https://medicaldevicecourses.com/members/ashleyfitzsimmons/activity/ Activity feed for ashleyfitzsimmons. Fri, 24 Apr 2026 18:53:59 -0400 https://buddypress.org/?v= en-US 30 hourly 2 a4cdc28514a191c8d212b66c19dd6c6a https://medicaldevicecourses.com/activity/p/15901/ Wed, 15 May 2019 19:15:06 -0400 For me, goals are what keep me motivated. When what I am doing aligns with my short term and long term goals, it makes me passionate about the work I do because it is helping me get to the places…   Read more»

]]> 5faaf2e2cd5b38584ece5433d0f97c5d https://medicaldevicecourses.com/activity/p/15900/ Wed, 15 May 2019 19:15:05 -0400 I think that an interesting thing to add to this thread is that while many people put in extra hours to increase productivity, research shows that it can actually make you less productive. There are a lot of different studies…   Read more»

]]> 0eafe87af3d42b8c30159f9151935c13 https://medicaldevicecourses.com/activity/p/15899/ Wed, 15 May 2019 19:15:05 -0400 Every project and team is unique. For example, certain projects may be straight forward and predictable while other projects are more complex and risky. These two different types of projects would have to be managed differently because of this. Likewise,…   Read more»

]]> 244b95d34f7a17bf26ff906e79ec620e https://medicaldevicecourses.com/activity/p/15767/ Wed, 15 May 2019 19:13:41 -0400 While an outline of a communication management plan documented as a SOP can be beneficial to keeping the entire company on the same page, I think it is also important to give the project manager leeway. The project manager should…   Read more»

]]> e66c65071fd759e29ff2e70bfc2c3d87 https://medicaldevicecourses.com/activity/p/15766/ Wed, 15 May 2019 19:13:41 -0400 A WBS should be a break down of every project task and deliverable defined by the project scope. If the WBS is poorly constructed the following can occur: missed deadlines, going over budget, scope creep, confused project team members, project…   Read more»

]]> bdcac40840333dbbfeefc79600898073 https://medicaldevicecourses.com/activity/p/15764/ Wed, 15 May 2019 19:13:40 -0400 I think another thing that is important to address in a supplier contract is to clearly define responsibilities. For example, if something goes wrong with the product, is it the company or supplier’s fault? According to the FDA, the device…   Read more»

]]> 495a8293be0e041d7173b9e6655fff83 https://medicaldevicecourses.com/activity/p/15655/ Wed, 15 May 2019 19:12:32 -0400 I think it is important to have some buffers in the schedule to account for any unexpected delays for any reason. The time frame and budget is set when a project is approved. It is better to overestimate the time…   Read more»

]]> ab78249d5bde8e2ede398d171bcb8e0d https://medicaldevicecourses.com/activity/p/15556/ Wed, 15 May 2019 19:07:37 -0400 One important component of closing is creating a project closure report. This project closure report lists every activity that is required in order to close the project. This report enables the project manager and the team to make sure they…   Read more»

]]> eb4c33beb4118460347bc2e03f9a1d34 https://medicaldevicecourses.com/activity/p/15555/ Wed, 15 May 2019 19:07:36 -0400 This semester I am in part 2 of my capstone project. We have all of our protocols written to begin construction and testing but we are missing one key component of the device. The materials got delivered about a month…   Read more»

]]> 584225b3091b9083e80986c2b01b853a https://medicaldevicecourses.com/activity/p/15530/ Wed, 15 May 2019 19:07:19 -0400 I think one of the main issues lies in increased customer demands. When the design team first hands off the project to the manufacturing team, a certain plan is made based on the expected demand. Once the product becomes more…   Read more»

]]> 6fe173dfae1fc2e63a118903b8652080 https://medicaldevicecourses.com/activity/p/15346/ Wed, 15 May 2019 19:05:26 -0400 I agree with everything that is said above. In addition, I think there should be a re-evaluation step which happens once the project has started to make sure that the way everything was planned is working out and that nothing…   Read more»

]]> c2dcfb69d9457ace36cf344574449e0d https://medicaldevicecourses.com/activity/p/15343/ Wed, 15 May 2019 19:05:25 -0400 If a problem in the planning is identified mid-scope it should be reassessed with the entire team present, taking into account resources and timing. Pushing forward with flaws in the scope can cause bigger issues down the line. Using a…   Read more»

]]> cde480c3505c88fce557a2c7883aaf9d https://medicaldevicecourses.com/activity/p/15340/ Wed, 15 May 2019 19:05:23 -0400 While I think all of the above are important, I think it is important to assess the situation. While a team member that is not good at communicating and keeping other team members up to date can certainly make a…   Read more»

]]> 7747dff679296c0086f3e61ab2adc61c https://medicaldevicecourses.com/activity/p/15174/ Wed, 15 May 2019 19:03:42 -0400 I am currently working on a capstone project. We won a $3000 URI grant to design and fabricate our device. This grant must be used only for this project. As a result, we based our entire budget around this $3000,…   Read more»

]]> 068bd827324827785d6a473640f4b35b https://medicaldevicecourses.com/activity/p/15172/ Wed, 15 May 2019 19:03:41 -0400 In my experience, at design review meetings, everyone attending the meeting reads the document beforehand. The meeting starts by everyone saying their initials one by one and how long it took them to review the document. The people who wrote…   Read more»

]]> 3b4822a269c2224b89efea8455c11fde https://medicaldevicecourses.com/activity/p/15171/ Wed, 15 May 2019 19:03:40 -0400 I think that it is certainly sometimes crucial to go back to the planning phase in order to ensure the success of a project. Regardless of how well a project is planned out, sometimes obstacles and setbacks are unforeseeable. However,…   Read more»

]]> 78d18112c88c40a1c66b13b84cfaabee https://medicaldevicecourses.com/activity/p/15115/ Wed, 15 May 2019 19:03:10 -0400 While it is important to manage risk, it is also important to encourage creativity and risk taking within a company. Risks are what lead to breakthroughs and great medical products that can advance the company. If everything is over prioritized…   Read more»

]]> 4edad3e703db61e29d4acaea13d232d4 https://medicaldevicecourses.com/activity/p/15112/ Wed, 15 May 2019 19:03:08 -0400 In addition to what ak977 said, the main mission of medical device companies is to improve healthcare. Cutting corners just to increase profit or prevent the company from losing money is unethical and could result in people having issues with…   Read more»

]]> 7b57712b04e9c6edc27552c5b56ac2f6 https://medicaldevicecourses.com/activity/p/15109/ Wed, 15 May 2019 19:03:07 -0400 I think an important thing to add to this discussion is how to adjust things when out of scope – whether it be due to budget or time. An example is in capstone, whenever something takes more time than our…   Read more»

]]> 80e23b8ab5a43314c8312c589b00e183 https://medicaldevicecourses.com/activity/p/14989/ Wed, 15 May 2019 19:01:59 -0400 I think that an additional topic to add to this discussion is while large corporations experience this issue with class II and class III devices, sometimes going the less creative or risky route with their devices to get it approved…   Read more»

]]> 2610d93459aff519da8e7e0455f61d88 https://medicaldevicecourses.com/activity/p/14981/ Wed, 15 May 2019 19:01:55 -0400 Online reviews of this book explain how Lenzer compares and contrasts pharmaceuticals with medical devices. Lenzer makes the claim that pharmaceuticals go through more testing than medical devices. Does anyone have an opinion on this statement from their experience? Also,…   Read more»

]]> b207b4cea0f2496c9ff866dd20b39974 https://medicaldevicecourses.com/activity/p/14977/ Wed, 15 May 2019 19:01:53 -0400 From reviews online, it says Lenzer has written about several devices that have been proven problematic. Investigative journalism can sometimes bring notice to problems that may be overlooked. For example, Lenzer makes a point, “So the FDA has a database…   Read more»

]]> a43e0003868ac4c877ef739b3972a8a6 https://medicaldevicecourses.com/activity/p/14856/ Wed, 15 May 2019 19:00:49 -0400 Through getting my bachelors degree at NJIT, I felt that my interpersonal skills have improved tremendously. Different experiences that improved my interpersonal skills included getting involved with clubs and organizations, being an the executive board of clubs and organizations, learning…   Read more»

]]> 67f84297c7138974a77a72b35a5daed4 https://medicaldevicecourses.com/activity/p/14852/ Wed, 15 May 2019 19:00:47 -0400 Of course emotional intelligence combined with technical knowledge are important qualities in a project manager, as well as all of the qualities people mentioned above. To me, one of the greatest skills in a project manager are the ability to…   Read more»

]]> f67284c5ac9fe3194eebb44e29f534cf https://medicaldevicecourses.com/activity/p/14836/ Wed, 15 May 2019 19:00:38 -0400 Verification and validation are one of a project’s largest costs. Rework is the only cost larger than verification and validation in a project. If it is not adequately planned, not only will the schedule have to be extended but the…   Read more»

]]> 1911cf5357128957ed4c7088dd74424a https://medicaldevicecourses.com/activity/p/14712/ Wed, 15 May 2019 18:59:24 -0400 I think that all of this definitely should, and hopefully is, going through medical device reporting to the FDA. In my opinion, spending money and time to re-test this device is not the responsibility of the company. I think a…   Read more»

]]> 682e79f8e2ddd099afa97677e609659a https://medicaldevicecourses.com/activity/p/14709/ Wed, 15 May 2019 18:59:23 -0400 In correction to my last post, fitbit does not currently monitor blood pressure. However, what I wrote about applies to the physiological factors it does monitor such as heart beat. On the other hand, there are a lot of different…   Read more»

]]> 30003b8c1f97b6688fa247d7bf75fe07 https://medicaldevicecourses.com/activity/p/14707/ Wed, 15 May 2019 18:59:22 -0400 In response to AnmolKaur, MDR is very important. If a medical device is resulting in deaths or injuries, it needs to be investigated and potentially taken off the market. After pre-clinical and clinical testing, even if a device is proven…   Read more»

]]> 6ff3b7dc848af24398d82dedd0a5607f https://medicaldevicecourses.com/activity/p/14705/ Wed, 15 May 2019 18:59:21 -0400 Class 1 devices are intended for devices that require general controls by the FDA. At home blood pressure monitors are considered a class 1 device. Although they are not intended to diagnose, people rely on these monitors to make sure…   Read more»

]]> 4dd4823a9665fce668daeca8d89e06d3 https://medicaldevicecourses.com/activity/p/14573/ Wed, 15 May 2019 18:58:08 -0400 As stated in Dr. Simon’s lecture, leadership is 30% academic and intelligence based and 70% interpersonal skills based. While I do not have experience in industry, I spent this entire past fall interviewing with medical device and pharmaceutical companies. I…   Read more»

]]> 0f15d5ff00753eaa1767d61382c14fad https://medicaldevicecourses.com/activity/p/14570/ Wed, 15 May 2019 18:58:07 -0400 In response to my last post, I found sponsor responsibilities after the significant risk (SR) versus non-significant risk (NSR) determination. If the IRB decides a study is SR, the sponsor must: Submit IDE to FDA Not begin the study until…   Read more»

]]> 8e123aafe20455d8508e1674d2f41bbc https://medicaldevicecourses.com/activity/p/14567/ Wed, 15 May 2019 18:58:05 -0400 I think to add to the discussion of significant risk (SR) versus non-significant risk (NSR) it is useful to read about the considerations that the FDA suggests to the IRB for SR and NSR determination. I got the below information…   Read more»

]]> 4295f43e4139daf5da1583ade5b436d4 https://medicaldevicecourses.com/activity/p/7445/ Sun, 22 Apr 2018 21:48:09 -0400 For me, goals are what keep me motivated. When what I am doing aligns with my short term and long term goals, it makes me passionate about the work I do because it is helping me get to the places I want to be. Throughout college, I had times when I was volunteering and working multiple jobs at once while participating in clubs while taking about…[Read more]

]]> 0 6a88b55414feaeca71725febaa67d7e9 https://medicaldevicecourses.com/activity/p/7444/ Sun, 22 Apr 2018 21:42:08 -0400 I think that an interesting thing to add to this thread is that while many people put in extra hours to increase productivity, research shows that it can actually make you less productive. There are a lot of different studies and sources that discuss this. I attached the link of one for an example. According to the article attached, research at…[Read more]

]]> 0 481aaf3623d403c05db3d74afcedd77a https://medicaldevicecourses.com/activity/p/7443/ Sun, 22 Apr 2018 21:20:23 -0400 Every project and team is unique. For example, certain projects may be straight forward and predictable while other projects are more complex and risky. These two different types of projects would have to be managed differently because of this. Likewise, different sized companies have different types of projects and different risk levels and…[Read more]

]]> 0 a61a9ba86ab8676bb968041b29b6d90b https://medicaldevicecourses.com/activity/p/7288/ Sun, 15 Apr 2018 20:27:40 -0400 While an outline of a communication management plan documented as a SOP can be beneficial to keeping the entire company on the same page, I think it is also important to give the project manager leeway. The project manager should know their team best and understand the best ways of communication and frequencies of communication that makes the team…[Read more]

]]> 0 5590b80d0850feba5d83455755c891cd https://medicaldevicecourses.com/activity/p/7287/ Sun, 15 Apr 2018 20:19:34 -0400 A WBS should be a break down of every project task and deliverable defined by the project scope. If the WBS is poorly constructed the following can occur: missed deadlines, going over budget, scope creep, confused project team members, project replanning and extensions. A WBS is a way to visualize and organize the scope of a whole project. If this…[Read more]

]]> 0 6255b04b1c8bbc7115636f4b2dd7373e https://medicaldevicecourses.com/activity/p/7285/ Sun, 15 Apr 2018 20:06:35 -0400 I think another thing that is important to address in a supplier contract is to clearly define responsibilities. For example, if something goes wrong with the product, is it the company or supplier’s fault? According to the FDA, the device company is responsible for every component, even if those components are from other suppliers. However, I…[Read more]

]]> 0 b842c553d82e070c3f926397c63643d2 https://medicaldevicecourses.com/activity/p/7137/ Mon, 02 Apr 2018 17:28:51 -0400 I think it is important to have some buffers in the schedule to account for any unexpected delays for any reason. The time frame and budget is set when a project is approved. It is better to overestimate the time and money needed for the project when getting approved. If the time and money is underestimated, the company may not have the resources…[Read more]

]]> 0 031396bfd58b84991313fc2b2dc829dc https://medicaldevicecourses.com/activity/p/7008/ Mon, 26 Mar 2018 02:28:37 -0400 One important component of closing is creating a project closure report. This project closure report lists every activity that is required in order to close the project. This report enables the project manager and the team to make sure they are completing every single activity required to close the report smoothly and efficiently. The project…[Read more]

]]> 0 b0af89ef02f741eb70ad3777b1b86446 https://medicaldevicecourses.com/activity/p/7007/ Mon, 26 Mar 2018 02:22:07 -0400 This semester I am in part 2 of my capstone project. We have all of our protocols written to begin construction and testing but we are missing one key component of the device. The materials got delivered about a month ago. Purchasing, the company, and the professor told us the order was there. In the meantime we could not start testing until our…[Read more]

]]> 0 7d66fc64e6cb3cf47b7b2c5df5cf754d https://medicaldevicecourses.com/activity/p/6981/ Sun, 25 Mar 2018 23:19:29 -0400 I think one of the main issues lies in increased customer demands. When the design team first hands off the project to the manufacturing team, a certain plan is made based on the expected demand. Once the product becomes more popular and there is increased demand, rather than manufacturing just scaling up I think it may be important to include the…[Read more]

]]> 0 0796d4beba64f7fd0683c3c1979d94ec https://medicaldevicecourses.com/activity/p/6759/ Mon, 05 Mar 2018 03:33:05 -0500 I agree with everything that is said above. In addition, I think there should be a re-evaluation step which happens once the project has started to make sure that the way everything was planned is working out and that nothing needs to be changed. For example, during re-evaluation it may bring to attention that there was too much work put on the…[Read more]

]]> 0 75f396ccae196a3452aac482dcc032a0 https://medicaldevicecourses.com/activity/p/6756/ Mon, 05 Mar 2018 03:15:09 -0500 If a problem in the planning is identified mid-scope it should be reassessed with the entire team present, taking into account resources and timing. Pushing forward with flaws in the scope can cause bigger issues down the line. Using a Gantt chart or a similar planning mechanism, the critical path can be identified and certain tasks can be chosen…[Read more]

]]> 0 e7313e88c3bf0d6cea49764a824acdc4 https://medicaldevicecourses.com/activity/p/6753/ Mon, 05 Mar 2018 03:08:21 -0500 While I think all of the above are important, I think it is important to assess the situation. While a team member that is not good at communicating and keeping other team members up to date can certainly make a project more difficult, they may bring a unique skill or talent to the team that is not easily replaceable. In addition, if more than one…[Read more]

]]> 0 952111814b95781f3ce27328bee898fc https://medicaldevicecourses.com/activity/p/6489/ Sat, 24 Feb 2018 20:18:15 -0500 I am currently working on a capstone project. We won a $3000 URI grant to design and fabricate our device. This grant must be used only for this project. As a result, we based our entire budget around this $3000, not considering if we could potentially do it for less or if we need more since those were not options. As a result, we unfortunately…[Read more]

]]> 0 c69692e43a0fd18a877176ccbf8cf0ef https://medicaldevicecourses.com/activity/p/6478/ Sat, 24 Feb 2018 19:18:07 -0500 In my experience, at design review meetings, everyone attending the meeting reads the document beforehand. The meeting starts by everyone saying their initials one by one and how long it took them to review the document. The people who wrote the document attend the review but cannot make commentary unless asked by the group. A reader reads line by…[Read more]

]]> 0 0beaaaf49a905c32d0232bf74734d82f https://medicaldevicecourses.com/activity/p/6475/ Sat, 24 Feb 2018 19:05:59 -0500 I think that it is certainly sometimes crucial to go back to the planning phase in order to ensure the success of a project. Regardless of how well a project is planned out, sometimes obstacles and setbacks are unforeseeable. However, when going back to the planning phase, it is still important to stay as on schedule as possible and to hit…[Read more]

]]> 0 d8094a13c4504aeb209cdb7f13bea28c https://medicaldevicecourses.com/activity/p/6413/ Mon, 19 Feb 2018 03:51:12 -0500 While it is important to manage risk, it is also important to encourage creativity and risk taking within a company. Risks are what lead to breakthroughs and great medical products that can advance the company. If everything is over prioritized and analyzed, the company will be playing it too safe and limit creativity. Risk is needed to make new…[Read more]

]]> 0 5b67c0956608d126ecd26cb87b590f44 https://medicaldevicecourses.com/activity/p/6410/ Mon, 19 Feb 2018 03:39:47 -0500 In addition to what ak977 said, the main mission of medical device companies is to improve healthcare. Cutting corners just to increase profit or prevent the company from losing money is unethical and could result in people having issues with the company’s products. Not only is this against the company’s mission but it could also cost the company…[Read more]

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