https://medicaldevicecourses.com/members/cs22/activity/ Activity feed for cs22. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 fb7794850a8ab761a054744df80df71c https://medicaldevicecourses.com/activity/p/16028/ Wed, 15 May 2019 19:16:22 -0400 Priorities and the scope of a project need to be managed like any other aspect. I think in the case of most projects the priorities differ between the upper and middle management and the research individuals and also the production…   Read more»

]]> 34b1bcfd25e04695771769a2025a073c https://medicaldevicecourses.com/activity/p/16027/ Wed, 15 May 2019 19:16:22 -0400 For me, this course reinforced the importance of good management of a project regardless of its size. I have noticed how a lot of the topics covered could have improved many projects at my own workplace and how they can…   Read more»

]]> 1264f77dbf2b24671ad3a3f6762375a7 https://medicaldevicecourses.com/activity/p/16026/ Wed, 15 May 2019 19:16:21 -0400 Some orders from vendors are also made to order to certain specifications. This means there is usually some delay between ordering and receiving from a vendor as they need time to fabricate the order. In cases such as this communication…   Read more»

]]> cd18cc2a018001943cb23fd62b980152 https://medicaldevicecourses.com/activity/p/15936/ Wed, 15 May 2019 19:15:24 -0400 Smaller companies have much less people to manage making it simpler in a way but in other ways more crucial as individuals in smaller companies are more than likely in charge of a larger portion of the work required to…   Read more»

]]> 28f8d14b81039f882f0bca0958c0f212 https://medicaldevicecourses.com/activity/p/15933/ Wed, 15 May 2019 19:15:23 -0400 The main motivator for me is the opportunity to create something new. I also enjoy finding solutions to the various problems that occur during the course of a project. Seeing the end result of months of work is also a…   Read more»

]]> 47db3a050992108da7689be47bdf2f2a https://medicaldevicecourses.com/activity/p/15793/ Wed, 15 May 2019 19:13:56 -0400 A metric for a specific feature should always fall within the defined specifications; otherwise the documentation is meaningless and must be changed accordingly. Certain metrics can most likely have only a lower or upper limit if the design calls for…   Read more»

]]> 48c674ec9b32989f35ff1a9fec4cfd7e https://medicaldevicecourses.com/activity/p/15792/ Wed, 15 May 2019 19:13:55 -0400 The method of communication management should be tailored to each specific company as various factors such as hierarchies, communication infrastructure, security protocols all differ between companies. Multiple methods of communication should be implemented to prevent issues where one is not…   Read more»

]]> 3292a0fe337782172a61dfa9a1ed4e05 https://medicaldevicecourses.com/activity/p/15791/ Wed, 15 May 2019 19:13:55 -0400 Six Sigma actually contains a specific project methodology when working with projects that will produce a new product as opposed to improving business practices: DMADV System: Define design goals that are consistent with customer demands and the enterprise strategy. Measure…   Read more»

]]> 4f92afd182c1ab2249c82a35ca501af9 https://medicaldevicecourses.com/activity/p/15559/ Wed, 15 May 2019 19:07:38 -0400 As the lecture also mentioned, a very important component of the closing phase is to properly record everything so that information can be used for future projects. This can help in not repeating the same mistakes in similar projects in…   Read more»

]]> d4cbf2796418b24ffaef1ccd969a9443 https://medicaldevicecourses.com/activity/p/15554/ Wed, 15 May 2019 19:07:36 -0400 I think its important to remember that the monitoring and control phase occurs throughout the entire lifespan of the project and is always a factor in decision making. With that in mind, the various metrics help greatly since they give…   Read more»

]]> 986b24e621979e12d7d88b89f3183980 https://medicaldevicecourses.com/activity/p/15553/ Wed, 15 May 2019 19:07:35 -0400 With a capstone project I was involved in, a major lesson we learned was adjusting the project scope due to limitations found in the design. With this project, one of the parts of the device required a much higher manufacturing…   Read more»

]]> 38d915d0950bab16bc6208d400956a15 https://medicaldevicecourses.com/activity/p/15437/ Wed, 15 May 2019 19:06:22 -0400 I think the consequences of risking the project with poor experimental data are much greater than any time delays. If poor experimentation fails to uncover a particular design issue or if it is not accepted by appropriate regulatory agencies, then…   Read more»

]]> 55750511b29d1da2bde23445a82c4082 https://medicaldevicecourses.com/activity/p/15408/ Wed, 15 May 2019 19:06:00 -0400 If the outsourced part is critical to the devices specific function, extra communication and scrutiny is required between the project team and the outsourcing company. Not only will the product need to meet all standards set, it will also need…   Read more»

]]> ad245bed72f3bd38a7642bba9b91fd09 https://medicaldevicecourses.com/activity/p/15407/ Wed, 15 May 2019 19:05:59 -0400 With all of these I think it depends on the severity of the deviation the failure causes to the original scope of the project. Sometimes losing a vendor or a new regulation might not have a available alternative or work…   Read more»

]]> f18bae0477af703793c4bdfe52a66c24 https://medicaldevicecourses.com/activity/p/15353/ Wed, 15 May 2019 19:05:29 -0400 Unforeseen occurrences are should be factored in with task scheduling. If a schedule is too tight then any delay will cascade into other tasks which depend on the initial task. This will in turn cause those tasks to be delayed,…   Read more»

]]> d1230b6f7a933bf47abba62fa08b4903 https://medicaldevicecourses.com/activity/p/15352/ Wed, 15 May 2019 19:05:29 -0400 Persistence is important with unresponsive team members or even sometimes with the PM themselves. In a capstone project I participated in, with the our advisor acting as PM, we found it difficult to contact them for input outside of our…   Read more»

]]> 53c38e56b931eb23b54cf32d63c00a0b https://medicaldevicecourses.com/activity/p/15319/ Wed, 15 May 2019 19:05:11 -0400 One possible way to save time and effort is to approach FactoSet in regards to validity testing. The company that developed the growth factor most likely has an established method to determine its level of activity or if it is…   Read more»

]]> 61384b04da5c04f886be9bd120c2a5ad https://medicaldevicecourses.com/activity/p/15110/ Wed, 15 May 2019 19:03:07 -0400 Any unethical practices should be avoided from a design standpoint. However, if a project does find itself in a situation like you have outlined the reality is they may take some of the actions you have mentioned. In contemplating taking…   Read more»

]]> ca63ef2e4ae6197c7fba2d0236572210 https://medicaldevicecourses.com/activity/p/14991/ Wed, 15 May 2019 19:02:00 -0400 I don’t think this situation will occur in any meaningful frequency. Most hospitals or physicians will only have FDA approved products on hand and those which do not are most likely not very reputable and will use any device they…   Read more»

]]> 7a8b8503186659feb91374a4ec6f59d1 https://medicaldevicecourses.com/activity/p/14990/ Wed, 15 May 2019 19:01:59 -0400 In response to the questionable services provided by acupuncturists in addition to their regular service, I feel this is acceptable provided that their primary service is FDA approved and they are properly licensed. The extra income from their secondary services,…   Read more»

]]> c0ae326741837766308129c9a4056e48 https://medicaldevicecourses.com/activity/p/14984/ Wed, 15 May 2019 19:01:56 -0400 I believe there is more scrutiny in the pharmaceutical industry simply because it is a much larger industry. This means many more companies with many more products for the FDA to regulate. Since Pharmaceuticals affect many more people and also…   Read more»

]]> c8a5a6cf3bec725354bc8cc1d9cb875c https://medicaldevicecourses.com/activity/p/14755/ Wed, 15 May 2019 18:59:46 -0400 I agree with aij5. The novel portion of this particular product is the sensor and reporting aspect, the drug is already an approved product. If the device portion is approved it has the potential to be used with other drugs….   Read more»

]]> ceffec9d7d8a5a924f259a6d7780a790 https://medicaldevicecourses.com/activity/p/14752/ Wed, 15 May 2019 18:59:45 -0400 Proper planing and deciding release schedules for different regions should be considered, but the major goal in developing a commercial product is to have it available in the primary market first and then expand into other regions. Having a simultaneous…   Read more»

]]> 32c3467d0a4d6e76e7d310c5933f7dc2 https://medicaldevicecourses.com/activity/p/14728/ Wed, 15 May 2019 18:59:33 -0400 Currently, there is a major issue involving the overuse of opioid painkillers in pain management. So much so that the FDA has released guidelines for doctors to explore the use of chiropractic methods and acupuncture as alternative treatments: https://www.fda.gov/downloads/Drugs/NewsEvents/UCM557071.pdf The…   Read more»

]]> d63a59e33427d831241ffb94686f9260 https://medicaldevicecourses.com/activity/p/14609/ Wed, 15 May 2019 18:58:27 -0400 I feel that, for adding more coatings to test, it becomes a balancing act between finding an ideal antibiotic and the increased time and resources of a larger study. In these situations I think it’s important to properly research beforehand…   Read more»

]]> 2c6fcca33397e20ac166a0c2da56bd8b https://medicaldevicecourses.com/activity/p/14606/ Wed, 15 May 2019 18:58:26 -0400 During my undergraduate studies, the majority of the BME courses within the B.S. program focused on group work and projects instead of the testing and individual work that Chemistry, Physics, or even Mechanical Engineering courses focused on. I believe this…   Read more»

]]> 74a5a729265049eb5bbab3346e643044 https://medicaldevicecourses.com/activity/p/14601/ Wed, 15 May 2019 18:58:23 -0400 I currently work in the Forensic Toxicology department of a diagnostic laboratory, mostly handling GC/MS confirmation of positively screened drug samples. Within the company, most project management communication is done through emails or in person between lab directors and supervisors…   Read more»

]]> 40b9bebd76d704f3887ed62c0ad4e72b https://medicaldevicecourses.com/activity/p/7601/ Mon, 30 Apr 2018 01:51:27 -0400 Priorities and the scope of a project need to be managed like any other aspect. I think in the case of most projects the priorities differ between the upper and middle management and the research individuals and also the production team. With all the different stakeholders weighing priorities, and some having more say as to which priorities are…[Read more]

]]> 0 4ba85d7235cd60c2a04c33407ae25bf3 https://medicaldevicecourses.com/activity/p/7600/ Mon, 30 Apr 2018 01:47:04 -0400 For me, this course reinforced the importance of good management of a project regardless of its size. I have noticed how a lot of the topics covered could have improved many projects at my own workplace and how they can be used to improve future projects. Communication seems to be an important aspect of project management, and something as simple…[Read more]

]]> 0 f857a59ba88281586a64bdb1cf8663b3 https://medicaldevicecourses.com/activity/p/7599/ Mon, 30 Apr 2018 01:42:57 -0400 Some orders from vendors are also made to order to certain specifications. This means there is usually some delay between ordering and receiving from a vendor as they need time to fabricate the order. In cases such as this communication and managing orders to the vendor is even more important as the production of your product may depend on that…[Read more]

]]> 0 0abee58e60ae9f6aa8e106362f3a4324 https://medicaldevicecourses.com/activity/p/7483/ Mon, 23 Apr 2018 03:14:36 -0400 Smaller companies have much less people to manage making it simpler in a way but in other ways more crucial as individuals in smaller companies are more than likely in charge of a larger portion of the work required to complete a project compared to a larger company where an individual’s specific contribution is a smaller fraction of the total w…[Read more]

]]> 0 e69fadc03b37772e882e2833c1efa4c6 https://medicaldevicecourses.com/activity/p/7480/ Mon, 23 Apr 2018 02:57:55 -0400 The main motivator for me is the opportunity to create something new. I also enjoy finding solutions to the various problems that occur during the course of a project. Seeing the end result of months of work is also a major motivating factor and gives me the desire to start new projects.

]]> 0 195dbb9cda9e3b34be12479ec26d660f https://medicaldevicecourses.com/activity/p/7318/ Mon, 16 Apr 2018 02:47:44 -0400 A metric for a specific feature should always fall within the defined specifications; otherwise the documentation is meaningless and must be changed accordingly. Certain metrics can most likely have only a lower or upper limit if the design calls for it, such as a coating having a curing time of at least 2 hours where any time spent curing after 2…[Read more]

]]> 0 845c6a4746b93bd68cf2ccce665ce311 https://medicaldevicecourses.com/activity/p/7317/ Mon, 16 Apr 2018 02:40:07 -0400 The method of communication management should be tailored to each specific company as various factors such as hierarchies, communication infrastructure, security protocols all differ between companies. Multiple methods of communication should be implemented to prevent issues where one is not available. Regular meetings can allow for communication…[Read more]

]]> 0 d7f81316b0de533cf4b0ff15bef41855 https://medicaldevicecourses.com/activity/p/7315/ Mon, 16 Apr 2018 02:28:01 -0400 Six Sigma actually contains a specific project methodology when working with projects that will produce a new product as opposed to improving business practices:
DMADV System:
Define design goals that are consistent with customer demands and the enterprise strategy.
Measure and identify characteristics that are Critical To Quality, product…[Read more]

]]> 0 05fb120d6f04b13e6f33a595b8cd1372 https://medicaldevicecourses.com/activity/p/7011/ Mon, 26 Mar 2018 03:08:54 -0400 As the lecture also mentioned, a very important component of the closing phase is to properly record everything so that information can be used for future projects. This can help in not repeating the same mistakes in similar projects in the future.

]]> 0 38fccb357b2dd645cd02150967571ae9 https://medicaldevicecourses.com/activity/p/7005/ Mon, 26 Mar 2018 02:03:54 -0400 I think its important to remember that the monitoring and control phase occurs throughout the entire lifespan of the project and is always a factor in decision making. With that in mind, the various metrics help greatly since they give quantitative and easy to understand values at any stage that the project is on. The process of calculating these…[Read more]

]]> 0 5ba96b0283377d5de23e84df634e97d1 https://medicaldevicecourses.com/activity/p/7004/ Mon, 26 Mar 2018 01:54:36 -0400 With a capstone project I was involved in, a major lesson we learned was adjusting the project scope due to limitations found in the design. With this project, one of the parts of the device required a much higher manufacturing precision that we were capable of producing given our budget and time frame. This caused us to select our second choice…[Read more]

]]> 0 9eea7d146920ab5abbe7c4ebeed01873 https://medicaldevicecourses.com/activity/p/6864/ Mon, 12 Mar 2018 03:29:36 -0400 I think the consequences of risking the project with poor experimental data are much greater than any time delays. If poor experimentation fails to uncover a particular design issue or if it is not accepted by appropriate regulatory agencies, then the delay to the project would be much greater than the alternative.

]]> 0 184f377893fc3fa69902f33da22ac0e0 https://medicaldevicecourses.com/activity/p/6832/ Sun, 11 Mar 2018 23:20:05 -0400 If the outsourced part is critical to the devices specific function, extra communication and scrutiny is required between the project team and the outsourcing company. Not only will the product need to meet all standards set, it will also need to be delivered reliably and on time for production to work. This should probably include a thorough…[Read more]

]]> 0 16a282bff37112b7cfb515ed3c1e716c https://medicaldevicecourses.com/activity/p/6831/ Sun, 11 Mar 2018 23:13:24 -0400 With all of these I think it depends on the severity of the deviation the failure causes to the original scope of the project. Sometimes losing a vendor or a new regulation might not have a available alternative or work around and the project cannot proceed or must make drastic or time and money consuming changes to continue. In cases where there…[Read more]

]]> 0 139a71bd61f5f5413c330aa282e06ca5 https://medicaldevicecourses.com/activity/p/6766/ Mon, 05 Mar 2018 04:32:57 -0500 Unforeseen occurrences are should be factored in with task scheduling. If a schedule is too tight then any delay will cascade into other tasks which depend on the initial task. This will in turn cause those tasks to be delayed, and so forth. In order to help with this task duration should be established with considerations in place in case of any…[Read more]

]]> 0 72ee9f3dc4ff5917d09b0a613e7feba3 https://medicaldevicecourses.com/activity/p/6765/ Mon, 05 Mar 2018 04:28:13 -0500 Persistence is important with unresponsive team members or even sometimes with the PM themselves. In a capstone project I participated in, with the our advisor acting as PM, we found it difficult to contact them for input outside of our weekly progress meetings due to their other obligations. To help with this issue our group was diligent in…[Read more]

]]> 0 cbe666cade225f9bd523041601d952a0 https://medicaldevicecourses.com/activity/p/6730/ Sun, 04 Mar 2018 23:43:30 -0500 One possible way to save time and effort is to approach FactoSet in regards to validity testing. The company that developed the growth factor most likely has an established method to determine its level of activity or if it is functional. Even if their particular method is proprietary and not available to the project team, FactoSet may still be…[Read more]

]]> 0 ad1acc5b78cdf016c4eb5507748b3127 https://medicaldevicecourses.com/activity/p/6408/ Mon, 19 Feb 2018 03:38:48 -0500 Any unethical practices should be avoided from a design standpoint. However, if a project does find itself in a situation like you have outlined the reality is they may take some of the actions you have mentioned. In contemplating taking these actions, the decision makers would most likely weigh what they stand to lose by remaining ethical against…[Read more]

]]> 0 55c39dc41b687db44ae7985b1d043f4a https://medicaldevicecourses.com/activity/p/6272/ Mon, 12 Feb 2018 01:30:31 -0500 I don’t think this situation will occur in any meaningful frequency. Most hospitals or physicians will only have FDA approved products on hand and those which do not are most likely not very reputable and will use any device they seem fit. As the previous post mentioned there are stipulations for extremely rare cases as well as for diseases or…[Read more]

]]> 0 ae4bbf3a503c5db9e500d66a95db4565 https://medicaldevicecourses.com/activity/p/6271/ Mon, 12 Feb 2018 01:24:09 -0500 In response to the questionable services provided by acupuncturists in addition to their regular service, I feel this is acceptable provided that their primary service is FDA approved and they are properly licensed. The extra income from their secondary services, provided these services are not harmful, help keep the business open and financially…[Read more]

]]> 0 8dda5041ac259520bcd45049f45f2a66 https://medicaldevicecourses.com/activity/p/6264/ Mon, 12 Feb 2018 00:22:34 -0500 I believe there is more scrutiny in the pharmaceutical industry simply because it is a much larger industry. This means many more companies with many more products for the FDA to regulate. Since Pharmaceuticals affect many more people and also involve products that may have far more subtle complications compared to an implant or other biomedical…[Read more]

]]> 0 054fa7b6eff072b0bb737d18162a4ef9 https://medicaldevicecourses.com/activity/p/5998/ Mon, 29 Jan 2018 04:06:17 -0500 I agree with aij5. The novel portion of this particular product is the sensor and reporting aspect, the drug is already an approved product. If the device portion is approved it has the potential to be used with other drugs. However, if the device somehow controlled the dosage administered to the patient then there would be more hurdles to cross…[Read more]

]]> 0 999ee562ca6ba88beb1be4cc8de5cc94 https://medicaldevicecourses.com/activity/p/5995/ Mon, 29 Jan 2018 03:56:04 -0500 Proper planing and deciding release schedules for different regions should be considered, but the major goal in developing a commercial product is to have it available in the primary market first and then expand into other regions. Having a simultaneous release of a product into every market would take too much time and resources. If an issue was…[Read more]

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