6956/ Sun, 25 Mar 2018 19:27:41 -0400 I agree with krp67 that communication and status meetings are a great start to design transfers. I also believe that organization of all files if very important, making it as easy as possible for the new team to find individual files, etc. All documents must be updated and organized in a fashion that is easy to follow to save the new team as much…[Read more]

]]> 0 1350d22bd9ef4489d6153edab8755aca bnb6 replied to the topic Post-project lessons learned in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6955/ Sun, 25 Mar 2018 19:21:14 -0400 This semester during my capstone project we had not anticipated a few delays, and learned a couple lessons. As a team we added additional tests to validate our design, but did not sit down and discuss all possible risks. During testing, one of our 3D pieces that we printed as an attachment to a force sensor kept breaking under the required load to…[Read more]

]]> 0 01bc09d2f9c395a72741ea5ba6a308ce bnb6 replied to the topic Overlapping activities in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6696/ Sat, 03 Mar 2018 21:56:59 -0500 Sometimes the planning phase consists of a lot of guessing, as stated above. I have experienced this at my internship over the summer and one of the engineers had overlapping tasks and projects within the main project. This was a large amount of responsibility and he had to plan his days weekly according to importance and project priority. During…[Read more]

]]> 0 3da1b82ce8eccae770ea1c44701f18d9 bnb6 replied to the topic Design Review Meeting Culture in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6695/ Sat, 03 Mar 2018 21:27:29 -0500 In my company the design reviews were pretty standard as discussed numerous times above. However the only point I would like to add that hasn’t been discussed is that I believe typing all of the changes during these meetings is the most efficient way. Some companies, or in capstone we are reviewing all of the documents before class and the scribe…[Read more]

]]> 0 22b1e45c1d2dcab9b374937b7e2501bc bnb6 replied to the topic Risk Management in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6694/ Sat, 03 Mar 2018 21:10:09 -0500 One medical device of my particular interest would be total knee replacements. One specific risk of knee replacements is loosening due to wear and tear over the years. Worst case scenario the implant would have to be removed, and a secondary replacement system will have to be implanted after resecting even more bone. Companies manage this risk by…[Read more]

]]> 0 01786ccfaf6fbc8836e0f96f42e10b32 bnb6 replied to the topic Discussion Topic: The critical path in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6605/ Sun, 25 Feb 2018 21:27:15 -0500 In industry there are many times where an extraneous task suddenly turns into the critical path for a project. I had experienced this while working at Stryker on surgical cut guides that were 3D printed out of grade 5 Titanium. It was not observed until after the design freeze during a cadaver lab that the cut guides created a lot of debris while…[Read more]

]]> 0 9ad0210bf990a89b439367983d0c146c bnb6 replied to the topic Preplanning for Risk in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6578/ Sun, 25 Feb 2018 18:26:38 -0500 Preventative maintenance is very important in projects, which is why there is a huge emphasis on risk analysis. I see your point that task scheduling can create risk as well since each task can ultimately severely delay the project. Some project planning softwares include features that incorporate employee’s 8 hour work days, vacations, and other…[Read more]

]]> 0 3a926a21f7971ebf2c7c559a2fc2b1e8 bnb6 replied to the topic Mapping- Gantt Chart in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6571/ Sun, 25 Feb 2018 17:14:27 -0500 I agree with the two posts above about Gant Charts, as they are very useful in the Medical Device Industry. However there are some downfalls included, such as the time estimates being inaccurate due to the guessing nature of the chart. The chart also does not account for personal obligations by the team, as there may be delays due to schedules,…[Read more]

]]> 0 3ec8b89e9865e8f3089a4bed608f1fac bnb6 replied to the topic Validation vs. Verification in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6102/ Sun, 04 Feb 2018 18:43:16 -0500 I agree and like all of the above examples of verification and validation for different projects. Over the summer I worked on patient specific cut guides used for total ankle replacements. Just by the name, you can tell that verification itself would not be sufficient, and there would be a substantial amount of validation. One aspect of…[Read more]

]]> 0 6cef13baa93d03aab84bfb6957529586 bnb6 replied to the topic Discussion Topic: State of your Organization in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6096/ Sun, 04 Feb 2018 18:15:40 -0500 I worked for Stryker last summer as an R&D intern on the Foot & Ankle team, and it is a matrix organization. My team consisted of two engineers leading the design of the project, and we worked closely with many other departments, such as quality, testing, advanced operations, additive engineering, marketing, etc. Our project had at least one…[Read more]

]]> 0 03e033eb557e8f9c5ab036c2eb0e9e52 bnb6 replied to the topic Validation and Verification in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6094/ Sun, 04 Feb 2018 18:01:53 -0500 The verification and validation process can be very lengthy, especially because of all of the detail that is required. I wouldn’t necessarily say that there are risks within the V&V process itself, but potentially because of the amount of time it takes. For example, if a test failed, or if the engineers cannot figure out how to perform the…[Read more]

]]> 0 0601c6539eeb5fca46cc47e33019b61d bnb6 replied to the topic Challenges to Overcome in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/5910/ Sun, 28 Jan 2018 02:14:39 -0500 I agree that this is a major problem that is prevalent within the medical device industry. I had similarly posted in this forum (see “Clinical Trials” post) about how patients and engineers are effected because of the time/cost of the class 2 or class 3 process as well. I hope there will be a decrease in cost but that is a large issue within the…[Read more]

]]> 0 4174accf192044b106056153bf6f9186 bnb6 replied to the topic How to initiate project successfully in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/5906/ Sun, 28 Jan 2018 01:29:05 -0500 I would first like to say I agree with all of the previous posts regarding the steps of the project initiation phase and I would like to add some of my feedback based off my internship experience. I believe the most successful projects come from a team of individuals who can be seen as the “subject matter experts.” Ideally, at least one person…[Read more]

]]> 0 38838100080dc4573fdd5425e5788eee bnb6 started the topic Clinical Trials Discussion in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/5905/ Sun, 28 Jan 2018 01:13:44 -0500 Clinical trials are very expensive, take several years to complete, and are essentially a large risky investment. This can deter many companies from pursuing new innovative solutions, and will instead make sure the device is close enough to something already on the market. This is unfortunate because the Engineers are restricted with their…[Read more]

]]> 0 adb155b0e6d4dd4d1e65307b5e7bb2b5 bnb6 started the topic Determining project priority in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/5681/ Sun, 21 Jan 2018 20:25:34 -0500 Dr. Simon said in his lecture, “Projects have a beginning and an end that are very well defined.” During my experience at Stryker, I have seen projects put on hold due to lower priority, and projects being canceled. These projects were canceled due to low funding, or because management wanted to place these employees on a newer project. When…[Read more]

]]> 0 3e726469a3bc9721af650751e7550e57 bnb6 replied to the topic Interpersonal Skills in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/5674/ Sun, 21 Jan 2018 20:03:23 -0500 Addressing the last question asked: “What do you believe is the most important trait an individual can possess that relates to interpersonal skills?”

I believe that the ability to make someone feel important when you talk to them is very important to the success of that person. I believe it is a learned trait, but also must be genuine and…[Read more]

]]> 0 dfee29e3e4459ece4543337296531f7b bnb6 replied to the topic Tests for validation and verification phase in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/5673/ Sun, 21 Jan 2018 19:49:23 -0500 I agree with all of the posts above, however I would like to elaborate on the high level understanding of verification and validation testing, based off my experience at Stryker. I was able to see many of these “tests” done on the patient specific cut guides created for ankle replacement surgeries. The verification of the device included many…[Read more]

]]> 0