Medical Device Courses | rjs84 | Activity https://medicaldevicecourses.com/members/rjs84/activity/ Activity feed for rjs84. Fri, 24 Apr 2026 14:09:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 097098fb3dc31283f4527748f5191702 rjs84 replied to the topic "Optimizing Clinical Trials Using Technology" - https://medicaldevicecourses.com/activity/p/15925/ Wed, 15 May 2019 19:15:19 -0400 The medical field has seen great advancement in creating digital networks for patient information. I think a similar system can be put in place for project management. Many components of a project are now outsorced including clinical trials. Keeping digital…   Read more»

]]> 516c4cf29a64d566aac0f966d75112ec rjs84 replied to the topic "What is retention ?" - https://medicaldevicecourses.com/activity/p/15866/ Wed, 15 May 2019 19:14:45 -0400 In theory, there should be a direct correlation between talent of an employee and his or her performance. If this were the case, it would make sense to retain the most talented employees at all costs. In reality, the relationship…   Read more»

]]> 3ba6ef4c08719080523a4322505806eb rjs84 replied to the topic "Factors to look for while preparing schedule and budget for Clinical Trial" - https://medicaldevicecourses.com/activity/p/15865/ Wed, 15 May 2019 19:14:44 -0400 When preparing the budget for a clinical trial, it needs to be flexible. If the trial goes over-budget, the sponsor must cover the cost. Budget items can be categorized in one of two ways: 1) fixed and upfront costs which…   Read more»

]]> fc1e4a1f3d34ba24d44406d90083194b rjs84 replied to the topic "Deadlines and SOP's" - https://medicaldevicecourses.com/activity/p/15810/ Wed, 15 May 2019 19:14:06 -0400 Preventative management is ideal. In a sense, reactive management leads to more of the documentation and other factors that you mentioned can lead to delays in progress. Preventative management is the best way to keep to a time and cost…   Read more»

]]> befa51cd6cdad7ae743a5dca80f69b1f rjs84 replied to the topic "Discussion Topic: Risk Analysis methods" - https://medicaldevicecourses.com/activity/p/15808/ Wed, 15 May 2019 19:14:05 -0400 The Monte Carlo Simulation can be used to model uncertainty in inputs or any problem having a probabilistic interpretation. It can be used to create prices for assets based on an average of hundreds to thousands of hypothetical scenarios. Because…   Read more»

]]> e204e282965952255f1a8f7c4e222e2f rjs84 replied to the topic "QA vs QC" - https://medicaldevicecourses.com/activity/p/15783/ Wed, 15 May 2019 19:13:50 -0400 The easiest way to categorize these two is to say that quality assurance deals with verification while quality control deals with validation. QA looks to prevent quality problems through planned and systematic activities. Their main goal is to improve development…   Read more»

]]> 398ecca68a7e7bbbd90a3cfd002a3e4f rjs84 replied to the topic "Medical Devices" - https://medicaldevicecourses.com/activity/p/15436/ Wed, 15 May 2019 19:06:22 -0400 I think each situation has different repercussions. Failing of experiments is something that should be accounted for during planning. Excessive failure of experiments may show that the project is not as feasible as was thought and should be terminated. I…   Read more»

]]> 7f661021590406eebaa30dbf7e3104c9 rjs84 replied to the topic "Work Breakdown Structure" - https://medicaldevicecourses.com/activity/p/15355/ Wed, 15 May 2019 19:05:31 -0400 One experience that I had with this was in my undergraduate research. The research I was doing was in collaboration with another lab on campus. The other group with electrospin PLLA based fibers and then I they would send them…   Read more»

]]> b0a435058c8dd731338e42c81961d67d rjs84 replied to the topic "Communication and Responsiveness" - https://medicaldevicecourses.com/activity/p/15350/ Wed, 15 May 2019 19:05:28 -0400 This was something that was a very common issue when I took capstone. First of all our capstone group of 5 people had many individual commitments that made it very difficult to meet at the same time. One way that…   Read more»

]]> d25a10b8024d4795c47fc1500fddd1d4 rjs84 replied to the topic "Missing a Milestone Experience" - https://medicaldevicecourses.com/activity/p/15342/ Wed, 15 May 2019 19:05:24 -0400 Similar too many other people who responded, I also experienced some setbacks during my capstone project. The project was to design an adhesive that would be applied to a graft intended to block a cerebral spinal fluid leak. Our initial…   Read more»

]]> f65ffb3fcf296a23f3392d4f293c0f24 rjs84 replied to the topic "Project Scope: When the timeline you have doesn't work" - https://medicaldevicecourses.com/activity/p/15254/ Wed, 15 May 2019 19:04:28 -0400 I don’t think that a company can authorize any of the unethical examples you just suggested. If a new regulation was established, designing a placebo study to circumvent this regulation would not only be unethical but most likely illegal. The…   Read more»

]]> d4e66a5f830c38d471988deb1d57d8e1 rjs84 replied to the topic "Change in PM" - https://medicaldevicecourses.com/activity/p/15243/ Wed, 15 May 2019 19:04:22 -0400 This is a great question but I think it needs to be specified why the change in PM occurred. If it was due to that person leaving your company to take another job or personal reasons… etc. I believe the…   Read more»

]]> 76c2b0af00b8ead0bf705f7575f225b5 rjs84 replied to the topic "The best strategy in running Risk Management Meeting" - https://medicaldevicecourses.com/activity/p/15117/ Wed, 15 May 2019 19:03:11 -0400 As a project manager the first thing I would do is brainstorm with my team all of the possible project and product risks in the initial risk management meeting. For future meetings I think it would be important to balance…   Read more»

]]> 35c52e21de56c8d29fabcf0c1e5ba14c rjs84 replied to the topic "Risk Management" - https://medicaldevicecourses.com/activity/p/15106/ Wed, 15 May 2019 19:03:05 -0400 I believe your post actually involves two different questions. You originally talked about project risks but then asked for an example of a product risk. Product risks refer to potential defects within the product itself. This could be something like…   Read more»

]]> 0af0b6e7cda91f7cc3cddbf44f8b7603 rjs84 replied to the topic "Definition of Risk/Benefit Ratio ?" - https://medicaldevicecourses.com/activity/p/15077/ Wed, 15 May 2019 19:02:50 -0400 To me, risk/benefit ratio for a company mainly comes down to money. For any company that wants to create a high quality product, cutting corners should be kept to a minimum. However, there are certain specifications that can be made…   Read more»

]]> 3a28e9d8a2a905fab51e2bc743a54258 rjs84 replied to the topic "Safety Recalls" - https://medicaldevicecourses.com/activity/p/15003/ Wed, 15 May 2019 19:02:05 -0400 I would say that even if the product itself is okay, something such as missing information on a label can still force a recall. If, for example, a drug label is missing an ingredient and a patient taking that drug…   Read more»

]]> 0e93e485537921ab3b16464aafdc2330 rjs84 replied to the topic "Funding in Medical Devices Industry" - https://medicaldevicecourses.com/activity/p/14966/ Wed, 15 May 2019 19:01:47 -0400 The company should absolutely go for the project and here’s why: Grants are not solely limited to academic institutions and non-profit companies. A for-profit company also has the ability to apply for grants. Large, well established companies may not need…   Read more»

]]> e59526065475be457f8e1e418ed64081 rjs84 replied to the topic "Project management team" - https://medicaldevicecourses.com/activity/p/14891/ Wed, 15 May 2019 19:01:06 -0400 One of the biggest disadvantages to a project team is that the people within the team can cause a poor culture to form within the group. More importantly, as stated in the notes, projects run well after the team adjusts….   Read more»

]]> 0a9527d70c7b12627a4916c6ff56a917 rjs84 replied to the topic "Initiating a Project Idea" - https://medicaldevicecourses.com/activity/p/14878/ Wed, 15 May 2019 19:01:00 -0400 On top of evaluating market appeal for a certain product, I believe one of the most important parts of the project proposal is the implications it can have on regulations. Obviously the more complex the design, the more time and…   Read more»

]]> dcbd03240c83a61577825790af9d5ce5 rjs84 replied to the topic "Does Product Classification also depend on the Material of the Product used?" - https://medicaldevicecourses.com/activity/p/14840/ Wed, 15 May 2019 19:00:40 -0400 Changing the material of the product can definitely change how the project is classified. Even though the syringe designs may have the same design specifications causing one to say they are similar products, the difference in material really makes these…   Read more»

]]> 4d6a8356f602b2299c105de058ff9149 rjs84 replied to the topic "Determining project priority" - https://medicaldevicecourses.com/activity/p/14562/ Wed, 15 May 2019 18:58:02 -0400 I think the definition for a project and the experiences you have listed actually complement one another. What I mean by this is that in the beginning a project created with the criteria listed as having a defined beginning and…   Read more»

]]> ff2763f1f8086be257de34e49c88f8b9 rjs84 replied to the topic "Program Management" - https://medicaldevicecourses.com/activity/p/14556/ Wed, 15 May 2019 18:57:59 -0400 I think we can all agree that all those responsible for a project, ranging from the upper management all the way down to “lowest level” employee needs to be on the same page requiring transparency and harmonization as previously mentioned….   Read more»

]]> eba14ef17695ff19f3ed20f5dfecbf47 rjs84 posted a new topic "Executing Process" - https://medicaldevicecourses.com/activity/p/10685/ Wed, 15 May 2019 16:35:35 -0400 Part of the executing process involves information distribution, solicitation, source selection, and managing vendor relations. Most of the time and money of the project go into its execution. I would argue that the parts of the executing process I mentioned…   Read more»

]]> 67c1d121f034d93b0fd3b8426dd8b39e rjs84 posted a new topic "Flaw in the design process" - https://medicaldevicecourses.com/activity/p/10649/ Wed, 15 May 2019 16:35:16 -0400 After last week’s focuses on the phases of a project and design controls. This combined with FDA regulations lays out a very strict process for which a medical device is to be created. This week’s forum involved one post about…   Read more»

]]> 5c5697b1c1139b7656ef510f632f813b rjs84 posted a new topic "Interpersonal skills vs technical knowledge" - https://medicaldevicecourses.com/activity/p/10615/ Wed, 15 May 2019 16:34:59 -0400 According to Daniel Goleman, success can be broken down to be 70% interpersonal skills and 30% technical knowledge. The idea of this balance being in favor of interpersonal skills is not what I am questioning. A Forbes article titled “Intelligence…   Read more»

]]> 36424432b81ea9f1b33d3da1ade8e0b1 rjs84 replied to the topic Optimizing Clinical Trials Using Technology in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7472/ Mon, 23 Apr 2018 01:52:08 -0400 The medical field has seen great advancement in creating digital networks for patient information. I think a similar system can be put in place for project management. Many components of a project are now outsorced including clinical trials. Keeping digital documentation would be easier to transfer each part of the project from one source to…[Read more]

]]> 0 9d17489a080f73831d5804faf3d00997 rjs84 replied to the topic What is retention ? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7404/ Sat, 21 Apr 2018 18:20:19 -0400 In theory, there should be a direct correlation between talent of an employee and his or her performance. If this were the case, it would make sense to retain the most talented employees at all costs. In reality, the relationship between performance and talent involves other variables. Motivation is one such variable. A lack of motivation can…[Read more]

]]> 0 bccaaa98cac5e8d378e3cb823ee91bfa rjs84 replied to the topic Factors to look for while preparing schedule and budget for Clinical Trial in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/7403/ Sat, 21 Apr 2018 17:12:06 -0400 When preparing the budget for a clinical trial, it needs to be flexible. If the trial goes over-budget, the sponsor must cover the cost. Budget items can be categorized in one of two ways: 1) fixed and upfront costs which are needed for study conduct and are incurred whether or not a subject is enrolled and 2) costs related to subject visits.…[Read more]

]]> 0 b81ead07e603a0e304bd275ec480cfb9 rjs84 replied to the topic Deadlines and SOP's in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7336/ Mon, 16 Apr 2018 03:57:26 -0400 Preventative management is ideal. In a sense, reactive management leads to more of the documentation and other factors that you mentioned can lead to delays in progress. Preventative management is the best way to keep to a time and cost budget. However, it is possible to go through an entire project without needing any reactive management.…[Read more]

]]> 0 8a25543596226796822e9b568c5dcbea rjs84 replied to the topic Discussion Topic: Risk Analysis methods in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7334/ Mon, 16 Apr 2018 03:40:09 -0400 The Monte Carlo Simulation can be used to model uncertainty in inputs or any problem having a probabilistic interpretation. It can be used to create prices for assets based on an average of hundreds to thousands of hypothetical scenarios.

Because this analysis is ultimately a statistical test, many of its drawbacks come from the assumptions that…[Read more]

]]> 0 d7b538cb15d91e2af56378c2b894bfa7 rjs84 replied to the topic QA vs QC in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/7306/ Mon, 16 Apr 2018 00:55:03 -0400 The easiest way to categorize these two is to say that quality assurance deals with verification while quality control deals with validation. QA looks to prevent quality problems through planned and systematic activities. Their main goal is to improve development and test processes so that defects do not arise when the product is being…[Read more]

]]> 0 72cb9636b91597a579971ff068af2e28 rjs84 started the topic Executing Process in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6863/ Mon, 12 Mar 2018 03:25:02 -0400 Part of the executing process involves information distribution, solicitation, source selection, and managing vendor relations. Most of the time and money of the project go into its execution. I would argue that the parts of the executing process I mentioned at the start of this post are actually the most important parts of the project and…[Read more]

]]> 0 ad269a02c3550a0461539eb6c80fe9fc rjs84 replied to the topic Medical Devices in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6862/ Mon, 12 Mar 2018 02:57:12 -0400 I think each situation has different repercussions. Failing of experiments is something that should be accounted for during planning. Excessive failure of experiments may show that the project is not as feasible as was thought and should be terminated. I think the other situations listed are slightly less predictable. We saw a similar situation…[Read more]

]]> 0 9f7a58d01b7d148f0798d1dc6ae7dea5 rjs84 replied to the topic Work Breakdown Structure in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6768/ Mon, 05 Mar 2018 04:53:54 -0500 One experience that I had with this was in my undergraduate research. The research I was doing was in collaboration with another lab on campus. The other group with electrospin PLLA based fibers and then I they would send them to me to mechanically characterize them. Doing a collaboration between two groups like this comes with a number of…[Read more]

]]> 0 a02657e6f2e393f422569016d5ee72e0 rjs84 replied to the topic Communication and Responsiveness in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6763/ Mon, 05 Mar 2018 03:51:29 -0500 This was something that was a very common issue when I took capstone. First of all our capstone group of 5 people had many individual commitments that made it very difficult to meet at the same time. One way that we addressed this was to break up into even smaller groups that could all meet at the same time and would focus on specific parts of…[Read more]

]]> 0 51fe3c4fa5bad876f9af71178b092e1c rjs84 replied to the topic Missing a Milestone Experience in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6755/ Mon, 05 Mar 2018 03:12:28 -0500 Similar too many other people who responded, I also experienced some setbacks during my capstone project. The project was to design an adhesive that would be applied to a graft intended to block a cerebral spinal fluid leak. Our initial timeline involved having nearly 2 months to test our prototype. Unfortunately the materials we purchased took…[Read more]

]]> 0 456d5fa8c10bd423daa34c9f9a4b126e rjs84 replied to the topic Project Scope: When the timeline you have doesn't work in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6652/ Mon, 26 Feb 2018 04:47:25 -0500 I don’t think that a company can authorize any of the unethical examples you just suggested. If a new regulation was established, designing a placebo study to circumvent this regulation would not only be unethical but most likely illegal. The first option in this scenario would be to attempt to reevaluate the schedule and see if it is still p…[Read more]

]]> 0 e72201dd30993a4e7c2dfb6b8912da4a rjs84 replied to the topic Change in PM in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6641/ Mon, 26 Feb 2018 02:53:40 -0500 This is a great question but I think it needs to be specified why the change in PM occurred. If it was due to that person leaving your company to take another job or personal reasons… etc. I believe the new PM should more or less ensure tasks are completed in the manner they were originally prescribed. However, this person will also be…[Read more]

]]> 0 a795bb5dc3a6d35c5e871e8379b4b9c9 rjs84 replied to the topic The best strategy in running Risk Management Meeting in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6415/ Mon, 19 Feb 2018 03:56:48 -0500 As a project manager the first thing I would do is brainstorm with my team all of the possible project and product risks in the initial risk management meeting. For future meetings I think it would be important to balance both a macroscopic and microscopic view of related risks. The major risks involved always need to be considered but time…[Read more]

]]> 0 87f8101ea4f290c4fe9d81ca7e6bfac1 rjs84 replied to the topic Risk Management in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6404/ Mon, 19 Feb 2018 03:00:03 -0500 I believe your post actually involves two different questions. You originally talked about project risks but then asked for an example of a product risk. Product risks refer to potential defects within the product itself. This could be something like designing a software that will need to continue to be updated after the product is initially…[Read more]

]]> 0 b37c6e19108db004d1361bbb6e6c7eab rjs84 replied to the topic Definition of Risk/Benefit Ratio ? in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6373/ Sun, 18 Feb 2018 22:15:11 -0500 To me, risk/benefit ratio for a company mainly comes down to money. For any company that wants to create a high quality product, cutting corners should be kept to a minimum. However, there are certain specifications that can be made that will have the benefit of keeping costs down. One example would be designing a device that is only meant to…[Read more]

]]> 0 d1a755fe40df3e25e1f48425771afa17 rjs84 started the topic Flaw in the design process in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6299/ Mon, 12 Feb 2018 04:37:12 -0500 After last week’s focuses on the phases of a project and design controls. This combined with FDA regulations lays out a very strict process for which a medical device is to be created. This week’s forum involved one post about safety recalls and another post about inadequate device testing. As already discussed in these posts, medical device…[Read more]

]]> 0 902e6b718495f09af3baf097af7d6e47 rjs84 replied to the topic Safety Recalls in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6288/ Mon, 12 Feb 2018 03:16:10 -0500 I would say that even if the product itself is okay, something such as missing information on a label can still force a recall. If, for example, a drug label is missing an ingredient and a patient taking that drug has is allergic to said ingredient, this poses a series health issue. The example of the label falling off is much less extreme…[Read more]

]]> 0 cb43e6646585f16a46e9dbd41f39c2e4 rjs84 replied to the topic Funding in Medical Devices Industry in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6244/ Sun, 11 Feb 2018 19:32:46 -0500 The company should absolutely go for the project and here’s why: Grants are not solely limited to academic institutions and non-profit companies. A for-profit company also has the ability to apply for grants. Large, well established companies may not need to take this route of funding a project but this is perfect for small start-up companies.…[Read more]

]]> 0 a8ff53b3c1746f279b8a618820b07171 rjs84 replied to the topic Project management team in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6162/ Mon, 05 Feb 2018 04:02:34 -0500 One of the biggest disadvantages to a project team is that the people within the team can cause a poor culture to form within the group. More importantly, as stated in the notes, projects run well after the team adjusts. The better everyone within the group gets along, the quicker progress can be made on the project. This can be due to a…[Read more]

]]> 0 f6142c9fc9355b987184b0b15aca93e9 rjs84 replied to the topic Initiating a Project Idea in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6148/ Mon, 05 Feb 2018 01:52:59 -0500 On top of evaluating market appeal for a certain product, I believe one of the most important parts of the project proposal is the implications it can have on regulations. Obviously the more complex the design, the more time and money that are required to go into the project. But having an idea of what classification the device will receive is…[Read more]

]]> 0 d23d98d5a5a42e41a3318a511b49dab7 rjs84 replied to the topic Does Product Classification also depend on the Material of the Product used? in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/6112/ Sun, 04 Feb 2018 20:00:40 -0500 Changing the material of the product can definitely change how the project is classified. Even though the syringe designs may have the same design specifications causing one to say they are similar products, the difference in material really makes these two separate products. The different materials will react differently with whatever the…[Read more]

]]> 0 5885e100a73c7412768b6939de101484 rjs84 replied to the topic Thoughts and Questions Related to Untested Medicine in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/5958/ Mon, 29 Jan 2018 01:36:58 -0500 I believe that the FDA should regulate electroacupuncture. I think traditional acupuncture would be hard to regulate but with this new advancement I would argue that addition of electrodes can qualify this as a medical device. Comparing this to something like ultrasound therapy, the FDA is not involved with ensuring the qualification of the…[Read more]

]]> 0 062d75b6d9a87cf777f23c1d80ce7467 rjs84 started the topic Interpersonal skills vs technical knowledge in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/5701/ Sun, 21 Jan 2018 23:00:38 -0500 According to Daniel Goleman, success can be broken down to be 70% interpersonal skills and 30% technical knowledge. The idea of this balance being in favor of interpersonal skills is not what I am questioning. A Forbes article titled “Intelligence is Overrated: What You Really Need to Succeed” stated that this imbalance is actually 85% impersonal…[Read more]

]]> 0 24df8da04cb7a7d226cb40d80f710134 rjs84 replied to the topic Determining project priority in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/5686/ Sun, 21 Jan 2018 20:50:46 -0500 I think the definition for a project and the experiences you have listed actually complement one another. What I mean by this is that in the beginning a project created with the criteria listed as having a defined beginning and end along with other related goals. Having a project placed on hold does not interfere with this definition. What was…[Read more]

]]> 0