https://medicaldevicecourses.com/members/rabotros/activity/ Activity feed for rab38. Fri, 24 Apr 2026 20:02:28 -0400 https://buddypress.org/?v= en-US 30 hourly 2 5c27dd5cb1e17428a14ffe328f33977e https://medicaldevicecourses.com/activity/p/12574/ Wed, 15 May 2019 16:57:15 -0400 I believe that I would like to follow a similar path as some of our classmates. I would like to be an engineer during the first stages of my career to get a hands on understanding of the duties and…   Read more»

]]> 3cbdc4e27504a763b470abbcaceb183d https://medicaldevicecourses.com/activity/p/12573/ Wed, 15 May 2019 16:57:15 -0400 I have seen similar situations in my experience. Often times the fear of termination and disagreeing with the higher ups forces employees to keep quiet. This is an issue that is continuing to increase and can cause a great deal…   Read more»

]]> 53acda159ee4ded69261ca4e446444c2 https://medicaldevicecourses.com/activity/p/12571/ Wed, 15 May 2019 16:57:14 -0400 That is a great question Talha! I believe our classmates shared some great reasons for why this might be. In addition to the aforementioned reasons including feeling stagnant, no longer receiving praise or finding new and exciting projects, there seems…   Read more»

]]> 5b86cf04f766d1bc1fcf73f01ed59cc6 https://medicaldevicecourses.com/activity/p/12439/ Wed, 15 May 2019 16:56:02 -0400 I have been in a similar situations Roberto. One one of my projects as an intern I was assigned to a team of 5 with 3 engineers and 1 other intern. Due to the urgency of another project the second…   Read more»

]]> cd9ab3901b080c2ff4df0f1ff0cce33e https://medicaldevicecourses.com/activity/p/12437/ Wed, 15 May 2019 16:56:00 -0400 I feel that often times projects, or at the very least what we learn from them can carry over. I was an intern at a biomedical manufacturer that produced intra-aortic balloons for counter-pulsation therapy. In my training I learned a…   Read more»

]]> 6b319324b68c378d898791af3830dd8f https://medicaldevicecourses.com/activity/p/12436/ Wed, 15 May 2019 16:55:59 -0400 You bring up a great point Talha. Depending on the product or service you are procuring a certain standard must be met by the vendor. For a critical component, one that will be part of the implanted device, the supplier…   Read more»

]]> 31bffee43030326f1efeae838f4b5b8b https://medicaldevicecourses.com/activity/p/12317/ Wed, 15 May 2019 16:54:49 -0400 My experience has been similar. It seems that a great deal of the process is rushed and results in having to repeat steps. I believe if these processes were completed adequately, it would save a great deal of time and…   Read more»

]]> 0132fd69b0647bf9d45a7d66b77af3fc https://medicaldevicecourses.com/activity/p/12316/ Wed, 15 May 2019 16:54:48 -0400 That is a great example jvv6. I have also come across many situations in which a risk was avoidable and minor changes to design or process were able to resolve the issue. However, there are also many situations in which…   Read more»

]]> 8c10bf2c8c9eab4717a695ed4e49b1ab https://medicaldevicecourses.com/activity/p/12315/ Wed, 15 May 2019 16:54:47 -0400 Like a few of our classmates mentioned, design reviews are typically more relaxed. I had the opportunity to sit in on a few design reviews during my time as an intern. In most cases the suggested changes had already been…   Read more»

]]> 4dbe73273da82ce1410bf65883cfc3c7 https://medicaldevicecourses.com/activity/p/12175/ Wed, 15 May 2019 16:53:30 -0400 Any necessary change to the design or documentation must go through COs. The purpose of ECOs and any change orders is to properly document the proposed changes for traceability purposes. These COs are then reviewed and sent to the various…   Read more»

]]> 0e828de0e325251df383acb0ff935e7f https://medicaldevicecourses.com/activity/p/12122/ Wed, 15 May 2019 16:52:58 -0400 I agree gingeranderson. Though suppliers are on the PMs mind from early on, these should be given serious consideration during the execution phase when the necessary items are finalized. This helps to reduce iteration and the need to qualify suppliers…   Read more»

]]> 76062d01c99ff67862f4d45ac7aa586d https://medicaldevicecourses.com/activity/p/12121/ Wed, 15 May 2019 16:52:58 -0400 I agree with your approach tn58. Having a personal relationship with members of the team is extremely important. This will better allow for comfortable communication in which members will be more honest when requesting time off. This will also make…   Read more»

]]> 27affdef681edeaaef463585e8efd52e https://medicaldevicecourses.com/activity/p/12120/ Wed, 15 May 2019 16:52:57 -0400 PMs face a great deal of challenges in a project. One of the most occurring and difficult to deal with in my opinion is employee conflict. When team members are not willing to perform their duties due to internal conflict…   Read more»

]]> 2739e1fd0b5790acb48a1fec970a6b64 https://medicaldevicecourses.com/activity/p/12043/ Wed, 15 May 2019 16:52:18 -0400 Though no one likes to miss milestones, as many of our classmates mentioned, I agree with your statement. Milestones do serve as checkpoints to ensure the project is on track. In my senior design class where we are currently working…   Read more»

]]> b4d66a2c09a71dbba1d571162cfa8c47 https://medicaldevicecourses.com/activity/p/12042/ Wed, 15 May 2019 16:52:17 -0400 You make a great point jp582. Since often situations, simulation and real life, are time sensitive it is of utmost importance that the team is entirely caught up and act as soon as possible. This ensures that there will be…   Read more»

]]> 94d25bc77ba682f8e01188416d7c4204 https://medicaldevicecourses.com/activity/p/12041/ Wed, 15 May 2019 16:52:17 -0400 I could not agree more. I had started interning in industry before taking any of Dr. Simon’s classes. I entered not knowing anything about the FDA, GDP or the design control process. Through my experience I learned what I could…   Read more»

]]> 4c65b99d3b4d315e625353d446729fea https://medicaldevicecourses.com/activity/p/11984/ Wed, 15 May 2019 16:51:41 -0400 In my senior design course we created a Gantt chart early on and estimated all of the required steps in the critical path. One of which was the procurement of the prototype components. This was a major milestone as it…   Read more»

]]> e90c02c7d5a76d661bc1fdd9d5264534 https://medicaldevicecourses.com/activity/p/11983/ Wed, 15 May 2019 16:51:41 -0400 You make a good point tn58. This will certainly affect the overall project and may require reallocation of time in the preliminary steps of the project schedule. Not only R&D, but other phases such as testing and verification will need…   Read more»

]]> 62d527e4946bc719f404f23d6c5eb083 https://medicaldevicecourses.com/activity/p/11980/ Wed, 15 May 2019 16:51:39 -0400 More often than not, certain tasks will take longer than estimated and push the project back. This is sometimes unavoidable as there may be many possible bottle necks and obstacles. These can include external suppliers and internal processes or approvals….   Read more»

]]> 59d61f31a562af23bbd767483824d355 https://medicaldevicecourses.com/activity/p/11905/ Wed, 15 May 2019 16:50:54 -0400 A budget cut certainly has an effect on cost estimation. I believe generally most projects hope to come under budget or plan ahead to have some wiggle room as more often than not, projects are more costly than expected. A…   Read more»

]]> 087341c68fb65ea97b1e3b66592b4f3f https://medicaldevicecourses.com/activity/p/11902/ Wed, 15 May 2019 16:50:53 -0400 Shachi, you bring up a good point. However, though it may delay other processes it is essential to, at the very least, carry on project development with verification in mind. Even though the official verification step comes later during the…   Read more»

]]> 938b234a852c29cce32799bd01e309a0 https://medicaldevicecourses.com/activity/p/11882/ Wed, 15 May 2019 16:50:41 -0400 I am also working on a capstone project where seemingly minor details have manifested into critical issues that impede the progress of the overall project. This is certainly something that has to be accounted for. One of these issues is…   Read more»

]]> 1ba21b75afa6ab4c6216936f8b723f1d https://medicaldevicecourses.com/activity/p/11822/ Wed, 15 May 2019 16:50:04 -0400 The validation and verification steps are extremely important and encompass the overall design control process. Verification ensures that the design outputs adhere to the requirements given in the design input and is constantly conducted until they do. Validation comes at…   Read more»

]]> 752373968b5431e79f59e980620b6cad https://medicaldevicecourses.com/activity/p/11821/ Wed, 15 May 2019 16:50:04 -0400 You make a great point Shachi. A team with cross filed knowledge would definitely be advantageous. Often times ideas come from those with different perspectives. In companies where there is little variety, projects may not come to effective solutions. Temporary…   Read more»

]]> 88a914781215a8d80f5b5f74fffe6a13 https://medicaldevicecourses.com/activity/p/11817/ Wed, 15 May 2019 16:50:01 -0400 Though there is usually more face to face communication in industry, a great deal gets done via email, phone calls or web chats. This is an essential part as projects can include individuals at other sites or suppliers. Not to…   Read more»

]]> 4fcffcee7eb25939f76ff32488b326f5 https://medicaldevicecourses.com/activity/p/2508/ Sun, 30 Apr 2017 01:25:31 -0400 I believe that I would like to follow a similar path as some of our classmates. I would like to be an engineer during the first stages of my career to get a hands on understanding of the duties and responsibilities. Later I would like to move into management, but still have a heavy involvement in the engineering field. This is because managers…[Read more]

]]> 0 857a3124f45f4f1c2b3ce2919d641046 https://medicaldevicecourses.com/activity/p/2507/ Sun, 30 Apr 2017 01:21:37 -0400 I have seen similar situations in my experience. Often times the fear of termination and disagreeing with the higher ups forces employees to keep quiet. This is an issue that is continuing to increase and can cause a great deal of issues down the line for employee moral as well as the company’s throughput. An unreported issue may lead to great…[Read more]

]]> 0 54b7faf4d85685e140ef9acd04b40412 https://medicaldevicecourses.com/activity/p/2505/ Sun, 30 Apr 2017 01:11:09 -0400 That is a great question Talha! I believe our classmates shared some great reasons for why this might be. In addition to the aforementioned reasons including feeling stagnant, no longer receiving praise or finding new and exciting projects, there seems to be another major reason. That is growth. Growth in position, title, status, responsibilities…[Read more]

]]> 0 e0ae80d3e370373ff5f996a6a186e205 https://medicaldevicecourses.com/activity/p/2308/ Mon, 17 Apr 2017 03:33:25 -0400 I have been in a similar situations Roberto. One one of my projects as an intern I was assigned to a team of 5 with 3 engineers and 1 other intern. Due to the urgency of another project the second intern was pulled from my project team, leaving a great deal of additional responsibility on each of the members. This was of course difficult, but the…[Read more]

]]> 0 f2146aaadd48f55ea8abcc0e37ba7b36 https://medicaldevicecourses.com/activity/p/2306/ Mon, 17 Apr 2017 03:26:56 -0400 I feel that often times projects, or at the very least what we learn from them can carry over. I was an intern at a biomedical manufacturer that produced intra-aortic balloons for counter-pulsation therapy. In my training I learned a great deal about the device and was able to carry my knowledge over to a course where we modeled physiological…[Read more]

]]> 0 94df3344b73585154e297043390028fc https://medicaldevicecourses.com/activity/p/2305/ Mon, 17 Apr 2017 03:20:23 -0400 You bring up a great point Talha. Depending on the product or service you are procuring a certain standard must be met by the vendor. For a critical component, one that will be part of the implanted device, the supplier must meet industry and OEM quality guidelines in order to be purchased. However, there may be a plethora of items that are low…[Read more]

]]> 0 bcb527481eb8fc8aa17ebc5df06bed84 https://medicaldevicecourses.com/activity/p/2167/ Sun, 09 Apr 2017 19:01:09 -0400 My experience has been similar. It seems that a great deal of the process is rushed and results in having to repeat steps. I believe if these processes were completed adequately, it would save a great deal of time and changes. However, because of changing requirements this is difficult to do right on the first iteration. Establishing better input/…[Read more]

]]> 0 1adaf72de67e9589a106963a34fcd8d2 https://medicaldevicecourses.com/activity/p/2166/ Sun, 09 Apr 2017 18:30:35 -0400 That is a great example jvv6. I have also come across many situations in which a risk was avoidable and minor changes to design or process were able to resolve the issue. However, there are also many situations in which this is not a feasible option. In which the level of risk needs to be lowered to an acceptable level.

]]> 0 a86d12f9618bf87ce8ae64bdb2b4a2e7 https://medicaldevicecourses.com/activity/p/2165/ Sun, 09 Apr 2017 18:11:49 -0400 Like a few of our classmates mentioned, design reviews are typically more relaxed. I had the opportunity to sit in on a few design reviews during my time as an intern. In most cases the suggested changes had already been given to the managers beforehand and the requested changes made. This is not to say that there were no additional changes, but…[Read more]

]]> 0 7f232ab9f18d7dab334272ebfdcd6518 https://medicaldevicecourses.com/activity/p/1972/ Sat, 25 Mar 2017 18:51:16 -0400 Any necessary change to the design or documentation must go through COs. The purpose of ECOs and any change orders is to properly document the proposed changes for traceability purposes. These COs are then reviewed and sent to the various departments for approval. These changes may undergo amendments based on the input of other departments if…[Read more]

]]> 0 abd8fe99531579527e42a1facc34b4de https://medicaldevicecourses.com/activity/p/1905/ Sun, 12 Mar 2017 17:16:05 -0400 I agree gingeranderson. Though suppliers are on the PMs mind from early on, these should be given serious consideration during the execution phase when the necessary items are finalized. This helps to reduce iteration and the need to qualify suppliers unnecessarily. I believe the purpose of putting this so late in the execution phase is to avoid…[Read more]

]]> 0 197021c944369f56022978ec77201363 https://medicaldevicecourses.com/activity/p/1904/ Sun, 12 Mar 2017 16:31:01 -0400 I agree with your approach tn58. Having a personal relationship with members of the team is extremely important. This will better allow for comfortable communication in which members will be more honest when requesting time off. This will also make assessing and resolving any issues the members have more easily possible if there is mutual respect…[Read more]

]]> 0 32dd0b8561b8d97d2b0cb5c8ed06d46a https://medicaldevicecourses.com/activity/p/1903/ Sun, 12 Mar 2017 15:28:40 -0400 PMs face a great deal of challenges in a project. One of the most occurring and difficult to deal with in my opinion is employee conflict. When team members are not willing to perform their duties due to internal conflict among themselves it leads to project delays and many other issues. This is also often a question asked in interviews to…[Read more]

]]> 0 1394f504e137d2ced1cc4e142a6179fe https://medicaldevicecourses.com/activity/p/1807/ Sun, 05 Mar 2017 02:44:29 -0500 Though no one likes to miss milestones, as many of our classmates mentioned, I agree with your statement. Milestones do serve as checkpoints to ensure the project is on track. In my senior design class where we are currently working on a year long development we encounter many issues that may delay or even cause us to miss milestones and this…[Read more]

]]> 0 901904c9c27ee59769344ac4c825cab9 https://medicaldevicecourses.com/activity/p/1806/ Sun, 05 Mar 2017 02:35:16 -0500 You make a great point jp582. Since often situations, simulation and real life, are time sensitive it is of utmost importance that the team is entirely caught up and act as soon as possible. This ensures that there will be time to offer various proposals in the case the initial does not succeed. It is also important that all members contribute in…[Read more]

]]> 0 f92ec4dbbaefcaa9baa0a965a7a209b7 https://medicaldevicecourses.com/activity/p/1805/ Sun, 05 Mar 2017 02:27:05 -0500 I could not agree more. I had started interning in industry before taking any of Dr. Simon’s classes. I entered not knowing anything about the FDA, GDP or the design control process. Through my experience I learned what I could from the limited facet that I had interacted with. In taking Dr. Simon’s Medical Device Development course I was much…[Read more]

]]> 0 9ac2bb0d8383f22e484804dae75f5e2d https://medicaldevicecourses.com/activity/p/1730/ Mon, 27 Feb 2017 03:24:51 -0500 In my senior design course we created a Gantt chart early on and estimated all of the required steps in the critical path. One of which was the procurement of the prototype components. This was a major milestone as it would allow the construction of the prototype. However, due to ordering small quantities of components, components were often…[Read more]

]]> 0 c5865ce6751b99896f3a22f681f1f168 https://medicaldevicecourses.com/activity/p/1729/ Mon, 27 Feb 2017 03:18:52 -0500 You make a good point tn58. This will certainly affect the overall project and may require reallocation of time in the preliminary steps of the project schedule. Not only R&D, but other phases such as testing and verification will need to be altered. This could create a significant delay, but the reconsideration of what criteria the device has to…[Read more]

]]> 0 3882a76762c8bd9cfcc2316e0e58d7c9 https://medicaldevicecourses.com/activity/p/1726/ Mon, 27 Feb 2017 03:10:25 -0500 More often than not, certain tasks will take longer than estimated and push the project back. This is sometimes unavoidable as there may be many possible bottle necks and obstacles. These can include external suppliers and internal processes or approvals. This can be combated by building in extra time to the project schedule in these cases. And if…[Read more]

]]> 0 e612f1107e3b0446411ddacdaf3364bd https://medicaldevicecourses.com/activity/p/1628/ Mon, 20 Feb 2017 04:30:54 -0500 A budget cut certainly has an effect on cost estimation. I believe generally most projects hope to come under budget or plan ahead to have some wiggle room as more often than not, projects are more costly than expected. A budget cut is an additional hurdle that may have grave consequences on the project. This could mean as much as its shut down.…[Read more]

]]> 0 747afeabd540151bbb15155af2d4e53b https://medicaldevicecourses.com/activity/p/1625/ Mon, 20 Feb 2017 04:19:59 -0500 Shachi, you bring up a good point. However, though it may delay other processes it is essential to, at the very least, carry on project development with verification in mind. Even though the official verification step comes later during the execution phase, unofficial verification tests should be carried out i order to ensure the appropriate…[Read more]

]]> 0 8fca30031d03850b6ea12eaa0e6b0b42 https://medicaldevicecourses.com/activity/p/1600/ Mon, 20 Feb 2017 01:14:38 -0500 I am also working on a capstone project where seemingly minor details have manifested into critical issues that impede the progress of the overall project. This is certainly something that has to be accounted for. One of these issues is contacting suppliers. We received the wrong part for one of our pinch valves and could not finish our…[Read more]

]]> 0 b2248dda143102009cbd6fd38ece17bc https://medicaldevicecourses.com/activity/p/1527/ Mon, 13 Feb 2017 03:00:09 -0500 The validation and verification steps are extremely important and encompass the overall design control process. Verification ensures that the design outputs adhere to the requirements given in the design input and is constantly conducted until they do. Validation comes at the end of the process when the device or prototype is produced to ensure…[Read more]

]]> 0 e69e2b55693538eb991b168e98c71b12 https://medicaldevicecourses.com/activity/p/1526/ Mon, 13 Feb 2017 02:52:13 -0500 You make a great point Shachi. A team with cross filed knowledge would definitely be advantageous. Often times ideas come from those with different perspectives. In companies where there is little variety, projects may not come to effective solutions. Temporary solutions are often arrived at, but constantly need adjustment. A diverse team can…[Read more]

]]> 0 ba87ec64915dd59059b6d4f22faf5a31 https://medicaldevicecourses.com/activity/p/1522/ Mon, 13 Feb 2017 02:26:58 -0500 Though there is usually more face to face communication in industry, a great deal gets done via email, phone calls or web chats. This is an essential part as projects can include individuals at other sites or suppliers. Not to mention international projects as some of our classmates have mentioned. Research is conducted similarly as in the…[Read more]

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